Phase 3
Completed N=335
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
Source: ClinicalTrials.gov NCT02073656 ↗Enrolled (actual)
335
Serious AEs
2.3%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 96.1 percentage of participants
◆ Published Evidence
Highly cited
469citations · ~43 / year
Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1.
Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1.
Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.
Linked Publications (3)
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Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1.
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Successful Re-treatment of Hepatitis C Virus in Patients Coinfected With HIV Who Relapsed After 12 Weeks of Ledipasvir/Sofosbuvir.
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How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
96.1 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
— | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
96.7; 96.1 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12 |
29.3; 81.2; 98.8; 99.1; 99.4; 100.0 | — |
| SECONDARY Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8 |
-4.68; -5.21; -5.30; -5.30; -5.33 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0.6; 3.0 | — |
| SECONDARY Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment |
98.5; 98.2; 97.9 | — |
| SECONDARY Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24 |
0.05; 0.03; -0.02 | — |
| SECONDARY For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24) |
88.9; 88.9; 88.9 | — |
| SECONDARY For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24 |
88.9; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8 |
-5.01; -5.04; -5.04 | — |
| SECONDARY For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure |
0; 11.1 | — |
Eligibility Criteria
Inclusion Criteria
- HCV RNA ≥ 10, 000 IU/mL at screening
- HCV genotype 1 or 4
- HIV-1 infection
- Cirrhosis determination, a fibroscan or liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male
Exclusion Criteria
- Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol
- Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC), or other malignancy (with the exception of certain resolved skin cancers)
- Hepatitis B virus (HBV) infection
- Pregnant or nursing female
- Chronic use of systemically administered immunosuppressive agents
Data sourced from ClinicalTrials.gov (NCT02073656) and the linked publication. 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.