Phase 2
Completed N=85
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection
Chronic Genotype 4 HCV · Chronic Genotype 5 HCV
Source: ClinicalTrials.gov NCT02081079 ↗
Enrolled (actual)
85
Serious AEs
1.2%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 95.5; 90.9; 95.2; 95.0 percentage of participants
Summary
This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
95.5; 90.9; 95.2; 95.0 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event |
0; 0 | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
95.5; 90.9; 95.2; 95.0; 95.5; 90.9 | — |
| SECONDARY Percentage of Patients With Virologic Failure |
0; 0; 0; 0; 4.5; 9.1 | — |
| SECONDARY Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12 |
-4.65; -4.77; -4.97; -4.94; -4.86; -5.17 | — |
Eligibility Criteria
Inclusion Criteria
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic genotype 4 or 5 HCV Infection
- Individuals may be treatment naive or treatment experienced
- Presence or absence of cirrhosis, a liver biopsy may be required
- Healthy according to medical history and physical examination with the exception of HCV diagnosis
- Agree to use two forms of highly effective contraception for the duration of the study
Exclusion Criteria
- History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
- Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
- History of any other clinically significant chronic liver disease
- Evidence of or history of decompensated liver disease
- HIV or chronic hepatitis B (HBV) infection
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of immunosuppressive agents or immunomodulatory agents
Data sourced from ClinicalTrials.gov (NCT02081079). 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.