HIV Infections
Conditions
Keywords
Switch study, Non-inferiority, Human immunodeficiency virus type 1, Tenofovir alafenamide, Dolutegravir, Lamivudine
Brief summary
The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult participants with current virologic suppression on a \>=3-drug tenofovir alafenamide (TAF) based regimen (TBR) remain suppressed upon switching to a two-drug regimen of dolutegravir (DTG) 50 milligram (mg) + lamivudine (3TC) 300 mg. This study will also provide important information regarding the safety and participant satisfaction with this two-drug regimen. The primary objective of this trial is to demonstrate the non-inferior antiviral activity of switching to DTG + 3TC once daily compared to continuation of TBR over 48 weeks in HIV-1 infected, antiretroviral therapy (ART)-experienced, virologically suppressed participants. This study also will characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC compared to TBR through Week 144 and characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC through Week 200. This will be a 200-week, Phase III, randomized, open-label, active-controlled, multicenter, parallel- group study. The study will include a screening phase (up to 28 days), a randomized early switch phase (Day 1 up to Week 148), a randomized late switch phase (Week 148 up to Week 200), and a continuation phase (post Week 200). HIV-1 infected adults on stable TBR will be randomized 1:1 to switch to DTG + 3TC once daily for up to 200 weeks, or to continue their TBR for 148 weeks, at which time and if HIV-1 ribonucleic acid (RNA) \<50 copies per milliliter (c/mL) at Week 144, these participants will switch to DTG + 3TC up to Week 200.
Interventions
DRUGDTG + 3TC
DTG+3TC is supplied as white, oval, film-coated, fixed dose combination tablet. The tablets will be available in packed high density polyethylene (HDPE) bottles with induction seals and child-resistant closures.
DRUGTAF based regimen (TBR)
Participants will continue to receive their TBR.
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This will be an open-label study and therefore no blinding is required. No summaries of the study data according to actual randomized treatment groups will be available to sponsor staff prior to the planned Week 24 preliminary analysis.
Intervention model description
This is a randomized study with parallel group assignment where participants will be randomized into one of the two treatment groups. Participants randomized to DTG + 3TC will receive DTG + 3TC up to Week 200. Participants randomized to TBR will continue to take their current regimen up to Week 148, at which time and if HIV-1 RNA \<50 c/mL at Week 144, these participants will switch to DTG + 3TC up to Week 200. Randomization will be stratified by Baseline third agent class (protease inhibitor \[PI\], integrase inhibitor \[INI\], or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be able to understand and comply with protocol requirements, instructions, and restrictions; * Participant must be likely to complete the study as planned; * Participant must be considered an appropriate candidate for participation in an investigative clinical trial with medication (example no active substance abuse, acute major organ disease, or planned long-term work assignments out of the country). * Aged 18 years or older (or older where required by local regulatory agencies), at the time of signing the informed consent. * HIV-1 infected men or women. * 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. * Must be on uninterrupted ART for at least 6 months prior to screening. Only the following regimens are allowed: * Participant on a TAF-based regimen for at least 6 months as the initial regimen, or * Participants who switched from a tenofovir disoproxil fumarate (TDF) first-regimen TAF, without any changes to the other drugs in their regimen, and have been on the TAF-based regimen for at least 3 months immediately prior to Screening i.e., the only switch made is from TDF to TAF. This switch must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for suspected or established treatment failure. A switch from a PI boosted with ritonavir to the same PI boosted with cobicistat is allowed (and vice versa). * A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin \[hCG\] test at screen and a negative urine hCG test at randomization \[a local serum hCG test at Randomization is allowed if it can be done, and results obtained, within 24 hours prior to randomization\]), not lactating, and at least one of the following conditions applies: a. Non-reproductive potential defined as: * Pre-menopausal females with one of the following: * Documented tubal ligation * Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion * Hysterectomy * Documented bilateral oophorectomy * Post-menopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone \[FSH\] and estradiol levels consistent with menopause \[refer to laboratory reference ranges for confirmatory levels\]). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. b. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and for at least 2 weeks after the last dose of study medication. * The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. All participants participating in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and the protocol. Eligible participants or their legal guardians must sign a written informed consent form before any protocol-specified assessments are conducted. Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.
Exclusion criteria
* Women who are breastfeeding or plan to become pregnant or breastfeed during the study. * Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease, EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/millimeter (mm)\^3 are NOT exclusionary. * Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification. * Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, 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), Hepatitis B surface antigen antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows: participants positive for HBsAg are excluded; participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. * Anticipated need for any hepatitis C virus (HCV) therapy during the first 48 weeks of the study, or anticipated need for HCV therapy based on interferon or for any drugs that have a potential for adverse drug-drug interactions with study treatment throughout the entire study period. * Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible. * History or presence of allergy or intolerance 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, anal or penile intraepithelial neoplasia. * Participants who in the investigator's judgment, poses a significant suicidality risk. * 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 systemic immune suppressant. * 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 the first dose of investigational product (IP). * Use of any regimen consisting of single or dual ART. * Any evidence of major nucleoside reverse transcriptase inhibitor (NRTI) mutation or presence of any major INSTI resistance-associated mutation in any available prior resistance genotype assay test result, if known, must be provided to ViiV after screening and before randomization for review by ViiV Virology. * Any verified Grade 4 laboratory abnormality. * Alanine aminotransferase (ALT) \>=5 times (\*) the upper limit of normal (ULN) or ALT \>=3 \* ULN and bilirubin \>=1.5 \* ULN (with \>35 percent \[%\] direct bilirubin). * Creatinine clearance of \<50 milliliter (mL)/minute/1.73 meter\^2 via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method. * 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. * 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. * Any drug holiday during the 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 history of switch to another 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 ≥400 c/mL. * Participants enrolled in France (or in other countries as required by local regulations or Ethics Committee/Institutional Review Board \[IRB\]) who: * Participated in any study using an investigational drug or vaccine during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to screening for the study, or * Participate simultaneously in another clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48 | Week 48 | Percentage of participants with virologic failure (plasma HIV-1 RNA \>=50 c/mL) was evaluated using FDA snapshot algorithm at Week 48. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. Intent-to-treat exposed (ITT-E) Population comprises of all randomized participants who received at least one dose of study treatment either DTG + 3TC or TBR. Participants were assessed according to the treatment to which the participant was randomized. Any participant receiving a treatment randomization number was considered to be randomized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24 | Week 24 | Percentage of participants with plasma HIV-1 RNA \>=50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. |
| Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144 | Weeks 96 and 144 | Percentage of participants with plasma HIV-1 RNA \>=50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144. |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24 | Week 24 | Percentage of participants with plasma HIV-1 RNA \<50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Percentage values are rounded off. |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144 | Weeks 96 and 144 | Percentage of participants with plasma HIV-1 RNA \<50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144. |
| Change From Baseline in CD4+ Cell Count at Weeks 24 and 48 | Baseline (Day 1) and at Weeks 24 and 48 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable. |
| Change From Baseline in CD4+ Cell Count at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | CD4+ cells are a type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+and evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable |
| Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48 | Baseline (Day 1) and at Weeks 24 and 48 | Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over 48 Weeks. Baseline (Day 1) values were the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable . |
| Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio and were evaluated by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over Weeks 96 and 144. Baseline (Day 1) values are the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable |
| Number of Participants With Disease Progression at Weeks 24 and 48 | At Weeks 24 and 48 | HIV-associated conditions were recorded during the study and were assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV were: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: \>=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3:Documented AIDS defining condition or CD4+ T-lymphocye count \<200 cells/mcL. Disease progression summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death. |
| Number of Participants With Disease Progression at Weeks 96 and 144 | At Weeks 96 and 144 | HIV-associated conditions were recorded during the study and assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV is: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: \>=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: Documented AIDS-defining condition or CD4+ T-lymphocye count \<200 cells/mcL. Indicators of clinical disease progression is defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death. |
| Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48 | Up to Week 48 | An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Safety Population included all participants who received at least one dose of study treatment either DTG + 3TC or TBR. This population was based on the treatment the participant actually received. Number of participants with any SAE and common (\>=2%) non-SAEs are presented. |
| Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48 | Up to Week 48 | An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Number of TDF-based regimen participants with any SAE and common (\>=2%) non-SAEs are presented. |
| Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148 | Up to Week 148 | An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment |
| Number of Participants With AEs by Their Severity Grades: Up to Week 48 | Up to Week 48 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. |
| Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48 | Up to Week 48 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of TDF-based regimen participants with adverse events by maximum grade have been presented. |
| Number of Participants With AEs by Their Severity Grades: Up to Week 144 | Up to Week 144 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. |
| Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48 | Up to Week 48 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented. |
| Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 48 | Up to Week 48 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented. |
| Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144 | Up to Week 144 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. |
| Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Up to Week 48 | Blood samples were collected up to Week 48 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented. |
| Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Up to Week 36 | Blood samples were collected up to the Week 36 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those TDF-based regimen participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented. |
| Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Up to Week 144 | Blood samples were collected up to Week 144 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters are were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. |
| Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Up to Week 48 | Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. |
| Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Up to Week 36 | samples were collected up to the Week 36 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. |
| Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Up to Week 144 | Blood samples were collected up to Week 144 for the analysis of clinical chemistry parameters: ALT, albumin, ALP, AST, bilirubin, CO2, cholesterol, CK, creatinine, direct bilirubin, GFR from creatinine adjusted for BSA, GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, LDL cholesterol, phosphate triglycerides and lactate dehydrogenase. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. |
| Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 | Baseline (Day 1) and at weeks 24 and 48 | Urine samples were collected at Baseline, Week 24 and Week 48. Baseline is defined as Day 1. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. Change from Baseline in UP/C and UA/C was calculated as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio calculated at Baseline, respectively. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen | Baseline (Day 1) and at weeks 24 and 48 | Urine samples were collected at Baseline, Week 24 and Week 48 to assess renal biomarkers - urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline was defined as the latest pre-dose assessment value with a non-missing value. (Day 1). Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Change from Baseline in UP/C was calculated as UP/C ratio at post-Baseline visit minus UP/C ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | Urine samples were collected at Baseline, Weeks 96 and 144. Baseline is defined as Day 1. Change from Baseline in UA/C is defined as UA/C ratio at post-Baseline visit minus UA/C ratio at Baseline. Change from Baseline in UP/C and UA/C is defined as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio at Baseline, respectively. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 | Baseline (Day 1) and at weeks 24 and 48 | Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine beta-2 microglobulin/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Baseline (Day 1) and at weeks 24 and 48 | Urine biomarker samples were collected to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine is defined as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 | Baseline (Day 1) and at weeks 24 and 48 | Urine biomarker samples were collected at Baseline and at Weeks 24 and 48 to assess urine phosphate. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Baseline (Day 1) and at weeks 24 and 48 | Urine biomarker samples were collected to assess urine phosphate. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine phosphate. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate is defined as urine phosphate at post-Baseline visit minus urine phosphate at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen |
| Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 | Baseline (Day 1) and at weeks 24 and 48 | Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine retinol binding protein 4/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio was calculated as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Baseline (Day 1) and at weeks 24 and 48 | Urine biomarker samples were collected to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine retinol binding protein 4/urine creatinine was calculated as urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio is defined as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen |
| Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Baseline (Day 1) and at weeks 24 and 48 | Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma high density lipoprotein (HDL) cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Baseline (Day 1) and at weeks 24 and 48 | Blood samples were collected at Baseline (Day 1), weeks 24 and 48 visit (participant withdrew from the study at Week 36) to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for fasting lipids in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | Blood samples were collected at Baseline (Day 1), Weeks 96 and 144 to assess fasting lipids which includes plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value is the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Number of Participants With Genotypic Resistance: Up to Week 48 | Up to Week 48 | Plasma samples were collected for drug resistance testing. Number of participants, who met confirmed virologic withdrawal (CVW) criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with genotypic resistance to INSTI, nucleoside reverse transcriptase inhibitor (NRTI), NNRTI and PI was summarized. |
| Number of Participants With Genotypic Resistance: Up to Week 144 | Up to Week 144 | Plasma samples were collected for drug resistance testing. Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with genotypic resistance to INSTI, NRTI, NNRTI and PI are summarized. |
| Number of Participants With Phenotypic Resistance: Up to Week 48 | Up to Week 48 | Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with phenotypic resistance to INSTI, NNRTI,NRTI and PI were summarized. Assessment of antiviral activity of ART using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented. |
| Number of Participants With Phenotypic Resistance: Up to Week 144 | Up to Week 144 | Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with phenotypic resistance to INSTI,NNRT,NRTI and PI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented. |
| Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | Baseline (Day 1) and at Weeks 24 and 48 | Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, body mass index (BMI) (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48 | Baseline (Day 1) and at Weeks 24 and 48 | Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1) . Change from Baseline is post-dose visit value minus Baseline value. Change from Baseline in bone biomarkers-serum bone-specific ALP (Bone-ALP), osteocalcin, serum P1NP and serum CTX-1 in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | Serum samples were collected for analysis of bone biomarkers. Baseline is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen |
| Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 | Baseline (Day 1) and at Weeks 24 and 48 | Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value was latest pre-dose assessment (Day 1) with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Baseline (Day 1) and at Weeks 24 and 48 | Serum samples were collected for the analysis of 25-hydroxyvitamin D. Baseline value was the value from latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum 25-hydroxyvitamin D in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen |
| Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 | Baseline (Day 1) and at Weeks 24 and 48 | Serum samples were collected to assess renal biomarker. Baseline was latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for following:treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen |
| Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Baseline (Day 1) and at Weeks 24 and 48 | Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - cystatin C. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum cystatin -C biomarker in TDF based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | Serum samples were collected to assess renal biomarker. Baseline is latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen |
| Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 | Baseline (Day 1) and at Weeks 24 and 48 | Serum samples assessed:serum GFR from cystatin C and from creatinine adjusted using CKD-EPI Baseline(Day 1) was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value.Adjusted mean and standard error is presented.Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class,CD4+ cell count(continuous),age(continuous), sex, race, BMI(continuous),presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen |
| Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Baseline (Day 1) and at Weeks 24 and 48 | Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarkers - serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48 | Week 48 | Percentage of participants with plasma HIV-1 RNA \<50 c/mL (virologic success) was evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. |
| Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 | Baseline (Day 1) and at Weeks 24 and 48 | Serum samples assessed: renal inflammation biomarker serum creatinine.Baseline(Day 1)was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen |
| Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Baseline (Day 1) and at Weeks 24 and 48 | Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - serum creatinine. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum creatinine in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. |
| Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | Serum samples were collected to assess renal inflammation biomarker - serum creatinine. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen |
| Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48 | Baseline (Day 1) and at Weeks 24 and 48 | EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. |
| Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | EQ-5D-5L questionnaire provides profile of participant function and global health state rating. Five-item measure has 1question assessing each of 5dimensions:mobility,self-care,usual activities,pain/discomfort,anxiety/depression and 5 levels for each dimension including 1=no problems,2=slight problems,3=moderate problems,4=severe problems,5=extreme problems. Health state is defined by combining levels of answers from each of 5 questions. Each health state is referred to in terms of a 5 digit code.Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state.EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.Baseline is latest pre-dose assessment value with a non-missing value (Day 1).Change from Baseline is post-dose visit value minus Baseline value. |
| Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48 | Baseline (Day 1) and at Weeks 24 and 48 | EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset. Baseline was the latest pre-dose assessment value with a non-missing value (Day 1) and change from Baseline is defined as post-dose value minus Baseline value. |
| Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 | Baseline (Day 1) and at Weeks 96 and 144 | Serum samples were collected to assess serum GFR from cystatin C and from creatinine adjusted for BSA. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen |
Countries
Australia, Belgium, Canada, France, Germany, Japan, Netherlands, Spain, United Kingdom, United States
Participant flow
Recruitment details
This non-inferiority study evaluated antiviral activity of switching to dolutegravir (DTG) + lamivudine (3TC) fixed dose combination (FDC) once daily compared to continuation of a Tenofovir alafenamide (TAF)-based regimen (TBR) over 148 weeks in virologically suppressed participants with human immunodeficiency type 1 infection. At week 148 all participants received DTG + 3TC FDC until week 196.
Pre-assignment details
A total of 743 participants were randomized to receive treatment. Two participants in the DTG+3TC group were randomized but not treated. A total of 741 participants received at least one dose of study treatment either DTG + 3TC or TBR creating the intent to treat-exposed (ITT-E) Population.
Participants by arm
| Arm | Count |
|---|---|
| DTG+3TC FDC Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) less than (\<)50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg in early switch phase (Day 1 to Week 148) and continued to receive DTG/3TC FDC in late switch phase (Week 148 to Week 196). | 369 |
| TAF-based Regimen Participants who were on a stable TBR and had an HIV-1 RNA\<50 c/mL at the time of screening received TBR up to Week 148 in early switch phase, these participants were switched to DTG/3TC FDC in late switch phase (Week 148 to Week 196). One participant randomized to this arm received TDF rather than TAF-and was presented within the TAF-based regimen arm (early switch phase) for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under TDF-based regimenarm (early switch phase) for Safety because the safety profiles of TDF and TAF differ. | 372 |
| Total | 741 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Early Switch Phase (Day 1 to Week 148) | Adverse Event | 23 | 7 |
| Early Switch Phase (Day 1 to Week 148) | Lack of Efficacy | 0 | 6 |
| Early Switch Phase (Day 1 to Week 148) | Lost to Follow-up | 4 | 10 |
| Early Switch Phase (Day 1 to Week 148) | Physician Decision | 2 | 11 |
| Early Switch Phase (Day 1 to Week 148) | Protocol Violation | 5 | 6 |
| Early Switch Phase (Day 1 to Week 148) | Randomized, but did not receive treatment | 2 | 0 |
| Early Switch Phase (Day 1 to Week 148) | Withdrawal by Subject | 16 | 33 |
| Late Switch Phase (Week 148 to Week 196) | Adverse Event | 2 | 9 |
| Late Switch Phase (Week 148 to Week 196) | Lack of Efficacy | 1 | 1 |
| Late Switch Phase (Week 148 to Week 196) | Lost to Follow-up | 5 | 6 |
| Late Switch Phase (Week 148 to Week 196) | Physician Decision | 0 | 1 |
| Late Switch Phase (Week 148 to Week 196) | Protocol Violation | 0 | 1 |
| Late Switch Phase (Week 148 to Week 196) | Withdrawal by Subject | 4 | 6 |
Baseline characteristics
| Characteristic | TAF-based Regimen | DTG+3TC FDC | Total |
|---|---|---|---|
| Age, Continuous | 40.9 Years STANDARD_DEVIATION 11.54 | 40.6 Years STANDARD_DEVIATION 10.76 | 40.8 Years STANDARD_DEVIATION 11.15 |
| Baseline third agents INSTI | 296 Participants | 289 Participants | 585 Participants |
| Baseline third agents NNRTI | 48 Participants | 51 Participants | 99 Participants |
| Baseline third agents PI | 28 Participants | 29 Participants | 57 Participants |
| Cluster of differentiation 4 plus (CD4+) cell count | 720.0 Cells per cubic millimeter (cells/mm^3) | 682.0 Cells per cubic millimeter (cells/mm^3) | 688.0 Cells per cubic millimeter (cells/mm^3) |
| HIV infection by Centers for Disease Control and Prevention (CDC) classification HIV infection Stage 1 | 259 Participants | 255 Participants | 514 Participants |
| HIV infection by Centers for Disease Control and Prevention (CDC) classification HIV infection Stage 2 | 94 Participants | 94 Participants | 188 Participants |
| HIV infection by Centers for Disease Control and Prevention (CDC) classification HIV infection Stage 3 | 19 Participants | 20 Participants | 39 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 8 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized Asian and White | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian Heritage (H) | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian-Japanese H/East Asian H/South East Asian H | 9 Participants | 10 Participants | 19 Participants |
| Race/Ethnicity, Customized Black or African American | 58 Participants | 50 Participants | 108 Participants |
| Race/Ethnicity, Customized Black or African American and White | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White-Arabic/NA H and white/caucasia/European H | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White-Arabic/North African (NA) H | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized White-White/caucasian/European H | 286 Participants | 292 Participants | 578 Participants |
| Sex: Female, Male Female | 33 Participants | 25 Participants | 58 Participants |
| Sex: Female, Male Male | 339 Participants | 344 Participants | 683 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 369 | 0 / 371 | 0 / 1 | 0 / 298 |
| other Total, other adverse events | 327 / 369 | 304 / 371 | 1 / 1 | 187 / 298 |
| serious Total, serious adverse events | 65 / 369 | 44 / 371 | 0 / 1 | 15 / 298 |
Outcome results
Primary
Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48
Percentage of participants with virologic failure (plasma HIV-1 RNA \>=50 c/mL) was evaluated using FDA snapshot algorithm at Week 48. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. Intent-to-treat exposed (ITT-E) Population comprises of all randomized participants who received at least one dose of study treatment either DTG + 3TC or TBR. Participants were assessed according to the treatment to which the participant was randomized. Any participant receiving a treatment randomization number was considered to be randomized.
