Phase 2
Completed N=5
Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection
Source: ClinicalTrials.gov NCT01924949 ↗Enrolled (actual)
5
Serious AEs
20.0%
Results posted
May 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) — 100.0 percentage of participants
Summary
This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 hepatitis C virus (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
100.0 | — |
| PRIMARY Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event |
— | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment |
60.0; 100.0; 100.0; 100.0 | — |
| SECONDARY HCV RNA Change From Baseline |
-4.36; -4.56; -4.56 | — |
| SECONDARY Percentage of Participants Experiencing Virologic Failure |
— | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) greater than or equal to 18 kg/m^2.
- HCV RNA greater than or equal to 1000 IU/mL at screening.
- Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
- Screening laboratory values within predefined thresholds.
- Use of two effective contraception methods if female of childbearing potential or sexually active male.
- Healthy according to medical history and physical examination with the exception of HCV diagnosis.
Exclusion Criteria
- Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
- Prior exposure to an HCV NS5a inhibitor.
- Pregnant or nursing female.
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
- History of solid organ transplantation.
- Current or prior history of clinical hepatic decompensation.
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
- Known hypersensitivity to LDV, SOF, or formulation excipients.
Data sourced from ClinicalTrials.gov (NCT01924949). 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.