High sustained virologic response in genotypes 3 and 6 with generic NS5A inhibitor and sofosbuvir regimens in chronic HCV in myanmar

摘要

Abstract Exclusive HCV therapy clinical trials with genotype 6 patients in high prevalence areas have been sparse. We analysed the safety and efficacy of two generic, pangenotypic NS5A/NS5B combination oral DAA regimens, primarily in genotypes 3 and 6, in a real‐world setting: (a) daclatasvir/sofosbuvir (DCV/SOF)?±?ribavirin (RBV) and (b) Velpatasvir/sofosbuvir (VEL/SOF?±?RBV). Between December 2015 and November 2017, data from 522 patients were analysed, 311 of whom were treated with DCV/SOF?±?RBV for 12/24?weeks (genotype 3: n?=?193, genotype 6: n?=?89) and 211 were treated with VEL/SOF?±?RBV for 12/24?weeks (genotype 3: n?=?83, genotype 6: n?=?77). Overall SVR rates were high for both DCV/SOF?±?RBV (96.1%, n?=?299/311) and VEL/SOF?±?RBV (95.3%, n?=?201/211), and there was a good adverse event profile. Treatment na?ve status and inclusion of RBV (in advanced fibrosis/cirrhosis) were significant independent predictors of achieving SVR12, while type of DAA regimen was not predictive. In this large cohort of genotypes 3 (n?=?276) and 6 (n?=?166; n?=?127 unique subtype of 6c‐l), high SVR rates of 94.9% (n?=?262/276) and 95.2% (n?=?158/166), respectively, were noted. In conclusion, generic and pangenotypic DCV/SOF and VEL/SOF?±?RBV regimens were highly effective and safe, in genotypes 3 and 6 chronic HCV in Myanmar. These efficacious pangenotypic regimens suggest that baseline genotype testing can be eliminated moving forward. While RBV may still be needed for those with advanced fibrosis/cirrhosis, in a global elimination strategy it would not be practical even if it does compromise SVR in a minority with difficult to treat characteristics.