Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) is a pan-genotypic direct active antiviral (DAA) regimen approved for patients who have previously failed anti-HCV treatment with other DAAs. Little is known about the effectiveness of this regimen in HIV/HCV coinfected patients. We evaluated the effectiveness and safety of SOF/VEL/VOX in a prospective registry of coinfected patients treated with DAAs.
For this study, we selected coinfected patients who started treatment with SOF/VEL/VOX and recorded in Madrid-CoRE, a compulsory prospective registry of coinfected patients receiving all-oral DAAs in the Madrid Regional Health Service hospitals (Hepatology 2017; 66:344). The planned treatment duration was 12 weeks. We assessed sustained virologic response (SVR) at 12 weeks by intention-to-treat (ITT) and by per-protocol analysis (PP) in which patients with no response data or discontinuations were excluded for the analysis.
A total of 56 patients met the inclusion criteria. The median (IQR) age was 51.9 (47-7-54.5) years, 92.9% were men, and 17.9% had cirrhosis. The genotype distribution was: G1, 67.8%; G3, 12.5%; G4, 16.1%; Other/mixed/unknown: 4.6%. The number of previous DAAs regimens was one in 76.5%, 2 in 15.5%, and three or more in 7.8%. The type of previous regimens included sofosbuvir/ledipasvir in 50% patients, ombitasvir/paritaprevir/ritonavir plus dasabuvir in 9.4%, sofosbuvir plus daclatasvir in 9.4%, elbasvir/grazoprevir in 9.4%, glecaprevir/pibrentasvir in 9.4% and 13.4% other regimens. SVR rates were 80.4% (95% CI, 68.2%-89.7%) by ITT and 95.7% (95% CI, 85.7%-98.8%) by PP analysis. A total of 9 patients were not included in the PP analysis (2 discontinuations and 7 without data). Liver cirrhosis and genotype did not influence treatment response (SVR by ITT 90% for cirrhosis and 85.8% for G3).
Our findings suggest that SOF/VEL/VOX is a highly effective regimen for treatment of coinfected patients previously failing to DAA regimens, across all genotypes and in the presence of cirrhosis.