Phase 2
Completed N=69
Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
Source: ClinicalTrials.gov NCT02300103 ↗Enrolled (actual)
69
Serious AEs
1.5%
Results posted
Jul 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 91.3 percentage of participants
Summary
The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
91.3 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
5.8 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
92.8; 89.9 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ On-treatment |
15.9; 60.9; 91.3; 98.5; 97.1; 98.5 | — |
| SECONDARY HCV RNA Change From Baseline |
-4.45; -5.04; -5.18; -5.23; -5.23; -5.23 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
7.2 | — |
Eligibility Criteria
Key Inclusion Criteria
- Willing and able to provide written informed consent
- HCV genotype determined by the Central Laboratory
- HCV RNA > LLOQ at screening
- Participated and completed a Gilead sponsored HCV treatment study of direct acting antiviral (DAA) containing regimens.
- Male and female of childbearing potential must agree to use protocol specified method(s) of contraception
Key Exclusion Criteria
- Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
- Screening ECG with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at screening
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02300103). 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.