Time frame: Week 48
Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG+3TC FDC (Early Switch) | Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48 | 0.3 Percentage of participants |
| TAF Based Regimen (Early Switch) | Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48 | 0.5 Percentage of participants |
95% CI: [-1.2, 0.7]
Secondary
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48
Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value was latest pre-dose assessment (Day 1) with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 | Week 24, n=351, 355 | 0.0 Nanomoles per liter | Standard Error 1.1 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 | Week 48, n=344, 343 | -5.8 Nanomoles per liter | Standard Error 1.21 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 | Week 24, n=351, 355 | 2.1 Nanomoles per liter | Standard Error 1.15 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 | Week 48, n=344, 343 | -3.5 Nanomoles per liter | Standard Error 1.13 |
p-value: 0.17395% CI: [-5.3, 1]Mixed Model Repeated Measures
p-value: 0.16895% CI: [-5.5, 1]Mixed Model Repeated Measures
Secondary
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Serum samples were collected for the analysis of 25-hydroxyvitamin D. Baseline value was the value from latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum 25-hydroxyvitamin D in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Week 24, n=1 | 2 Nanomoles per liter |
Secondary
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144
Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144 | Week 96, n=315, 291 | -11.5 Nanomoles per liter | Standard Error 1.17 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144 | Week 144, n=315, 303 | -7.5 Nanomoles per liter | Standard Error 1.28 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144 | Week 96, n=315, 291 | -2.2 Nanomoles per liter | Standard Error 2.06 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144 | Week 144, n=315, 303 | -1.9 Nanomoles per liter | Standard Error 1.5 |
p-value: <0.00195% CI: [-14, -4.7]Mixed Model Repeated Measures
p-value: 0.00595% CI: [-9.4, -1.7]Mixed Model Repeated Measures
Secondary
Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144
Serum samples were collected for analysis of bone biomarkers. Baseline is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | Bone-ALP, Week 96, n=316, 289 | -0.62 Micrograms per liter | Standard Error 0.145 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | P1NP, Week 96, n=316 ,290 | 6.7 Micrograms per liter | Standard Error 0.87 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | Osteocalcin, Week 96, n=315 , 288 | -1.97 Micrograms per liter | Standard Error 0.288 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | P1NP, Week 144, n=315, 302 | 3.9 Micrograms per liter | Standard Error 0.94 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | Bone-ALP, Week 144, n=314, 301 | -0.27 Micrograms per liter | Standard Error 0.163 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | CTX-1, Week 96 ,n=315, 289 | 0.0201 Micrograms per liter | Standard Error 0.01123 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | CTX-1, Week 48, n=315, 300 | 0.0022 Micrograms per liter | Standard Error 0.00947 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | Osteocalcin, Week 144, n=315, 301 | -0.74 Micrograms per liter | Standard Error 0.266 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | CTX-1, Week 48, n=315, 300 | -0.0104 Micrograms per liter | Standard Error 0.00907 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | Bone-ALP, Week 96, n=316, 289 | -0.79 Micrograms per liter | Standard Error 0.137 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | Bone-ALP, Week 144, n=314, 301 | -0.40 Micrograms per liter | Standard Error 0.177 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | Osteocalcin, Week 96, n=315 , 288 | -0.10 Micrograms per liter | Standard Error 0.306 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | Osteocalcin, Week 144, n=315, 301 | 1.21 Micrograms per liter | Standard Error 0.32 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | P1NP, Week 96, n=316 ,290 | 4.7 Micrograms per liter | Standard Error 0.8 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | P1NP, Week 144, n=315, 302 | 3.5 Micrograms per liter | Standard Error 1.04 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 | CTX-1, Week 96 ,n=315, 289 | 0.0050 Micrograms per liter | Standard Error 0.00929 |
p-value: 0.38695% CI: [-0.22, 0.57]Mixed Model Repeated Measures
p-value: 0.57395% CI: [-0.34, 0.61]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-2.7, -1.04]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-2.77, -1.14]Mixed Model Repeated Measures
p-value: 0.08295% CI: [-0.3, 4.4]Mixed Model Repeated Measures
p-value: 0.76595% CI: [-2.3, 3.2]Mixed Model Repeated Measures
p-value: 0.30195% CI: [-0.0136, 0.0438]Mixed Model Repeated Measures
p-value: 0.3495% CI: [-0.0133, 0.0384]Mixed Model Repeated Measures
Secondary
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48
Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1) . Change from Baseline is post-dose visit value minus Baseline value. Change from Baseline in bone biomarkers-serum bone-specific ALP (Bone-ALP), osteocalcin, serum P1NP and serum CTX-1 in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48 | Bone-ALP, Week 24, n=1 | 0.3 Micrograms per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48 | Osteocalcin, Week 24, n=1 | 13.4 Micrograms per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48 | P1NP, Week24, n=1 | 11 Micrograms per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48 | CTX-1, Week 24,n=1 | 0.045 Micrograms per liter |
Secondary
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48
Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, body mass index (BMI) (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | CTX-1, Week 48, n=343, 343 | 0.0602 Micrograms per liter | Standard Error 0.01024 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | Bone-ALP, Week 24, n=350, 354 | -0.77 Micrograms per liter | Standard Error 0.112 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | Bone-ALP, Week 48, n=343, 342 | -0.03 Micrograms per liter | Standard Error 0.145 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | Osteocalcin, Week 24, n=350 ,353 | -1.08 Micrograms per liter | Standard Error 0.248 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | Osteocalcin, Week 48, n=343, 342 | -1.15 Micrograms per liter | Standard Error 0.26 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | P1NP, Week24, n=349 ,356 | 7.0 Micrograms per liter | Standard Error 0.87 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | CTX-1, Week 24,n=350,356 | 0.0350 Micrograms per liter | Standard Error 0.01057 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | P1NP, Week48, n=342, 343 | 9.3 Micrograms per liter | Standard Error 1.06 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | P1NP, Week48, n=342, 343 | 6.4 Micrograms per liter | Standard Error 1 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | CTX-1, Week 48, n=343, 343 | 0.0310 Micrograms per liter | Standard Error 0.00889 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | Osteocalcin, Week 48, n=343, 342 | 0.69 Micrograms per liter | Standard Error 0.279 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | Bone-ALP, Week 24, n=350, 354 | -1.05 Micrograms per liter | Standard Error 0.089 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | CTX-1, Week 24,n=350,356 | -0.0031 Micrograms per liter | Standard Error 0.00833 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | Bone-ALP, Week 48, n=343, 342 | -0.34 Micrograms per liter | Standard Error 0.117 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | P1NP, Week24, n=349 ,356 | 5.0 Micrograms per liter | Standard Error 0.72 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 | Osteocalcin, Week 24, n=350 ,353 | 0.26 Micrograms per liter | Standard Error 0.229 |
p-value: 0.04795% CI: [0, 0.57]Mixed Model Repeated Measures
p-value: 0.09495% CI: [-0.05, 0.68]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-2.01, -0.68]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-2.59, -1.09]Mixed Model Repeated Measures
p-value: 0.06695% CI: [-0.1, 4.3]Mixed Model Repeated Measures
p-value: 0.04695% CI: [0, 5.8]Mixed Model Repeated Measures
p-value: 0.00595% CI: [0.0117, 0.0646]Mixed Model Repeated Measures
p-value: 0.03295% CI: [0.0025, 0.0559]Mixed Model Repeated Measures
Secondary
Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48
Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over 48 Weeks. Baseline (Day 1) values were the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable .
