Phase 3
Completed N=558
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection
Source: ClinicalTrials.gov NCT02201953 ↗Enrolled (actual)
558
Serious AEs
3.8%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 95.3; 80.7 percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
850citations · ~77 / year
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Summary
The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.
Linked Publications (3)
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Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
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Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
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The tolerability of sofosbuvir/velpatasvir for 12 weeks in patients treated in the ASTRAL 1, 2 and 3 studies: A pooled safety analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
95.3; 80.7 | <0.001 sig |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0; 3.3 | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
96.8; 82.2; 95.3; 80.7 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
18.4; 17.5; 62.0; 50.0; 91.7; 88.2 | — |
| SECONDARY Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
-4.26; -4.16; -4.82; -4.79; -5.02; -5.09 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
4.0; 14.2 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL
- HCV genotype 3
- Chronic HCV infection (≥ 6 months)
- Females of childbearing potential must have a negative serum pregnancy test
- Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Exclusion Criteria
- Current or prior history of clinically-significant illness (other than HCV) that may interfere with subject treatment, assessment or compliance with the protocol
- Screening ECG with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at Screening
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Data sourced from ClinicalTrials.gov (NCT02201953) 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.