Phase 2
Completed N=183
Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV
Source: ClinicalTrials.gov NCT04143594 ↗Enrolled (actual)
183
Serious AEs
8.2%
Results posted
Dec 2022
Primary outcomePrimary: Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 54 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm — 90.4; 84.9; 84.6; 92.0 percentage of participants — p=0.7178
Summary
The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with human immunodeficiency virus (HIV) (PLWH).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 54 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm |
90.4; 84.9; 84.6; 92.0 | 0.7178 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 28 as Determined by the US FDA-defined Snapshot Algorithm |
94.2; 92.5; 94.2; 100.0 | 0.2398 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 38 as Determined by the US FDA-defined Snapshot Algorithm |
90.4; 88.7; 88.5; 96.0 | 0.3142 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 80 as Determined by the US FDA-defined Snapshot Algorithm |
86.5; 75.5; 86.5; 92 | 0.3686 |
| SECONDARY Change From Baseline in Log10 HIV-1 RNA at Week 28 |
-2.92; -3.04; -3.01; -3.07 | 0.5755 |
| SECONDARY Change From Baseline in Log10 HIV-1 RNA at Week 38 |
-2.96; -3.06; -3.02; -3.04 | 0.8942 |
| SECONDARY Change From Baseline in Log10 HIV-1 RNA at Week 54 |
-2.95; -3.12; -2.85; -3.08 | 0.7864 |
| SECONDARY Change From Baseline in Log10 HIV-1 RNA at Week 80 |
-2.96; -3.08; -2.96; -3.09 | 0.5640 |
| SECONDARY Change From Baseline in Clusters of Differentiation 4+ (CD4+) Cell Count at Week 28 |
172; 158; 206; 163 | 0.7751 |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 38 |
195; 220; 211; 232 | 0.4827 |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 54 |
204; 213; 220; 193 | 0.6614 |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 80 |
275; 262; 245; 248 | 0.5492 |
| SECONDARY Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) |
98.1; 88.7; 90.4; 84.0 | — |
| SECONDARY Percentage of Participants Who Experienced Maximum Postbaseline Laboratory Abnormalities |
9.6; 3.8; 9.6; 0; 55.8; 56.6 | — |
| SECONDARY Pharmacokinetics (PK) of LEN: Plasma LEN Pre-dose Concentrations for SC LEN |
28.3; 26.1; 34.5; 32.1; 30.9; 31.2 | — |
| SECONDARY PK of LEN : Plasma LEN Single Anytime Concentrations for the Oral LEN + DVY |
29.8; 78.7; 97.2; 96.6; 98.4 | — |
| SECONDARY PK of TAF (Tenofovir Alafenamide) and TFV (Tenofovir): Area Under the Concentration Versus Time Curve (AUClast) on Day 1 |
298.0; 260.0; 27.1; 40.5 | — |
| SECONDARY PK of TAF and TFV (Tenofovir): Maximum Observed Concentration of Drug (Cmax) on Day 1 |
278.8; 318.4; 5.4; 13.8 | — |
| SECONDARY PK of TAF and TFV: Time (Observed Time Point) of Cmax (Tmax) on Day 1 |
0.50; 0.50; 1.50; 1.00 | — |
| SECONDARY PK of TFV: Last Observed Quantifiable Concentration of the Drug (Clast) on Day 1 |
2.7; 3.9 | — |
| SECONDARY PK of TAF and TFV: AUClast at Weeks 16, 22, or 28 |
231.2; 173.1 | — |
| SECONDARY PK of TAF and TFV: Cmax at Weeks 16, 22, or 28 |
308.7; 31.2 | — |
| SECONDARY PK of TAF and TFV: Tmax at Weeks 16, 22, or 28 |
0.53; 1.00 | — |
| SECONDARY PK of TFV: Clast at Weeks 16, 22, or 28 |
22.2 | — |
| SECONDARY PK of TAF: AUClast at Week 38 |
211.5 | — |
| SECONDARY PK of TAF: Cmax at Week 38 |
279.0 | — |
| SECONDARY PK of TAF: Tmax at Week 38 |
0.50 | — |
| SECONDARY PK of Tenofovir Diphosphate (TFV-DP): AUClast at Weeks 4, 10, 16, or 22 |
16.2; 21.6 | — |
| SECONDARY PK of TFV-DP: Cmax at Weeks 4, 10, 16, or 22 |
3.3; 4.3 | — |
| SECONDARY PK of TFV-DP: Tmax at Weeks 4, 10, 16, or 22 |
2.00; 6.00 | — |
| SECONDARY PK of Bictegravir (BIC): AUClast at Week 38 |
72865.9 | — |
| SECONDARY PK of BIC: Cmax at Week 38 |
10180.0 | — |
| SECONDARY PK of BIC: Tmax at Week 38 |
2.00 | — |
| SECONDARY PK of BIC: Clast at Week 38 |
8474.5 | — |
Eligibility Criteria
Key Inclusion Criteria
- Antiretroviral (ARV) naive with no use of any ARV within one month of screening. Use of pre-exposure prophylaxis (PrEP) (any duration), post-exposure prophylaxis (PEP) (any duration), or HIV-1 treatment ( 1 month prior to screening is permitted
- HIV-1 ribonucleic acid (RNA) ≥ 200 copies/mL at screening
- Cluster Determinant 4+ (CD4+) cell count ≥ 200 cells/microliter at screening
Key Exclusion Criteria
- Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04143594). 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.