HIV Infections
Conditions
Keywords
HIV, Cabotegravir, Rilpivirine, BIKTARVY, Antiretroviral therapy
Brief summary
This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.
Interventions
CAB tablets were available as film coated tablets for oral administration.
CAB LA was available as sterile suspension for injection in GSK1265744 for administration as IM injection.
RPV was administered as tablets for oral administration.
DRUGRilpivirine Injectable Suspension (RPV LA)
RPV LA was available as a sterile suspension of RPV to be administered as an IM injection.
DRUGBIKTARVY Tablets (BIK)
BIK was a three-drug fixed dose combination product BIC, FTC, and TAF for oral administration.
Sponsors
Janssen, LP
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants aged 18 years or older (or \>=19 where required by local regulatory agencies), at the time of signing the informed consent. * A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at screen and a negative urine hCG test at Randomization), not lactating, and at least one of the following conditions applies. 1. Non-reproductive potential defined as: * Pre-menopausal females with one of the following: 1. Documented tubal ligation. 2. Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion. 3. Hysterectomy. 4. Documented Bilateral Oophorectomy * Postmenopausal 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). 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 enrollment. 2. 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, throughout the study, for at least 30 days after discontinuation of all oral study medications, and for at least 52 weeks after discontinuation of CAB LA and RPV LA. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible participants or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrollment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures. * Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category. * Must be on the uninterrupted current regimen of BIK for at least 6 months prior to Screening with an undetectable HIV-1 viral load for at least 6 months prior to Screening. BIK must be the participant's first or second regimen. If BIK is the second regimen, the first regimen must be an integrase inhibitor (INI) regimen. Only a single prior Integrase inhibitor (INI) regimen is allowed if BIK is a second line regimen \>=6 months prior to screening. Any history of non-integrase strand transfer inhibitor regimens (that is. non-nucleoside reverse transcriptase inhibitor, protease inhibitor, C-C chemokine receptor 5 and other entry inhibitors) are not permitted. Any prior change in regimen, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must not have been done for treatment failure (HIV-1 RNA \>=400 c/mL). The following are limited exceptions: * A change from Tenofovir disoproxil fumarate (TDF) to TAF will not be considered a regimen change. * Historical perinatal use of Nucleoside reverse transcriptase inhibitor (NRTI) when given in addition to an ongoing Highly active antiretroviral therapy (HAART) will not be considered a change in ART therapy regimen. * The past use of ARVs in the context of Post Exposure Prophylaxis (PEP) or Pre-Exposure Prophylaxis (PrEP) while the participant was HIV negative will be allowed. Such cases will be evaluated on a case by case basis with the Medical Monitor, and may require documentation of HIV negative serology during time of PEP or PrEP. * A change in dosing scheme of the same drug from twice daily to once daily will not be considered a change in ART regimen if data support similar exposures and efficacy. * A change in formulation from multiple class regimens to single treatment regimens (of the same medications) would not be considered a change in ART regimen. * Documented evidence of plasma HIV-1 RNA measurements \<50 c/mL in the 6 months prior to Screening. * Plasma HIV-1 RNA \<50 c/mL at Screening.
Exclusion criteria
* Within 6 months prior to Screening, any plasma HIV-1 RNA measurement \>=50 c/mL. * Within the 6 to 12-month window prior to Screening, documented evidence of any plasma HIV-1 RNA measurement greater than (\>)200 c/mL, or 2 or more plasma HIV-1 RNA measurements \>=50 c/mL. * History of prior treatment failure to any Department of Health and Human Services (DHHS) recommended ART regimen. * History of drug holiday \>1 month for any reason prior to Screening visit, except where all ART was stopped due to tolerability and/or safety concerns. * Any change to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV 1 RNA measurement \>=200 c/mL after initial suppression to \<50 c/mL while on first line HIV therapy regimen). * Participants who are currently participating in or anticipate being selected for any other interventional study. * Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study. * Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ counts \<200 cells/microliter are not exclusionary. * Participants with moderate to severe hepatic impairment. * Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. * Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrollment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrollment. * All participants will be screened for syphilis. * Participants with untreated secondary (late latent) or tertiary syphilis infection, defined as a positive rapid plasma reagin (RPR) and a positive treponemal test without clear documentation of treatment, are excluded. * Participants with a false positive RPR (with negative treponemal test) or serofast RPR result (persistence of a reactive nontreponemal syphilis test despite history of adequate therapy and no evidence of re-exposure) may enroll after consultation with the Medical Monitor. * Participants with primary syphilis or early latent secondary syphilis (acquired within the preceding year) who have a positive RPR test and have not been treated may be treated during the screening period and if completion of antibiotic treatment occurs during the screening period, may be allowed entry after consultation with the Medical Monitor. If antibiotic treatment cannot be completed before the screening window ends, participants may be rescreened once following completion of antibiotic therapy for primary or early latent secondary syphilis. * Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. * The participant has a tattoo, gluteal implant/enhancements or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions. * 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 antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows: 1. Participants positive for HBsAg are excluded. 2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded. * Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who require or qualify for immediate HCV treatment are excluded for those co-infected participants who post entry into Switch Onto Long Acting Regimen (SOLAR) decide treatment for HCV infection is warranted or desired either by the participant or by the treating physician. Participants with HCV co-infection will be allowed entry into this study if: 1. Liver enzymes meet entry criteria 2. HCV Disease has undergone appropriate work-up, and is not advanced, and will not require treatment prior to the Month 14 visit. Additional information (where available) on participants with HCV co-infection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. 3. In the event that recent biopsy or imaging data is not available or inconclusive, the fibrosis (Fib)-4 score will be used to verify eligibility i. Fib-4 score \>3.25 is exclusionary ii. Fib-4 scores 1.45-3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula: d. Age x aspartate aminotransferase (AST)/ Platelets x (square \[Alanine aminotransferase {ALT}\]). * Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis, or decompensated cirrhosis \[for example {e.g.} ascites, encephalopathy, or variceal bleeding\]), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). * History of liver cirrhosis with or without hepatitis viral co-infection. * Ongoing or clinically relevant pancreatitis * Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease. * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization. * Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication. * History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during pharmacokinetic (PK) sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled. * Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (less than or equal to \[\<=\]325 milligram) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease. * Corrected QT interval (QTc \[Bazett\]) \>450 milliseconds (msec) or QTc (Bazett) \>480 msec for participants with bundle branch block. * Known or suspected active Coronavirus Disease-2019 (COVID-19) infection or has had contact with an individual with known COVID-19, within 14 days of study enrollment. * Known or suspected presence of resistance mutations as defined by the International Antiviral Society-United States of America (IAS-USA) resistance guidelines to the individual components of BIK (BIC, FTC, TAF), RPV, and CAB by any historical resistance test result. * Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result. * Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound. * Participant has estimated creatine clearance \<30mL/minute per 1.73 meter square (m\^2) via Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Method. * ALT \>=3 times upper limit of normal (ULN). * Exposure to an experimental drug or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study. * Treatment with any of the following agents within 28 days of Screening: * radiation therapy; * cytotoxic chemotherapeutic agents; * tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid/INH); * anti-coagulation agents; * Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. * Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of study Day 1. Treatment with acyclovir/valacyclovir is permitted. * Use of medications which are associated with Torsade de Pointes. * Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma Human Immunodeficiency Viruses (HIV)-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=) 50 Copies Per Milliliter (c/mL) at Month 12/11 - ITT-E Population | At month 12/11 | Percentage of participants with plasma HIV 1 RNA \>= 50 c/mL at month 12 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately. |
| Percentage of Participants With Plasma HIV-1 RNA Greater >=50 Copies Per Milliliter (c/mL) at Month 12/11 - mITT-E Population | At month 12/11 | Percentage of participants with plasma HIV 1 RNA \>= 50 c/mL at month 12 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population | At month 6/5 | Percentage of participants with plasma HIV 1 RNA \< 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately. |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population | At month 6/5 | Percentage of participants with plasma HIV 1 RNA \< 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately. |
| Number of Participants With Protocol-defined Confirmed Virologic Failure (CVF) Through Month 6/5 and 12/11 | Up to month 12 | Protocol-defined confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels \>= 200 c/mL (Day 1 values are not applicable) after prior suppression to \<200 c/mL. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at Month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. Cumulative number of participants with protocol defined CVF through Month 6/5 and 12/11 has been presented. |
| Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL at Month 6/5 | At month 6/5 | Percentage of participants with plasma HIV 1 RNA \>= 50 c/mL at month 6 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately. |
| Absolute Values of HIV Viral Load | Baseline (Day 1) and up to Month 12 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Change From Baseline in HIV Viral Load | Baseline (Day 1) and up to Month 12 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. Logarithm to base 10 values for plasma HIV-1 RNA has been presented. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count | Baseline (Day 1) and up to Month 12 | Blood samples were collected and CD4+ cell count was assessed using flow cytometry. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Change From Baseline in CD4+ Cell Count | Baseline (Day 1) and up to Month 12 | Blood samples were collected and CD4+ cell count was assessed using flow cytometry. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 12/11 | Up to Month 12/11 | Blood samples were collected to evaluate the phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of phenotype, fold changes to CAB, RPV, and BIC, replication capacity of Integrase, protease, and reverse transcriptase enzymes at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. No participants in the BIK arm met CVF. |
| Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 6/5 | Up to Month 6/5 | Blood samples were collected to evaluate the phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of phenotype, fold changes to CAB, RPV, and BIC, replication capacity of Integrase, protease, and reverse transcriptase enzymes at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. No participants in the BIK arm met CVF. |
| Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 | Up to Month 12/11 | Blood samples were collected to evaluate the genotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of resistance mutations and genotypic susceptibility at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. No participants in the BIK arm met CVF. |
| Number of Participants With Treatment-emergent Genotypic Resistance Through Month 6/5 | Up to Month 6/5 | Blood samples were collected to evaluate the genotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of resistance mutations and genotypic susceptibility at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. No participants in the BIK arm met CVF. |
| Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Baseline (Day 1) and up to Month 12 | Serum samples were collected to evaluate bone specific biomarkers: specific alkaline phosphatase, procollagen type 1 N-propeptide, type 1 collagen cross-linked C-telopeptide, osteocalcin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L)) | Baseline (Day 1) and up to Month 12 | Serum samples were collected to evaluate bone specific biomarkers: serum 25-hydroxyvitamin D. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Percentage of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL at Month 12/11 - ITT-E Population | At month 12/11 | Percentage of participants with plasma HIV 1 RNA \< 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately. |
| Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L)) | Baseline (Day 1) and up to Month 12 | Serum samples were collected to evaluate renal specific biomarkers: urine phosphate. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L)) | Baseline (Day 1) and up to Month 12 | Serum samples were collected to evaluate renal specific biomarkers: urine retinol binding protein 4. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol)) | Baseline (Day 1) and up to Month 12 | Serum samples were collected to evaluate renal specific biomarkers: urine retinol binding protein/creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol)) | Baseline (Day 1) and up to Month 12 | Serum samples were collected to evaluate renal specific biomarkers: urine beta-2 microglobulin/ creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | Baseline (Day 1) and at Month 12/11 | Metabolic syndrome defined as cluster of conditions that occurred together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions included increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | Baseline (Day 1) and at month 6/5 | Metabolic syndrome defined as cluster of conditions that occurred together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions included increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. |
| Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR) | Baseline (Day 1) and up to Month 12 | The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. HOMA-IR is calculated as fasting insulin microunits per liter (microU/L) multiplied by fasting glucose (nmol/L) divided by 22.5. Higher HOMA-IR values indicate increased insulin resistance; values \<2 is generally regarded as normal. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M | Up to month 12/11 | Participants who had switched from the daily oral BIK regimen to CAB + RPV, were assessed as per the preference questionnaire every two months. There were 3 preference questions included to assess the preferred treatment 1) Long-acting injectable HIV medication, 2) Daily oral HIV medication, 3) No Preference. This endpoint was only planned to be analyzed for Q2M arm only. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. Data represented included maintenance withdrawal or Month 12/11. |
| Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) | Baseline (Day 1) and up to Month 12 | The HIVTSQs total treatment satisfaction score comprised of 11 items based on HIVTSQ questionnaire each graded on a scale of 0 (very dissatisfied) to 6 (very satisfied) which were summed to produce a total score range of 0-66. Higher scores represent greater treatment satisfaction. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Change From Baseline in Individual Item Scores Using HIVTSQs | Baseline (Day 1) and up to Month 12 | The individual item scores on HIVTSQs scale were rated on a scale of 6 (very satisfied, convenient, flexible, etc.) to -6 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) Total Score at Month 12/11 | At Month 12/11 | HIV treatment satisfaction change questionnaire (HIVTSQc) total Score is computed with items 1-11 which were summed to produce a total score range of -33 to 33. Higher score indicated greater improvement in the satisfaction with the treatment and lower score indicated greater deterioration in treatment satisfaction. A score of 0 represents no change. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Individual Item Scores of HIVTSQc at Month 12/11 | At Month 12/11 | Individual item scores were rated on a scale of +3 (much more satisfied', 'much more convenient', 'much more flexible') to -3 (much less satisfied', 'much less convenient', 'much less flexible'). Higher score indicates greater improvement, and lower score indicates greater deterioration in satisfaction with each aspect of treatment. A score of 0 represents no change. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | From Month 2/1 up to Month 12 | The PIN questionnaire was used to explore the dimension scores based on 4 dimensions including acceptance of injection site reactions (ISRs), Bother from ISRs, Leg movement and Sleep categories. Domain scores were calculated as a mean of all items with the domain. The PIN response options range from 1 (totally acceptable) to 5 (not at all acceptable). This endpoint was only planned to be analyzed for Q2M arm. Month 2/1 refers to the Month 2 (OLI and BIK) visit/Month 1 (DTI) visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | From Month 2/1 up to Month 12 | The PIN questionnaire was used to explore the individual item scores based on anxiety before, pain, satisfaction, anxiety after and willingness categories. The items in the scale are rated on a 5-point scale and questions are phrased in such a way as to ensure that 1 is very dissatisfied and 5 was very satisfied. This endpoint was only planned to be analyzed for Q2M arm. Month 2/1 refers to the Month 2 (OLI and BIK) visit/Month 1 (DTI) visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Baseline (Day 1) and up to Month 12 | Serum samples were collected to evaluate renal specific biomarkers: specific serum beta-2 microglobulin, cystatin c, retinol binding protein, urine beta-2 microglobulin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population | At month 12/11 | Percentage of participants with plasma HIV 1 RNA \< 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately. |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
The study consists in 2 periods: Maintenance Period and Extension Period. Any participants who successfully completed 12 months of CAB+RPV treatment in the Maintenance Phase had the option to enter the Extension Phase and continued to have access to CAB + RPV.
Pre-assignment details
687 participants were enrolled in this study, out of which 681 were included in intent-to-treat exposed population (ITT-E).The Modified ITT-E (excluded participants due to eligibility criteria violations and GCP non-compliance) was used to primarily present the participant flow, baseline characteristics and efficacy analysis. Safety analyses were primarily presented based on Safety set, which included all participants including the ones with eligibility criteria violations and GCP non-compliance
Participants by arm
| Arm | Count |
|---|---|
| Oral lead-in Phase (OLI) Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase. | 175 |
| Direct to Injections (D2I) Participants with HIV-1 who chose direct to injections (D2I) received the first injections of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading doses at Day 1 one month, followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and month 3 followed by Q2M until Month 11. The participants had the option to continue the regimen in the Extension Phase. | 279 |
| Biktarvy (BIK) Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF). | 227 |
| Total | 681 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Extension Period (Month 13 - Month 27) | Adverse Event | 0 | 0 | 0 | 4 |
| Extension Period (Month 13 - Month 27) | Lack of Efficacy | 0 | 0 | 0 | 1 |
| Extension Period (Month 13 - Month 27) | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Extension Period (Month 13 - Month 27) | Physician Decision | 0 | 0 | 0 | 2 |
| Extension Period (Month 13 - Month 27) | Withdrawal by Subject | 0 | 0 | 0 | 5 |
| Maintenance + Extension Period | Adverse Event | 10 | 2 | 0 | 0 |
| Maintenance + Extension Period | Lack of Efficacy | 2 | 2 | 0 | 0 |
| Maintenance + Extension Period | Lost to Follow-up | 3 | 4 | 0 | 0 |
| Maintenance + Extension Period | Physician Decision | 1 | 1 | 0 | 0 |
| Maintenance + Extension Period | Protocol-specified withdrawal criterion met | 1 | 1 | 0 | 0 |
| Maintenance + Extension Period | Protocol Violation | 2 | 5 | 0 | 0 |
| Maintenance + Extension Period | Withdrawal by Subject | 4 | 12 | 0 | 0 |
| Maintenance Period (Day 1 - Month 12) | Adverse Event | 10 | 3 | 1 | 0 |
| Maintenance Period (Day 1 - Month 12) | Lack of Efficacy | 1 | 2 | 0 | 0 |
| Maintenance Period (Day 1 - Month 12) | Lost to Follow-up | 3 | 4 | 2 | 0 |
| Maintenance Period (Day 1 - Month 12) | Physician Decision | 1 | 0 | 1 | 0 |
| Maintenance Period (Day 1 - Month 12) | Protocol Deviation | 2 | 6 | 1 | 0 |
| Maintenance Period (Day 1 - Month 12) | Protocol-Specified Withdrawal Criterion Met | 1 | 1 | 0 | 0 |
| Maintenance Period (Day 1 - Month 12) | Withdrawal by Subject | 5 | 8 | 9 | 0 |
Baseline characteristics
| Characteristic | Oral lead-in Phase (OLI) | Total | Biktarvy (BIK) | Direct to Injections (D2I) |
|---|---|---|---|---|
| Age, Continuous | 38.5 YEARS STANDARD_DEVIATION 11.38 | 38.7 YEARS STANDARD_DEVIATION 11.26 | 38.6 YEARS STANDARD_DEVIATION 11.41 | 39.0 YEARS STANDARD_DEVIATION 11.09 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 10 Participants | 16 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 4 Participants | 20 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 2 Participants | 8 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 40 Participants | 145 Participants | 49 Participants | 56 Participants |
| Race/Ethnicity, Customized Mixed White Race | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Multiple | 4 Participants | 12 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 10 Participants | 25 Participants | 10 Participants | 5 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 104 Participants | 447 Participants | 149 Participants | 194 Participants |
| Sex: Female, Male Female | 27 Participants | 120 Participants | 41 Participants | 52 Participants |
| Sex: Female, Male Male | 148 Participants | 561 Participants | 186 Participants | 227 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 | 0 / 175 | 0 / 279 | 1 / 227 | 1 / 145 |
| other Total, other adverse events | 156 / 175 | 257 / 279 | 77 / 227 | 76 / 145 |
| serious Total, serious adverse events | 11 / 175 | 10 / 279 | 15 / 227 | 5 / 145 |
Outcome results
Primary
Percentage of Participants With Plasma HIV-1 RNA Greater >=50 Copies Per Milliliter (c/mL) at Month 12/11 - mITT-E Population
Percentage of participants with plasma HIV 1 RNA \>= 50 c/mL at month 12 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately.
