Phase 2 N=9 Treatment

Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation

Hepatitis C Virus Infection

Bottom Line

View on ClinicalTrials.gov: NCT02728206 ↗

Enrolled (actual)

Serious AEs

55.6%

Results posted

Feb 2019

Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 77.8 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SOF/VEL (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gilead Sciences
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	77.8	—
PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	11.1	—
SECONDARY Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)	88.9	—
SECONDARY Percentage of Participants With HCV RNA < LLOQ On Treatment	0; 0; 0; 33.3; 85.7; 85.7	—
SECONDARY Percentage of Participants With Overall Virologic Failure	—	—

Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing liver transplantation.

Eligibility Criteria

Key Inclusion Criteria

HCV-infected, male and non-pregnant/non-lactating females, who are undergoing liver transplantation

Key Exclusion Criteria

Receiving an HCV-infected liver
HIV or hepatitis B virus (HBV) co-infected

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02728206). 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.