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

• Published in: Journal of viral hepatitis Vol. 26; no. 10; pp. 1186 - 1199
• Main Authors: Hlaing, Naomi Khaing Than, Nangia, Gayatri, Tun, Kyaw Thet, Lin, Sithu, Maung, Moe Zaw, Myint, Khin Thuzar, Kyaw, A. Mi Mi, Maung, Soe Thiha, Sein Win, Sithu, Bwa, Aung Hlaing, Loza, Bao‐Li, Win, Khin Maung, Reddy, K. Rajender
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.10.2019
• Subjects: Antiviral drugs; chronic hepatitis C; Cirrhosis; Clinical trials; direct‐acting antiviral agents; Fibrosis; generic; Genotype & phenotype; genotype 6; Genotypes; Liver cirrhosis; pangenotypic; Patients; Ribavirin; pangenotypic; direct-acting antiviral agents; generic; chronic hepatitis C; genotype 6
• ISSN: 1352-0504; 1365-2893
• DOI: 10.1111/jvh.13133

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 naïve 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.