Hepatitis B New Drug Vemlidy Has Been Approved by the FDA

On November 10, 2016, Gilead Scientific announced that the new drug Tenofovir Alafenamide (Tenofovir Alafenamide, TAF, trade name Vemlidy®, 25 mg, once daily) has been used in the treatment of hepatitis B. FDA approved treatment for chronic hepatitis B in adults without decompensated liver disease.

Clinical data show that the newly approved Vemlidy has greater plasma stability and can more effectively deliver tenofovir to hepatocytes, which can lower the concentration of tenofovir in blood due to the lower dosage Therefore, compared with Viread, Vemlidy can more effectively improve the safety parameters of patients' kidneys and bones.

Vemlidy obtained data support for up to 48 weeks in two International Phase 3 trials (Research 108 and Study 110). A total of 1298 adult patients with newly diagnosed and treated chronic HBV infection participated in clinical trials. Study 108 Randomized treatment of 425 HBeAg-negative patients with Vemlidy or Viread. Study 110 randomized 873 HBeAg-positive patients treated with Vemlidy or Viread. Both studies have reached their primary clinical endpoint: Vemlidy shows relative Viread based on the percentage of patients with chronic hepatitis B who have plasma HBV DNA levels below 29 IU/mL at week 48 of treatment. Non-inferiority.

In addition, Vemlidy and Viread performed well in both studies, and discontinuation of treatment due to adverse reactions was 1.0% and 1.2%, respectively. The most common adverse reactions in both studies were headache, abdominal pain, fatigue, cough, nausea, and back pain, and the incidence of adverse reactions was essentially the same in patients treated with Vemlidy or Viread.

Dr. John Milligan, President and CEO of Gilead Sciences, said: “Since the mid-1990s, Gilead has been working to improve and simplify the treatment of patients with chronic hepatitis B. Vemlidy was approved for treatment in the past decade The first drug for this disease (CB), we are pleased to offer a new and effective treatment option to help promote long-term health care for patients.”

However, it is worth noting that Vemlidy has a black box warning in his product label to alert him to severe acute exacerbation of hepatitis B after treatment, severe hepatomegaly with steatosis, and risk of lactic acidosis.