Combination is first all-oral treatment in China, where Gilead’s Sovaldi is not yet approved
The China Food and Drug Administration (CFDA) has approved two combinations of Bristol-Myers Squibb’s (BMS) hepatitis C medicines. A combination of Daklinza (daclatasvir) with Sunvepra (asunaprevir) has been approved for patients with genotype 1b of the disease, while Daklinza in combination with Gilead’s Sovaldi (sofosbuvir) has been approved across genotypes 1–6.
Sovaldi alone, which has brought Gilead billions of dollars in sales elsewhere around the world, is not approved in China (it is currently under review by the CFDA). These combinations represent China’s first approval of drugs for hepatitis C that do not also require interferon or ribavirin treatment, which are associated with serious side effects.