Phase 3
N=111
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection
Hepatitis C Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT02613871 ↗Enrolled (actual)
111
Serious AEs
3.6%
Results posted
Feb 2018
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 100.0; 100.0; 100.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LDV/SOF (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
100.0; 100.0; 100.0 | — |
| PRIMARY Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug |
0.0 | — |
| SECONDARY Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ While on Treatment |
33.3; 82.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY HCV RNA Change From Baseline While on Treatment |
-4.14; -4.63; -4.73; -4.73; -4.73 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
— | — |
| SECONDARY Plasma HBV DNA Change From Baseline While on Treatment |
-0.06; 0.08; 0.37; 0.51; 0.24 | — |
| SECONDARY Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 |
0.49; 0.66; 0.56; 0.67; 0.68; 0.70 | — |
| SECONDARY HBsAg Level Change From Baseline While on Treatment |
-0.14; -0.18; -0.25; -0.41; -0.47 | — |
| SECONDARY HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 |
-0.16; -0.01; -0.02; -0.07; -0.10; -0.16 | — |
| SECONDARY Serum LOXL-2 Level Change From Baseline While on Treatment |
-2; -6; -15; -22; -27 | — |
| SECONDARY Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36 |
-30; -32; -41 | — |
| SECONDARY Percentage of Participants That Required HBV Therapy During the Study |
7.2 | — |
| SECONDARY Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108 |
8.0; 7.2; 7.1 | — |
| SECONDARY Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study |
0.0 | — |
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 chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.
Eligibility Criteria
Key Inclusion Criteria
- Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection
- Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1.
- Cirrhosis determination by Fibroscan
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female or male is of childbearing potential
Key Exclusion Criteria
- Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
- Pregnant or nursing female
- Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)
- Hepatocellular carcinoma (HCC) or other malignancy
- Current or prior history of clinical hepatic decompensation
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02613871). 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.