Phase 2
Completed N=26
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
Hepatitis C Infection With HIV Co-Infection
Source: ClinicalTrials.gov NCT02457611 ↗
Enrolled (actual)
26
Serious AEs
3.9%
Results posted
Feb 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12) — 76.9 percentage of participants
Summary
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12) |
76.9 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
— | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4) |
84.6 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment |
73.1; 88.5; 96.2 | — |
| SECONDARY Change From Baseline in HCV RNA at Weeks 2, 4, and 6 |
-4.01; -4.16; -4.17 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
15.4 | — |
| SECONDARY Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study. |
— | — |
| SECONDARY Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4 |
100.0; 100.0; 95.2; 100.0 | — |
| SECONDARY Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4 |
-0.3; 0.4 | — |
Eligibility Criteria
Key Inclusion Criteria
- Acute, untreated, hepatitis C infection, genotype 1 or 4, with an estimated duration less than 24 weeks
- Confirmed HIV-1 infection
- CD4 T cell count >200/μL for individuals receiving antiretroviral therapy (ART), CD4 T cell count > 500/μL at screening for individuals without ART
- Use of two effective contraception methods if female of childbearing potential or sexually active male with female partner
Key Exclusion Criteria
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non HCV etiology
- Coinfection with hepatitis B virus (HBV)
- Treatment with any investigational drug or device within 60 days of the screening visit.
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02457611). 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.