HIV Infections
Conditions
Keywords
HIV, NNRTI-sparing, two-drug regimen, nucleoside reverse transcriptase inhibitors, protease inhibitor, integrase inhibitor, non-nucleoside reverse transcriptase inhibitor, dolutegravir plus rilpivirine, virologically-suppressed
Brief summary
The aim of this study was to determine if virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors \[NRTIs\] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study primarily assessed the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to the continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR included 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study included a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria participated in the Early Switch Phase where they either switched from their CAR to DTG + RPV, or continued taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants proceeded to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups received DTG + RPV therapy until Week 148. After Week 148, subjects could have been eligible to continue to receive DTG +RPV in the Continuation Phase.
Interventions
Participants received one oral tablet of 50 mg DTG daily administered concomitantly with RPV. Each DTG tablet contained 52.62 mg dolutegravir sodium salt, which was equivalent to 50 mg dolutegravir free acid.
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148), one oral tablet of 25 mg RPV daily administered concomitantly with DTG along with a meal. Each RPV tablet contained 27.5 mg of rilpivirine hydrochloride, which was equivalent to 25 mg of RPV.
CAR included the following combinations: 2 NRTIs + 1 INI, 2 NRTIs + 1 NNRTI, or 2 NRTIs + 1 PI.
Sponsors
Study design
Eligibility
Inclusion criteria
* Participants must have been able to understand and comply with protocol requirements, instructions, and restrictions. * Participants must have been likely to complete the study as planned. * Participants must have been considered appropriate candidates for participation in an investigative clinical trial with oral medication (e.g., no active substance abuse, acute major organ disease, or planned long-term work assignments out of the country, etc.). * HIV-1 infected men or women of greater than or equal to (\>=)18 years of age. * Must have been on uninterrupted current regimen (either the initial or second combination antiretroviral therapy \[cART\] regimen) for at least 6 months prior to screening; Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability and/or safety concerns or access to medications, or convenience/simplification. Acceptable stable cART regimens prior to screening include 2 NRTIs plus INI (either the initial or second cART regimen), or an NNRTI (either the initial or second cART regimen), or a Boosted PI (or atazanavir unboosted) (either the initial or second PI-based cART regimen). * Documented evidence of at least two plasma HIV-1 RNA measurements \<50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening; * Plasma HIV-1 RNA \<50 c/mL at Screening; * A female may have been eligible to enter and participate in the study if she was of : Non-child-bearing potential either defined as post-menopausal (12 months of spontaneous amenorrhea and \>=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, Child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy: Complete abstinence from intercourse from 2 weeks prior to administration of study drug, throughout the study, and for at least 2 weeks after discontinuation of all study medications and completion of the Follow-up visit; Any intrauterine device (IUD) with published data showing that the expected failure rate is \<1% per year (not all IUDs meet this criterion); Male partner sterilization with documentation of azoospermia prior to the female participant's entry into the study and this male is the sole partner for that participant; The documentation on male sterility could come from the site personnel's review of participant's medical records, medical examination, and/or semen analysis, or medical history interview provided by her or her partner; Approved hormonal contraception for participants randomly assigned to DTG + RPV arm (and for participants randomly assigned to CAR following switch to DTG + RPV at Week 52) or approved hormonal contraception plus a barrier method for participants assigned to CAR through Week 52; Approved hormonal contraception included: Combined estrogen and progestogen oral contraceptive, Contraceptive subdermal implant, Injectable progestogen, Contraceptive vaginal ring, Percutaneous contraceptive patches. Any other method with published data showing that the expected failure rate is \<1% per year. Any contraception method must have been used consistently, in accordance with the approved product label during treatment with study drug and for at least 2 weeks after discontinuation of study drug and completion of the Follow-Up Visit. The investigator was responsible for ensuring that participants understand how to properly use these methods of contraception. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception. * Participants who were willing and able to understand requirements of study participation and provided signed and dated written informed consent prior to screening. * For participants enrolled in France: participants were eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria
Exclusionary Criteria prior to screening or Day 1: * Within 6 months prior to Screening and after confirmed suppression to \<50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement \>=50 c/mL. * Within the 6 to 12 month window prior to screening and after confirmed suppression to \<50 c/mL, any plasma HIV-1 RNA measurement \>200 c/mL. * Within the 6 to 12 month window prior to screening and after confirmed suppression to \<50 c/mL, 2 or more plasma HIV-1 RNA measurements \>=50 c/mL. * Any drug holiday during the window between initiating first HIV ART and 6 months prior to screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns. * Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV 1 RNA measurement \>=400 c/mL after initial suppression to \<50 c/mL while on first line HIV therapy regimen). Exclusionary medical conditions: * Women who were pregnant, breastfeeding or planned to become pregnant or breastfeed during the study. * Any evidence of an active Centers for Disease Control and Prevention Category C disease. Exceptions included cutaneous Kaposi's sarcoma not requiring systemic therapy and historic CD4+ lymphocyte counts of \<200 cells per cubic millimeter (cells/mm\^3). * Participants with severe hepatic impairment (Class C) as determined by Child-Pugh Classification. * Unstable liver disease (as defined by the presence of any of the following: ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), and Hepatitis B surface antibody (HBsAb) as follows: Participants positive for HBsAg were excluded; Participants positive for anti-HBc (negative HBsAg status) and negative for HBsAb were excluded. * Participants with an anticipated need for any Hepatitis C virus (HCV) therapy during the Early Switch Phase and for interferon-based therapy for HCV throughout the entire study period. * History or presence of allergy to the study drugs or their components or drugs of their class; * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization; * Participants who in the investigator's judgment posed a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should have been considered when evaluating for suicide risk; * Any pre-existing physical or mental condition which, in the opinion of the Investigator, could have interfered with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which could have compromised the safety of the participants; * Any condition which, in the opinion of the Investigator, could have interfered with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication; Exclusionary Treatments prior to Screening or Day 1: * Use of medications which were associated with Torsades de Pointes. * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. * Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses. * Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study. * Participants who were participating or anticipated to be selected to participate in any other interventional study, with the exception of the DEXA sub-study 202094, after randomization * A history of use of any regimen consisting of only single NNRTI therapy (even if only for peri-partum treatment), or only single or dual NRTI therapy prior to starting cART. * Current or prior history of etravirine (ETR) use. * Current use of tipranavir/ritonavir or fosamprenavir/ritonavir. * Participants receiving any prohibited medication and who were unwilling or unable to switch to an alternate medication. Exclusionary Laboratory Values or Clinical Assessments at Screening: * Evidence of viral resistance based on the presence of any resistance associated major PI, INI, NRTI, or NNRTI mutation and integrase (IN) resistance associated substitution R263K in any available prior resistance genotype assay results. * Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. A single repeat test was allowed during the Screening period to verify a result. * Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound. * Alanine aminotransferase (ALT) \>=5 × upper limit of normal (ULN), or ALT \>=3 × ULN and bilirubin \>=1.5 × ULN (with greater than \[\>\] 35% direct bilirubin). * Corrected QT interval (QTc \[Bazett\]) \>450 milliseconds or QTc (Bazett) \>480 milliseconds for participants with bundle branch block. The QTc was the QT interval corrected for heart rate according to Bazett's formula (QTcB).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm | Week 48 | Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG+RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | Week 52 to Week 410 | For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Number of participants with genotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI) were summarized. |
| Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | Up to Week 410 | Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential genotypic evolution of resistance. Genotypic Resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r. |
| Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | Up to Week 410 | Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic Resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r. |
| Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | Week 52 to Week 410 | Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic Resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r. |
| Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | Week 52 to Week 410 | Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic resistance data for the following drugs was presented: DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r. |
| Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48 | At Weeks 24 and 48 | Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Number of Participants With Phenotypic Resistance-Early Switch Phase | Up to Week 52 | Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, RAL, EVG, RPV, ETR, 3TC, ABC, FTC, TDF, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented. |
| Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm | Week 24 | Percentage of participants with plasma HIV 1 RNA \<50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity of DTG +RPV once daily compared to continuation of CAR. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA. |
| Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Up to Week 410 or study discontinuation | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. AEs were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. Common AEs were those with \>5% incidence for either treatment. |
| Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks | Up to 48 weeks | Blood samples were collected to evaluate alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, blood urea nitrogen (BUN), total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in clinical chemistry over 48 weeks was summarized. Clinical chemistry toxicities were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity. |
| Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks | Up to 48 weeks | Blood samples were collected to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count and platelet count. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in hematology over 48 weeks was summarized. Hematology toxicities were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a hematology toxicity. |
| Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48 | At Week 48 | Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess hs-CRP. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Mean Change From Baseline in Cystatin C at Week 48 | At Week 48 | Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess cystatin C. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Mean Change From Baseline in D-Dimer at Week 48 | At Week 48 | Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess D-Dimer. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48 | At Week 48 | Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble CD14. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48 | At Week 48 | Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess soluble CD163 and oxidized LDL. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48 | At Week 48 | Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess RBP, serum creatinine and glucose. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Mean Change From Baseline in Urine Phosphate at Week 48 | At Week 48 | Urine biomarker samples were collected to at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48 | At Week 48 | Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess B2M and 25 hydroxy-vitamin D. Urine biomarker samples were collected to assess B2M and RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. |
| Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48 | At Week 48 | Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine albumin/creatinine ratio and urine protein/creatinine ratio. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48 | At Week 48 | Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type 1 Collagen C-telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from Baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. |
| Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48 | At Week 48 | Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess IL-6. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48 | At Week 48 | Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR ) index , the product of basal glucose and insulin levels divided by 22.5, is regarded as a simple, inexpensive, and reliable surrogate measure of insulin resistance. |
| Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | At Weeks 24 and 48 | Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Number of Participants With Genotypic Resistance-Early Switch Phase | Up to Week 48 | Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (Rilpivirine \[RPV\], Dolutegravir \[DTG\]) in participants Meeting Confirmed Virologic Withdrawal (CVW) criteria has been presented. |
| Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | Up to Week 148 | Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented. |
| Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | Up to Week 148 | Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, Elvitegravir \[EVG\], Raltegravir \[RAL\], Delavirdine \[DLV\], Efavirenz \[EFV\], Etravirine \[ETR\], Nevirapine \[NVP\], RPV, Lamivudine \[3TC\], Abacavir \[ABC\], FTC, TDF, Zidovudine \[ZDV\], Stavudine \[d4T\], Didanosine \[ddI\], Atazanavir/r \[ATV/r\], DRV/r, Fosamprenavir/r \[FPV/r\], Indinavir/r \[IDV/r\], Lopinavir/r \[LPV/r\], Nelfinavir \[NFV\], Ritonavir \[RTV\], Saquinavir/r \[SQV/r\], Tipranavir/r \[TPV/r\]) in participants Meeting Confirmed Virologic Withdrawal Criteria has been presented. |
| Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | Post-Late switch (LS) Baseline (Week 52) up to Week 148 | Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented. |
| Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | Post-LS Baseline (Week 52) up to Week 148 | Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented. |
| Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Pre-dose at Week 4, 24, 48, 56, 76 and 100 | Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24, 48, 56, 76 and 100. Pre-dose concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the early+late switch phase. |
| Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch Phase | Pre-dose at Weeks 56, 76 and 100 | Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 56, 76 and 100. Pre-dose concentrations of DTG and RPV at Weeks 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the late switch phase. |
| Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV | Pre-dose at Weeks 2, 4 and 8 | Two blood samples were collected pre-dose for DTG and RPV at Weeks 2 and 8 only for the first 20 participants who switch from EFV or NVP to DTG+RPV, in addition to the pre-dose blood sample collected at Week 4 for all participants. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. PK Parameter NNRTI Subset Extra Sampling Population consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2 and 8. |
| Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class | At Week 48 | Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 48 using the FDA snapshot algorithm was assessed by Baseline third agent class to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. The analysis was done using Cochran-Mantel Haenszel test stratified by current antiretroviral third-agent class. |
| Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class | At Week 48 | Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out at Baseline (Day 1) and Week 48 to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | Up to 48 weeks | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any AE, AELD or AE with maximum grade toxicity experienced by any one participant over 48 weeks by Baseline third agent class (INSTI, NNRTI, or PI) is summarized. AEs were graded using the Division of AIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. |
| Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | Up to 48 weeks | Blood samples were collected at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Number of participants who experienced maximum toxicity grade post-baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) is summarized. Clinical chemistry toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. |
| Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | Up to 48 weeks | Blood samples were collected at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Number of participants who experienced maximum toxicity grade post-baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized. Hematology toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. |
| Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class | Week 48 | For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were to be analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were to be collected at Day 1. Number of participants with genotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. |
| Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class | Week 48 | For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were to be analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were to be collected at Day 1. Number of participants with phenotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. |
| Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | At Weeks 24 and 48 | Blood samples were collected at Baseline (Day 1), Weeks 24 and 48 to assess fasting lipids which included total cholesterol (CHO), LDL cholesterol, HDL cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | At Weeks 4, 24 and 48 | The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant and is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). Last observation carried forward (LOCF) was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | At Weeks 56, 76, 100 and 148 | The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant and is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | At Weeks 56, 76, 100 and 148 | The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant and is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value. |
| Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | At Weeks 4, 24 and 48 | The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 to 6 where a higher score indicates the greater improvement in the past few weeks. These items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscales: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | At Weeks 56, 76, 100 and 148 | The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Change from Baseline is calculated as the value at specified time point minus Baseline value. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis. |
| Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | At Weeks 56, 76, 100 and 148 | The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Change from LS Baseline is calculated as the value at specified time point minus LS Baseline value. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. |
| Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | Up to Week 410 | For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were collected at Day 1. Number of participants with genotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI) were summarized. |
| Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | Up to Week 410 | For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were collected at Day 1. Number of participants with phenotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI) were summarized. |
| Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | Week 52 to Week 410 | For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Number of participants with phenotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI) were summarized. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Group Through Late Switch Phase | Weeks 100 and 148 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA \< 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. |
| Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch Phase | LS Baseline (Week 48), Weeks 100 and 148 | Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value. |
| Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | At Weeks 100 and 148 | Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from Baseline was calculated as value at indicated time point minus Baseline value. |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch Phase | Weeks 100 and 148 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA \< 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. |
Countries
Argentina, Australia, Canada, France, Germany, Italy, Russia, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 60 centers in 11 countries.
Pre-assignment details
518 participants were randomized and 2 participants withdrew before being exposed to study drug. The study included an Early Switch Phase, a Late Switch Phase, and a Continuation Phase.
Participants by arm
| Arm | Count |
|---|---|
| DTG + RPV Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148). | 261 |
| Current Antiretroviral Regimen (CAR) Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148. | 255 |
| Total | 516 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Continuation Phase(Week 148 to Week 410) | Adverse Event | 0 | 2 |
| Continuation Phase(Week 148 to Week 410) | Investigator discretion | 1 | 2 |
| Continuation Phase(Week 148 to Week 410) | Lack of Efficacy | 1 | 1 |
| Continuation Phase(Week 148 to Week 410) | Lost to Follow-up | 0 | 3 |
| Continuation Phase(Week 148 to Week 410) | Protocol Violation | 0 | 1 |
| Continuation Phase(Week 148 to Week 410) | Subject reached protocol-defined stopping criteria | 1 | 0 |
| Continuation Phase(Week 148 to Week 410) | Withdrawal by Subject | 4 | 1 |
| Early Switch Phase (Up to Week 52) | Adverse Event | 11 | 1 |
| Early Switch Phase (Up to Week 52) | Lack of Efficacy | 1 | 2 |
| Early Switch Phase (Up to Week 52) | Lost to Follow-up | 1 | 1 |
| Early Switch Phase (Up to Week 52) | Physician Decision | 0 | 1 |
| Early Switch Phase (Up to Week 52) | Protocol Violation | 0 | 3 |
| Early Switch Phase (Up to Week 52) | Reached stopping criteria | 1 | 1 |
| Early Switch Phase (Up to Week 52) | Withdrawal by Subject | 2 | 7 |
| Late Switch Phase (Week 52 to Week 148) | Adverse Event | 10 | 6 |
| Late Switch Phase (Week 52 to Week 148) | Lack of Efficacy | 5 | 3 |
| Late Switch Phase (Week 52 to Week 148) | Lost to Follow-up | 2 | 2 |
| Late Switch Phase (Week 52 to Week 148) | Physician Decision | 0 | 1 |
| Late Switch Phase (Week 52 to Week 148) | Protocol Violation | 3 | 0 |
| Late Switch Phase (Week 52 to Week 148) | Reached stopping criteria | 1 | 0 |
| Late Switch Phase (Week 52 to Week 148) | Withdrawal by Subject | 2 | 6 |
Baseline characteristics
| Characteristic | DTG + RPV | Current Antiretroviral Regimen (CAR) | Total |
|---|---|---|---|
| Age, Continuous | 43.3 Years STANDARD_DEVIATION 11.34 | 43.2 Years STANDARD_DEVIATION 9.64 | 43.3 Years STANDARD_DEVIATION 10.52 |
| Race/Ethnicity, Customized African American/ African H. and White | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 11 Participants | 7 Participants | 18 Participants |
| Race/Ethnicity, Customized Black/African American | 13 Participants | 19 Participants | 32 Participants |
| Race/Ethnicity, Customized Central/South Asian Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Japanese/East Asian (EA) Heritage (H.)/South EA H. | 13 Participants | 15 Participants | 28 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 223 Participants | 212 Participants | 435 Participants |
| Sex: Female, Male Female | 62 Participants | 57 Participants | 119 Participants |
| Sex: Female, Male Male | 199 Participants | 198 Participants | 397 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 261 | 0 / 255 | 2 / 261 | 0 / 239 | 0 / 208 | 0 / 204 |
