Efficacy and safety of direct‐acting antiviral therapies and baseline predictors for treatment outcomes in hepatitis C patients: A multicenter, real‐world study in Guangdong, China

Abstract

The data on direct-acting antivirals (DAAs) in chronic hepatitis C (CHC) patients in southern China with multiple genotypes circulating are limited. This study aims to evaluate the efficacy and safety of DAA regimens among CHC patients in Guangdong, China. A total of 220 patients receiving a variety of DAA were enrolled. The primary outcome was sustained virologic response (SVR) at 12 weeks. Resistance associated substitutions (RASs) were evaluated by deep sequencing. The overall SVR rate was 96.4%, and was 97.7% for genotype 1, 100% for genotype 2, 91.9% for genotype 3, 95.7% for genotype 6, and 100% for untyped. The overall incidence of adverse events (AEs) was 8.2% (18/220) and all the AEs were mild. Nonstructural proteins 5A RAS, 30K/31M, and Y93H were most prevalent at baseline and the end of treatment in non-SVR patients, respectively. Logistics regression showed that elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) at baseline were specifically associated with non-SVR in patients with genotype 3 and 6 infections (p = 0.029 and p = 0.017) but not genotype 1 infection (p = 0.746 and p = 0.971), and baseline AST was the best predictor for SVR in genotypes 3 and 6 patients (area under curve = 0.890). Our studies demonstrated all DAA regimens achieved ideal SVR and

Rise in alanine aminotransferase after HCV treatment is a highly sensitive screen for treatment failure

“…Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are nonspecific markers of liver inflammation that are routinely tested before and after HCV treatment. Elevated pretreatment ALT levels have been associated with slower virological response,3 and pretreatment levels of both enzymes have been associated with failure to achieve SVR,4 though neither are reliably predictive. Both enzymes decline on therapy,5–7 and in the pre-DAA era, a “sustained biochemical response” was used as a surrogate for SVR 6,7.…”