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

NCT02745535 | Completed Phase 2 Results DMC

• 1 other identifier: HP-00067213
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C relapse

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Grade 3 and 4 Adverse Events

  Number of participants with grade 3 and 4 adverse events during treatment with and/or within 30 of completion of SOF/VEL/VOX in HCV infected

  up to 16 weeks

• Number of Participants Who Achieve Sustained Virologic Response (SVR) 12 Weeks After Completion of Therapy (SVR12)

  Intention to treat (ITT) analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 12 weeks after completion of therapy.

  Post-treatment week 12

Secondary Outcomes (3)

• Number of Participants Who Achieve End of Treatment Virologic Response (ETR) at Completion of Therapy.

  Week 12

• Number of Participants Who Achieve Sustained Virologic Response (SVR) 4 Weeks After Completion of Therapy.

  Post-treatment week 4

• Number of Participants Who Achieve Sustained Virologic Response (SVR) 24 Weeks After Completion of Therapy.

  Post-treatment week 24

Study Arms (1)

SOF/VEL/VOX

EXPERIMENTAL

Fixed dose combination of SOF/VEL/VOX (Sofosbuvir 400mg/Velpatasvir 100mg/ Voxilaprevir 100mg) dosed once daily for 12 weeks.

Drug: Sofosbuvir/Velpatasvir/Voxilaprevir

Interventions

Sofosbuvir/Velpatasvir/Voxilaprevir DRUG

Also known as: SOF/VEL/VOX, GS-7977/GS-5816/GS-9857

SOF/VEL/VOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• HIV untreated for \>8 weeks prior to screening, CD4 \>500, no intention of initiating ARV therapy for the duration of the trial.
• HIV suppressed on a stable, protocol-approved ARV regimen for \>4 weeks prior to screening.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Unity Health Care, Inc.: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

sofosbuvir velpatasvir voxilaprevir drug combination

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Eleanor Wilson
• Organization: Institute of Human Virology, University of Maryland

eleanor.wilson@ihv.umaryland.edu

1(410)706-1710

Study Officials

• Eleanor Wilson, MD

  University of Maryland Institute of Virology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 20, 2016
• Study Start: May 1, 2016
• Primary Completion: October 24, 2018
• Study Completion: October 24, 2018
• Last Updated: March 10, 2022
• Results First Posted: March 27, 2019

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)