HIV-1 Infection
Conditions
Keywords
HIV-1, HIV, Treatment Experienced
Brief summary
The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment. Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit. After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.
Interventions
DRUGFTC/RPV/TDF
Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily (QD)
DRUGPI
Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir. PIs were administered according to prescribing information.
DRUGRTV
Ritonavir (RTV) was administered according to prescribing information.
DRUGNRTIs
NRTIs included abacavir, emtricitabine, Combivir (lamivudine/zidovudine, coformulated), Epzicom (abacavir/lamivudine, coformulated), lamivudine, stavudine, tenofovir DF, Truvada® (emtricitabine/tenofovir DF, coformulated), and zidovudine. NRTIs were administered according to prescribing information.
Sponsors
Gilead Sciences
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
* Ability to understand and sign a written informed consent form * Receiving antiretroviral therapy with a ritonavir-boosted PI and two NRTIs continuously for ≥ 6 months preceding the screening visit * Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for ≥ 6 months prior to the screening visit and HIV-1 RNA \< 50 copies/mL at the screening visit * On their first or second antiretroviral drug regimen; if on their second regimen, HIV-1 RNA ≤ 50 copies/mL required at the time of the first change in antiretroviral drugs, and no HIV RNA \> 50 copies/mL measured at two consecutive time points after first achieving HIV RNA \< 50 copies/mL * No previous use of any approved or experimental nonnucleoside reverse transcriptase inhibitor (NNRTI) drug for any length of time * Have a genotype prior to starting initial antiretroviral therapy and no known resistance to any of the study agents * Normal ECG * Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN) * Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin * Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm\^3; platelets ≥ 50,000/mm\^3; hemoglobin ≥ 8.5 g/dL) * Serum amylase ≤ 5 x ULN (subjects with serum amylase \> 5 x ULN eligible if serum lipase ≤ 5 x ULN) * Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula) * Males and females of childbearing potential must agree to utilize highly effective contraception methods (two separate forms of contraception, one of which must have been an effective barrier method, or been nonheterosexually active, practice sexual abstinence, or have a vasectomized partner) from screening throughout the duration of the study period and for 30 days following the last dose of study drug. * Age ≥ 18 years * Life expectancy ≥ 1 year
Exclusion criteria
* A new AIDS-defining condition diagnosed within 30 days prior to screening except cluster of differentiation 4 (CD4) cell count and/or percentage criteria * Females who are breastfeeding * Positive serum pregnancy test (female of childbearing potential) * Proven or suspected acute hepatitis 30 days prior to study entry. * Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance. * History of malignancy within 5 years prior to study entry or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma * Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline * Anticipated need to initiate contraindicated drugs during the study, including drugs not to be used with FTC, TDF, RPV; or subjects with known allergies to the excipients of FTC/RPV/TDF STR tablets or Truvada® tablets * All investigational drugs * Medications and use of herbal/natural supplements excluded or to be used with caution while participating in the study, including those not to be taken with Viread®, Emtriva®, Truvada, and Rilpivirine. * Participation in any other clinical trial without prior approval from the sponsor was prohibited while participating in this trial * Treatment with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study * History of liver disease, including Gilbert's Disease * Any other clinical condition or prior therapy making the subject unsuitable for the study or unable to comply with the dosing requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis) | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24 | Baseline to Week 24 | The mean (SD) change in CD4 count was analyzed from baseline through Week 24. |
| Change From Baseline in CD4 Count Through Week 48 | Baseline to Week 48 | The mean (SD) change in CD4 count was analyzed from baseline through Week 48. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF. |
| Change From Baseline in Fasting Total Cholesterol Through Week 24 | Baseline to Week 24 | The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 24 was analyzed. |
| Change From Baseline in Fasting Total Cholesterol Through Week 48 | Baseline to Week 48 | The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF. |
| Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24 | Baseline to Week 24 | The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 24 was analyzed. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis) | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF. |
| Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24 | Baseline to Week 24 | The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 24 was analyzed. |
| Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48 | Baseline to Week 48 | The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF. |
| Change From Baseline in Fasting Triglycerides Through Week 24 | Baseline to Week 24 | The mean (SD) change from baseline in fasting triglycerides through Week 24 was analyzed. |
| Change From Baseline in Fasting Triglycerides Through Week 48 | Baseline to Week 48 | The mean (SD) change from baseline in fasting triglycerides through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF. |
| Change From Baseline in Fasting HDL Cholesterol Through Week 48 | Baseline to Week 48 | The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF. |
Countries
Austria, Belgium, Canada, France, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at 110 sites in the North America and Europe. The first participant was screened on 17 November 2010. The last participant observation was on 28 October 2014.