| other Total, other adverse events | 121 / 261 | 106 / 255 | 170 / 261 | 132 / 239 | 0 / 208 | 0 / 204 |
| serious Total, serious adverse events | 19 / 261 | 9 / 255 | 38 / 261 | 22 / 239 | 12 / 208 | 12 / 204 |
Outcome results
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG+RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Time frame: Week 48
Population: The Analysis was performed on the Intent-to-Treat Exposed (ITT-E) population which consisted of all randomly assigned participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG + RPV | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm | 94 Percentage of participants |
| Current Antiretroviral Regimen (CAR) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm | 94 Percentage of participants |
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Blood samples were collected at Baseline (Day 1), Weeks 24 and 48 to assess fasting lipids which included total cholesterol (CHO), LDL cholesterol, HDL cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | CHO, Week 48, overall | -0.165 mmol/L | Standard Deviation 15.9301 |
| DTG + RPV | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | Triglycerides, Overall, Week 48 | 1.169 mmol/L | Standard Deviation 51.9844 |
| DTG + RPV | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | CHO, Week 24, overall | 1.015 mmol/L | Standard Deviation 15.7472 |
| DTG + RPV | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | LDL CHO calculation, Overall, Week 24 | 5.838 mmol/L | Standard Deviation 22.9614 |
| DTG + RPV | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | HDL CHO direct, Overall, Week 48 | 6.384 mmol/L | Standard Deviation 20.9244 |
| DTG + RPV | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | LDL CHO calculation, Overall, Week 48 | 1.137 mmol/L | Standard Deviation 23.3849 |
| DTG + RPV | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | HDL CHO direct, Overall, Week 24 | 0.557 mmol/L | Standard Deviation 19.4929 |
| DTG + RPV | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | Triglycerides, Overall, Week 24 | -0.825 mmol/L | Standard Deviation 42.5565 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | CHO, Week 24, PI | 0.936 mmol/L | Standard Deviation 11.853 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | CHO, Week 48, PI | -1.971 mmol/L | Standard Deviation 12.2195 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | HDL CHO direct, Overall, Week 48 | 4.723 mmol/L | Standard Deviation 18.3253 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | HDL CHO direct, NNRTI, Week 24 | -2.562 mmol/L | Standard Deviation 15.3521 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | HDL CHO direct, NNRTI, Week 48 | 4.307 mmol/L | Standard Deviation 17.8013 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | HDL CHO direct, INSTI, Week 24 | -3.097 mmol/L | Standard Deviation 20.0002 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | HDL CHO direct, INSTI, Week 48 | 5.386 mmol/L | Standard Deviation 20.6791 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | HDL CHO direct, PI, Week 24 | -2.031 mmol/L | Standard Deviation 15.9582 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | HDL CHO direct, PI, Week 48 | 5.140 mmol/L | Standard Deviation 17.8779 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | LDL CHO calculation, Overall, Week 24 | 4.395 mmol/L | Standard Deviation 21.6685 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | LDL CHO calculation, Overall, Week 48 | -0.598 mmol/L | Standard Deviation 20.6931 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | LDL CHO calculation, NNRTI, Week 24 | 5.959 mmol/L | Standard Deviation 21.5692 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | LDL CHO calculation, NNRTI, Week 48 | 0.747 mmol/L | Standard Deviation 19.2299 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | LDL CHO calculation, INSTI, Week 24 | 3.787 mmol/L | Standard Deviation 17.6755 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | LDL CHO calculation, INSTI, Week 48 | 2.647 mmol/L | Standard Deviation 24.043 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | LDL CHO calculation, PI, Week 24 | 0.983 mmol/L | Standard Deviation 24.5052 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | LDL CHO calculation, PI, Week 48 | -6.212 mmol/L | Standard Deviation 20.4774 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | Triglycerides, Overall, Week 24 | 9.379 mmol/L | Standard Deviation 45.5529 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | Triglycerides, Overall, Week 48 | 7.183 mmol/L | Standard Deviation 44.7044 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | Triglycerides, NNRTI, Week 24 | 4.962 mmol/L | Standard Deviation 40.6201 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | Triglycerides, NNRTI, Week 48 | 5.248 mmol/L | Standard Deviation 41.7728 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | Triglycerides, INSTI, Week 24 | 18.204 mmol/L | Standard Deviation 47.2348 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | Triglycerides, PI, Week 24 | 13.241 mmol/L | Standard Deviation 54.2327 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | Triglycerides, INSTI, Week 48 | 14.627 mmol/L | Standard Deviation 56.2824 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | Triglycerides, PI, Week 48 | 5.806 mmol/L | Standard Deviation 41.2106 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | HDL CHO direct, Overall, Week 24 | -2.533 mmol/L | Standard Deviation 16.3641 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | CHO, Week 24, overall | 1.300 mmol/L | Standard Deviation 12.2269 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | CHO, Week 48, overall | 0.194 mmol/L | Standard Deviation 13.1071 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | CHO, Week 24, NNRTI | 1.238 mmol/L | Standard Deviation 12.4889 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | CHO, Week 48, NNRTI | 0.281 mmol/L | Standard Deviation 12.2469 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | CHO, Week 24, INSTI | 1.973 mmol/L | Standard Deviation 12.1365 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class | CHO, Week 48, INSTI | 2.798 mmol/L | Standard Deviation 16.1468 |
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant and is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). Last observation carried forward (LOCF) was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Weeks 4, 24 and 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | Symptom count, Week 48 | -0.5 Scores on a scale | Standard Deviation 4.33 |
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | Symptom Bother Score, Week 24 | -1.8 Scores on a scale | Standard Deviation 8.4 |
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | Symptom count, Week 24 | -0.7 Scores on a scale | Standard Deviation 4.31 |
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | Symptom Bother Score, Week 48 | -1.5 Scores on a scale | Standard Deviation 7.97 |
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | Symptom Bother Score, Week 4 | -2.8 Scores on a scale | Standard Deviation 7.44 |
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | Symptom count, Week 4 | -1.1 Scores on a scale | Standard Deviation 4.11 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | Symptom Bother Score, Week 4 | -1.8 Scores on a scale | Standard Deviation 7.24 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | Symptom count, Week 24 | -0.8 Scores on a scale | Standard Deviation 4.64 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | Symptom count, Week 48 | -0.4 Scores on a scale | Standard Deviation 4.82 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | Symptom count, Week 4 | -0.8 Scores on a scale | Standard Deviation 4.02 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | Symptom Bother Score, Week 24 | -1.7 Scores on a scale | Standard Deviation 8.72 |
| Current Antiretroviral Regimen (CAR) | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase | Symptom Bother Score, Week 48 | -0.7 Scores on a scale | Standard Deviation 9.3 |
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant and is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Weeks 56, 76, 100 and 148
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Symptom count, Week 56 | -0.8 Scores on a scale | Standard Deviation 4.8 |
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Symptom count, Week 76 | -0.6 Scores on a scale | Standard Deviation 4.66 |
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Symptom count, Week 100 | -0.5 Scores on a scale | Standard Deviation 5.03 |
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Symptom count, Week 148 | -0.7 Scores on a scale | Standard Deviation 4.87 |
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Symptom Bother Score, Week 56 | -1.8 Scores on a scale | Standard Deviation 9.23 |
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Symptom Bother Score, Week 76 | -1.6 Scores on a scale | Standard Deviation 8.7 |
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Symptom Bother Score, Week 100 | -1.4 Scores on a scale | Standard Deviation 9.4 |
| DTG + RPV | Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Symptom Bother Score, Week 148 | -1.7 Scores on a scale | Standard Deviation 9.54 |
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 to 6 where a higher score indicates the greater improvement in the past few weeks. These items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscales: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Weeks 4, 24 and 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | Total score, Week 24 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | lifestyle/ease Sub-score, Week 48 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | lifestyle/ease Sub-score, Week 4 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | General Satisfaction/CS, Week 4 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | Total score, Week 48 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | General Satisfaction/CS, Week 24 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | lifestyle/ease Sub-score, Week 24 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | General Satisfaction/CS, Week 48 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | Total score, Week 4 | 0.0 Score on a scale |
| Current Antiretroviral Regimen (CAR) | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | General Satisfaction/CS, Week 48 | 0.0 Score on a scale |
| Current Antiretroviral Regimen (CAR) | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | Total score, Week 4 | 0.0 Score on a scale |
| Current Antiretroviral Regimen (CAR) | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | Total score, Week 24 | 0.0 Score on a scale |
| Current Antiretroviral Regimen (CAR) | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | Total score, Week 48 | 0.0 Score on a scale |
| Current Antiretroviral Regimen (CAR) | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | lifestyle/ease Sub-score, Week 4 | 0.0 Score on a scale |
| Current Antiretroviral Regimen (CAR) | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | lifestyle/ease Sub-score, Week 24 | 0.0 Score on a scale |
| Current Antiretroviral Regimen (CAR) | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | lifestyle/ease Sub-score, Week 48 | 0.0 Score on a scale |
| Current Antiretroviral Regimen (CAR) | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | General Satisfaction/CS, Week 4 | 0.0 Score on a scale |
| Current Antiretroviral Regimen (CAR) | Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase | General Satisfaction/CS, Week 24 | 0.0 Score on a scale |
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Change from Baseline is calculated as the value at specified time point minus Baseline value. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis.
Time frame: At Weeks 56, 76, 100 and 148
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Total score, Week 56 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Total score, Week 76 | 1.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Total score, Week 100 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Total score, Week 148 | 1.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | lifestyle/ease Sub-score, Week 56 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | lifestyle/ease Sub-score, Week 76 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | lifestyle/ease Sub-score, Week 100 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | lifestyle/ease Sub-score, Week 148 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | General Satisfaction/CS, Week 56 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | General Satisfaction/CS, Week 76 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | General Satisfaction/CS, Week 100 | 0.0 Score on a scale |
| DTG + RPV | Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | General Satisfaction/CS, Week 148 | 0.0 Score on a scale |
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant and is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.
