Author information
1 Division of Clinical Care and Research, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD 21201, USA.
2 Division of Clinical Care and Research, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD 21201, USA; Critical Care Medicine Department, Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA.
3 Critical Care Medicine Department, Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA.
Abstract
BACKGROUND:
Cure rates in response to retreatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) are high, but this regimen has not been studied in patients with a history of poor adherence or treatment interruption, nor in patients with HIV/HCV coinfection.
METHODS:
The RESOLVE study assessed the safety and efficacy of SOF/VEL/VOX in patients with relapse of genotype 1 HCV infection following FDA-approved combination DAA-based therapy, regardless of HIV infection or previous treatment course.
FINDINGS:
In an intent-to-treat analysis 70/77 (90.9%, 95% confidence interval 82.1-95.8%) achieved SVR12, including 14/17 (82.4%) of HIV co-infected participants and 18/22 (81.8%) of those with previous noncompletion of DAA therapy. In an analysis of all patients who completed 12 weeks of study medication, 70/71 patients (99%) achieved SVR12.
INTERPRETATION:
Retreatment with twelve weeks of SOF/VEL/VOX was safe and effective in patients with relapsed HCV following initial combination DAA-based treatment. Treatment response was not diminished with HIV-infection or previous noncompletion of or poor adherence to DAA-based therapy.
FUNDING:
This study was supported with drug and funding as part of an investigator-initiated grant from Gilead Sciences, Inc.
LAY SUMMARY:
Twelve weeks of SOF/VEL/VOX was safe and effective in patients with relapsed HCV after initial combination oral Hepatitis C therapy. Treatment response was not diminished with HIV-infection or previous poor adherence or noncompletion of DAA-based therapy.