Pre-assignment details
617 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| FTC/RPV/TDF Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study. | 317 |
| SBR/Delayed Switch Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit. | 159 |
| Total | 476 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Extension Phase | Adverse Event | 2 | 1 |
| Extension Phase | Lack of Efficacy | 1 | 0 |
| Extension Phase | Lost to Follow-up | 5 | 0 |
| Extension Phase | Physician Decision | 0 | 1 |
| Extension Phase | Subject Non-compliance | 1 | 0 |
| Extension Phase | Withdrawal by Subject | 1 | 1 |
| Main Study Phase | Adverse Event | 3 | 1 |
| Main Study Phase | Lack of Efficacy | 1 | 0 |
| Main Study Phase | Lost to Follow-up | 6 | 1 |
| Main Study Phase | Physician Decision | 1 | 0 |
| Main Study Phase | Protocol Violation | 4 | 2 |
| Main Study Phase | Randomized but not treated | 4 | 2 |
| Main Study Phase | Subject Non-compliance | 1 | 1 |
| Main Study Phase | Withdrawal by Subject | 6 | 5 |
Baseline characteristics
| Characteristic | FTC/RPV/TDF | Total | SBR/Delayed Switch |
|---|---|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 9.2 | 42 years STANDARD_DEVIATION 9.4 | 43 years STANDARD_DEVIATION 9.7 |
| Baseline HIV-1 RNA Category ≥ 1000 Copies/mL | 4 participants | 5 participants | 1 participants |
| Baseline HIV-1 RNA Category 200 to < 400 Copies/mL | 2 participants | 2 participants | 0 participants |
| Baseline HIV-1 RNA Category 400 to < 1000 Copies/mL | 2 participants | 2 participants | 0 participants |
| Baseline HIV-1 RNA Category < 50 Copies/mL | 299 participants | 451 participants | 152 participants |
| Baseline HIV-1 RNA Category 50 to < 200 Copies/mL | 10 participants | 16 participants | 6 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 51 Participants | 82 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 264 Participants | 392 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 participants | 5 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 6 participants | 8 participants | 2 participants |
| Race/Ethnicity, Customized Black or African American | 61 participants | 83 participants | 22 participants |
| Race/Ethnicity, Customized Other | 6 participants | 15 participants | 9 participants |
| Race/Ethnicity, Customized White | 241 participants | 365 participants | 124 participants |
| Region of Enrollment Austria | 18 participants | 26 participants | 8 participants |
| Region of Enrollment Belgium | 15 participants | 28 participants | 13 participants |
| Region of Enrollment Canada | 15 participants | 25 participants | 10 participants |
| Region of Enrollment France | 29 participants | 43 participants | 14 participants |
| Region of Enrollment Germany | 31 participants | 43 participants | 12 participants |
| Region of Enrollment Italy | 16 participants | 26 participants | 10 participants |
| Region of Enrollment Puerto Rico | 16 participants | 18 participants | 2 participants |
| Region of Enrollment Spain | 15 participants | 20 participants | 5 participants |
| Region of Enrollment United Kingdom | 17 participants | 23 participants | 6 participants |
| Region of Enrollment United States | 149 participants | 230 participants | 81 participants |
| Sex: Female, Male Female | 44 Participants | 59 Participants | 15 Participants |
| Sex: Female, Male Male | 273 Participants | 417 Participants | 144 Participants |
| Stratification based on antiretroviral (ARV) use Non-TDF-containing regimen + LPV/RTV | 15 participants | 24 participants | 9 participants |
| Stratification based on antiretroviral (ARV) use Non-TDF-containing regimen + Other PI+RTV | 42 participants | 62 participants | 20 participants |
| Stratification based on antiretroviral (ARV) use TDF or FTC/TDF + lopinavir (LPV)/ritonavir (RTV) | 82 participants | 131 participants | 49 participants |
| Stratification based on antiretroviral (ARV) use TDF or FTC/TDF + Other PI+RTV | 178 participants | 259 participants | 81 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 150 / 317 | 38 / 159 | 59 / 152 |
| serious Total, serious adverse events | 21 / 317 | 8 / 159 | 9 / 152 |
Outcome results
Primary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.