Time frame: At Weeks 56, 76, 100 and 148
Population: LS ITT-E Population comprised of all participants randomized to CAR who received at least one dose of study treatment at or after the Week 52 Switch visit. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | Symptom Bother Score, Week 100 | -0.8 Scores on a scale | Standard Deviation 8.43 |
| DTG + RPV | Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | Symptom count, Week 56 | -0.9 Scores on a scale | Standard Deviation 4.74 |
| DTG + RPV | Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | Symptom count, Week 76 | -0.7 Scores on a scale | Standard Deviation 4.29 |
| DTG + RPV | Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | Symptom count, Week 100 | -0.4 Scores on a scale | Standard Deviation 5.04 |
| DTG + RPV | Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | Symptom count, Week 148 | -0.6 Scores on a scale | Standard Deviation 4.81 |
| DTG + RPV | Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | Symptom Bother Score, Week 56 | -2.1 Scores on a scale | Standard Deviation 7.56 |
| DTG + RPV | Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | Symptom Bother Score, Week 76 | -1.0 Scores on a scale | Standard Deviation 7.61 |
| DTG + RPV | Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | Symptom Bother Score, Week 148 | -1.0 Scores on a scale | Standard Deviation 8.54 |
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Change from LS Baseline is calculated as the value at specified time point minus LS Baseline value. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis.
Time frame: At Weeks 56, 76, 100 and 148
Population: LS ITT-E Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DTG + RPV | Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | Total score, Week 56 | 0.0 Score on a scale |
| DTG + RPV | Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | Total score, Week 76 | 0.0 Score on a scale |
| DTG + RPV | Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | Total score, Week 100 | 0.0 Score on a scale |
| DTG + RPV | Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | Total score, Week 148 | 0.0 Score on a scale |
| DTG + RPV | Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | lifestyle/ease Sub-score, Week 56 | 0.0 Score on a scale |
| DTG + RPV | Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | lifestyle/ease Sub-score, Week 76 | 0.0 Score on a scale |
| DTG + RPV | Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | lifestyle/ease Sub-score, Week 100 | 0.0 Score on a scale |
| DTG + RPV | Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | lifestyle/ease Sub-score, Week 148 | 0.0 Score on a scale |
| DTG + RPV | Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | General Satisfaction/CS, Week 56 | 0.0 Score on a scale |
| DTG + RPV | Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | General Satisfaction/CS, Week 76 | 0.0 Score on a scale |
| DTG + RPV | Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | General Satisfaction/CS, Week 100 | 0.0 Score on a scale |
| DTG + RPV | Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase | General Satisfaction/CS, Week 148 | 0.0 Score on a scale |
Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out at Baseline (Day 1) and Week 48 to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Week 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class | PI | 10.5 Cells per mm^3 | Standard Deviation 163.67 |
| DTG + RPV | Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class | NNRTI | 49.7 Cells per mm^3 | Standard Deviation 166.4 |
| DTG + RPV | Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class | INSTI | -11.2 Cells per mm^3 | Standard Deviation 176.56 |
| Current Antiretroviral Regimen (CAR) | Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class | NNRTI | 24.3 Cells per mm^3 | Standard Deviation 160.32 |
| Current Antiretroviral Regimen (CAR) | Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class | INSTI | 10.3 Cells per mm^3 | Standard Deviation 155.53 |
| Current Antiretroviral Regimen (CAR) | Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class | PI | 12.2 Cells per mm^3 | Standard Deviation 163.32 |
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Weeks 24 and 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48 | Week 24 | 42.0 Cells per millimeter cube (mm^3) | Standard Deviation 172.29 |
| DTG + RPV | Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48 | Week 48 | 28.0 Cells per millimeter cube (mm^3) | Standard Deviation 169.35 |
| Current Antiretroviral Regimen (CAR) | Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48 | Week 24 | 42.4 Cells per millimeter cube (mm^3) | Standard Deviation 164.85 |
| Current Antiretroviral Regimen (CAR) | Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48 | Week 48 | 18.4 Cells per millimeter cube (mm^3) | Standard Deviation 159.34 |
Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess B2M and 25 hydroxy-vitamin D. Urine biomarker samples were collected to assess B2M and RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.
Time frame: At Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48 | B2M, blood | -16.8800 Nanomoles (nmol)/L | Standard Deviation 34.8933 |
| DTG + RPV | Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48 | 25 hydroxy-vitamin D, blood | -13.9 Nanomoles (nmol)/L | Standard Deviation 25.3 |
| DTG + RPV | Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48 | Urine B2M | -173.2820 Nanomoles (nmol)/L | Standard Deviation 1311.24142 |
| DTG + RPV | Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48 | Urine RBP | -6.8123 Nanomoles (nmol)/L | Standard Deviation 24.0965 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48 | Urine RBP | -0.0631 Nanomoles (nmol)/L | Standard Deviation 11.99886 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48 | B2M, blood | -4.7501 Nanomoles (nmol)/L | Standard Deviation 43.04355 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48 | Urine B2M | 62.3209 Nanomoles (nmol)/L | Standard Deviation 391.32049 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48 | 25 hydroxy-vitamin D, blood | -9.2 Nanomoles (nmol)/L | Standard Deviation 19.55 |
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type 1 Collagen C-telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from Baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.
Time frame: At Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48 | Procollagen type 1 N-propeptide | -5.8 Microgram (ug)/L | Standard Deviation 20 |
| DTG + RPV | Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48 | Type I Collagen C-Telopeptides | -0.15 Microgram (ug)/L | Standard Deviation 0.313 |
| DTG + RPV | Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48 | Osteocalcin | -5.11 Microgram (ug)/L | Standard Deviation 7.334 |
| DTG + RPV | Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48 | sVCAM | -2.63 Microgram (ug)/L | Standard Deviation 571.182 |
| DTG + RPV | Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48 | Bone-specific alkaline phosphatase | -3.18 Microgram (ug)/L | Standard Deviation 5.678 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48 | sVCAM | 37.42 Microgram (ug)/L | Standard Deviation 617.486 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48 | Bone-specific alkaline phosphatase | 0.92 Microgram (ug)/L | Standard Deviation 4.634 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48 | Procollagen type 1 N-propeptide | 0.3 Microgram (ug)/L | Standard Deviation 19.28 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48 | Osteocalcin | -1.14 Microgram (ug)/L | Standard Deviation 6.017 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48 | Type I Collagen C-Telopeptides | -0.09 Microgram (ug)/L | Standard Deviation 0.344 |
Mean Change From Baseline in Cystatin C at Week 48
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess cystatin C. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in Cystatin C at Week 48 | -0.02 mg/L | Standard Deviation 0.11 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Cystatin C at Week 48 | -0.01 mg/L | Standard Deviation 0.108 |
Mean Change From Baseline in D-Dimer at Week 48
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess D-Dimer. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in D-Dimer at Week 48 | 0.01 Nanomole/L fibrinogen equivalent units | Standard Deviation 1.629 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in D-Dimer at Week 48 | -0.13 Nanomole/L fibrinogen equivalent units | Standard Deviation 2.932 |
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Total cholesterol, Week 24 | -0.015 Millimoles (mmol)/L | Standard Deviation 0.7539 |
| DTG + RPV | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Total cholesterol, Week 48 | -0.079 Millimoles (mmol)/L | Standard Deviation 0.7926 |
| DTG + RPV | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | LDL cholesterol calculation, Week 24 | 0.085 Millimoles (mmol)/L | Standard Deviation 0.594 |
| DTG + RPV | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | LDL cholesterol calculation, Week 48 | -0.049 Millimoles (mmol)/L | Standard Deviation 0.6276 |
| DTG + RPV | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | HDL cholesterol direct, Week 24 | -0.024 Millimoles (mmol)/L | Standard Deviation 0.2365 |
| DTG + RPV | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | HDL cholesterol direct, Week 48 | 0.051 Millimoles (mmol)/L | Standard Deviation 0.2386 |
| DTG + RPV | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Triglycerides, Week 24 | -0.184 Millimoles (mmol)/L | Standard Deviation 1.0102 |
| DTG + RPV | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Triglycerides, Week 48 | -0.169 Millimoles (mmol)/L | Standard Deviation 1.0062 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Triglycerides, Week 48 | -0.021 Millimoles (mmol)/L | Standard Deviation 1.0156 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Total cholesterol, Week 24 | 0.020 Millimoles (mmol)/L | Standard Deviation 0.5777 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | HDL cholesterol direct, Week 24 | -0.051 Millimoles (mmol)/L | Standard Deviation 0.2258 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Total cholesterol, Week 48 | -0.038 Millimoles (mmol)/L | Standard Deviation 0.6148 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Triglycerides, Week 24 | 0.040 Millimoles (mmol)/L | Standard Deviation 0.9164 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | LDL cholesterol calculation, Week 24 | 0.055 Millimoles (mmol)/L | Standard Deviation 0.5232 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | HDL cholesterol direct, Week 48 | 0.049 Millimoles (mmol)/L | Standard Deviation 0.2489 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48 | LDL cholesterol calculation, Week 48 | -0.076 Millimoles (mmol)/L | Standard Deviation 0.528 |
Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble CD14. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48 | FABP | -1.50 Nanogram/milliliter | Standard Deviation 1.278 |
| DTG + RPV | Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48 | Soluble CD14 | 456.69 Nanogram/milliliter | Standard Deviation 731.833 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48 | FABP | -0.99 Nanogram/milliliter | Standard Deviation 1.441 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48 | Soluble CD14 | 802.26 Nanogram/milliliter | Standard Deviation 878.304 |
Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess hs-CRP. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48 | 0.10 mg/Liter (L) | Standard Deviation 5.383 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48 | 0.80 mg/Liter (L) | Standard Deviation 8.527 |
Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR ) index , the product of basal glucose and insulin levels divided by 22.5, is regarded as a simple, inexpensive, and reliable surrogate measure of insulin resistance.
