China FDA approves country's first all-oral regimen for chronic hepatitis C

The China Food and Drug Administration (CFDA) has approved a direct-acting antiviral regimen comprised of Daklinza (daclatasvir) and Sunvepra (asunaprevir), for the treatment of treatment-naive or -experienced patients, with or without compensated cirrhosis, infected with genotype 1b chronic hepatitis C virus (HCV).

The drugs’ maker, US pharma major Bristol-Myers Squibb (NYSE: BMY), said this is China’s first all-oral, interferon- and ribavirin-free HCV treatment regimen. In addition, Daklinza has been approved in China for combination use with other agents, including sofosbuvir, for adult patients with HCV genotypes 1-6 infection. This is the only all-oral pan-genotypic regimen recommended by China’s HCV Prevention and Treatment Guideline. Daklinza must not be administered as monotherapy. Sofosbuvir is under review by the CFDA, and is not currently licensed in China.