Time frame: Week 24
Population: Full Analysis Set: participants who were randomized into the study and received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/RPV/TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis) | 93.7 percentage of participants |
| SBR/Delayed Switch | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis) | 89.9 percentage of participants |
95% CI: [-1.6, 9.1]
Secondary
Change From Baseline in CD4 Count Through Week 48
The mean (SD) change in CD4 count was analyzed from baseline through Week 48. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time frame: Baseline to Week 48
Population: Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 48 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTC/RPV/TDF | Change From Baseline in CD4 Count Through Week 48 | 10 cells/mm^3 | Standard Deviation 144.1 |
| SBR/Delayed Switch | Change From Baseline in CD4 Count Through Week 48 | -7 cells/mm^3 | Standard Deviation 154.1 |
Secondary
Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24
The mean (SD) change in CD4 count was analyzed from baseline through Week 24.
Time frame: Baseline to Week 24
Population: Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 24 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTC/RPV/TDF | Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24 | 20 cells/mm^3 | Standard Deviation 149.3 |
| SBR/Delayed Switch | Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24 | 32 cells/mm^3 | Standard Deviation 158.1 |
Secondary
Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48
The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time frame: Baseline to Week 48
Population: Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 48 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTC/RPV/TDF | Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48 | -16 mg/dL | Standard Deviation 27.1 |
| SBR/Delayed Switch | Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48 | -14 mg/dL | Standard Deviation 26.8 |
Secondary
Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24
The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 24 was analyzed.
Time frame: Baseline to Week 24
Population: Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 24 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTC/RPV/TDF | Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24 | -16 mg/dL | Standard Deviation 25.6 |
| SBR/Delayed Switch | Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24 | 0 mg/dL | Standard Deviation 23.7 |
Secondary
Change From Baseline in Fasting HDL Cholesterol Through Week 48
The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time frame: Baseline to Week 48
Population: Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 48 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTC/RPV/TDF | Change From Baseline in Fasting HDL Cholesterol Through Week 48 | -2 mg/dL | Standard Deviation 11.6 |
| SBR/Delayed Switch | Change From Baseline in Fasting HDL Cholesterol Through Week 48 | -2 mg/dL | Standard Deviation 8 |
Secondary
Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24
The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 24 was analyzed.
Time frame: Baseline to Week 24
Population: Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 24 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTC/RPV/TDF | Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24 | -4 mg/dL | Standard Deviation 10.3 |
| SBR/Delayed Switch | Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24 | -1 mg/dL | Standard Deviation 8.2 |
Secondary
Change From Baseline in Fasting Total Cholesterol Through Week 24
The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 24 was analyzed.
Time frame: Baseline to Week 24
Population: Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 24 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTC/RPV/TDF | Change From Baseline in Fasting Total Cholesterol Through Week 24 | -25 mg/dL | Standard Deviation 30.2 |
| SBR/Delayed Switch | Change From Baseline in Fasting Total Cholesterol Through Week 24 | -1 mg/dL | Standard Deviation 25.9 |
Secondary
Change From Baseline in Fasting Total Cholesterol Through Week 48
The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time frame: Baseline to Week 48
Population: Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 48 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTC/RPV/TDF | Change From Baseline in Fasting Total Cholesterol Through Week 48 | -24 mg/dL | Standard Deviation 32.9 |
| SBR/Delayed Switch | Change From Baseline in Fasting Total Cholesterol Through Week 48 | -24 mg/dL | Standard Deviation 32 |
Secondary
Change From Baseline in Fasting Triglycerides Through Week 24
The mean (SD) change from baseline in fasting triglycerides through Week 24 was analyzed.
Time frame: Baseline to Week 24
Population: Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 24 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTC/RPV/TDF | Change From Baseline in Fasting Triglycerides Through Week 24 | -53 mg/dL | Standard Deviation 110 |
| SBR/Delayed Switch | Change From Baseline in Fasting Triglycerides Through Week 24 | 3 mg/dL | Standard Deviation 100.1 |
Secondary
Change From Baseline in Fasting Triglycerides Through Week 48
The mean (SD) change from baseline in fasting triglycerides through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time frame: Baseline to Week 48
Population: Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 48 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTC/RPV/TDF | Change From Baseline in Fasting Triglycerides Through Week 48 | -64 mg/dL | Standard Deviation 126.4 |
| SBR/Delayed Switch | Change From Baseline in Fasting Triglycerides Through Week 48 | -80 mg/dL | Standard Deviation 141.1 |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time frame: Week 48
Population: Participants in the Full Analysis Set in the FTC/RPV/TDF and the Delayed Switch to FTC/RPV/TDF groups were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/RPV/TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis) | 89.3 percentage of participants |
| SBR/Delayed Switch | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis) | 92.1 percentage of participants |