The General Administration of Market Regulation approved the marketing of daclatasvir hydrochloride tablets and asunaprevir soft capsules

On April 28, 2017, the State Food and Drug Administration approved the import and marketing of Daclatasvir Hydrochloride Tablets and Asunaprevir Soft Capsules for the combined treatment of chronic hepatitis C in adults.

Chronic hepatitis C (CHC) is a common chronic and serious infectious disease in clinical practice. As the disease progresses, it gradually develops into cirrhosis and liver cancer. Previously, the standard treatment for CHC in China was a combination of pegylated interferon (PegαIFN) and ribavirin (RBV).

Recent studies have shown that oral direct anti-HCV drugs (DAA) have achieved good results in the treatment of hepatitis C. Daclatasvir (DCV) and Asunaprevir Soft Capsules (ASV) are DAA drugs developed by Bristol-Myers Squibb. Daclatasvir (DCV) is a selective HCV nonstructural protein 5a replication complex inhibitor that is highly specific to multiple HCV genotypes/subtypes and has low toxicity to host cells. This time, the State Food and Drug Administration approved it in combination with other drugs for the treatment of chronic hepatitis C virus infection in adults.

Asunaprevir soft capsules (ASV) are selective hepatitis C virus (HCV) nonstructural protein 3 protease inhibitors. This time, the State Food and Drug Administration approved it in combination with daclatasvir hydrochloride tablets for the treatment of adult genotype 1b chronic hepatitis C (non-cirrhotic or compensated cirrhosis). This regimen is a completely oral administration regimen without interferon administration, suitable for the treatment of adult patients with compensated liver disease of chronic hepatitis C (CHC) genotype 1b, including patients who are not suitable or intolerant to interferon alone or interferon combined with ribavirin.

The State Food and Drug Administration has put forward relevant post-marketing monitoring and evaluation requirements for daclatasvir hydrochloride tablets and asunaprevir soft capsules, and the approved drug instructions include instructions for use and potential risk information for taking the drug.

In the future, the State Food and Drug Administration will continue to accelerate the review of oral direct-acting anti-hepatitis C virus drugs and promote the listing of such drugs.