Time frame: At month 12/11
Population: Modified intent-to-treat exposed (mITT-E) population included all ITT-E participants (that is all randomized participants who received at least one dose of IP during the Maintenance Phase of the study \[(on or after Day 1\])) excluding those from a GSK Investigational site where Good Clinical Practice noncompliance was observed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q2M (OLI + D2I) | Percentage of Participants With Plasma HIV-1 RNA Greater >=50 Copies Per Milliliter (c/mL) at Month 12/11 - mITT-E Population | 1.1 Percentage of participants |
| Biktarvy (BIK) | Percentage of Participants With Plasma HIV-1 RNA Greater >=50 Copies Per Milliliter (c/mL) at Month 12/11 - mITT-E Population | 0.4 Percentage of participants |
95% CI: [-0.6, 2]
95% CI: [-0.7, 2]
Primary
Percentage of Participants With Plasma Human Immunodeficiency Viruses (HIV)-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=) 50 Copies Per Milliliter (c/mL) at Month 12/11 - ITT-E Population
Percentage of participants with plasma HIV 1 RNA \>= 50 c/mL at month 12 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately.
Time frame: At month 12/11
Population: Intent-to-treat exposed (ITT-E) population included all randomized participants who receive at least one dose of IP during the Maintenance Phase of the study (on or after Day 1).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q2M (OLI + D2I) | Percentage of Participants With Plasma Human Immunodeficiency Viruses (HIV)-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=) 50 Copies Per Milliliter (c/mL) at Month 12/11 - ITT-E Population | 1.3 Percentage of participants |
| Biktarvy (BIK) | Percentage of Participants With Plasma Human Immunodeficiency Viruses (HIV)-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=) 50 Copies Per Milliliter (c/mL) at Month 12/11 - ITT-E Population | 0.4 Percentage of participants |
95% CI: [-0.5, 2.2]
95% CI: [-0.5, 2.2]
Secondary
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count
Blood samples were collected and CD4+ cell count was assessed using flow cytometry. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count | Baseline (Day 1) | 670.9 cells per cubic millimeter(cells/mm^3) | Standard Deviation 282.11 |
| Q2M (OLI + D2I) | Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count | Month 6/5 | 689.1 cells per cubic millimeter(cells/mm^3) | Standard Deviation 284.89 |
| Q2M (OLI + D2I) | Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count | Month 12/11 | 711.9 cells per cubic millimeter(cells/mm^3) | Standard Deviation 297.13 |
| Biktarvy (BIK) | Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count | Baseline (Day 1) | 679.4 cells per cubic millimeter(cells/mm^3) | Standard Deviation 306.89 |
| Biktarvy (BIK) | Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count | Month 6/5 | 673.7 cells per cubic millimeter(cells/mm^3) | Standard Deviation 290.46 |
| Biktarvy (BIK) | Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count | Month 12/11 | 717.3 cells per cubic millimeter(cells/mm^3) | Standard Deviation 317.82 |
Secondary
Absolute Values of HIV Viral Load
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Absolute Values of HIV Viral Load | Baseline (Day 1) | 1.5993 log10 copies per milliliter(c/mL) | Standard Deviation 0.10559 |
| Q2M (OLI + D2I) | Absolute Values of HIV Viral Load | Month 6/5 | 1.6002 log10 copies per milliliter(c/mL) | Standard Deviation 0.09268 |
| Q2M (OLI + D2I) | Absolute Values of HIV Viral Load | Month 12/11 | 1.6019 log10 copies per milliliter(c/mL) | Standard Deviation 0.13064 |
| Biktarvy (BIK) | Absolute Values of HIV Viral Load | Baseline (Day 1) | 1.5947 log10 copies per milliliter(c/mL) | Standard Deviation 0.0664 |
| Biktarvy (BIK) | Absolute Values of HIV Viral Load | Month 6/5 | 1.5910 log10 copies per milliliter(c/mL) | Standard Deviation 0.01182 |
| Biktarvy (BIK) | Absolute Values of HIV Viral Load | Month 12/11 | 1.5911 log10 copies per milliliter(c/mL) | Standard Deviation 0.01552 |
Secondary
Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L))
Serum samples were collected to evaluate bone specific biomarkers: serum 25-hydroxyvitamin D. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L)) | Baseline (Day 1) | 61.0 nanomoles per liter (nmol/L) | Standard Deviation 34.69 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L)) | Month 6/5 | 2.8 nanomoles per liter (nmol/L) | Standard Deviation 29.24 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L)) | Month 12/11 | -2.3 nanomoles per liter (nmol/L) | Standard Deviation 29 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L)) | Baseline (Day 1) | 59.9 nanomoles per liter (nmol/L) | Standard Deviation 33.3 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L)) | Month 6/5 | 6.0 nanomoles per liter (nmol/L) | Standard Deviation 34.16 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L)) | Month 12/11 | -3.1 nanomoles per liter (nmol/L) | Standard Deviation 26.38 |
Secondary
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L))
Serum samples were collected to evaluate bone specific biomarkers: specific alkaline phosphatase, procollagen type 1 N-propeptide, type 1 collagen cross-linked C-telopeptide, osteocalcin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Safety Population included all randomly assigned participants who received at least one dose of study drug. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Bone Specific Alkaline Phosphatase, Baseline (Day 1) | 12.7 micrograms per liter (ug/L) | Standard Deviation 4.27 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Bone Specific Alkaline Phosphatase, Month 6/5 | 0.3 micrograms per liter (ug/L) | Standard Deviation 9.89 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Bone Specific Alkaline Phosphatase, Month 12/11 | 0.1 micrograms per liter (ug/L) | Standard Deviation 5.03 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Osteocalcin, Baseline (Day 1) | 21.0 micrograms per liter (ug/L) | Standard Deviation 7.35 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Osteocalcin, Month 6/5 | 0.4 micrograms per liter (ug/L) | Standard Deviation 5.53 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Osteocalcin, Month 12/11 | 0.9 micrograms per liter (ug/L) | Standard Deviation 6.11 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Procollagen 1 N-Terminal Propeptide, Baseline (Day 1) | 59.1 micrograms per liter (ug/L) | Standard Deviation 23.06 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Procollagen 1 N-Terminal Propeptide, Month 6/5 | -1.5 micrograms per liter (ug/L) | Standard Deviation 15.7 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Procollagen 1 N-Terminal Propeptide, Month 12/11 | -0.7 micrograms per liter (ug/L) | Standard Deviation 19.73 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Type I Collagen C-Telopeptides, Baseline (Day 1) | 0.4 micrograms per liter (ug/L) | Standard Deviation 0.25 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Type I Collagen C-Telopeptides, Month 6/5 | -0.1 micrograms per liter (ug/L) | Standard Deviation 0.23 |
| Q2M (OLI + D2I) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Type I Collagen C-Telopeptides, Month 12/11 | 0.0 micrograms per liter (ug/L) | Standard Deviation 0.25 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Type I Collagen C-Telopeptides, Month 6/5 | -0.1 micrograms per liter (ug/L) | Standard Deviation 0.21 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Bone Specific Alkaline Phosphatase, Baseline (Day 1) | 12.9 micrograms per liter (ug/L) | Standard Deviation 4.6 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Procollagen 1 N-Terminal Propeptide, Baseline (Day 1) | 59.2 micrograms per liter (ug/L) | Standard Deviation 23.88 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Bone Specific Alkaline Phosphatase, Month 6/5 | 0.2 micrograms per liter (ug/L) | Standard Deviation 2.6 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Type I Collagen C-Telopeptides, Baseline (Day 1) | 0.5 micrograms per liter (ug/L) | Standard Deviation 0.25 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Bone Specific Alkaline Phosphatase, Month 12/11 | 0.5 micrograms per liter (ug/L) | Standard Deviation 3.55 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Procollagen 1 N-Terminal Propeptide, Month 6/5 | 0.1 micrograms per liter (ug/L) | Standard Deviation 18.53 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Osteocalcin, Baseline (Day 1) | 20.4 micrograms per liter (ug/L) | Standard Deviation 7.48 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Type I Collagen C-Telopeptides, Month 12/11 | 0.0 micrograms per liter (ug/L) | Standard Deviation 0.22 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Osteocalcin, Month 6/5 | -0.4 micrograms per liter (ug/L) | Standard Deviation 5.11 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Procollagen 1 N-Terminal Propeptide, Month 12/11 | 0.6 micrograms per liter (ug/L) | Standard Deviation 19.63 |