Time frame: At Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48 | 0.50 HOMA-IR Score | Standard Deviation 4.78 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48 | 0.80 HOMA-IR Score | Standard Deviation 3.938 |
Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess IL-6. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48 | -0.08 Nanograms (ng)/L | Standard Deviation 2.373 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48 | -0.07 Nanograms (ng)/L | Standard Deviation 2.761 |
Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess RBP, serum creatinine and glucose. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48 | RBP | -0.13 mg/deciliter (dL) | Standard Deviation 0.825 |
| DTG + RPV | Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48 | Serum creatinine | 0.100 mg/deciliter (dL) | Standard Deviation 0.1053 |
| DTG + RPV | Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48 | Glucose | 0.187 mg/deciliter (dL) | Standard Deviation 19.5808 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48 | RBP | 0.00 mg/deciliter (dL) | Standard Deviation 0.872 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48 | Serum creatinine | -0.003 mg/deciliter (dL) | Standard Deviation 0.0847 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48 | Glucose | 3.220 mg/deciliter (dL) | Standard Deviation 10.0987 |
Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess soluble CD163 and oxidized LDL. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48 | Soluble CD163 | 65.38 Microgram(µg)/Liter | Standard Deviation 180.869 |
| DTG + RPV | Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48 | Oxidized LDL | 60.87 Microgram(µg)/Liter | Standard Deviation 504.345 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48 | Soluble CD163 | 53.94 Microgram(µg)/Liter | Standard Deviation 215.621 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48 | Oxidized LDL | 13.92 Microgram(µg)/Liter | Standard Deviation 575.305 |
Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48
Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine albumin/creatinine ratio and urine protein/creatinine ratio. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48 | Urine albumin/creatinine ratio | -0.78 Grams (g)/mol | Standard Deviation 5.116 |
| DTG + RPV | Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48 | Urine protein/creatinine ratio | -2.73 Grams (g)/mol | Standard Deviation 12.683 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48 | Urine albumin/creatinine ratio | -0.64 Grams (g)/mol | Standard Deviation 9.538 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48 | Urine protein/creatinine ratio | 1.23 Grams (g)/mol | Standard Deviation 5.088 |
Mean Change From Baseline in Urine Phosphate at Week 48
Urine biomarker samples were collected to at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + RPV | Mean Change From Baseline in Urine Phosphate at Week 48 | 1.335 Millimoles (mmol)/L | Standard Deviation 16.7211 |
| Current Antiretroviral Regimen (CAR) | Mean Change From Baseline in Urine Phosphate at Week 48 | -0.798 Millimoles (mmol)/L | Standard Deviation 15.3771 |
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any AE, AELD or AE with maximum grade toxicity experienced by any one participant over 48 weeks by Baseline third agent class (INSTI, NNRTI, or PI) is summarized. AEs were graded using the Division of AIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Time frame: Up to 48 weeks
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | Any AE, NNRTI | 106 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | Any AE, INSTI | 47 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | Any AE, PI | 42 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Maximum toxicity Grade 1 AE | 68 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Maximum toxicity Grade 2 AE | 30 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Maximum toxicity Grade 3 AE | 8 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Maximum toxicity Grade 4 AE | 0 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Maximum toxicity Grade 1 AE | 27 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Maximum toxicity Grade 2 AE | 15 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Maximum toxicity Grade 3 AE | 5 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Maximum toxicity Grade 4 AE | 0 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Maximum toxicity Grade 1 AE | 24 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Maximum toxicity Grade 2 AE | 14 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Maximum toxicity Grade 3 AE | 3 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Maximum toxicity Grade 4 AE | 1 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | AELD, NNRTI | 5 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | AELD, INSTI | 4 Participants |
| DTG + RPV | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | AELD, PI | 3 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Maximum toxicity Grade 3 AE | 3 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | Any AE, NNRTI | 96 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Maximum toxicity Grade 3 AE | 1 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | Any AE, INSTI | 36 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | AELD, PI | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | Any AE, PI | 42 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Maximum toxicity Grade 4 AE | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Maximum toxicity Grade 1 AE | 76 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Maximum toxicity Grade 4 AE | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Maximum toxicity Grade 2 AE | 19 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Maximum toxicity Grade 1 AE | 26 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Maximum toxicity Grade 3 AE | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | AELD, INSTI | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Maximum toxicity Grade 4 AE | 1 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Maximum toxicity Grade 2 AE | 13 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Maximum toxicity Grade 1 AE | 20 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | AELD, NNRTI | 1 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Maximum toxicity Grade 2 AE | 15 Participants |
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. AEs were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. Common AEs were those with \>5% incidence for either treatment.
Time frame: Up to Week 410 or study discontinuation
Population: Safety Population included all randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Maximum toxicity Grade 1 AE | 78 Participants |
| DTG + RPV | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Maximum toxicity Grade 3 AE | 33 Participants |
| DTG + RPV | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Any SAE | 50 Participants |
| DTG + RPV | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Maximum toxicity Grade 4 AE | 13 Participants |
| DTG + RPV | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Maximum toxicity Grade 2 AE | 104 Participants |
| DTG + RPV | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | AELD | 23 Participants |
| DTG + RPV | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Common non-serious AE | 166 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | AELD | 8 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Common non-serious AE | 132 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Any SAE | 32 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Maximum toxicity Grade 1 AE | 85 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Maximum toxicity Grade 2 AE | 95 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Maximum toxicity Grade 3 AE | 29 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD) | Maximum toxicity Grade 4 AE | 11 Participants |
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.
Time frame: Post-Late switch (LS) Baseline (Week 52) up to Week 148
Population: The analysis was performed on the Late Switch (LS) CVW resistance Population which was comprised of all participants in the LS ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and had available on-treatment genotypic resistance data at the time CVW criterion is met. Only those participants with data available at the specified time point were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, DTG, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, DTG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, DTG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, DTG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, DTG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, EVG, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, EVG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, EVG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, EVG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, EVG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, RAL, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, RAL, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, RAL, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, RAL, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | INI, RAL, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, DLV, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, DLV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, DLV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, DLV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, DLV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, EFV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, EFV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, EFV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, EFV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, EFV, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, ETR, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, ETR, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, ETR, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, ETR, Intermediate resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, ETR, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, NVP, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, NVP, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, NVP, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, NVP, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, NVP, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, RPV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, RPV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, RPV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, RPV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NNRTI, RPV, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, 3TC, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, 3TC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, 3TC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, 3TC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, 3TC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ABC, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ABC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ABC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ABC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ABC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, FTC, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, FTC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, FTC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, FTC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, FTC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, TDF, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, TDF, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, TDF, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, TDF, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, TDF, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ZDV, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ZDV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ZDV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ZDV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ZDV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, d4T, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, d4T, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, d4T, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, d4T, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, d4T, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ddI, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ddI, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ddI, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ddI, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | NRTI, ddI, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, ATV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, ATV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, ATV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, ATV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, ATV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, DRV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, DRV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, DRV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, DRV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, DRV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, FPV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, FPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, FPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, FPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, FPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, IDV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, IDV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, IDV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, IDV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, IDV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, LPV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, LPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, LPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, LPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, LPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, NFV, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, NFV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, NFV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, NFV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, NFV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, RTV, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, RTV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, RTV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, RTV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, RTV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, SQV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, SQV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, SQV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, SQV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, SQV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, TPV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, TPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, TPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, TPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase | PI, TPV/r, High-level resistance | 0 Participants |
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic Resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.
