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CFDA approved the marketing of dalatavir hydrochloride tablets and asurevir soft capsules
Chronic hepatitis C (CHC) is a common chronic and serious infectious disease in clinic. With the progress of the disease, it gradually develops into liver cirrhosis and liver cancer. Previously, the standard treatment for CHC in China was pegylated interferon (PEG-α IFN) combined with ribavirin (RBV).
Recent studies have shown that oral direct anti-HCV drugs (DAA) are effective in the treatment of hepatitis C. Daclatasvir (DCV) and Asunaprevir (ASV) are DAA drugs developed by Bristol-Myers Squibb. Daclatasvir (DCV) is a selective HCV non-structural protein 5a replication complex inhibitor with high specificity for multiple HCV genotypes/subtypes and low toxicity to host cells. It was approved by the State Food and Drug Administration in combination with other drugs for the treatment of chronic hepatitis C virus infection in adults.
Asunaprevir (ASV) is a selective non-structural protease 3 inhibitor of hepatitis C virus (HCV). This time, the State Food and Drug Administration approved it in combination with dalatavir hydrochloride tablets for the treatment of chronic hepatitis C genotype 1b (non-cirrhotic or compensated cirrhosis) in adults. This regimen is a complete oral administration regimen without interferon for the treatment of chronic hepatitis C (CHC) compensated liver disease in adults with genotype 1b, including patients who are ineligible or intolerant to interferon therapy alone or interferon combined with ribavirin.
The State Food and Drug Administration has put forward relevant post-marketing monitoring and evaluation requirements for Dakatavir hydrochloride tablets and asurevir soft capsules. The approved drug package guide includes instructions for use and information on potential risks of taking the drug.
Subsequently, the State Food and Drug Administration will continue to speed up the evaluation of oral direct anti-HCV drugs and promote the marketing of such drugs.