| Biktarvy (BIK) | Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) | Serum Osteocalcin, Month 12/11 | -0.6 micrograms per liter (ug/L) | Standard Deviation 5.51 |
Secondary
Change From Baseline in CD4+ Cell Count
Blood samples were collected and CD4+ cell count was assessed using flow cytometry. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in CD4+ Cell Count | Baseline (Day 1) | 670.9 cells/mm^3 | Standard Deviation 282.11 |
| Q2M (OLI + D2I) | Change From Baseline in CD4+ Cell Count | Month 6/5 | 20.4 cells/mm^3 | Standard Deviation 202.38 |
| Q2M (OLI + D2I) | Change From Baseline in CD4+ Cell Count | Month 12/11 | 35.2 cells/mm^3 | Standard Deviation 219.79 |
| Biktarvy (BIK) | Change From Baseline in CD4+ Cell Count | Baseline (Day 1) | 679.4 cells/mm^3 | Standard Deviation 306.89 |
| Biktarvy (BIK) | Change From Baseline in CD4+ Cell Count | Month 6/5 | -3.1 cells/mm^3 | Standard Deviation 197.62 |
| Biktarvy (BIK) | Change From Baseline in CD4+ Cell Count | Month 12/11 | 32.2 cells/mm^3 | Standard Deviation 208.29 |
Secondary
Change From Baseline in HIV Viral Load
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. Logarithm to base 10 values for plasma HIV-1 RNA has been presented. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in HIV Viral Load | Baseline (Day 1) | 1.5993 log10 c/mL | Standard Deviation 0.10559 |
| Q2M (OLI + D2I) | Change From Baseline in HIV Viral Load | Month 6/5 | 0.0015 log10 c/mL | Standard Deviation 0.13997 |
| Q2M (OLI + D2I) | Change From Baseline in HIV Viral Load | Month 12/11 | 0.0029 log10 c/mL | Standard Deviation 0.17038 |
| Biktarvy (BIK) | Change From Baseline in HIV Viral Load | Baseline (Day 1) | 1.5947 log10 c/mL | Standard Deviation 0.0664 |
| Biktarvy (BIK) | Change From Baseline in HIV Viral Load | Month 6/5 | -0.0039 log10 c/mL | Standard Deviation 0.06826 |
| Biktarvy (BIK) | Change From Baseline in HIV Viral Load | Month 12/11 | -0.0041 log10 c/mL | Standard Deviation 0.07172 |
Secondary
Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR)
The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. HOMA-IR is calculated as fasting insulin microunits per liter (microU/L) multiplied by fasting glucose (nmol/L) divided by 22.5. Higher HOMA-IR values indicate increased insulin resistance; values \<2 is generally regarded as normal. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR) | Baseline (Day 1) | 2.8 HOMA-IR score | Standard Deviation 4.05 |
| Q2M (OLI + D2I) | Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR) | Month 6/5 | 0.3 HOMA-IR score | Standard Deviation 4.11 |
| Q2M (OLI + D2I) | Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR) | Month 12/11 | 0.2 HOMA-IR score | Standard Deviation 3.99 |
| Biktarvy (BIK) | Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR) | Baseline (Day 1) | 3.1 HOMA-IR score | Standard Deviation 5.06 |
| Biktarvy (BIK) | Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR) | Month 6/5 | -0.1 HOMA-IR score | Standard Deviation 5.09 |
| Biktarvy (BIK) | Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR) | Month 12/11 | -0.4 HOMA-IR score | Standard Deviation 3.76 |
Secondary
Change From Baseline in Individual Item Scores Using HIVTSQs
The individual item scores on HIVTSQs scale were rated on a scale of 6 (very satisfied, convenient, flexible, etc.) to -6 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 2=Controlled HIV), Baseline (Day 1) | 5.8 Scores on scale | Standard Deviation 0.54 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 7=Satisfaction with understanding of HIV), Baseline (Day 1) | 5.5 Scores on scale | Standard Deviation 0.8 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 3=Satisfaction with side effects of present treatment), Month 12/11 | -0.1 Scores on scale | Standard Deviation 1.38 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 7=Satisfaction with understanding of HIV), Month 6/5 | 0.2 Scores on scale | Standard Deviation 0.81 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 1=Satisfaction with current treatment), Month 6/5 | 0.1 Scores on scale | Standard Deviation 1.1 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 7=Satisfaction with understanding of HIV), Month 12/11 | 0.1 Scores on scale | Standard Deviation 0.86 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 4=Satisfaction with current treatment demands), Baseline (Day 1) | 5.2 Scores on scale | Standard Deviation 1.16 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 8=Treatment fitting in with lifestyle), Baseline (Day 1) | 5.0 Scores on scale | Standard Deviation 1.2 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 2=Controlled HIV), Month 6/5 | 0.0 Scores on scale | Standard Deviation 0.8 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 8=Treatment fitting in with lifestyle), Month 6/5 | 0.7 Scores on scale | Standard Deviation 1.36 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 4=Satisfaction with current treatment demands), Month 6/5 | 0.4 Scores on scale | Standard Deviation 1.32 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 8=Treatment fitting in with lifestyle), Month 12/11 | 0.7 Scores on scale | Standard Deviation 1.31 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 1=Satisfaction with current treatment), Baseline (Day 1) | 5.5 Scores on scale | Standard Deviation 0.86 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 9=Recommendation of current treatment for HIV), Baseline (Day 1) | 5.5 Scores on scale | Standard Deviation 0.86 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 4=Satisfaction with current treatment demands), Month 12/11 | 0.3 Scores on scale | Standard Deviation 1.33 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 9=Recommendation of current treatment for HIV), Month 6/5 | 0.2 Scores on scale | Standard Deviation 1.1 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 2=Controlled HIV), Month 12/11 | 0.0 Scores on scale | Standard Deviation 0.7 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 9=Recommendation of current treatment for HIV), Month 12/11 | 0.2 Scores on scale | Standard Deviation 1.04 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 5=Treatment convenience), Baseline (Day 1) | 5.0 Scores on scale | Standard Deviation 1.24 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 10=Satisfaction with present treatment continuation), Baseline (Day 1) | 4.9 Scores on scale | Standard Deviation 1.23 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 1=Satisfaction with current treatment), Month 12/11 | 0.2 Scores on scale | Standard Deviation 1.07 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 10=Satisfaction with present treatment continuation), Month 6/5 | 0.8 Scores on scale | Standard Deviation 1.54 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 5=Treatment convenience), Month 6/5 | 0.6 Scores on scale | Standard Deviation 1.42 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 10=Satisfaction with present treatment continuation), Month 12/11 | 0.9 Scores on scale | Standard Deviation 1.49 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 3=Satisfaction with side effects of present treatment), Baseline (Day 1) | 5.5 Scores on scale | Standard Deviation 0.91 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 5=Treatment convenience), Month 12/11 | 0.7 Scores on scale | Standard Deviation 1.43 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 11=Ease or difficulty with current treatment), Month 6/5 | 0.5 Scores on scale | Standard Deviation 1.34 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 6=Treatment flexibility), Baseline (Day 1) | 4.7 Scores on scale | Standard Deviation 1.7 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 11=Ease or difficulty with current treatment), Month 12/11 | 0.5 Scores on scale | Standard Deviation 1.34 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 11=Ease or difficulty with current treatment), Baseline (Day 1) | 5.2 Scores on scale | Standard Deviation 1.1 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 12=Satisfaction with amount of discomfort/pain with current treatment), Baseline (Day 1) | 5.5 Scores on scale | Standard Deviation 1.02 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 6=Treatment flexibility), Month 6/5 | 0.9 Scores on scale | Standard Deviation 1.77 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 12=Satisfaction with amount of discomfort/pain with current treatment), Month 6/5 | -0.6 Scores on scale | Standard Deviation 1.64 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 3=Satisfaction with side effects of present treatment), Month 6/5 | -0.3 Scores on scale | Standard Deviation 1.42 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 12=Satisfaction with amount of discomfort/pain with current treatment), Month 12/11 | -0.5 Scores on scale | Standard Deviation 1.54 |
