On April 28, 2017, the State Food and Drug Administration approved the import and marketing of Dalatavir Hydrochloride Tablets and Asurivir Soft Capsules for the combined treatment of adult chronic hepatitis C.
Chronic hepatitis C (CHC) is a common chronic severe infectious disease in clinical practice, which gradually develops into cirrhosis and liver cancer as the condition progresses. Previously, the standard treatment for CHC in China was pegylated interferon (Peg α IFN) in combination with Ribavirin (RBV).
Recent studies have shown that oral direct antiviral drugs (DAA) have achieved good results 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. The State Food and Drug Administration has approved its combination with other drugs for the treatment of chronic hepatitis C virus infection in adults.
Asunaprevir soft capsules (ASV) are selective inhibitors of non-structural protein 3 proteases of hepatitis C virus (HCV). The State Food and Drug Administration has approved its combination with dalatavir hydrochloride tablets for the treatment of adult genotype 1b chronic hepatitis C (non cirrhosis or compensatory cirrhosis). This protocol is a complete Oral administration protocol without interferon administration, which is applicable to the treatment of adult patients with chronic hepatitis C (CHC) compensatory liver disease of genotype 1b, including patients who are not suitable or tolerant to interferon treatment alone or interferon combined with Ribavirin treatment.
The State Food and Drug Administration has put forward relevant post marketing monitoring and evaluation requirements for Dacatavir Hydrochloride Tablets and Asurevir Soft Capsules. The approved Medication package insert include instructions for use and information on potential risks of taking the drug.
Subsequently, the State Food and Drug Administration will continue to accelerate the evaluation of oral direct anti hepatitis C virus drugs and promote the listing of such drugs.