- Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX; Vosevi) achieved a 96% HCV clearance rate in a real-world study of patients refractory to initial direct-acting antivirals (DAAs).
Why this matters
- Results add to mounting evidence supporting the DAA triplet as salvage therapy.
- Real-world 27-center Italian study (NAVIGATORE) of 179 patients (median age, 57 years; 74% male) with DAA-refractory HCV receiving 12 weeks of SOF/VEL/VOX; 22% also received ribavirin.
- Main prior DAAs were sofosbuvir with velpatasvir (Epclusa, 20%) or ledipasvir (Harvoni, 20%), and ritonavir-boosted paritaprevir/ombitasvir±dasabuvir (Viekira, 17%).
- Primary endpoint: sustained virologic response at 12 weeks posttherapy (SVR12).
- Funding: Unrestricted grant for NAVIGATORE-Lombardia web-based platform from AbbVie, Gilead, Merck & Co., Inc., Kenilworth, NJ, USA).
- Genotypes (GTs) included GT1 (1b, 33%; 1a, 24%), GT3 (23%), GT2 (10%), and GT4 (9%).
- 65% had advanced liver disease (F3 fibrosis, 21%; F4, 44%); 35% had multiple resistance-associated substitutions (RAS).
- 74% cleared HCV RNA at week 4, and 99% at week 12.
- Intent-to-treat SVR12 rate was 90.5% (162/179); 10 patients lost to follow-up.
- Per-protocol SVR12 rate was 95.9% (162/169).
- 6 relapses, 1 nonresponse reported.
- SVR12 was unaffected by genotype, baseline RAS, or prior DAA type, but was lower with:
- F4 vs F0-3 fibrosis: 91% vs 100% (P=.005), and
- Onset of hepatocellular carcinoma: 71% vs 97% (P=.02).
- Retrospective design.