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: ITT-E Population. All 741 (369+372) participants were analyzed, however only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48 | Week 24, n=346, 358 | 0.010 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48 | Week 48, n=342, 343 | 0.030 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48 | Week 24, n=346, 358 | 0.040 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48 | Week 48, n=342, 343 | 0.050 Ratio |
Secondary
Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144
Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio and were evaluated by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over Weeks 96 and 144. Baseline (Day 1) values are the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144 | Week 96, n=312, 292 | 0.035 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144 | Week 144, n=307, 300 | 0.060 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144 | Week 96, n=312, 292 | 0.080 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144 | Week 144, n=307, 300 | 0.100 Ratio |
Secondary
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: ITT-E Population. All 741 (369+372) participants were analyzed, however only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in CD4+ Cell Count at Weeks 24 and 48 | Week 24, n=351, 359 | 21.0 Cells per cubic millimeter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in CD4+ Cell Count at Weeks 24 and 48 | Week 48, n=344, 345 | 22.5 Cells per cubic millimeter |
| TAF Based Regimen (Early Switch) | Change From Baseline in CD4+ Cell Count at Weeks 24 and 48 | Week 24, n=351, 359 | 6.0 Cells per cubic millimeter |
| TAF Based Regimen (Early Switch) | Change From Baseline in CD4+ Cell Count at Weeks 24 and 48 | Week 48, n=344, 345 | 11.0 Cells per cubic millimeter |
Secondary
Change From Baseline in CD4+ Cell Count at Weeks 96 and 144
CD4+ cells are a type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+and evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in CD4+ Cell Count at Weeks 96 and 144 | Week 96, n=315, 295 | 61.0 Cells per cubic millimeter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in CD4+ Cell Count at Weeks 96 and 144 | Week 144, n=309, 301 | 36.0 Cells per cubic millimeter |
| TAF Based Regimen (Early Switch) | Change From Baseline in CD4+ Cell Count at Weeks 96 and 144 | Week 96, n=315, 295 | 45.0 Cells per cubic millimeter |
| TAF Based Regimen (Early Switch) | Change From Baseline in CD4+ Cell Count at Weeks 96 and 144 | Week 144, n=309, 301 | 35.0 Cells per cubic millimeter |
Secondary
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset. Baseline was the latest pre-dose assessment value with a non-missing value (Day 1) and change from Baseline is defined as post-dose value minus Baseline value.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48 | Week 24 | 1.2 Scores on a scale | Standard Error 0.49 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48 | Week 48 | 1.1 Scores on a scale | Standard Error 0.52 |
| TAF Based Regimen (Early Switch) | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48 | Week 24 | 1.3 Scores on a scale | Standard Error 0.44 |
| TAF Based Regimen (Early Switch) | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48 | Week 48 | 1.7 Scores on a scale | Standard Error 0.43 |
p-value: 0.87995% CI: [-1.4, 1.2]Mixed Model Repeated Measures
p-value: 0.41495% CI: [-1.9, 0.8]Mixed Model Repeated Measures
Secondary
Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144 | Week 144, n=364, 368 | 0.2 Scores on a scale | Standard Error 0.58 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144 | Week 96, n=364, 369 | 0.7 Scores on a scale | Standard Error 0.52 |
| TAF Based Regimen (Early Switch) | Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144 | Week 144, n=364, 368 | 1.4 Scores on a scale | Standard Error 0.5 |
| TAF Based Regimen (Early Switch) | Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144 | Week 96, n=364, 369 | 1.9 Scores on a scale | Standard Error 0.48 |
p-value: 0.10295% CI: [-2.5, 0.2]Mixed Model Repeated Measures
p-value: 0.09395% CI: [-2.8, 0.2]Mixed Model Repeated Measures
Secondary
Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144
EQ-5D-5L questionnaire provides profile of participant function and global health state rating. Five-item measure has 1question assessing each of 5dimensions:mobility,self-care,usual activities,pain/discomfort,anxiety/depression and 5 levels for each dimension including 1=no problems,2=slight problems,3=moderate problems,4=severe problems,5=extreme problems. Health state is defined by combining levels of answers from each of 5 questions. Each health state is referred to in terms of a 5 digit code.Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state.EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.Baseline is latest pre-dose assessment value with a non-missing value (Day 1).Change from Baseline is post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144 | Week 96, n=364, 370 | -0.0036 Scores on a scale | Standard Error 0.00442 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144 | Week 144, n=364, 369 | -0.0151 Scores on a scale | Standard Error 0.00502 |
| TAF Based Regimen (Early Switch) | Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144 | Week 96, n=364, 370 | -0.0038 Scores on a scale | Standard Error 0.00446 |
| TAF Based Regimen (Early Switch) | Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144 | Week 144, n=364, 369 | -0.0042 Scores on a scale | Standard Error 0.00492 |
p-value: 0.96595% CI: [-0.0121, 0.0126]Mixed Model Repeated Measures
p-value: 0.1295% CI: [-0.0247, 0.0029]Mixed Model Repeated Measures
Secondary
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48 | Week 48 | 0.0037 Scores on a scale | Standard Error 0.00407 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48 | Week 24 | 0.0029 Scores on a scale | Standard Error 0.00383 |
| TAF Based Regimen (Early Switch) | Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48 | Week 24 | 0.0046 Scores on a scale | Standard Error 0.00352 |
| TAF Based Regimen (Early Switch) | Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48 | Week 48 | 0.0023 Scores on a scale | Standard Error 0.00373 |
p-value: 0.74195% CI: [-0.0119, 0.0085]Mixed Model Repeated Measures
p-value: 0.79295% CI: [-0.0094, 0.0123]Mixed Model Repeated Measures
Secondary
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 plasma cholesterol, plasma LDL cholesterol, plasma high density lipoprotein (HDL) cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at weeks 24 and 48
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma HDL Cholesterol, Week 48, n=275, 263 | 0.000 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma cholesterol, Week 48, n=275, 263 | -0.200 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma Triglycerides, Week 24, n=282, 264 | -0.100 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma cholesterol, Week 24, n=282, 264 | -0.325 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma LDL Cholesterol, Week 24, n=282, 264 | -0.210 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma LDL Cholesterol, Week 48, n=275, 263 | -0.170 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma Triglycerides, Week 48, n=275, 263 | -0.100 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma HDL Cholesterol, Week 24, n=282, 264 | -0.050 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma Triglycerides, Week 48, n=275, 263 | 0.100 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma LDL Cholesterol, Week 24, n=282, 264 | -0.060 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma LDL Cholesterol, Week 48, n=275, 263 | 0.070 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma cholesterol, Week 24, n=282, 264 | 0.000 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma Triglycerides, Week 24, n=282, 264 | 0.060 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma HDL Cholesterol, Week 48, n=275, 263 | 0.050 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma HDL Cholesterol, Week 24, n=282, 264 | 0.050 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 | Plasma cholesterol, Week 48, n=275, 263 | 0.100 Millimoles per liter |
Secondary
Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Blood samples were collected at Baseline (Day 1), weeks 24 and 48 visit (participant withdrew from the study at Week 36) to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for fasting lipids in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Plasma cholesterol, Week 24, n=1 | 0 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Plasma LDL Cholesterol, Week 24, n=1 | -0.67 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Plasma Triglycerides, Week 24, n=1 | 1.36 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Plasma HDL Cholesterol, Week 24, n=1 | 0.05 Millimoles per liter |
Secondary
Change From Baseline in Fasting Lipids at Weeks 96 and 144
Blood samples were collected at Baseline (Day 1), Weeks 96 and 144 to assess fasting lipids which includes plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value is the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma LDL Cholesterol, Week 96, n=238, 213 | -5.6 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma LDL Cholesterol, Week 144, n=243, 230 | -5.0 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma Triglycerides, Week 144, n=243, 230 | -9.4 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma HDL Cholesterol, Week 96, n=238, 213 | -3.8 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma HDL Cholesterol, Week 144, n=243, 230 | -3.8 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma cholesterol, Week 96, n=238, 213 | -3.7 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma cholesterol, Week 144, n=243, 230 | -4.0 Millimoles per liter |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma Triglycerides, Week 96, n=238, 213 | -2.1 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma cholesterol, Week 144, n=243, 230 | 3.8 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma LDL Cholesterol, Week 96, n=238, 213 | 1.7 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma LDL Cholesterol, Week 144, n=243, 230 | 4.2 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma Triglycerides, Week 96, n=238, 213 | 4.9 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma cholesterol, Week 96, n=238, 213 | 1.2 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma Triglycerides, Week 144, n=243, 230 | 2.2 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma HDL Cholesterol, Week 144, n=243, 230 | 3.8 Millimoles per liter |
| TAF Based Regimen (Early Switch) | Change From Baseline in Fasting Lipids at Weeks 96 and 144 | Plasma HDL Cholesterol, Week 96, n=238, 213 | 0.0 Millimoles per liter |
Secondary
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48
Serum samples assessed: renal inflammation biomarker serum creatinine.Baseline(Day 1)was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 | Week 24, n=351, 359 | 7.47 Micromoles per liter | Standard Error 0.466 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 | Week 48, n=344, 345 | 6.67 Micromoles per liter | Standard Error 0.493 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 | Week 48, n=344, 345 | 2.18 Micromoles per liter | Standard Error 0.45 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 | Week 24, n=351, 359 | 3.11 Micromoles per liter | Standard Error 0.495 |
p-value: <0.00195% CI: [3.03, 5.7]Mixed Model Repeated Measures
p-value: <0.00195% CI: [3.18, 5.81]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - serum creatinine. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum creatinine in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Week 24, n=1 | -8 Micromoles per liter |
Secondary
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144
Serum samples were collected to assess renal inflammation biomarker - serum creatinine. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144 | Week 96, n=316, 294 | 5.53 Micromoles per liter | Standard Error 0.553 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144 | Week 144, n=311, 302 | 9.25 Micromoles per liter | Standard Error 0.637 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144 | Week 96, n=316, 294 | 0.58 Micromoles per liter | Standard Error 0.515 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144 | Week 144, n=311, 302 | 5.17 Micromoles per liter | Standard Error 0.633 |
p-value: <0.00195% CI: [3.47, 6.43]Mixed Model Repeated Measures
p-value: <0.00195% CI: [2.32, 5.85]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48
Serum samples were collected to assess renal biomarker. Baseline was latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for following:treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 | Week 24, n=351, 357 | -0.03 Milligrams per liter | Standard Error 0.005 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 | Week 48, n=344, 343 | 0.00 Milligrams per liter | Standard Error 0.006 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 | Week 24, n=351, 357 | -0.02 Milligrams per liter | Standard Error 0.004 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 | Week 48, n=344, 343 | 0.01 Milligrams per liter | Standard Error 0.005 |
p-value: 0.02795% CI: [-0.03, 0]Mixed Model Repeated Measures
