Phase 3
Completed N=269
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection
Source: ClinicalTrials.gov NCT02220998 ↗Enrolled (actual)
269
Serious AEs
1.5%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 99.3; 93.9 percentage of participants — p=0.018
◆ 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 evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 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) |
99.3; 93.9 | 0.018 sig |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0.7; 0 | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
99.3; 96.2; 99.3; 93.9 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12 |
12.8; 22.7; 57.1; 59.8; 90.2; 90.2 | — |
| SECONDARY Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12 |
-4.51; -4.51; -5.08; -5.04; -5.29; -5.24 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0; 4.5 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL
- HCV genotype 2
- 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
- Must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator.
Exclusion Criteria
- Current or prior history of clinically-significant illness (other than HCV that may interfere with treatment, assessment or compliance with the protocol;
- Screening electrocardiogram (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 (NCT02220998) 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.