Phase 2
Completed N=98
Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Source: ClinicalTrials.gov NCT02397694 ↗Enrolled (actual)
98
Serious AEs
6.3%
Results posted
Mar 2018
Primary outcomePrimary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm. — 96.9; 93.9 percentage of participants — p=0.5
Summary
This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm. |
96.9; 93.9 | 0.5 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12 |
93.8; 93.9 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48 |
96.9; 90.9 | — |
| SECONDARY The Change From Baseline in log10 HIV-1 RNA at Week 12 |
-3.03; -3.15 | — |
| SECONDARY The Change From Baseline in log10 HIV-1 RNA at Week 24 |
-3.09; -3.12 | — |
| SECONDARY The Change From Baseline in log10 HIV-1 RNA at Week 48 |
-3.09; -3.11 | — |
| SECONDARY The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12 |
170; 173 | — |
| SECONDARY The Change From Baseline in CD4+ Cell Count at Week 24 |
190; 155 | — |
| SECONDARY The Change From Baseline in CD4+ Cell Count at Week 48 |
258; 188 | — |
| SECONDARY Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase |
87.7; 72.7 | — |
| SECONDARY Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase |
87.5; 87.5 | — |
| SECONDARY PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State |
9344.3; NA; 1919.1; 2157.1; 249.1; 260.8 | — |
| SECONDARY PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State |
2.00; NA; 1.50; 1.50; 1.00; 1.00 | — |
| SECONDARY PK Parameter:Ctau for BIC, FTC and TFV |
3508.6; NA; 76.6; 102.6; 10.7; 12.2 | — |
| SECONDARY PK Parameter: AUCtau for BIC, FTC, TAF, and TFV |
139778.8; NA; 11605.4; 14689.8; 247.4; 245.6 | — |
| SECONDARY PK Parameter: t1/2 of BIC, FTC, TAF, and TFV |
16.73; NA; 5.46; 5.70; 0.37; 0.42 | — |
Eligibility Criteria
Key Inclusion Criteria
- Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent)
- Plasma HIV-1 RNA levels ≥ 1, 000 copies/mL at screening
- Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC)
- Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula
- CD4+ cell count ≥ 200 cells/µL at screening
Key Exclusion Criteria
- A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol
- Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)
- Chronic hepatitis B virus (HBV) infection
- Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible)
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
- Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02397694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.