p-value: 0.06195% CI: [-0.03, 0]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - cystatin C. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum cystatin -C biomarker in TDF based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Week 24, n=1 | 0 Milligrams per liter |
Secondary
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144
Serum samples were collected to assess renal biomarker. Baseline is latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144 | Week 96, n=316, 290 | 0.07 Milligrams per liter | Standard Error 0.008 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144 | Week 144, n=315, 302 | 0.13 Milligrams per liter | Standard Error 0.006 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144 | Week 96, n=316, 290 | 0.10 Milligrams per liter | Standard Error 0.009 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144 | Week 144, n=315, 302 | 0.14 Milligrams per liter | Standard Error 0.006 |
p-value: 0.09495% CI: [-0.03, 0]Mixed Model Repeated Measures
p-value: 0.00495% CI: [-0.06, -0.01]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48
Serum samples assessed:serum GFR from cystatin C and from creatinine adjusted using CKD-EPI Baseline(Day 1) was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value.Adjusted mean and standard error is presented.Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class,CD4+ cell count(continuous),age(continuous), sex, race, BMI(continuous),presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 | GFR from creatinine CKD-EPI, Week 24, n=351, 359 | -8.8 Milliliters/minute/1.73*meter square | Standard Error 0.48 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 | GFR from cystatin C CKD-EPI, Week 24, n=351, 357 | 3.2 Milliliters/minute/1.73*meter square | Standard Error 0.52 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 | GFR from creatinine CKD-EPI, Week 48, n=344, 345 | -7.7 Milliliters/minute/1.73*meter square | Standard Error 0.48 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 | GFR from cystatin C CKD-EPI, Week 48, n=344, 343 | 0.1 Milliliters/minute/1.73*meter square | Standard Error 0.61 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 | GFR from creatinine CKD-EPI, Week 48, n=344, 345 | -2.9 Milliliters/minute/1.73*meter square | Standard Error 0.48 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 | GFR from cystatin C CKD-EPI, Week 48, n=344, 343 | -1.6 Milliliters/minute/1.73*meter square | Standard Error 0.59 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 | GFR from creatinine CKD-EPI, Week 24, n=351, 359 | -3.8 Milliliters/minute/1.73*meter square | Standard Error 0.47 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 | GFR from cystatin C CKD-EPI, Week 24, n=351, 357 | 1.5 Milliliters/minute/1.73*meter square | Standard Error 0.46 |
p-value: 0.01295% CI: [0.4, 3.1]Mixed Model Repeated Measures
p-value: 0.05995% CI: [-0.1, 3.3]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-6.3, -3.7]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-6.1, -3.4]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarkers - serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | GFR from cystatin C CKD-EPI, Week 24, n=1 | 0 Milliliters/minute/1.73*meter square |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | GFR from creatinine CKD-EPI, Week 24, n=1 | 4 Milliliters/minute/1.73*meter square |
Secondary
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144
Serum samples were collected to assess serum GFR from cystatin C and from creatinine adjusted for BSA. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 | GFR from cystatin C CKD-EPI, Week 96, n=316, 290 | -7.6 Milliliters/minute/1.73*meter square | Standard Error 0.89 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 | GFR from cystatin C CKD-EPI, Week 144, n=315, 302 | -13.9 Milliliters/minute/1.73*meter square | Standard Error 0.71 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 | GFR from creatinine adjusted for BSA, Week 96, n=315, 294 | -7.2 Milliliters/minute/1.73*meter square | Standard Error 0.55 |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 | GFR from creatinine adjusted for BSA, Week 144, n=311, 300 | -11.5 Milliliters/minute/1.73*meter square | Standard Error 0.62 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 | GFR from creatinine adjusted for BSA, Week 144, n=311, 300 | -7.0 Milliliters/minute/1.73*meter square | Standard Error 0.6 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 | GFR from cystatin C CKD-EPI, Week 96, n=316, 290 | -11.7 Milliliters/minute/1.73*meter square | Standard Error 0.99 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 | GFR from creatinine adjusted for BSA, Week 96, n=315, 294 | -1.9 Milliliters/minute/1.73*meter square | Standard Error 0.52 |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 | GFR from cystatin C CKD-EPI, Week 144, n=315, 302 | -15.8 Milliliters/minute/1.73*meter square | Standard Error 0.7 |
p-value: 0.00295% CI: [1.5, 6.7]Mixed Model Repeated Measures
p-value: 0.06495% CI: [-0.1, 3.8]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-6.7, -3.8]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-6.2, -2.8]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen
Urine samples were collected at Baseline, Week 24 and Week 48 to assess renal biomarkers - urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline was defined as the latest pre-dose assessment value with a non-missing value. (Day 1). Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Change from Baseline in UP/C was calculated as UP/C ratio at post-Baseline visit minus UP/C ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen | UA/C, Week 24, n=1 | 0 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen | UP/C, Week 24, n=1 | 0.3 Ratio |
Secondary
Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144
Urine samples were collected at Baseline, Weeks 96 and 144. Baseline is defined as Day 1. Change from Baseline in UA/C is defined as UA/C ratio at post-Baseline visit minus UA/C ratio at Baseline. Change from Baseline in UP/C and UA/C is defined as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio at Baseline, respectively. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 | UA/C, Week 96, n=208, 175 | 1.058 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 | UA/C, Week 144, n=202, 179 | 1.203 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 | UP/C, Week 96, n=245, 206 | 1.048 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 | UP/C, Week 144, n=237, 220 | 1.182 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 | UP/C, Week 144, n=237, 220 | 1.188 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 | UA/C, Week 96, n=208, 175 | 1.075 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 | UP/C, Week 96, n=245, 206 | 1.105 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 | UA/C, Week 144, n=202, 179 | 1.200 Ratio |
p-value: 0.795% CI: [0.866, 1.102]Mixed Model Repeated Measures
p-value: 0.795% CI: [0.835, 1.129]Mixed Model Repeated Measures
p-value: 0.35695% CI: [0.907, 1.036]Mixed Model Repeated Measures
p-value: 0.81495% CI: [0.916, 1.071]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48
Urine samples were collected at Baseline, Week 24 and Week 48. Baseline is defined as Day 1. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. Change from Baseline in UP/C and UA/C was calculated as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio calculated at Baseline, respectively. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at weeks 24 and 48
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 | UA/C, Week 24, n=235, 230 | 1.080 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 | UA/C, Week 48, n=230, 224 | 1.125 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 | UP/C, Week 24, n=267, 261 | 0.955 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 | UP/C, Week 48, n=261, 257 | 0.971 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 | UP/C, Week 48, n=261, 257 | 1.016 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 | UA/C, Week 24, n=235, 230 | 1.022 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 | UP/C, Week 24, n=267, 261 | 0.976 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 | UA/C, Week 48, n=230, 224 | 1.059 Ratio |
p-value: 0.25795% CI: [0.96, 1.164]Mixed Model Repeated Measures
p-value: 0.3595% CI: [0.936, 1.205]Mixed Model Repeated Measures
p-value: 0.47395% CI: [0.924, 1.037]Mixed Model Repeated Measures
p-value: 0.21295% CI: [0.891, 1.026]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48
Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine beta-2 microglobulin/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at weeks 24 and 48
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 | Week 24, n=136, 141 | 0.991 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 | Week 48, n=126, 141 | 0.973 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 | Week 24, n=136, 141 | 1.034 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 | Week 48, n=126, 141 | 0.922 Ratio |
p-value: 0.5695% CI: [0.83, 1.106]Mixed Model Repeated Measures
p-value: 0.48995% CI: [0.906, 1.229]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Urine biomarker samples were collected to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at weeks 24 and 48
Population: Safety Population. Data was not collected for this arm. Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Week 24 | — |
| Unknown | Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Week 48 | — |
Secondary
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144
Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine is defined as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category title)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144 | Week 96, n=109, 107 | 1.080 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144 | Week 144, n=101, 97 | 0.904 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144 | Week 96, n=109, 107 | 0.986 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144 | Week 144, n=101, 97 | 0.958 Ratio |
p-value: 0.08195% CI: [0.981, 1.384]Mixed Model Repeated Measures
p-value: 0.83495% CI: [0.819, 1.175]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48
Urine biomarker samples were collected at Baseline and at Weeks 24 and 48 to assess urine phosphate. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at weeks 24 and 48
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 | Week 24, n=348, 352 | 0.955 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 | Week 48, n=342, 340 | 0.969 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 | Week 24, n=348, 352 | 0.940 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 | Week 48, n=342, 340 | 0.970 Ratio |
p-value: 0.75895% CI: [0.915, 1.13]Mixed Model Repeated Measures
p-value: 0.98595% CI: [0.894, 1.116]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Urine biomarker samples were collected to assess urine phosphate. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Week 24, n=1 | 2.9 Ratio |
Secondary
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144
Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine phosphate. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate is defined as urine phosphate at post-Baseline visit minus urine phosphate at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144 | Week 96, n=312, 286 | 0.960 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144 | Week 144, n=313, 298 | 0.890 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144 | Week 96, n=312, 286 | 0.978 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144 | Week 144, n=313, 298 | 0.912 Ratio |
p-value: 0.80695% CI: [0.904, 1.139]Mixed Model Repeated Measures
p-value: 0.74595% CI: [0.909, 1.142]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48
Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine retinol binding protein 4/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio was calculated as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at weeks 24 and 48
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 | Week 24, n=344, 343 | 0.860 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 | Week 48, n=340, 335 | 1.063 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 | Week 24, n=344, 343 | 0.920 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 | Week 48, n=340, 335 | 1.068 Ratio |
p-value: 0.26495% CI: [0.83, 1.052]Mixed Model Reported Measures
p-value: 0.93295% CI: [0.903, 1.098]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Urine biomarker samples were collected to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine retinol binding protein 4/urine creatinine was calculated as urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen | Week 24, n=1 | 1.04 Ratio |
Secondary
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144
Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio is defined as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144 | Week 96, n=310, 282 | 0.926 Ratio |
| DTG+3TC FDC (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144 | Week 144, n=304, 288 | 1.188 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144 | Week 96, n=310, 282 | 0.851 Ratio |
| TAF Based Regimen (Early Switch) | Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144 | Week 144, n=304, 288 | 1.227 Ratio |
p-value: 0.01195% CI: [1.032, 1.281]Mixed Model Repeated Measures
p-value: 0.89595% CI: [0.905, 1.121]Mixed Model Repeated Measures
Secondary
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.
