Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection

Phase 3

Completed

• Conditions: Hepatitis C Virus Infection
• Interventions: Drug: Placebo; Drug: SOF/VEL

• Registration Number: NCT02201940
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-28
• Primary Completion: 2015-06
• Study Completion: 2015-09
• Disposition First Submitted: 2016-04-08
• Disposition First Submitted QC: 2016-04-08
• Disposition First Posted: 2016-05-05
• Status Verified: 2016-07
• Results First Submitted: 2016-07-27
• Results First Submitted QC: 2016-07-27
• Results First Posted: 2016-09-16
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 741

Inclusion Criteria

• Willing and able to provide written informed consent
• HCV RNA ≥ 10^4 IU/mL at screening
• HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central laboratory
• Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
• 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

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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 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	SOF/VEL placebo for 12 weeks
SOF/VEL	SOF/VEL	SOF/VEL for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12	Weeks 1, 2, 4, 6, 8, 10, and 12
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12	Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12
Percentage of Participants With Virologic Failure	Up to Posttreatment Week 24	Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or; * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.