Rates of sustained virologic response (SVR) to currently recommended therapy against hepatitis C virus (HCV) infection based on all-oral direct-acting antivirals (DAA) are generally high. However, in specific subsets, as it is the case for HCV genotype 3-infected, cirrhotic individuals, SVR rates can be suboptimal. The aim of this study was to determine the predictive capacity of response at week 4 for the achievement of sustained virologic response 12 weeks after the scheduled end of therapy date (SVR12) to treatment against HCV infection with all-oral DAA-based regimens.
From a prospective multicohort study, patients who completed a course of currently recommended DAA-based therapy at 33 Spanish hospitals and who had reached SVR12 evaluation timepoint were selected. Treatment week 4 HCV-RNA levels were categorized in target not detected (TND), below the lower limit of quantitation (LLOQTD) and ≥LLOQ.
A total of 818 patients were included. SVR12 rates [n/N (%)] for HCV genotypes 1a, 1b, 3 and 4 in an on-treatment approach were 275/282 (97.5%), 283/286 (99%), 114/123 (92.7%) and 123/127 (94.5%). Of the HCV genotype 3-infected patients, 86 (70%) received sofosbuvir/daclatasvir+/-ribavirin, 27 (22%) sofosbuvir/ledipasvir/ribavirin and 10 (8.1%) sofosbuvir/ribavirin, respectively. In this subgroup, in those that achieved TND, LLOQTD and ≥LLOQ, SVR12 was 81 (97.6%), 24 (85.7%) and 9 (75%), respectively; p (linear association)=0.001. Corresponding numbers for HCV genotype 3-infected subjects with cirrhosis were: 52 (96.3%), 14 (77.8%) and 7 (70%); p=0.004. There was no association between response at week 4 and SVR12 for the other HCV genotypes.
Treatment week 4-response indicates the probability to achieve SVR12 to currently used DAA-based therapy in HCV genotype 3-infected individuals. This finding may be useful to tailor treatment strategy in this setting.