Time frame: Week 52 to Week 410
Population: The analysis was performed on the Late Switch CVW resistance population which included all participants from the Late Switch ITT-E population who met CVW through the end of visit window and had available on-treatment genotypic resistance data at the time the CVW criterion was met.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, DTG, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, DTG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, DTG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, DTG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, DTG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, EVG, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, EVG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, EVG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, EVG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, EVG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, RAL, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, RAL, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, RAL, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, RAL, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | INI, RAL, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, DLV, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, DLV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, DLV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, DLV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, DLV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, EFV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, EFV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, EFV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, EFV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, EFV, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, ETR, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, ETR, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, ETR, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, ETR, Intermediate resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, ETR, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, NVP, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, NVP, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, NVP, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, NVP, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, NVP, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, RPV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, RPV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, RPV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, RPV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NNRTI, RPV, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, 3TC, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, 3TC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, 3TC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, 3TC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, 3TC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ABC, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ABC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ABC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ABC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ABC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, FTC, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, FTC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, FTC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, FTC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, FTC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, TDF, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, TDF, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, TDF, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, TDF, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, TDF, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ZDV, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ZDV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ZDV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ZDV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ZDV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, d4T, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, d4T, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, d4T, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, d4T, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, d4T, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ddI, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ddI, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ddI, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ddI, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | NRTI, ddI, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, ATV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, ATV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, ATV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, ATV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, ATV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, DRV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, DRV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, DRV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, DRV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, DRV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, FPV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, FPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, FPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, FPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, FPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, IDV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, IDV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, IDV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, IDV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, IDV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, LPV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, LPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, LPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, LPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, LPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, NFV, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, NFV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, NFV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, NFV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, NFV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, RTV, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, RTV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, RTV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, RTV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, RTV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, SQV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, SQV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, SQV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, SQV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, SQV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, TPV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, TPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, TPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, TPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase | PI, TPV/r, High-level resistance | 0 Participants |
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, Elvitegravir \[EVG\], Raltegravir \[RAL\], Delavirdine \[DLV\], Efavirenz \[EFV\], Etravirine \[ETR\], Nevirapine \[NVP\], RPV, Lamivudine \[3TC\], Abacavir \[ABC\], FTC, TDF, Zidovudine \[ZDV\], Stavudine \[d4T\], Didanosine \[ddI\], Atazanavir/r \[ATV/r\], DRV/r, Fosamprenavir/r \[FPV/r\], Indinavir/r \[IDV/r\], Lopinavir/r \[LPV/r\], Nelfinavir \[NFV\], Ritonavir \[RTV\], Saquinavir/r \[SQV/r\], Tipranavir/r \[TPV/r\]) in participants Meeting Confirmed Virologic Withdrawal Criteria has been presented.
Time frame: Up to Week 148
Population: CVW resistance Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, RTV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, DTG, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, DTG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, DTG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, DTG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, DTG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, EVG, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, EVG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, EVG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, EVG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, EVG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, RAL, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, RAL, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, RAL, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, RAL, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | INI, RAL, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, DLV, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, DLV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, DLV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, DLV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, DLV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, EFV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, EFV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, ETR, Low-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, EFV, Low-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, EFV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, EFV, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, ETR, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, ETR, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, ETR, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, ETR, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, NVP, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, NVP, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, NVP, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, NVP, Intermediate resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, NVP, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, RPV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, RPV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, RPV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, RPV, Intermediate resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NNRTI, RPV, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, 3TC, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, 3TC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, 3TC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, 3TC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, 3TC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ABC, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ABC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ABC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ABC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ABC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, FTC, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, FTC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, FTC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, FTC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, FTC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, TDF, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, TDF, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, TDF, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, TDF, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, TDF, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ZDV, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ZDV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ZDV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ZDV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ZDV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, d4T, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, d4T, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, d4T, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, d4T, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, d4T, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ddI, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ddI, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ddI, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ddI, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | NRTI, ddI, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, ATV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, ATV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, ATV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, ATV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, ATV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, DRV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, DRV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, DRV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, DRV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, DRV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, FPV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, FPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, FPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, FPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, FPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, IDV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, IDV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, IDV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, IDV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, IDV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, LPV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, LPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, LPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, LPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, LPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, NFV, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, NFV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, NFV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, NFV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, NFV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, RTV, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, RTV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, RTV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, RTV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, SQV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, SQV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, SQV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, SQV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, SQV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, TPV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, TPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, TPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, TPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase | PI, TPV/r, High-level resistance | 0 Participants |
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential genotypic evolution of resistance. Genotypic Resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.
Time frame: Up to Week 410
Population: The analysis was performed on the CVW Resistance population which included all participants from the Intent-to-Treat Exposed (ITT-E) population who met CVW through the end of the visit window and had available on-treatment genotypic resistance data at the time the CVW criterion was met.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, RAL, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, RAL, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, DLV, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, DTG, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, DTG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, DTG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, DTG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, DTG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, EVG, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, EVG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, EVG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, EVG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, EVG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, RAL, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, RAL, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, RAL, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, DLV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, DLV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, DLV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, DLV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, EFV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, EFV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, EFV, Low-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, EFV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, EFV, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, ETR, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, ETR, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, ETR, Low-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, ETR, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, ETR, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, NVP, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, NVP, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, NVP, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, NVP, Intermediate resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, NVP, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, RPV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, RPV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, RPV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, RPV, Intermediate resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, RPV, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, 3TC, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, 3TC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, 3TC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, 3TC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, 3TC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ABC, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ABC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ABC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ABC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ABC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, FTC, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, FTC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, FTC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, FTC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, FTC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, TDF, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, TDF, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, TDF, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, TDF, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, TDF, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ZDV, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ZDV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ZDV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ZDV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ZDV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, d4T, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, d4T, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, d4T, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, d4T, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, d4T, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ddI, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ddI, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ddI, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ddI, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ddI, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, ATV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, ATV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, ATV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, ATV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, ATV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, DRV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, DRV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, DRV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, DRV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, DRV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, FPV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, FPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, FPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, FPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, FPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, IDV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, IDV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, IDV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, IDV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, IDV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, LPV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, LPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, LPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, LPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, LPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, NFV, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, NFV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, NFV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, NFV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, NFV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, RTV, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, RTV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, RTV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, RTV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, RTV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, SQV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, SQV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, SQV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, SQV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, SQV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, TPV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, TPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, TPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, TPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, TPV/r, High-level resistance | 0 Participants |
Number of Participants With Genotypic Resistance-Early Switch Phase
Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (Rilpivirine \[RPV\], Dolutegravir \[DTG\]) in participants Meeting Confirmed Virologic Withdrawal (CVW) criteria has been presented.
Time frame: Up to Week 48
Population: The analysis was performed on the CVW resistance Population which was comprised of all participants in the ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and have available on-treatment genotypic resistance data at the time CVW criterion is met.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Genotypic Resistance-Early Switch Phase | INSTI, DTG, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-Early Switch Phase | INSTI, DTG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-Early Switch Phase | INSTI, DTG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-Early Switch Phase | INSTI, DTG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-Early Switch Phase | INSTI, DTG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-Early Switch Phase | NNRTI, RPV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-Early Switch Phase | NNRTI, RPV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-Early Switch Phase | NNRTI, RPV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-Early Switch Phase | NNRTI, RPV, Intermediate resistance | 1 Participants |
| DTG + RPV | Number of Participants With Genotypic Resistance-Early Switch Phase | NNRTI, RPV, High-level resistance | 0 Participants |
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Blood samples were collected to evaluate alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, blood urea nitrogen (BUN), total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in clinical chemistry over 48 weeks was summarized. Clinical chemistry toxicities were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity.
Time frame: Up to 48 weeks
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks | Grade 1 | 92 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks | Grade 2 | 72 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks | Grade 3 | 11 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks | Grade 4 | 1 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks | Grade 4 | 10 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks | Grade 1 | 80 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks | Grade 3 | 16 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks | Grade 2 | 79 Participants |
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
Blood samples were collected at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Number of participants who experienced maximum toxicity grade post-baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) is summarized. Clinical chemistry toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Time frame: Up to 48 weeks
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Grade 1 | 51 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Grade 2 | 31 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Grade 3 | 7 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Grade 4 | 1 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Grade 1 | 19 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Grade 2 | 23 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Grade 3 | 3 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Grade 4 | 0 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Grade 1 | 22 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Grade 2 | 18 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Grade 3 | 1 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Grade 4 | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Grade 3 | 9 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Grade 1 | 52 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Grade 3 | 3 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Grade 2 | 40 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Grade 2 | 21 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Grade 3 | 4 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Grade 4 | 2 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI, Grade 4 | 5 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Grade 4 | 3 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Grade 1 | 11 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI, Grade 1 | 17 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INSTI, Grade 2 | 18 Participants |
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks
Blood samples were collected to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count and platelet count. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in hematology over 48 weeks was summarized. Hematology toxicities were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a hematology toxicity.
Time frame: Up to 48 weeks
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks | Grade 1 | 11 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks | Grade 2 | 2 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks | Grade 3 | 3 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks | Grade 4 | 1 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks | Grade 4 | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks | Grade 1 | 11 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks | Grade 3 | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks | Grade 2 | 2 Participants |
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
Blood samples were collected at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Number of participants who experienced maximum toxicity grade post-baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized. Hematology toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Time frame: Up to 48 weeks
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI; Grade 1 | 7 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI; Grade 2 | 1 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI; Grade 3 | 1 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI; Grade 4 | 1 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INI; Grade 1 | 1 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INI; Grade 2 | 0 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INI; Grade 3 | 0 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INI; Grade 4 | 0 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI; Grade 1 | 3 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI; Grade 2 | 1 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI; Grade 3 | 2 Participants |
| DTG + RPV | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI; Grade 4 | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI; Grade 3 | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI; Grade 1 | 6 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INI; Grade 3 | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI; Grade 2 | 2 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI; Grade 2 | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI; Grade 3 | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INI; Grade 4 | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | NNRTI; Grade 4 | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI; Grade 4 | 0 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INI; Grade 1 | 1 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | PI; Grade 1 | 4 Participants |
| Current Antiretroviral Regimen (CAR) | Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class | INI; Grade 2 | 0 Participants |
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class
For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were to be analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were to be collected at Day 1. Number of participants with genotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized.
Time frame: Week 48
Population: CVW resistance Population. This outcome has not been analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Number of participants with genotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI) were summarized.
