Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

Phase 3

Completed

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

• Registration Number: NCT02480712
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-24
• Study Start: 2015-07-01
• Primary Completion: 2016-04-29
• Study Completion: 2016-06-22
• Status Verified: 2017-04
• Results First Submitted: 2017-04-26
• Results First Submitted QC: 2017-04-26
• Results First Posted: 2017-06-01
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• HCV RNA ≥ 10^4 IU/mL at screening
• HCV genotype 1, 2, 3, 4, 5, 6
• Cirrhosis determination, a fibroscan or liver biopsy may be required
• HIV-1 infection
• Use of protocol specified method(s) of contraception
• Screening laboratory values within defined thresholds

Key

Exclusion Criteria

• Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
• Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers)
• Screening ECG with clinically significant abnormalities
• Pregnant or nursing female or male with pregnant female partner
• Infection with hepatitis B virus (HBV)
• Use of any prohibited concomitant medications as described in the protocol
• Chronic use of systemically administered immunosuppressive agents

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SOF/VEL	SOF/VEL	Participants will receive SOF/VEL for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
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 That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment	Up to 12 Weeks
Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12	Week 12; Posttreatment Week 12
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
HCV RNA Change From Baseline/Day 1	Baseline to Week 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
Percentage of Participants With HCV RNA < LLOQ on Treatment	Up to 12 Weeks