Phase 3
Completed N=111
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
Source: ClinicalTrials.gov NCT02346721 ↗Enrolled (actual)
111
Serious AEs
4.5%
Results posted
May 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 97.3 percentage of participants
◆ Published Evidence
Emerging
9citations · ~1 / year
Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection.
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.
Linked Publications
-
Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
97.3 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0.9 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
98.2; 97.3 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ While on Treatment |
18.0; 55.0; 94.6; 99.1; 100.0; 100.0 | — |
| SECONDARY HCV RNA Change From Baseline |
-4.23; -4.79; -5.10; -5.11; -5.11; -5.11 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0.9 | — |
Eligibility Criteria
Key Inclusion Criteria
- Willing and able to provide written informed consent
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138
- HCV RNA ≥ 10^4 IU/mL at screening
- Classification as treatment naive or treatment experienced
- Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Key Exclusion Criteria
- Current or prior history of 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 electrocardiogram (ECG) with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at screening
- Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
- 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 (NCT02346721) and the linked publication. 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.