Time frame: Week 52 to Week 410
Population: The analysis was performed on the Late Switch CVW Resistance population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, DTG, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, DTG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, DTG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, DTG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, DTG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, EVG, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, EVG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, EVG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, EVG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, EVG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, RAL, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, RAL, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, RAL, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, RAL, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, INI, RAL, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, DLV, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, DLV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, DLV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, DLV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, DLV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, EFV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, EFV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, EFV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, EFV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, EFV, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, ETR, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, ETR, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, ETR, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, ETR, Intermediate resistance | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, ETR, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, RPV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, RPV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, RPV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, RPV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, RPV, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, 3TC, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, 3TC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, 3TC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, 3TC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, 3TC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ABC, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ABC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ABC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ABC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ABC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, FTC, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, FTC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, FTC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, FTC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, FTC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, TDF, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, TDF, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, TDF, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, TDF, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, TDF, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ZDF, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ZDF, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ZDF, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ZDF, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ZDF, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, d4T, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, d4T, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, d4T, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, d4T, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, d4T, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, ATV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, ATV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, ATV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, ATV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, ATV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, DRV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, DRV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, DRV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, DRV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, DRV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, FPV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, FPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, FPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, FPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, FPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, IDV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, IDV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, IDV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, IDV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, IDV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, LPV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, LPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, LPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, LPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, LPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, NFV, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, NFV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, NFV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, NFV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, NFV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, RTV, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, RTV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, RTV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, RTV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, RTV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, SQV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, SQV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, SQV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, SQV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, SQV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, TPV/r, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, TPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, TPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, TPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, PI, TPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, NVP, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, NCP, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, NVP, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, NVP, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NNRTI, NVP, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ddI, Susceptible | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ddI, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ddI, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ddI, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase | NNRTI, NRTI, ddI, High-level resistance | 0 Participants |
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were collected at Day 1. Number of participants with genotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI) were summarized.
Time frame: Up to Week 410
Population: The analysis was performed on the CVW Resistance population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, TDF, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, DTG, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, DTG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, DTG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, DTG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, DTG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, EVG, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, EVG, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, EVG, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, EVG, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, EVG, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, RAL, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, RAL, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, RAL, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, RAL, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, RAL, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, DLV, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, DLV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, DLV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, DLV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, DLV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, EFV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, EFV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, EFV, Low-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, EFV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, EFV, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, ETR, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, ETR, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, ETR, Low-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, ETR, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, ETR, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, NVF, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, NVF, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, NVF, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, NVF, Intermediate resistance | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, NVF, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, RPV, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, RPV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, RPV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, RPV, Intermediate resistance | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, RPV, High-level resistance | 1 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, 3TC, Susceptible | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, 3TC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, 3TC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, 3TC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, 3TC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ABC, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ABC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ABC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ABC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ABC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, FTC, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, FTC, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, FTC, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, FTC, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, FTC, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, TDF, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, TDF, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, TDF, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, TDF, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ZDF, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ZDF, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ZDF, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ZDF, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ZDF, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, d4T, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, d4T, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, d4T, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, d4T, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, d4T, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, ATV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, ATV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, ATV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, ATV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, ATV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, DRV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, DRV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, DRV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, DRV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, DRV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, FPV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, FPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, FPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, FPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, FPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, IDV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, IDV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, IDV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, IDV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, IDV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, LPV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, LPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, LPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, LPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, LPV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, NFV, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, NFV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, NFV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, NFV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, NFV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, RTV, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, RTV, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, RTV, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, RTV, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, RTV, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, SQV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, SQV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, SQV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, SQV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, SQV/r, High-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, TPV/r, Susceptible | 2 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, TPV/r, Potential low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, TPV/r, Low-level resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, TPV/r, Intermediate resistance | 0 Participants |
| DTG + RPV | Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, TPV/r, High-level resistance | 0 Participants |
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class
For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were to be analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were to be collected at Day 1. Number of participants with phenotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized.
Time frame: Week 48
Population: CVW resistance Population. This outcome was not analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Number of participants with phenotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI) were summarized.
Time frame: Week 52 to Week 410
Population: The analysis was performed on the Late Switch CVW resistance population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, DLV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, DLV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, DLV, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, EFV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, EFV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, EFV, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, ETR, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, ETR, Partially Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, ETR, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, NVP, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, NVP, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, NVP, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, RPV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, RPV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NNRTI, RPV, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, 3TC, Reistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, 3TC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, 3TC, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, ABC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, ABC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, ABC, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, FTC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, FTC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, FTC, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, TDF, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, TDF, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, TDF, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, ZDF, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, ZDF, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, ZDF, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, d4T, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, d4T, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, d4T, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, ddI, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, ddI, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, NRTI, ddI, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, ATV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, ATV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, ATV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, DRV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, DRV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, DRV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, FPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, FPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, FPV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, IDV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, IDV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, IDV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, LPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, LPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, LPV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, NFV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, NFV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, NFV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, RTV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, RTV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, RTV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, SQV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, SQV/r, Partiallly Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, SQV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, TPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, TPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase | NNRTI, PI, TPV/r, Sensitive | 1 Participants |
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were collected at Day 1. Number of participants with phenotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI) were summarized.
Time frame: Up to Week 410
Population: The analysis was performed on the CVW Resistance population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, RAL, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, RAL, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, DTG, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, DTG, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, DTG, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, EVG, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, EVG, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, EVG, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, INI, RAL, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, DLV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, DLV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, DLV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, EFV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, EFV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, EFV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, ETR, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, ETR, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, ETR, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, NVP, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, NVP, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, NVP, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, RPV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, RPV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NNRTI, RPV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, 3TC, Reistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, 3TC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, 3TC, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ABC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ABC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ABC, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, FTC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, FTC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, FTC, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, TDF, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, TDF, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, TDF, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ZDF, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ZDF, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ZDF, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, d4T, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, d4T, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, d4T, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ddI, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ddI, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, NRTI, ddI, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, ATV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, ATV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, ATV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, DRV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, DRV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, DRV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, FPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, FPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, FPV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, IDV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, IDV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, IDV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, LPV/r, yResistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, LPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, LPV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, NFV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, NFV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, NFV, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, RTV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, RTV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, RTV, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, SQV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, SQV/r, Partiallly Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, SQV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, TPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, TPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase | NNRTI, PI, TPV/r, Sensitive | 2 Participants |
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic resistance data for the following drugs was presented: DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.
Time frame: Week 52 to Week 410
Population: The analysis was performed on the Late Switch CVW Resistance population which included all participants from the Late Switch ITT-E population who met CVW through the end of visit window and had available on-treatment phenotypic resistance data at the time the CVW criterion was met.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, DLV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, DLV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, DLV, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, EFV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, EFV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, EFV, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, ETR, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, ETR, Partially Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, ETR, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, NVP, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, NVP, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, NVP, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, RPV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, RPV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NNRTI, RPV, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, 3TC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, 3TC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, 3TC, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, ABC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, ABC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, ABC, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, FTC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, FTC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, FTC, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, TDF, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, TDF, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, TDF, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, ZDV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, ZDV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, ZDV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, d4T, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, d4T, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, d4T, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, ddI, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, ddI, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | NRTI, ddI, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, ATV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, ATV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, ATV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, DRV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, DRV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, DRV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, FPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, FPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, FPV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, IDV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, IDV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, IDV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, LPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, LPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, LPV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, NFV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, NFV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, NFV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, RTV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, RTV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, RTV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, SQV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, SQV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, SQV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, TPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, TPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase | PI, TPV/r, Sensitive | 1 Participants |
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.
Time frame: Post-LS Baseline (Week 52) up to Week 148
Population: LS CVW resistance Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, ddI, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, ATV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, SQV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, FTC, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, DLV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, DLV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, DLV, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, EFV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, EFV, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, EFV, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, ETR, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, ETR, Partially sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, ETR, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, NVP, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, NVP, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, NVP, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, RPV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, RPV, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NNRTI, RPV, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, 3TC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, 3TC, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, 3TC, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, ABC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, ABC, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, ABC, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, FTC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, FTC, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, TDF, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, TDF, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, TDF, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, ZDV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, ZDV, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, ZDV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, d4T, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, d4T, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, d4T, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, ddI, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | NRTI, ddI, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, ATV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, ATV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, DRV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, DRV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, DRV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, FPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, FPV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, FPV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, IDV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, IDV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, IDV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, LPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, LPV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, LPV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, NFV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, NFV, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, NFV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, RTV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, RTV, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, RTV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, SQV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, SQV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, TPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, TPV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase | PI, TPV/r, Sensitive | 1 Participants |
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic Resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.
Time frame: Up to Week 410
Population: The analysis was performed on the CVW Resistance population which included all participants from the ITT-E population who met CVW through the end of the visit window and had available on-treatment phenotypic resistance data at the time the CVW criterion was met.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, EVG, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, DLV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, DLV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, EFV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, EFV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, EFV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, ETR, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, ETR, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, ETR, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, NVP, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, NVP, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, NVP, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, RPV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, RPV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, RPV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, 3TC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, 3TC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, 3TC, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ABC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ABC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ABC, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, FTC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, FTC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, FTC, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, TDF, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, TDF, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, TDF, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ZDV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ZDV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ZDV, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, d4T, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, d4T, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, DRV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, DRV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, FPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, FPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, IDV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, IDV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, IDV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, LPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, LPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, LPV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, NFV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, NFV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, NFV, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, RTV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, DTG, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, DTG, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, DTG, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, EVG, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, EVG, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, RAL, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, RAL, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | INI, RAL, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NNRTI, DLV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, d4T, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ddI, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ddI, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | NRTI, ddI, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, ATV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, ATV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, ATV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, DRV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, FPV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, RTV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, RTV, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, SQV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, SQV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, SQV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, TPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, TPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase | PI, TPV/r, Sensitive | 2 Participants |
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.