| Q2M (OLI + D2I) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 6=Treatment flexibility), Month 12/11 | 0.9 Scores on scale | Standard Deviation 1.74 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 6=Treatment flexibility), Month 12/11 | -0.1 Scores on scale | Standard Deviation 1.58 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 1=Satisfaction with current treatment), Baseline (Day 1) | 5.6 Scores on scale | Standard Deviation 0.75 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 1=Satisfaction with current treatment), Month 6/5 | -0.2 Scores on scale | Standard Deviation 0.91 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 1=Satisfaction with current treatment), Month 12/11 | -0.3 Scores on scale | Standard Deviation 1 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 2=Controlled HIV), Baseline (Day 1) | 5.8 Scores on scale | Standard Deviation 0.45 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 2=Controlled HIV), Month 6/5 | -0.1 Scores on scale | Standard Deviation 0.55 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 2=Controlled HIV), Month 12/11 | -0.1 Scores on scale | Standard Deviation 0.69 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 3=Satisfaction with side effects of present treatment), Baseline (Day 1) | 5.5 Scores on scale | Standard Deviation 1.02 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 3=Satisfaction with side effects of present treatment), Month 6/5 | 0.0 Scores on scale | Standard Deviation 1.21 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 3=Satisfaction with side effects of present treatment), Month 12/11 | 0.0 Scores on scale | Standard Deviation 1.16 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 4=Satisfaction with current treatment demands), Baseline (Day 1) | 5.2 Scores on scale | Standard Deviation 1.21 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 4=Satisfaction with current treatment demands), Month 6/5 | -0.1 Scores on scale | Standard Deviation 1.28 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 4=Satisfaction with current treatment demands), Month 12/11 | -0.2 Scores on scale | Standard Deviation 1.35 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 5=Treatment convenience), Baseline (Day 1) | 5.2 Scores on scale | Standard Deviation 1.16 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 5=Treatment convenience), Month 6/5 | -0.1 Scores on scale | Standard Deviation 1.3 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 6=Treatment flexibility), Baseline (Day 1) | 4.9 Scores on scale | Standard Deviation 1.55 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 6=Treatment flexibility), Month 6/5 | 0.0 Scores on scale | Standard Deviation 1.58 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 5=Treatment convenience), Month 12/11 | -0.2 Scores on scale | Standard Deviation 1.33 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 7=Satisfaction with understanding of HIV), Baseline (Day 1) | 5.5 Scores on scale | Standard Deviation 0.92 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 7=Satisfaction with understanding of HIV), Month 6/5 | 0.1 Scores on scale | Standard Deviation 0.75 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 7=Satisfaction with understanding of HIV), Month 12/11 | 0.1 Scores on scale | Standard Deviation 0.78 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 8=Treatment fitting in with lifestyle), Baseline (Day 1) | 5.1 Scores on scale | Standard Deviation 1.11 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 8=Treatment fitting in with lifestyle), Month 6/5 | -0.1 Scores on scale | Standard Deviation 1.26 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 8=Treatment fitting in with lifestyle), Month 12/11 | -0.2 Scores on scale | Standard Deviation 1.38 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 9=Recommendation of current treatment for HIV), Baseline (Day 1) | 5.5 Scores on scale | Standard Deviation 1.02 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 9=Recommendation of current treatment for HIV), Month 6/5 | 0.0 Scores on scale | Standard Deviation 1.09 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 9=Recommendation of current treatment for HIV), Month 12/11 | -0.1 Scores on scale | Standard Deviation 1.04 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 10=Satisfaction with present treatment continuation), Baseline (Day 1) | 4.9 Scores on scale | Standard Deviation 1.28 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 10=Satisfaction with present treatment continuation), Month 6/5 | 0.0 Scores on scale | Standard Deviation 1.38 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 10=Satisfaction with present treatment continuation), Month 12/11 | -0.2 Scores on scale | Standard Deviation 1.45 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 11=Ease or difficulty with current treatment), Baseline (Day 1) | 5.3 Scores on scale | Standard Deviation 1.06 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 11=Ease or difficulty with current treatment), Month 6/5 | -0.2 Scores on scale | Standard Deviation 1.2 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 11=Ease or difficulty with current treatment), Month 12/11 | -0.3 Scores on scale | Standard Deviation 1.13 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 12=Satisfaction with amount of discomfort/pain with current treatment), Baseline (Day 1) | 5.6 Scores on scale | Standard Deviation 0.94 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 12=Satisfaction with amount of discomfort/pain with current treatment), Month 6/5 | -0.1 Scores on scale | Standard Deviation 0.93 |
| Biktarvy (BIK) | Change From Baseline in Individual Item Scores Using HIVTSQs | (Item 12=Satisfaction with amount of discomfort/pain with current treatment), Month 12/11 | -0.2 Scores on scale | Standard Deviation 1.09 |
Secondary
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11
Metabolic syndrome defined as cluster of conditions that occurred together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions included increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and at Month 12/11
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | Yes (Baseline) to Yes (Month 12/11) | 9 Percentage of participants |
| Q2M (OLI + D2I) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | Yes (Baseline) to No (Month 12/11) | 5 Percentage of participants |
| Q2M (OLI + D2I) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | Yes (Baseline) to Missing (Month 12/11) | 2 Percentage of participants |
| Q2M (OLI + D2I) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | No (Baseline) to Yes (Month 12/11) | 6 Percentage of participants |
| Q2M (OLI + D2I) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | No (Baseline) to No (Month 12/11) | 69 Percentage of participants |
| Q2M (OLI + D2I) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | No (Baseline) to Missing ((Month 12/11)) | 8 Percentage of participants |
| Biktarvy (BIK) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | No (Baseline) to No (Month 12/11) | 70 Percentage of participants |
| Biktarvy (BIK) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | Yes (Baseline) to Yes (Month 12/11) | 9 Percentage of participants |
| Biktarvy (BIK) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | No (Baseline) to Yes (Month 12/11) | 8 Percentage of participants |
| Biktarvy (BIK) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | Yes (Baseline) to No (Month 12/11) | 7 Percentage of participants |
| Biktarvy (BIK) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | No (Baseline) to Missing ((Month 12/11)) | 6 Percentage of participants |
| Biktarvy (BIK) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 | Yes (Baseline) to Missing (Month 12/11) | 1 Percentage of participants |
Secondary
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5
Metabolic syndrome defined as cluster of conditions that occurred together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions included increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit.