Time frame: Up to Week 48
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 48 | 0 Participants |
Secondary
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of TDF-based regimen participants with adverse events by maximum grade have been presented.
Time frame: Up to Week 48
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48 | Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48 | Grade 2 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48 | Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48 | Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48 | Grade 5 | 0 Participants |
Secondary
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Number of TDF-based regimen participants with any SAE and common (\>=2%) non-SAEs are presented.
Time frame: Up to Week 48
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.Data not collected post week 48 as the participant withdrew from the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48 | Any non-SAE (>=2%) | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48 | Any SAE | 0 Participants |
Secondary
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36
samples were collected up to the Week 36 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
Time frame: Up to Week 36
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. Data not collected post week 36 as the participant withdrew from the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | ALT, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | ALT, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | ALT, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Albumin, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Albumin, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Albumin, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | ALP, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | ALP, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | ALP, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | ALP, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | AST, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | AST, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | AST, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | AST, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Bilirubin, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Bilirubin, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Bilirubin, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Bilirubin, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | CO2, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | CO2, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | CO2, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Cholesterol, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Cholesterol, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Cholesterol, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | CK, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | CK, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | CK, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | CK, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Creatinine, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Creatinine, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Creatinine, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Direct bilirubin, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Direct bilirubin, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Direct bilirubin, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | GFR from creatinine adjusted using CKD EPI,Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | GFR from creatinine adjusted using CKD EPI,Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | GFR from creatinine adjusted using CKD EPI,Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | GFR from creatinine adjusted using CKD EPI,Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | GFR from cystatin C adjusted using CKD-EPI,Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | GFR from cystatin C adjusted using CKD-EPI,Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | GFR from cystatin C adjusted using CKD-EPI,Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypercalcemia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hyperglycemia, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hyperglycemia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hyperglycemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hyperglycemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hyperkalemia, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hyperkalemia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hyperkalemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hyperkalemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypernatremia, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypernatremia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypernatremia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypernatremia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypocalcemia, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypocalcemia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypocalcemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypoglycemia, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypoglycemia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypoglycemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypoglycemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypokalemia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypokalemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypokalemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hyponatremia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hyponatremia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | LDL cholesterol, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | LDL cholesterol, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | LDL cholesterol, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Phosphate, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Phosphate, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Phosphate, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Phosphate, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Triglycerides, Grade 1 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Triglycerides, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Triglycerides, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Albumin, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | CO2, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Cholesterol, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | ALT, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Creatinine, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Direct bilirubin, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | GFR from cystatin C adjusted using CKD-EPI,Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypercalcemia, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypercalcemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypercalcemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypocalcemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hypokalemia, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hyponatremia, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Hyponatremia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | LDL cholesterol, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 | Triglycerides, Grade 2 | 0 Participants |
Secondary
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36
Blood samples were collected up to the Week 36 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those TDF-based regimen participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.
Time frame: Up to Week 36
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen. Data not collected post week 36 as the participant withdrew from the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Leukocytes, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Hemoglobin, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Hemoglobin, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Hemoglobin, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Hemoglobin, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Leukocytes, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Leukocytes, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Leukocytes, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Neutrophils, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Neutrophils, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Neutrophils, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Neutrophils, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Platelets, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Platelets, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Platelets, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 | Platelets, Grade 4 | 0 Participants |
Secondary
Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Time frame: Up to Week 144
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144 | 23 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144 | 7 Participants |
Secondary
Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.
Time frame: Up to Week 48
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48 | 13 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48 | 2 Participants |
Secondary
Number of Participants With AEs by Their Severity Grades: Up to Week 144
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Time frame: Up to Week 144
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 144 | Grade 2 | 217 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 144 | Grade 4 | 9 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 144 | Grade 3 | 50 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 144 | Grade 5 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 144 | Grade 1 | 57 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 144 | Grade 5 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 144 | Grade 1 | 65 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 144 | Grade 2 | 208 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 144 | Grade 3 | 54 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 144 | Grade 4 | 8 Participants |
Secondary
Number of Participants With AEs by Their Severity Grades: Up to Week 48
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Time frame: Up to Week 48
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 48 | Grade 2 | 170 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 48 | Grade 4 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 48 | Grade 3 | 19 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 48 | Grade 5 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 48 | Grade 1 | 102 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 48 | Grade 5 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 48 | Grade 1 | 94 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 48 | Grade 2 | 177 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 48 | Grade 3 | 15 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With AEs by Their Severity Grades: Up to Week 48 | Grade 4 | 6 Participants |
Secondary
Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment
Time frame: Up to Week 148
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148 | Any non-SAE (>=2%) | 307 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148 | Any SAE | 57 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148 | Any non-SAE (>=2%) | 304 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148 | Any SAE | 44 Participants |
Secondary
Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Safety Population included all participants who received at least one dose of study treatment either DTG + 3TC or TBR. This population was based on the treatment the participant actually received. Number of participants with any SAE and common (\>=2%) non-SAEs are presented.
Time frame: Up to Week 48
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48 | Any non-SAE (>=2%) | 222 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48 | Any SAE | 21 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48 | Any non-SAE (>=2%) | 204 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48 | Any SAE | 16 Participants |
Secondary
Number of Participants With Disease Progression at Weeks 24 and 48
HIV-associated conditions were recorded during the study and were assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV were: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: \>=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3:Documented AIDS defining condition or CD4+ T-lymphocye count \<200 cells/mcL. Disease progression summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death.
Time frame: At Weeks 24 and 48
Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 24 and 48 | From CDC Stage 2 to CDC Stage 3 Event | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 24 and 48 | From CDC Stage 1, 2 or 3 to Death | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 24 and 48 | From CDC Stage 3 to new CDC Stage 3 Event | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 24 and 48 | No HIV-1 disease progression | 367 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 24 and 48 | From CDC Stage 1 to CDC Stage 3 Event | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 24 and 48 | No HIV-1 disease progression | 372 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 24 and 48 | From CDC Stage 1 to CDC Stage 3 Event | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 24 and 48 | From CDC Stage 2 to CDC Stage 3 Event | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 24 and 48 | From CDC Stage 3 to new CDC Stage 3 Event | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 24 and 48 | From CDC Stage 1, 2 or 3 to Death | 0 Participants |
Secondary
Number of Participants With Disease Progression at Weeks 96 and 144
HIV-associated conditions were recorded during the study and assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV is: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: \>=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: Documented AIDS-defining condition or CD4+ T-lymphocye count \<200 cells/mcL. Indicators of clinical disease progression is defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death.
Time frame: At Weeks 96 and 144
Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 144, No HIV-1 disease progression | 364 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 96, From CDC Stage 1 to CDC Stage 3 Event | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 96, From CDC Stage 2 to CDC Stage 3 Event | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 96, From CDC Stage 3 to new CDC Stage 3 Event | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 96, From CDC Stage 1, 2 or 3 to Death | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 96, No HIV-1 disease progression | 365 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 144, From CDC Stage 1 to CDC Stage 3 Event | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 144, From CDC Stage 2 to CDC Stage 3 Event | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 144,From CDC Stage 3 to new CDC Stage 3 Event | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 144, From CDC Stage 1, 2 or 3 to Death | 3 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 144, From CDC Stage 2 to CDC Stage 3 Event | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 144, No HIV-1 disease progression | 371 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 96, From CDC Stage 1 to CDC Stage 3 Event | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 96, No HIV-1 disease progression | 372 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 144, From CDC Stage 1, 2 or 3 to Death | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 96, From CDC Stage 2 to CDC Stage 3 Event | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 144, From CDC Stage 1 to CDC Stage 3 Event | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 96, From CDC Stage 3 to new CDC Stage 3 Event | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 144,From CDC Stage 3 to new CDC Stage 3 Event | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Disease Progression at Weeks 96 and 144 | Week 96, From CDC Stage 1, 2 or 3 to Death | 0 Participants |
Secondary
Number of Participants With Genotypic Resistance: Up to Week 144
Plasma samples were collected for drug resistance testing. Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with genotypic resistance to INSTI, NRTI, NNRTI and PI are summarized.
Time frame: Up to Week 144
Population: CVW Population comprises all participants in the ITT-E Population who had met the derived CVW criteria and who had resistance data. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAF Based Regimen (Early Switch) | Number of Participants With Genotypic Resistance: Up to Week 144 | INSTI | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Genotypic Resistance: Up to Week 144 | NRTI | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Genotypic Resistance: Up to Week 144 | NNRTI | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Genotypic Resistance: Up to Week 144 | PI | 0 Participants |
Secondary
Number of Participants With Genotypic Resistance: Up to Week 48
Plasma samples were collected for drug resistance testing. Number of participants, who met confirmed virologic withdrawal (CVW) criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with genotypic resistance to INSTI, nucleoside reverse transcriptase inhibitor (NRTI), NNRTI and PI was summarized.
