Phase 2
N=122
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
Chronic HCV Infection
Bottom Line
View on ClinicalTrials.gov: NCT02120300 ↗Enrolled (actual)
122
Serious AEs
5.0%
Results posted
Dec 2016
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 99.0; 100.0; 100.0; 83.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LDV/SOF (Drug); SOF (Drug); RBV (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
99.0; 100.0; 100.0; 83.3 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
99.0; 100.0; 100.0; 83.3 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 |
28.3; 20.0; 20.0; 16.7; 68.7; 40.0 | — |
| SECONDARY Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 |
6.21; 6.02; 6.20; 6.6; -4.41; -4.32 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0; 0; 0; 16.7 | — |
| SECONDARY Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only) |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only) |
0.94; 1.01; 0.94; 0.04; -0.03; -0.03 | — |
Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.
Eligibility Criteria
Inclusion Criteria
- Hemophilia A, B or C, or Von Willebrand's disease
- Chronic genotype 1, 2, 3 or 4 HCV infection
- HCV RNA ≥ 1000 IU/mL at screening
- Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male
- Screening laboratory values within defined thresholds
- For HIV-1/HCV co-infected individuals:
- Suppressed HIV-1 RNA on an antiretroviral (ARV) regimen for at least 6 months prior to screening
- Stable protocol-approved ARV regimen for > 8 weeks prior to screening
- CD4 T-cell count > 200 cells/mm^3 at screening
Exclusion Criteria
- Clinically-significant illness (other than HCV, inherited bleeding disorder or HIV-1) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- Current or prior history of any of the following:
- Hepatic decompensation
- Chronic liver disease of a non-HCV etiology
- Hepatocellular carcinoma (HCC)
- Infection with hepatitis B virus (HBV)
- Pregnant or nursing female
- Prior treatment with inhibitors of nonstructural protein 5A (NS5A) or the NS5B polymerase
- Chronic use of systemically administered immunosuppressive agents
- For HIV-1/HCV co-infected individuals:
- Opportunistic infection within 6 months prior to screening
- Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline
Data sourced from ClinicalTrials.gov (NCT02120300). 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.