Time frame: Baseline (Day 1) and at month 6/5
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | Yes (Baseline) to Yes (Month 6/5) | 9 Percentage of participants |
| Q2M (OLI + D2I) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | Yes (Baseline) to No (Month 6/5) | 7 Percentage of participants |
| Q2M (OLI + D2I) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | Yes (Baseline) to Missing (Month 6/5) | 1 Percentage of participants |
| Q2M (OLI + D2I) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | No (Baseline) to Yes (Month 6/5) | 5 Percentage of participants |
| Q2M (OLI + D2I) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | No (Baseline) to No (Month 6/5) | 74 Percentage of participants |
| Q2M (OLI + D2I) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | No (Baseline) to Missing (Month 6/5) | 5 Percentage of participants |
| Biktarvy (BIK) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | No (Baseline) to No (Month 6/5) | 71 Percentage of participants |
| Biktarvy (BIK) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | Yes (Baseline) to Yes (Month 6/5) | 11 Percentage of participants |
| Biktarvy (BIK) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | No (Baseline) to Yes (Month 6/5) | 10 Percentage of participants |
| Biktarvy (BIK) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | Yes (Baseline) to No (Month 6/5) | 6 Percentage of participants |
| Biktarvy (BIK) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | No (Baseline) to Missing (Month 6/5) | 2 Percentage of participants |
| Biktarvy (BIK) | Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 | Yes (Baseline) to Missing (Month 6/5) | 0 Percentage of participants |
Secondary
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L])
Serum samples were collected to evaluate renal specific biomarkers: specific serum beta-2 microglobulin, cystatin c, retinol binding protein, urine beta-2 microglobulin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum beta-2 microglobulin, Baseline (Day 1) | 1.8 milligrams per liter (mg/L) | Standard Deviation 0.4 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum beta-2 microglobulin, Month 6/5 | 0.0 milligrams per liter (mg/L) | Standard Deviation 0.28 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum beta-2 microglobulin, Month 12/11 | 0.0 milligrams per liter (mg/L) | Standard Deviation 0.33 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum cystatin C, Baseline (Day 1) | 0.9 milligrams per liter (mg/L) | Standard Deviation 0.13 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum cystatin C, Month 6/5 | 0.0 milligrams per liter (mg/L) | Standard Deviation 0.08 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum cystatin C, Month 12/11 | 0.0 milligrams per liter (mg/L) | Standard Deviation 0.08 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum retinol binding protein, Baseline (Day 1) | 51.3 milligrams per liter (mg/L) | Standard Deviation 13.01 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum retinol binding protein, Month 6/5 | -1.0 milligrams per liter (mg/L) | Standard Deviation 9 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum retinol binding protein, Month 12/11 | -1.2 milligrams per liter (mg/L) | Standard Deviation 9.24 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Urine beta-2 microglobulin, Baseline (Day 1) | 0.2 milligrams per liter (mg/L) | Standard Deviation 0.34 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Urine beta-2 microglobulin, Month 6/5 | 0.0 milligrams per liter (mg/L) | Standard Deviation 0.4 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Urine beta-2 microglobulin, Month 12/11 | 0.0 milligrams per liter (mg/L) | Standard Deviation 0.24 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Urine beta-2 microglobulin, Month 6/5 | 0.1 milligrams per liter (mg/L) | Standard Deviation 0.65 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum beta-2 microglobulin, Baseline (Day 1) | 1.8 milligrams per liter (mg/L) | Standard Deviation 0.38 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum retinol binding protein, Baseline (Day 1) | 52.2 milligrams per liter (mg/L) | Standard Deviation 12.61 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum beta-2 microglobulin, Month 6/5 | 0.0 milligrams per liter (mg/L) | Standard Deviation 0.28 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Urine beta-2 microglobulin, Baseline (Day 1) | 0.2 milligrams per liter (mg/L) | Standard Deviation 0.4 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum beta-2 microglobulin, Month 12/11 | 0.0 milligrams per liter (mg/L) | Standard Deviation 0.32 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum retinol binding protein, Month 6/5 | -0.3 milligrams per liter (mg/L) | Standard Deviation 8.75 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum cystatin C, Baseline (Day 1) | 0.9 milligrams per liter (mg/L) | Standard Deviation 0.14 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Urine beta-2 microglobulin, Month 12/11 | 0.1 milligrams per liter (mg/L) | Standard Deviation 0.52 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum cystatin C, Month 6/5 | 0.0 milligrams per liter (mg/L) | Standard Deviation 0.08 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum retinol binding protein, Month 12/11 | 0.2 milligrams per liter (mg/L) | Standard Deviation 9.06 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) | Serum cystatin C, Month 12/11 | 0.0 milligrams per liter (mg/L) | Standard Deviation 0.08 |
Secondary
Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L))
Serum samples were collected to evaluate renal specific biomarkers: urine phosphate. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L)) | Baseline (Day 1) | 20.0 millimoles per liter (mmol/L) | Standard Deviation 14.03 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L)) | Month 6/5 | -1.0 millimoles per liter (mmol/L) | Standard Deviation 16.29 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L)) | Month 12/11 | 0.1 millimoles per liter (mmol/L) | Standard Deviation 16.17 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L)) | Baseline (Day 1) | 18.4 millimoles per liter (mmol/L) | Standard Deviation 13.1 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L)) | Month 6/5 | 0.4 millimoles per liter (mmol/L) | Standard Deviation 15.6 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L)) | Month 12/11 | -0.6 millimoles per liter (mmol/L) | Standard Deviation 15.16 |
Secondary
Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol))
Serum samples were collected to evaluate renal specific biomarkers: urine beta-2 microglobulin/ creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol)) | Baseline (Day 1) | 0.0 grams per mole (g/mol) | Standard Deviation 0.03 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol)) | Month 6/5 | 0.0 grams per mole (g/mol) | Standard Deviation 0.03 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol)) | Month 12/11 | 0.0 grams per mole (g/mol) | Standard Deviation 0.02 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol)) | Baseline (Day 1) | 0.0 grams per mole (g/mol) | Standard Deviation 0.04 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol)) | Month 6/5 | 0.0 grams per mole (g/mol) | Standard Deviation 0.19 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol)) | Month 12/11 | 0.0 grams per mole (g/mol) | Standard Deviation 0.04 |
Secondary
Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L))
Serum samples were collected to evaluate renal specific biomarkers: urine retinol binding protein 4. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L)) | Baseline (Day 1) | 114.2 microgram per liter (ug/L) | Standard Deviation 111.45 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L)) | Month 6/5 | 0.8 microgram per liter (ug/L) | Standard Deviation 139.88 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L)) | Month 12/11 | -0.6 microgram per liter (ug/L) | Standard Deviation 123.52 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L)) | Baseline (Day 1) | 100.0 microgram per liter (ug/L) | Standard Deviation 82 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L)) | Month 6/5 | 5.7 microgram per liter (ug/L) | Standard Deviation 105.08 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L)) | Month 12/11 | -1.2 microgram per liter (ug/L) | Standard Deviation 105.26 |
Secondary
Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol))
Serum samples were collected to evaluate renal specific biomarkers: urine retinol binding protein/creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol)) | Baseline (Day 1) | 8.6 milligram per mole (mg/mol) | Standard Deviation 6.32 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol)) | Month 6/5 | 0.8 milligram per mole (mg/mol) | Standard Deviation 6 |
| Q2M (OLI + D2I) | Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol)) | Month 12/11 | -0.5 milligram per mole (mg/mol) | Standard Deviation 6.41 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol)) | Baseline (Day 1) | 8.0 milligram per mole (mg/mol) | Standard Deviation 5.75 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol)) | Month 6/5 | -0.8 milligram per mole (mg/mol) | Standard Deviation 7.23 |
| Biktarvy (BIK) | Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol)) | Month 12/11 | 0.0 milligram per mole (mg/mol) | Standard Deviation 4.15 |
Secondary
Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs)
The HIVTSQs total treatment satisfaction score comprised of 11 items based on HIVTSQ questionnaire each graded on a scale of 0 (very dissatisfied) to 6 (very satisfied) which were summed to produce a total score range of 0-66. Higher scores represent greater treatment satisfaction. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: Baseline (Day 1) and up to Month 12
Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) | Baseline (Day 1) | 57.88 Scores on scale | Standard Deviation 7.906 |
| Q2M (OLI + D2I) | Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) | Month 6/5 | 3.99 Scores on scale | Standard Deviation 9.67 |
| Q2M (OLI + D2I) | Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) | Month 12/11 | 4.21 Scores on scale | Standard Deviation 9.273 |
