Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience

• Status: Completed
• Trial end date: 2018-10-24
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, and efficacy of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C infection who have failed to eradicate hepatitis C despite previous combination directly acting antiviral therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborators: Gilead Sciences; Unity Health Care, Inc.
• Treatments: Sofosbuvir; Velpatasvir

Criteria

Inclusion Criteria:

• Available for clinical follow-up through Week 44 after enrollment.

• Recurrent HCV GT-1

• Exposure to combination DAA therapy

• Able and willing to complete the informed consent process.

• Use of protocol specified methods of contraception

• Hepatitis B coinfected participants must have evidence of chronic infection and controlled on treatment

• HIV coinfected participants must have HIV status of one of the following:

1. HIV untreated for >8 weeks prior to screening, CD4 >500, no intention of initiating ARV therapy for the duration of the trial.

2. HIV suppressed on a stable, protocol-approved ARV regimen for >4 weeks prior to screening.

Exclusion Criteria:

• Combination DAA therapy was completed or discontinued less than 8 weeks prior to enrollment.

• Current or prior history of any clinically significant illness, organ transplantation, and/or concomitant medication that may interfere with the subject treatment, assessment of compliance with the protocol.

• Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)

• Laboratory results outside acceptable ranges at screening.

• Female who is pregnant, breast-feeding or planning to become pregnant during study.