Hepatitis B super heavy news! Vemlidy (TAF), the safest new drug in Gilead's history, has been approved by China

U.S. pharmaceutical giant Gilead recently announced that the antiviral drug Vemlidy (tenofovir alafenamide, TAF, tinofovir phenolamine fumaric acid) has been approved by China's State Drug Administration (NMPA) as a daily drug for the treatment of adults and adolescents with chronic hepatitis B (HBV) (12 years and older, weighing ≥35 kg).
this approval, making Vemlidy the first new oral drug approved in the Chinese market for the treatment of hepatitis B in 10 years. Vemlidy is a new nucleoside reverse transcriptase inhibitor (NRTI), an upgraded version of Gilead's listed drug Viread (Fumarate Novovir dioxin, TDF). In clinical trials, TAF has been shown to have very high antiviral efficacy at doses below one-tenth of TDF, while exhibiting better safety, improved renal function and bone safety parameters.
Viread (TDF) is also a new type of NRTI drug, which is now widely used in the treatment of HIV (AIDS) and HBV (hepatitis B). Viread is an effective treatment option for hepatitis B patients who are suitable for the drug. But hepatitis B, like AIDS, is a chronic viral disease that requires long-term treatment. Vemlidy's launch will provide a much-improved treatment for patients with hepatitis B, which will promote long-term care for hepatitis B.
approval of Vemlidy is based on data from two international Phase III studies (Study 108 and Study 110). Both studies were randomized, double-blind, 96-week Phase III clinical studies, and evaluated Vemlidy's efficacy and safety relative to Viread in 1,632 patients (including 334 patients in China) who had not been treated in the past (primary treatment) and in adult patients who had received treatment (treatment) with HBeAg negative and HBeAg-positive hepatitis B.
analysis of the data show that the research data prove that Vemlidy is not inferior to Viread. Vemlidy also improves kidney function and bone safety parameters compared to Viread. During the 96-week treatment period, no patient developed resistance to tynofove. In 2 studies, the most common adverse reactions reported during the 96-week treatment period included headache, abdominal pain, fatigue, cough, nausea and back pain, with similar rates in the Vemlidy treatment combination Viread treatment group.
the United States, Vemlidy is only available to adult patients with prosaic liver disease, and its prescription information contains a black-box warning of the risk of severe acute exacerbation after treatment with medication. Vemlidy was approved by Japan and the United States in 2016 and by the European Union in 2017.The status quo of hepatitis B: China is a big country of hepatitis B
It is estimated that there are as many as 350-400 million hepatitis B patients worldwide, the disease can lead to cirrhosis of the liver, 80% of the world's primary liver cancer direct cause. China is a large country with hepatitis B, according to conservative estimates, of the country's 1.3 billion people, 100 million are carriers of hepatitis B virus, accounting for about 1/3 of the total number of hepatitis B carriers in the world, and the incidence of hepatitis B in China continues to rise, about 300,000 people die each year from HBV-related cirrhosis.
"With The approval of Vemlidy, clinicians in China can now provide hepatitis B patients with a new drug that retains TDF efficacy while having parameters to improve kidney and bone safety," said Professor Hou Jinlin, Director of Infection Medicine at Southern Medical University. Gregg Alton, chief patient officer at
Gilead, said, "Chronic hepatitis B remains an urgent public health issue in China, and many patients still need effective, well-to-to-do, high-resistance treatment options, especially given that hepatitis B is a lifelong treatment. Gilead is committed to working with regulators and medical institutions to help address the hepatitis B challenges currently facing China. (Bio Valley)