Time frame: Up to Week 48
Population: CVW Population comprised of all participants in the ITT-E Population who had met the derived CVW criteria. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAF Based Regimen (Early Switch) | Number of Participants With Genotypic Resistance: Up to Week 48 | INSTI | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Genotypic Resistance: Up to Week 48 | NRTI | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Genotypic Resistance: Up to Week 48 | NNRTI | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Genotypic Resistance: Up to Week 48 | PI | 0 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144
Blood samples were collected up to Week 144 for the analysis of clinical chemistry parameters: ALT, albumin, ALP, AST, bilirubin, CO2, cholesterol, CK, creatinine, direct bilirubin, GFR from creatinine adjusted for BSA, GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, LDL cholesterol, phosphate triglycerides and lactate dehydrogenase. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
Time frame: Up to Week 144
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALT, Grade 1 | 55 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALT, Grade 2 | 11 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALT, Grade 3 | 5 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALT, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Albumin, Grade 1 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Albumin, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Albumin, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALP, Grade 1 | 6 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALP, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALP, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | AST, Grade 1 | 34 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | AST, Grade 2 | 13 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | AST, Grade 3 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | AST, Grade 4 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Bilirubin, Grade 1 | 24 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Bilirubin, Grade 3 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Bilirubin, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CO2, Grade 1 | 110 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CO2, Grade 2 | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CO2, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Cholesterol, Grade 1 | 42 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Cholesterol, Grade 3 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CK, Grade 1 | 41 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CK, Grade 3 | 12 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CK, Grade 4 | 10 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Creatinine, Grade 2 | 5 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Creatinine, Grade 3 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Creatinine, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Direct bilirubin, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Direct bilirubin, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Direct bilirubin, Grade 3 | 13 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Direct bilirubin, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from creatinine adjusted using CKD EPI,Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from creatinine adjusted using CKD EPI,Grade 2 | 165 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from creatinine adjusted using CKD EPI,Grade 3 | 38 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from creatinine adjusted using CKD EPI,Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from cystatin C adjusted using CKD-EPI,Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from cystatin C adjusted using CKD-EPI,Grade 3 | 46 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypercalcemia, Grade 1 | 8 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypercalcemia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypercalcemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypercalcemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperglycemia, Grade 3 | 4 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperglycemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperkalemia, Grade 1 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperkalemia, Grade 2 | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperkalemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperkalemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypernatremia, Grade 1 | 4 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypernatremia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypocalcemia, Grade 2 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypocalcemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypoglycemia, Grade 2 | 4 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypokalemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyponatremia, Grade 1 | 21 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | LDL cholesterol, Grade 3 | 8 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Phosphate, Grade 1 | 61 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Albumin, Grade 2 | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALP, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Bilirubin, Grade 2 | 9 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CO2, Grade 3 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Cholesterol, Grade 2 | 26 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Cholesterol, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CK, Grade 2 | 12 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Creatinine, Grade 1 | 21 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from cystatin C adjusted using CKD-EPI,Grade 2 | 169 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from cystatin C adjusted using CKD-EPI,Grade 4 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperglycemia, Grade 1 | 73 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperglycemia, Grade 2 | 40 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypernatremia, Grade 2 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypernatremia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypocalcemia, Grade 1 | 14 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypocalcemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypoglycemia, Grade 1 | 9 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypoglycemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypoglycemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypokalemia, Grade 1 | 10 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypokalemia, Grade 2 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypokalemia, Grade 3 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyponatremia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyponatremia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyponatremia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | LDL cholesterol, Grade 1 | 41 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | LDL cholesterol, Grade 2 | 19 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | LDL cholesterol, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Phosphate, Grade 2 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Phosphate, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Phosphate, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Triglycerides, Grade 1 | 60 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Triglycerides, Grade 2 | 6 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Triglycerides, Grade 3 | 6 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Triglycerides, Grade 4 | 4 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Lactate Dehydrogenase Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Lactate Dehydrogenase Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Lactate Dehydrogenase Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Lactate Dehydrogenase Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperkalemia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALT, Grade 1 | 49 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | LDL cholesterol, Grade 1 | 56 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperkalemia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALT, Grade 3 | 3 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Triglycerides, Grade 2 | 15 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALT, Grade 4 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypernatremia, Grade 1 | 3 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Albumin, Grade 1 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | LDL cholesterol, Grade 3 | 9 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Albumin, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypernatremia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Albumin, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypocalcemia, Grade 1 | 5 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALP, Grade 1 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALP, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Lactate Dehydrogenase Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALP, Grade 3 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypocalcemia, Grade 2 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALP, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypoglycemia, Grade 1 | 10 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | AST, Grade 1 | 45 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypocalcemia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | AST, Grade 2 | 9 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypocalcemia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | AST, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypoglycemia, Grade 2 | 3 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | AST, Grade 4 | 3 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Triglycerides, Grade 3 | 5 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Bilirubin, Grade 1 | 12 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Bilirubin, Grade 2 | 4 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypokalemia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Bilirubin, Grade 3 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypoglycemia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Bilirubin, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyponatremia, Grade 1 | 26 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CO2, Grade 1 | 97 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | LDL cholesterol, Grade 2 | 24 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CO2, Grade 2 | 4 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CO2, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Phosphate, Grade 2 | 9 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CO2, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | LDL cholesterol, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Cholesterol, Grade 1 | 70 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypoglycemia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Cholesterol, Grade 3 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Cholesterol, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Phosphate, Grade 1 | 71 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CK, Grade 1 | 30 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CK, Grade 2 | 13 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Creatinine, Grade 2 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CK, Grade 3 | 12 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | ALT, Grade 2 | 9 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | CK, Grade 4 | 10 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Creatinine, Grade 1 | 12 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Lactate Dehydrogenase Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Albumin, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Creatinine, Grade 3 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypokalemia, Grade 1 | 7 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Creatinine, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Phosphate, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Direct bilirubin, Grade 1 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypokalemia, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Direct bilirubin, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Triglycerides, Grade 4 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Direct bilirubin, Grade 3 | 3 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Cholesterol, Grade 2 | 34 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Direct bilirubin, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypokalemia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from creatinine adjusted using CKD EPI,Grade 1 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Phosphate, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from creatinine adjusted using CKD EPI,Grade 2 | 101 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyponatremia, Grade 2 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from creatinine adjusted using CKD EPI,Grade 3 | 24 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Lactate Dehydrogenase Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from creatinine adjusted using CKD EPI,Grade 4 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyponatremia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from cystatin C adjusted using CKD-EPI,Grade 1 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from cystatin C adjusted using CKD-EPI,Grade 2 | 183 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypercalcemia, Grade 1 | 9 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from cystatin C adjusted using CKD-EPI,Grade 3 | 58 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | GFR from cystatin C adjusted using CKD-EPI,Grade 4 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypercalcemia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Triglycerides, Grade 1 | 77 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypercalcemia, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperglycemia, Grade 1 | 77 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypercalcemia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyponatremia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperglycemia, Grade 2 | 31 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperglycemia, Grade 3 | 4 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperglycemia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Lactate Dehydrogenase Grade 1 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperkalemia, Grade 1 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypernatremia, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hyperkalemia, Grade 2 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 | Hypernatremia, Grade 3 | 0 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48
Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
Time frame: Up to Week 48
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Direct bilirubin, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Phosphate, Grade 1 | 38 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from creatinine adjusted using CKD EPI,Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypocalcemia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from creatinine adjusted using CKD EPI,Grade 2 | 135 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Phosphate, Grade 2 | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from creatinine adjusted using CKD EPI,Grade 3 | 26 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypokalemia, Grade 1 | 7 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from creatinine adjusted using CKD EPI,Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Phosphate, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from cystatin C adjusted using CKD-EPI,Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypokalemia, Grade 2 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from cystatin C adjusted using CKD-EPI,Grade 2 | 52 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Phosphate, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from cystatin C adjusted using CKD-EPI,Grade 3 | 5 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypernatremia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from cystatin C adjusted using CKD-EPI,Grade 4 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Triglycerides, Grade 1 | 34 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypercalcemia, Grade 1 | 7 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypercalcemia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypokalemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypercalcemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Triglycerides, Grade 2 | 4 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypercalcemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Triglycerides, Grade 3 | 4 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperglycemia, Grade 1 | 56 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypernatremia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperglycemia, Grade 2 | 21 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Triglycerides, Grade 4 | 4 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperglycemia, Grade 3 | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypocalcemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperglycemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperkalemia, Grade 2 | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Cholesterol, Grade 1 | 27 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperkalemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypernatremia, Grade 1 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyponatremia, Grade 1 | 8 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Cholesterol, Grade 2 | 12 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypernatremia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypocalcemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypoglycemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Cholesterol, Grade 3 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyponatremia, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALT, Grade 1 | 24 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALT, Grade 2 | 6 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Cholesterol, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALT, Grade 3 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypokalemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypoglycemia, Grade 1 | 5 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CK, Grade 1 | 28 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALT, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyponatremia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Albumin, Grade 1 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CK, Grade 2 | 4 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Albumin, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperkalemia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Albumin, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CK, Grade 3 | 9 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Albumin, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyponatremia, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALP, Grade 1 | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CK, Grade 4 | 6 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALP, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | LDL cholesterol, Grade 1 | 28 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALP, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Creatinine, Grade 1 | 16 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALP, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypoglycemia, Grade 2 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | AST, Grade 1 | 21 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Creatinine, Grade 2 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | AST, Grade 2 | 7 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | LDL cholesterol, Grade 2 | 13 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | AST, Grade 3 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Creatinine, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | AST, Grade 4 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypocalcemia, Grade 1 | 8 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Bilirubin, Grade 1 | 17 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Creatinine, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Bilirubin, Grade 2 | 5 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | LDL cholesterol, Grade 3 | 6 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Bilirubin, Grade 3 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Direct bilirubin, Grade 1 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Bilirubin, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypoglycemia, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CO2, Grade 1 | 73 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Direct bilirubin, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CO2, Grade 2 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | LDL cholesterol, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CO2, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Direct bilirubin, Grade 3 | 8 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CO2, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperkalemia, Grade 1 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CO2, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypercalcemia, Grade 1 | 3 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperglycemia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperkalemia, Grade 1 