- A 12-week course of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX; Vosevi) is highly effective for clearing HCV-1 in patients who relapse after initial treatment with combination direct-acting antivirals (DAAs).
Why this matters
- SOF/VEL/VOX has not previously been studied in patients with HIV and/or HBV, or in patients with prior poor adherence/noncompletion of DAA therapy.
- Phase 2b RESOLVE study of 77 patients with relapsed HCV-1 (genotype 1a, 75%) receiving 12 weeks of SOF/VEL/VOX.
- All had previously received DAA combination therapy, primarily ledipasvir/sofosbuvir (Harvoni, 89%).
- Primary endpoint: sustained virologic response at 12 weeks posttreatment (SVR12).
- Funding: Gilead Sciences.
- 22.1% of patients were HIV-positive and on antiretroviral therapy (dolutegravir-based, 47%), 2.6% were HBV-positive, and 28.6% had failed to complete a prior DAA regimen.
- 50.6% reported prior intravenous drug use and 32.5% reported heavy alcohol use.
- 40.2% of patients had compensated cirrhosis, and 36.4% had stage ≤II hepatic fibrosis.
- Intent-to-treat SVR12 rate was 90.9% (95% CI, 82.1%-95.8%).
- SVR12 rate in HIV-coinfected patients was 82.4%.
- SVR12 rate in patients who had failed to complete prior therapy was 81.8%.
- Per-protocol analysis yielded an SVR12 rate of 98.6% (70/71).
- Adverse events were generally mild and most commonly included fatigue (27.3%), headache (24.7%), and diarrhea (20.8%).
- Open-label design.