| Biktarvy (BIK) | Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) | Baseline (Day 1) | 58.38 Scores on scale | Standard Deviation 8.229 |
| Biktarvy (BIK) | Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) | Month 6/5 | -0.66 Scores on scale | Standard Deviation 7.417 |
| Biktarvy (BIK) | Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) | Month 12/11 | -1.93 Scores on scale | Standard Deviation 8.045 |
Secondary
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M
The PIN questionnaire was used to explore the dimension scores based on 4 dimensions including acceptance of injection site reactions (ISRs), Bother from ISRs, Leg movement and Sleep categories. Domain scores were calculated as a mean of all items with the domain. The PIN response options range from 1 (totally acceptable) to 5 (not at all acceptable). This endpoint was only planned to be analyzed for Q2M arm. Month 2/1 refers to the Month 2 (OLI and BIK) visit/Month 1 (DTI) visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: From Month 2/1 up to Month 12
Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Bother of ISRs, Month 2/1 | 1.58 Scores on scale | Standard Deviation 0.568 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Bother of ISRs, Month 6/5 | 0.01 Scores on scale | Standard Deviation 0.528 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Bother of ISRs, Month 12/11 | 0.08 Scores on scale | Standard Deviation 0.594 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Leg Movement, Month 2/1 | 1.93 Scores on scale | Standard Deviation 1.013 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Leg Movement, Month 6/5 | -0.14 Scores on scale | Standard Deviation 0.779 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Leg Movement, Month 12/11 | -0.18 Scores on scale | Standard Deviation 0.859 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Sleep, Month 2/1 | 1.83 Scores on scale | Standard Deviation 0.936 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Sleep, Month 6/5 | -0.01 Scores on scale | Standard Deviation 0.915 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Sleep, Month 12/11 | -0.07 Scores on scale | Standard Deviation 0.948 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Acceptance, Month 2/1 | 2.02 Scores on scale | Standard Deviation 1.017 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Acceptance, Month 6/5 | -0.14 Scores on scale | Standard Deviation 0.906 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Acceptance, Month 12/11 | -0.20 Scores on scale | Standard Deviation 0.873 |
| Biktarvy (BIK) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Acceptance, Month 6/5 | -0.13 Scores on scale | Standard Deviation 0.879 |
| Biktarvy (BIK) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Bother of ISRs, Month 2/1 | 1.60 Scores on scale | Standard Deviation 0.583 |
| Biktarvy (BIK) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Sleep, Month 2/1 | 1.87 Scores on scale | Standard Deviation 0.965 |
| Biktarvy (BIK) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Bother of ISRs, Month 6/5 | -0.03 Scores on scale | Standard Deviation 0.59 |
| Biktarvy (BIK) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Acceptance, Month 2/1 | 2.05 Scores on scale | Standard Deviation 0.949 |
| Biktarvy (BIK) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Bother of ISRs, Month 12/11 | -0.04 Scores on scale | Standard Deviation 0.583 |
| Biktarvy (BIK) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Sleep, Month 6/5 | -0.16 Scores on scale | Standard Deviation 0.869 |
| Biktarvy (BIK) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Leg Movement, Month 2/1 | 1.83 Scores on scale | Standard Deviation 0.913 |
| Biktarvy (BIK) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Acceptance, Month 12/11 | -0.26 Scores on scale | Standard Deviation 0.856 |
| Biktarvy (BIK) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Leg Movement, Month 6/5 | -0.22 Scores on scale | Standard Deviation 0.868 |
| Biktarvy (BIK) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Sleep, Month 12/11 | -0.17 Scores on scale | Standard Deviation 0.87 |
| Biktarvy (BIK) | Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M | Leg Movement, Month 12/11 | -0.24 Scores on scale | Standard Deviation 0.817 |
Secondary
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M
The PIN questionnaire was used to explore the individual item scores based on anxiety before, pain, satisfaction, anxiety after and willingness categories. The items in the scale are rated on a 5-point scale and questions are phrased in such a way as to ensure that 1 is very dissatisfied and 5 was very satisfied. This endpoint was only planned to be analyzed for Q2M arm. Month 2/1 refers to the Month 2 (OLI and BIK) visit/Month 1 (DTI) visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: From Month 2/1 up to Month 12
Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Satisfaction, Month 6/5 | -0.06 Scores on scale | Standard Deviation 0.837 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Anxiety Before, Month 2/1 | 1.9 Scores on scale | Standard Deviation 1.02 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Satisfaction, Month 12/11 | -0.12 Scores on scale | Standard Deviation 0.861 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Pain, Month 6/5 | 0.09 Scores on scale | Standard Deviation 0.907 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Anxiety After, Month 2/1 | 1.8 Scores on scale | Standard Deviation 1.12 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Anxiety Before, Month 12/11 | -0.28 Scores on scale | Standard Deviation 0.973 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Anxiety After, Month 6/5 | -0.14 Scores on scale | Standard Deviation 0.994 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Anxiety After, Month 12/11 | -0.24 Scores on scale | Standard Deviation 0.947 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Pain, Month 12/11 | 0.13 Scores on scale | Standard Deviation 0.995 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Willingness, Month 2/1 | 1.4 Scores on scale | Standard Deviation 0.76 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Anxiety Before, Month 6/5 | -0.14 Scores on scale | Standard Deviation 1.021 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Willingness, Month 6/5 | 0.01 Scores on scale | Standard Deviation 0.716 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Satisfaction, Month 2/1 | 1.7 Scores on scale | Standard Deviation 0.9 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Willingness, Month 12/11 | -0.01 Scores on scale | Standard Deviation 0.744 |
| Q2M (OLI + D2I) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Pain, Month 2/1 | 1.8 Scores on scale | Standard Deviation 0.88 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Willingness, Month 12/11 | -0.10 Scores on scale | Standard Deviation 0.742 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Anxiety Before, Month 2/1 | 1.9 Scores on scale | Standard Deviation 1.02 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Anxiety Before, Month 6/5 | -0.22 Scores on scale | Standard Deviation 1 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Anxiety Before, Month 12/11 | -0.22 Scores on scale | Standard Deviation 0.914 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Pain, Month 2/1 | 2.0 Scores on scale | Standard Deviation 0.93 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Pain, Month 6/5 | -0.03 Scores on scale | Standard Deviation 0.935 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Pain, Month 12/11 | 0.02 Scores on scale | Standard Deviation 0.943 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Satisfaction, Month 2/1 | 1.6 Scores on scale | Standard Deviation 0.81 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Satisfaction, Month 6/5 | 0.00 Scores on scale | Standard Deviation 0.867 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Satisfaction, Month 12/11 | -0.11 Scores on scale | Standard Deviation 0.83 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Anxiety After, Month 2/1 | 1.7 Scores on scale | Standard Deviation 0.96 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Anxiety After, Month 12/11 | -0.16 Scores on scale | Standard Deviation 0.85 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Willingness, Month 2/1 | 1.4 Scores on scale | Standard Deviation 0.78 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Willingness, Month 6/5 | -0.08 Scores on scale | Standard Deviation 0.794 |
| Biktarvy (BIK) | Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M | Anxiety After, Month 6/5 | -0.04 Scores on scale | Standard Deviation 0.916 |
Secondary
HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) Total Score at Month 12/11
HIV treatment satisfaction change questionnaire (HIVTSQc) total Score is computed with items 1-11 which were summed to produce a total score range of -33 to 33. Higher score indicated greater improvement in the satisfaction with the treatment and lower score indicated greater deterioration in treatment satisfaction. A score of 0 represents no change. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: At Month 12/11
Population: Modified Intent-to-Treat Exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Q2M (OLI + D2I) | HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) Total Score at Month 12/11 | 26.97 Scores on scale | Standard Deviation 10.135 |
| Biktarvy (BIK) | HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) Total Score at Month 12/11 | 16.89 Scores on scale | Standard Deviation 14.299 |
Secondary
Individual Item Scores of HIVTSQc at Month 12/11
Individual item scores were rated on a scale of +3 (much more satisfied', 'much more convenient', 'much more flexible') to -3 (much less satisfied', 'much less convenient', 'much less flexible'). Higher score indicates greater improvement, and lower score indicates greater deterioration in satisfaction with each aspect of treatment. A score of 0 represents no change. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.