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperkalemia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperkalemia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypernatremia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypocalcemia, Grade 1 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypocalcemia, Grade 2 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypocalcemia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypocalcemia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypoglycemia, Grade 1 | 6 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypoglycemia, Grade 2 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypoglycemia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypoglycemia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypokalemia, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypokalemia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypokalemia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyponatremia, Grade 1 | 13 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyponatremia, Grade 2 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyponatremia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | LDL cholesterol, Grade 1 | 35 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | LDL cholesterol, Grade 2 | 15 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | LDL cholesterol, Grade 3 | 3 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | LDL cholesterol, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Phosphate, Grade 1 | 47 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Phosphate, Grade 2 | 7 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Phosphate, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Phosphate, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Triglycerides, Grade 1 | 48 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Triglycerides, Grade 3 | 4 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Triglycerides, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Cholesterol, Grade 1 | 52 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Cholesterol, Grade 2 | 19 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Cholesterol, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Cholesterol, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CK, Grade 1 | 19 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CK, Grade 2 | 9 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CK, Grade 3 | 8 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CK, Grade 4 | 5 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Creatinine, Grade 1 | 7 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Creatinine, Grade 2 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Creatinine, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Creatinine, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Direct bilirubin, Grade 1 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Direct bilirubin, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Direct bilirubin, Grade 3 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Direct bilirubin, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from creatinine adjusted using CKD EPI,Grade 1 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from creatinine adjusted using CKD EPI,Grade 2 | 83 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from creatinine adjusted using CKD EPI,Grade 3 | 13 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from creatinine adjusted using CKD EPI,Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from cystatin C adjusted using CKD-EPI,Grade 1 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from cystatin C adjusted using CKD-EPI,Grade 2 | 66 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from cystatin C adjusted using CKD-EPI,Grade 3 | 4 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | GFR from cystatin C adjusted using CKD-EPI,Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypercalcemia, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypercalcemia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypercalcemia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperglycemia, Grade 1 | 64 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperglycemia, Grade 2 | 19 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperglycemia, Grade 3 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyperkalemia, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypernatremia, Grade 1 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypernatremia, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypernatremia, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hypokalemia, Grade 1 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALT, Grade 1 | 18 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALT, Grade 2 | 4 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Hyponatremia, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Triglycerides, Grade 2 | 11 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALT, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Albumin, Grade 1 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Albumin, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Albumin, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Albumin, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALP, Grade 1 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALP, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALP, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALP, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | AST, Grade 1 | 29 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | AST, Grade 2 | 4 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | AST, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | AST, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Bilirubin, Grade 1 | 7 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Bilirubin, Grade 2 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Bilirubin, Grade 3 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | Bilirubin, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CO2, Grade 1 | 70 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CO2, Grade 2 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | CO2, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 | ALT, Grade 3 | 1 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144
Blood samples were collected up to Week 144 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters are were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
Time frame: Up to Week 144
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Neutrophils, Grade 2 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Platelets, Grade 1 | 8 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Hemoglobin, Grade 1 | 7 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Hemoglobin, Grade 2 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Hemoglobin, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Hemoglobin, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Leukocytes, Grade 1 | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Leukocytes, Grade 2 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Leukocytes, Grade 3 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Leukocytes, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Neutrophils, Grade 1 | 5 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Neutrophils, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Neutrophils, Grade 4 | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Platelets, Grade 2 | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Platelets, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Platelets, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Platelets, Grade 1 | 7 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Leukocytes, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Platelets, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Hemoglobin, Grade 1 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Neutrophils, Grade 1 | 5 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Hemoglobin, Grade 2 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Neutrophils, Grade 2 | 8 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Hemoglobin, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Platelets, Grade 2 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Hemoglobin, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Neutrophils, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Leukocytes, Grade 1 | 4 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Platelets, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Leukocytes, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Neutrophils, Grade 4 | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 | Leukocytes, Grade 3 | 0 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48
Blood samples were collected up to Week 48 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.
Time frame: Up to Week 48
Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Hemoglobin, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Leukocytes, Grade 2 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Hemoglobin, Grade 1 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Hemoglobin, Grade 2 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Hemoglobin, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Leukocytes, Grade 1 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Leukocytes, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Leukocytes, Grade 4 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Neutrophils, Grade 1 | 3 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Neutrophils, Grade 2 | 2 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Neutrophils, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Neutrophils, Grade 4 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Platelets, Grade 1 | 6 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Platelets, Grade 2 | 1 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Platelets, Grade 3 | 0 Participants |
| DTG+3TC FDC (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Platelets, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Platelets, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Neutrophils, Grade 1 | 4 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Platelets, Grade 1 | 5 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Hemoglobin, Grade 1 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Neutrophils, Grade 2 | 4 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Hemoglobin, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Platelets, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Hemoglobin, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Hemoglobin, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Neutrophils, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Leukocytes, Grade 1 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Leukocytes, Grade 2 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Platelets, Grade 2 | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Leukocytes, Grade 3 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Neutrophils, Grade 4 | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 | Leukocytes, Grade 4 | 0 Participants |
Secondary
Number of Participants With Phenotypic Resistance: Up to Week 144
Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with phenotypic resistance to INSTI,NNRT,NRTI and PI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented.
Time frame: Up to Week 144
Population: CVW Population comprised of all participants in the ITT-E Population who had met the derived CVW criteria. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | INSTI, Elvitegravir (EVG), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | INSTI, EVG, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NNRTI, Etravirine (ETR), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, IDV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, Nelfinavir (NFV), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, TPV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NNRTI, EFV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | INSTI, DTG, Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | INSTI, DTG, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | INSTI, Bictegravir (BIC), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | INSTI, BIC, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NNRTI, ETR, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | INSTI, Raltegravir (RAL), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | INSTI, RAL, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NNRTI, Delavirdine (DLV), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NNRTI, DLV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NNRTI, Efavirenz (EFV), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NNRTI, Nevirapine (NVP), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NNRTI, NVP, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NNRTI, Rilpivirine (RPV), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NNRTI, RPV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, 3TC, Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, 3TC, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, Abacavir (ABC), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, ABC, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, Zidovudine (AZT), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, AZT, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, Stavudine (D4T), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, D4T, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, Didanosine (DDI), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, DDI, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, Emtricitabine (FTC), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, FTC, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, Tenofovir (TDF), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | NRTI, TDF, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, Atazanavir (ATV), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, ATV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, Darunavir (DRV), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, DRV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, Fosamprenavir (FPV), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, FPV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, Indinavir (IDV), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, Lopinavir (LPV), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, LPV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, NFV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, Ritonavir (RTV), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, RTV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, Saquinavir (SQV), Sensitive | 2 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, SQV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 144 | PI, Tipranavir (TPV), Sensitive | 2 Participants |
Secondary
Number of Participants With Phenotypic Resistance: Up to Week 48
Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with phenotypic resistance to INSTI, NNRTI,NRTI and PI were summarized. Assessment of antiviral activity of ART using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented.
Time frame: Up to Week 48
Population: CVW Population. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NNRTI, Efavirenz (EFV), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NNRTI, EFV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NNRTI, RPV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, 3TC, Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, 3TC, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, Abacavir (ABC), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, ABC, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, Zidovudine (AZT), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, AZT, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, Tipranavir (TPV), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | INSTI, DTG, Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | INSTI, DTG, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | INSTI, Bictegravir (BIC), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | INSTI, BIC, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | INSTI, Elvitegravir (EVG), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | INSTI, EVG, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | INSTI, Raltegravir (RAL), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | INSTI, RAL, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NNRTI, Delavirdine (DLV), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NNRTI, DLV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NNRTI, Etravirine (ETR), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NNRTI, ETR, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NNRTI, Nevirapine (NVP), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NNRTI, NVP, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NNRTI, Rilpivirine (RPV), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, Stavudine (D4T), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, D4T, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, Didanosine (DDI), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, DDI, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, Emtricitabine (FTC), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, FTC, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, Tenofovir (TDF), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | NRTI, TDF, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, Atazanavir (ATV), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, ATV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, Darunavir (DRV), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, DRV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, Fosamprenavir (FPV), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, FPV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, Indinavir (IDV), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, IDV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, Lopinavir (LPV), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, LPV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, Nelfinavir (NFV), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, NFV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, Ritonavir (RTV), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, RTV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, Saquinavir (SQV), Sensitive | 1 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, SQV, Resistant | 0 Participants |
| TAF Based Regimen (Early Switch) | Number of Participants With Phenotypic Resistance: Up to Week 48 | PI, TPV, Resistant | 0 Participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24
Percentage of participants with plasma HIV-1 RNA \<50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Percentage values are rounded off.
Time frame: Week 24
Population: ITT-E Population. Only those participants with data available at specified time points has been presented. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG+3TC FDC (Early Switch) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24 | 95 Percentage of participants |
| TAF Based Regimen (Early Switch) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24 | 96 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48
Percentage of participants with plasma HIV-1 RNA \<50 c/mL (virologic success) was evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.
Time frame: Week 48
Population: ITT-E Population. Only those participants with data available at specified time points has been analyzed. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG+3TC FDC (Early Switch) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48 | 93.2 Percentage of participants |
| TAF Based Regimen (Early Switch) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48 | 93.0 Percentage of participants |
95% CI: [-3.4, 3.9]
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144
Percentage of participants with plasma HIV-1 RNA \<50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144.
Time frame: Weeks 96 and 144
Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144 | Week 96 | 85.9 Percentage of participants |
| DTG+3TC FDC (Early Switch) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144 | Week 144 | 85.9 Percentage of participants |
| TAF Based Regimen (Early Switch) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144 | Week 96 | 79.0 Percentage of participants |
| TAF Based Regimen (Early Switch) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144 | Week 144 | 81.7 Percentage of participants |
Secondary
Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24
Percentage of participants with plasma HIV-1 RNA \>=50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.
Time frame: Week 24
Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG+3TC FDC (Early Switch) | Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24 | 0.3 Percentage of participants |
| TAF Based Regimen (Early Switch) | Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24 | 0.8 Percentage of participants |
Secondary
Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144
Percentage of participants with plasma HIV-1 RNA \>=50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144.
Time frame: Weeks 96 and 144
Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG+3TC FDC (Early Switch) | Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144 | Week 96 | 0.3 Percentage of participants |
| DTG+3TC FDC (Early Switch) | Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144 | Week 144 | 0.3 Percentage of participants |
| TAF Based Regimen (Early Switch) | Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144 | Week 96 | 1.1 Percentage of participants |
| TAF Based Regimen (Early Switch) | Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144 | Week 144 | 1.3 Percentage of participants |