Time frame: Up to Week 148
Population: CVW resistance Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, RPV, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, RPV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | INI, DTG, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | INI, DTG, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | INI, DTG, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | INI, EVG, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | INI, EVG, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | INI, EVG, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | INI, RAL, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | INI, RAL, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | INI, RAL, Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, DLV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, DLV, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, DLV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, EFV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, EFV, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, EFV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, ETR, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, ETR, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, ETR, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, NVP, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, NVP, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, NVP, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NNRTI, RPV, Resistant | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, 3TC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, 3TC, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, 3TC, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, ABC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, ABC, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, ABC, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, FTC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, FTC, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, FTC, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, TDF, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, TDF, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, TDF, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, ZDV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, ZDV, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, ZDV, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, d4T, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, d4T, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, d4T, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, ddI, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, ddI, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | NRTI, ddI, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, ATV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, ATV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, ATV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, DRV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, DRV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, DRV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, FPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, FPV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, FPV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, IDV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, IDV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, IDV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, LPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, LPV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, LPV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, NFV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, NFV, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, NFV, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, RTV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, RTV, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, RTV, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, SQV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, SQV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, SQV/r, Sensitive | 2 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, TPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, TPV/r, Partially sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase | PI, TPV/r, Sensitive | 2 Participants |
Number of Participants With Phenotypic Resistance-Early Switch Phase
Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, RAL, EVG, RPV, ETR, 3TC, ABC, FTC, TDF, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.
Time frame: Up to Week 52
Population: The analysis was performed on the CVW resistance Population which was comprised of all participants in the ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and have available on-treatment genotypic resistance data at the time CVW criterion is met. Only participants from the DTG + RPV were analyzed as the CAR participants did not receive study treatment until Week 52.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NNRTI, RPV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NNRTI, RPV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NNRTI, ETR, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NNRTI, ETR, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NNRTI, ETR, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NNRTI, DLV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NNRTI, DLV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NNRTI, EFV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NNRTI, EFV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NNRTI, NVP, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NNRTI, NVP, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, 3TC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, 3TC, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, ABC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, ABC, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, ABC, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, TDF, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, TDF, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, TDF, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, d4T, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, d4T, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, ddI, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, ddI, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, ddI, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, FTC, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, FTC, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, ZDV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | NRTI, ZDV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, ATV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, ATV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, DRV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, DRV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, DRV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, FPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, FPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, FPV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, IDV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, IDV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, LPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, LPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, LPV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, SQV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, SQV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, SQV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, TPV/r, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, TPV/r, Partially Sensitive | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, TPV/r, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, NFV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, NFV, Sensitive | 1 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, RTV, Resistant | 0 Participants |
| DTG + RPV | Number of Participants With Phenotypic Resistance-Early Switch Phase | PI, RTV, Sensitive | 1 Participants |
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm
Percentage of participants with plasma HIV 1 RNA \<50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity of DTG +RPV once daily compared to continuation of CAR. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Time frame: Week 24
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG + RPV | Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm | 97 Percentage of participants |
| Current Antiretroviral Regimen (CAR) | Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm | 98 Percentage of participants |
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 48 using the FDA snapshot algorithm was assessed by Baseline third agent class to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. The analysis was done using Cochran-Mantel Haenszel test stratified by current antiretroviral third-agent class.
Time frame: At Week 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG + RPV | Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class | NNRTI | 97 Percentage of participants |
| DTG + RPV | Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class | INSTI | 92 Percentage of participants |
| DTG + RPV | Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class | PI | 91 Percentage of participants |
| Current Antiretroviral Regimen (CAR) | Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class | NNRTI | 93 Percentage of participants |
| Current Antiretroviral Regimen (CAR) | Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class | INSTI | 94 Percentage of participants |
| Current Antiretroviral Regimen (CAR) | Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class | PI | 97 Percentage of participants |
Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch Phase
Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 56, 76 and 100. Pre-dose concentrations of DTG and RPV at Weeks 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the late switch phase.
Time frame: Pre-dose at Weeks 56, 76 and 100
Population: The analysis was performed on the Pharmacokinetic (PK) Parameter Population which consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0). Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch Phase | Week 56 | 1544.75 ug/ L | Standard Deviation 1049.595 |
| DTG + RPV | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch Phase | Week 76 | 1806.77 ug/ L | Standard Deviation 1019.3 |
| DTG + RPV | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch Phase | Week 100 | 1881.97 ug/ L | Standard Deviation 1160.587 |
| Current Antiretroviral Regimen (CAR) | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch Phase | Week 56 | 77.27 ug/ L | Standard Deviation 38.931 |
| Current Antiretroviral Regimen (CAR) | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch Phase | Week 76 | 91.46 ug/ L | Standard Deviation 48.568 |
| Current Antiretroviral Regimen (CAR) | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch Phase | Week 100 | 90.89 ug/ L | Standard Deviation 47.762 |
Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase
Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24, 48, 56, 76 and 100. Pre-dose concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the early+late switch phase.
Time frame: Pre-dose at Week 4, 24, 48, 56, 76 and 100
Population: The analysis was performed on the Pharmacokinetic (PK) Parameter Population which consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0). Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Week 4 | 1578.88 ug/ L | Standard Deviation 1170.967 |
| DTG + RPV | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Week 24 | 1447.23 ug/ L | Standard Deviation 917.677 |
| DTG + RPV | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Week 48 | 1384.36 ug/ L | Standard Deviation 889.829 |
| DTG + RPV | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Week 56 | 1637.74 ug/ L | Standard Deviation 1063.391 |
| DTG + RPV | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Week 76 | 1507.81 ug/ L | Standard Deviation 913.263 |
| DTG + RPV | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Week 100 | 1532.10 ug/ L | Standard Deviation 916.975 |
| Current Antiretroviral Regimen (CAR) | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Week 76 | 92.51 ug/ L | Standard Deviation 46.223 |
| Current Antiretroviral Regimen (CAR) | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Week 4 | 79.50 ug/ L | Standard Deviation 38.23 |
| Current Antiretroviral Regimen (CAR) | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Week 56 | 90.55 ug/ L | Standard Deviation 45.686 |
| Current Antiretroviral Regimen (CAR) | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Week 24 | 90.21 ug/ L | Standard Deviation 46.302 |
| Current Antiretroviral Regimen (CAR) | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Week 100 | 91.98 ug/ L | Standard Deviation 44.683 |
| Current Antiretroviral Regimen (CAR) | Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase | Week 48 | 91.41 ug/ L | Standard Deviation 47.073 |
Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV
Two blood samples were collected pre-dose for DTG and RPV at Weeks 2 and 8 only for the first 20 participants who switch from EFV or NVP to DTG+RPV, in addition to the pre-dose blood sample collected at Week 4 for all participants. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. PK Parameter NNRTI Subset Extra Sampling Population consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2 and 8.
Time frame: Pre-dose at Weeks 2, 4 and 8
Population: PK Parameter NNRTI Subset extra sampling Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV | Week 2 | 834.58 ug/ L | Standard Deviation 639.622 |
| DTG + RPV | Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV | Week 4 | 1218.23 ug/ L | Standard Deviation 842.703 |
| DTG + RPV | Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV | Week 8 | 1472.50 ug/ L | Standard Deviation 818.774 |
| Current Antiretroviral Regimen (CAR) | Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV | Week 2 | 57.342 ug/ L | Standard Deviation 29.5436 |
| Current Antiretroviral Regimen (CAR) | Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV | Week 4 | 78.338 ug/ L | Standard Deviation 31.4825 |
| Current Antiretroviral Regimen (CAR) | Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV | Week 8 | 79.652 ug/ L | Standard Deviation 40.7546 |
Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Time frame: At Weeks 100 and 148
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Week 100 | 55.9 Cells/mm^3 | Standard Deviation 202.56 |
| DTG + RPV | Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch Phase | Week 148 | 51.5 Cells/mm^3 | Standard Deviation 205.98 |
Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch Phase
Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.
Time frame: LS Baseline (Week 48), Weeks 100 and 148
Population: LS ITT-E Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch Phase | Week 100 | 20.9 Cells/mm^3 | Standard Deviation 173.39 |
| DTG + RPV | Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch Phase | Week 148 | 6.5 Cells/mm^3 | Standard Deviation 167.44 |
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Group Through Late Switch Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA \< 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.
Time frame: Weeks 100 and 148
Population: LS ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG + RPV | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Group Through Late Switch Phase | Week 100 | 97 Percentage of participants |
| DTG + RPV | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Group Through Late Switch Phase | Week 148 | 93 Percentage of participants |
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA \< 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.
Time frame: Weeks 100 and 148
Population: ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG + RPV | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch Phase | Week 100 | 89 Percentage of participants |
| DTG + RPV | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch Phase | Week 148 | 84 Percentage of participants |