Time frame: At Month 12/11
Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Q2M (OLI + D2I) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 2=Controlled HIV | 2.47 Scores on scale | Standard Deviation 1.086 |
| Q2M (OLI + D2I) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 1=Satisfaction with current treatment | 2.56 Scores on scale | Standard Deviation 1.043 |
| Q2M (OLI + D2I) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 3=Satisfaction with side effects of present treatment | 2.10 Scores on scale | Standard Deviation 1.388 |
| Q2M (OLI + D2I) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 4=Satisfaction with current treatment demands | 2.41 Scores on scale | Standard Deviation 1.109 |
| Q2M (OLI + D2I) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 5=Treatment convenience | 2.50 Scores on scale | Standard Deviation 1.07 |
| Q2M (OLI + D2I) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 6=Treatment flexibility | 2.41 Scores on scale | Standard Deviation 1.138 |
| Q2M (OLI + D2I) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 7=Satisfaction with understanding of HIV | 2.35 Scores on scale | Standard Deviation 1.065 |
| Q2M (OLI + D2I) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 8=Treatment fitting in with lifestyle | 2.56 Scores on scale | Standard Deviation 0.994 |
| Q2M (OLI + D2I) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 9=Recommendation of current treatment for HIV | 2.61 Scores on scale | Standard Deviation 1.065 |
| Q2M (OLI + D2I) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 10=Satisfaction with present treatment continuation | 2.58 Scores on scale | Standard Deviation 1.093 |
| Q2M (OLI + D2I) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 11=Ease or difficulty with current treatment | 2.46 Scores on scale | Standard Deviation 1.107 |
| Q2M (OLI + D2I) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 12=Satisfaction with amount of discomfort/pain with current treatment | 1.85 Scores on scale | Standard Deviation 1.53 |
| Biktarvy (BIK) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 11=Ease or difficulty with current treatment | 1.43 Scores on scale | Standard Deviation 1.542 |
| Biktarvy (BIK) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 7=Satisfaction with understanding of HIV | 1.94 Scores on scale | Standard Deviation 1.297 |
| Biktarvy (BIK) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 1=Satisfaction with current treatment | 1.60 Scores on scale | Standard Deviation 1.417 |
| Biktarvy (BIK) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 2=Controlled HIV | 1.88 Scores on scale | Standard Deviation 1.375 |
| Biktarvy (BIK) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 10=Satisfaction with present treatment continuation | 1.22 Scores on scale | Standard Deviation 1.602 |
| Biktarvy (BIK) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 3=Satisfaction with side effects of present treatment | 1.63 Scores on scale | Standard Deviation 1.463 |
| Biktarvy (BIK) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 8=Treatment fitting in with lifestyle | 1.43 Scores on scale | Standard Deviation 1.489 |
| Biktarvy (BIK) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 4=Satisfaction with current treatment demands | 1.42 Scores on scale | Standard Deviation 1.56 |
| Biktarvy (BIK) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 12=Satisfaction with amount of discomfort/pain with current treatment | 1.64 Scores on scale | Standard Deviation 1.465 |
| Biktarvy (BIK) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 5=Treatment convenience | 1.38 Scores on scale | Standard Deviation 1.52 |
| Biktarvy (BIK) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 9=Recommendation of current treatment for HIV | 1.73 Scores on scale | Standard Deviation 1.467 |
| Biktarvy (BIK) | Individual Item Scores of HIVTSQc at Month 12/11 | Item 6=Treatment flexibility | 1.24 Scores on scale | Standard Deviation 1.591 |
Secondary
Number of Participants With Protocol-defined Confirmed Virologic Failure (CVF) Through Month 6/5 and 12/11
Protocol-defined confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels \>= 200 c/mL (Day 1 values are not applicable) after prior suppression to \<200 c/mL. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at Month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. Cumulative number of participants with protocol defined CVF through Month 6/5 and 12/11 has been presented.
Time frame: Up to month 12
Population: Modified intent-to-treat exposed (mITT-E) population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Q2M (OLI + D2I) | Number of Participants With Protocol-defined Confirmed Virologic Failure (CVF) Through Month 6/5 and 12/11 | Month 6/5 | 1 Participants |
| Q2M (OLI + D2I) | Number of Participants With Protocol-defined Confirmed Virologic Failure (CVF) Through Month 6/5 and 12/11 | Month 12/11 | 2 Participants |
| Biktarvy (BIK) | Number of Participants With Protocol-defined Confirmed Virologic Failure (CVF) Through Month 6/5 and 12/11 | Month 6/5 | 0 Participants |
| Biktarvy (BIK) | Number of Participants With Protocol-defined Confirmed Virologic Failure (CVF) Through Month 6/5 and 12/11 | Month 12/11 | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11
Blood samples were collected to evaluate the genotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of resistance mutations and genotypic susceptibility at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. No participants in the BIK arm met CVF.
Time frame: Up to Month 12/11
Population: Confirmed Virologic Failure (CVF) population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Q2M (OLI + D2I) | Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 | M230L | 1 Participants |
| Q2M (OLI + D2I) | Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 | Q148R | 1 Participants |
| Q2M (OLI + D2I) | Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 | K101E | 1 Participants |
| Q2M (OLI + D2I) | Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 | G118R | 1 Participants |
| Biktarvy (BIK) | Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 | G118R | 0 Participants |
| Biktarvy (BIK) | Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 | M230L | 0 Participants |
| Biktarvy (BIK) | Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 | K101E | 0 Participants |
| Biktarvy (BIK) | Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 | Q148R | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Genotypic Resistance Through Month 6/5
Blood samples were collected to evaluate the genotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of resistance mutations and genotypic susceptibility at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. No participants in the BIK arm met CVF.
Time frame: Up to Month 6/5
Population: Confirmed Virologic Failure (CVF) population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Q2M (OLI + D2I) | Number of Participants With Treatment-emergent Genotypic Resistance Through Month 6/5 | M230L | 1 Participants |
| Q2M (OLI + D2I) | Number of Participants With Treatment-emergent Genotypic Resistance Through Month 6/5 | Q148R | 1 Participants |
| Biktarvy (BIK) | Number of Participants With Treatment-emergent Genotypic Resistance Through Month 6/5 | M230L | 0 Participants |
| Biktarvy (BIK) | Number of Participants With Treatment-emergent Genotypic Resistance Through Month 6/5 | Q148R | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 12/11
Blood samples were collected to evaluate the phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of phenotype, fold changes to CAB, RPV, and BIC, replication capacity of Integrase, protease, and reverse transcriptase enzymes at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. No participants in the BIK arm met CVF.
Time frame: Up to Month 12/11
Population: Confirmed Virologic Failure (CVF) population included all participants in the ITT-E population who met Confirmed Virologic Failure (CVF).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Q2M (OLI + D2I) | Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 12/11 | NNRTI | 2 Participants |
| Q2M (OLI + D2I) | Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 12/11 | IN | 2 Participants |
| Biktarvy (BIK) | Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 12/11 | NNRTI | 0 Participants |
| Biktarvy (BIK) | Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 12/11 | IN | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 6/5
Blood samples were collected to evaluate the phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of phenotype, fold changes to CAB, RPV, and BIC, replication capacity of Integrase, protease, and reverse transcriptase enzymes at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. No participants in the BIK arm met CVF.
Time frame: Up to Month 6/5
Population: Confirmed Virologic Failure (CVF) population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Q2M (OLI + D2I) | Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 6/5 | NNRTI | 1 Participants |
| Q2M (OLI + D2I) | Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 6/5 | IN | 1 Participants |
| Biktarvy (BIK) | Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 6/5 | NNRTI | 0 Participants |
| Biktarvy (BIK) | Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 6/5 | IN | 0 Participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately.
Time frame: At month 12/11
Population: Modified intent-to-treat exposed (mITT-E) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q2M (OLI + D2I) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population | 90.2 Percentage of participants |
| Biktarvy (BIK) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population | 92.8 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately.
Time frame: At month 6/5
Population: Intent-to-treat exposed (ITT-E) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q2M (OLI + D2I) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population | 92.7 Percentage of participants |
| Biktarvy (BIK) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population | 97.8 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately.
Time frame: At month 6/5
Population: Modified intent-to-treat exposed (mITT-E) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q2M (OLI + D2I) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population | 93.5 Percentage of participants |
| Biktarvy (BIK) | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population | 97.8 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL at Month 6/5
Percentage of participants with plasma HIV 1 RNA \>= 50 c/mL at month 6 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately.
Time frame: At month 6/5
Population: Modified intent-to-treat exposed (mITT-E) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q2M (OLI + D2I) | Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL at Month 6/5 | 0.4 Percentage of participants |
| Biktarvy (BIK) | Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL at Month 6/5 | 0 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL at Month 12/11 - ITT-E Population
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot (No virologic data) is not pre-defined as an endpoint and therefore not reported separately.
Time frame: At month 12/11
Population: Intent-to-treat exposed (ITT-E) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q2M (OLI + D2I) | Percentage of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL at Month 12/11 - ITT-E Population | 89.4 Percentage of participants |
| Biktarvy (BIK) | Percentage of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL at Month 12/11 - ITT-E Population | 93.0 Percentage of participants |
Secondary
Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M
Participants who had switched from the daily oral BIK regimen to CAB + RPV, were assessed as per the preference questionnaire every two months. There were 3 preference questions included to assess the preferred treatment 1) Long-acting injectable HIV medication, 2) Daily oral HIV medication, 3) No Preference. This endpoint was only planned to be analyzed for Q2M arm only. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. Data represented included maintenance withdrawal or Month 12/11.
Time frame: Up to month 12/11
Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Q2M (OLI + D2I) | Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M | Long-acting injectable HIV medication | 87 Percentage of participants |
| Q2M (OLI + D2I) | Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M | Daily oral HIV medication | 7 Percentage of participants |
| Q2M (OLI + D2I) | Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M | No Preference | 6 Percentage of participants |
| Biktarvy (BIK) | Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M | Long-acting injectable HIV medication | 92 Percentage of participants |
| Biktarvy (BIK) | Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M | Daily oral HIV medication | 4 Percentage of participants |
| Biktarvy (BIK) | Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M | No Preference | 5 Percentage of participants |