The world's first new drug, vosevi, has been approved for marketing in China

Hepatitis C is known as the "silent killer" Different from hepatitis B, hepatitis C usually has no symptoms and is easily ignored by patients, leading to an increased risk of disease progression to cirrhosis and liver cancer It is estimated that nearly 10 million people in China are infected with HCV, accounting for 5.4% of the global population Hepatitis C virus is mainly divided into six genotypes In China, more than 50% of the patients are type 1b, the rest are type 2, type 3 and type 6, and the proportion varies in different regions On December 18, Geely's hepatitis C drug vosevi was approved for marketing in China Vosevi is a fixed dose compound composed of sophibuvir, vepatavir and foxirivir, which is known as "Jisi generation" in the industry Vosevi was approved by FDA on July 18, 2017 for the treatment of adult patients with hepatitis C virus type 1-6 infection with or without mild cirrhosis This is the first one-day piece of hepatitis C therapy approved for previous treatment with suofibuvir or with NS5A inhibitors In China, vosevi was included in the first batch of clinically urgent overseas drugs in March 2019 In June 2019, Gilead submitted the application for listing of the drug, and it took six months from the application for listing to today's approval Gilead is a leading enterprise in the field of hepatitis C sophibuvir, the first NS5B polymerase inhibitor in the world, has achieved the cure of hepatitis C by effectively inhibiting the replication of HCV In 2017, Gilead entered China In the same year, sophibuvir tablets were approved for marketing in China, becoming the first direct antiviral drug (DAA) covering the pan genotype of hepatitis C in China In May and November 2018, Gilead successively launched the "third generation of Jiji" suophobuvpatavir tablets and the "second generation of Jiji" Lai Di Pai vaophobuvir tablets in China Now, the two new drugs have been negotiated into the national health insurance category B directory in 2019, but the specific payment standard is confidential The safety and efficacy of vosevi were confirmed in two phase III studies involving 750 patients with hepatitis C The first study evaluated the efficacy and safety of vosevi over placebo in patients with type 1 hepatitis C who had previously received an NS5A inhibitor but failed to receive the treatment Patients with genotype 2-6 also received vosevi treatment for 12 weeks In the second study, we compared the efficacy and placebo differences between vosevi and sufebuvir + vpatavir (NS5B + NS5A) for 12 weeks in patients with hepatitis C who had previously received sufebuvir (NS5B) but failed to receive the treatment The results showed that 96% ~ 97% of the patients detected the virus in the blood at the end of 12 weeks after the completion of the treatment Adverse reactions associated with vosevi therapy are associated with viral genotypes, with the most common adverse reactions including headache, fatigue, diarrhea, and nausea.