"Best-in-Class" Hepatitis B Drug Tenofovir Alafenamide (Vemlidy) Approved in China

Recently, the antiviral drug tenofovir alafenamide (abbreviated as TAF; Chinese name: Vemlidy), developed by the U.S. pharmaceutical giant Gilead Sciences,Approved for marketing in China, indicated for the treatment of patients with chronic hepatitis B.

China is a country with a high prevalence of hepatitis B. The "2016 Global Hepatitis B Infection Rate and Prevention and Control Report" released by The Lancet shows that,There are currently 86 million hepatitis B virus-infected individuals in China.Among these patients, 32 million require immediate initiation of appropriate antiviral therapy.

Vemlidy is the only new hepatitis B drug approved globally in the past decade. In the "2017 Hepatitis B Management Guidelines" published by the European Association for the Study of the Liver (EASL), TAF is recommended as a first-line treatment for patients with chronic hepatitis B.

Tenofovir disoproxil fumarate (TDF), previously the preferred first-line medication, was once hailed as a “miracle drug” due to its potent antiviral efficacy and low resistance rate. However, since most patients with hepatitis B require lifelong therapy, long-term use of TDF may cause renal impairment and reduced bone mineral density.

Yan Jie, chief physician at the Liver Disease Center of Beijing Ditan Hospital, stated that compared with the previous generation of tenofovir disoproxil fumarate (TDF),Vemlidy requires only one-tenth of the dosage (25 mg/300 mg) to achieve the same antiviral efficacy as tenofovir disoproxil fumarate.

Furthermore, compared with tenofovir disoproxil fumarate (TDF), Vemlidy effectively improves bone safety parameters, reduces the risk of osteoporosis, and poses less nephrotoxicity. In other words, it offers the best long-term safety and efficacy among all currently available hepatitis B treatments.

According to the 96-week efficacy and safety results from the Phase III study of Vemlidy, Vemlidy maintains a high rate of viral suppression with virtually no risk of resistance mutations.

Yan Jie reminded,Vemlidy lacks clinical trial data in pregnant women; caution is advised for use in pregnant patients.

Original Title: "Best-Ever" Hepatitis B Drug Approved!