Gilead Sciences' Two Phase Three Trials Meet Primary Endpoints

Gilead Sciences, Inc.

disclosed detailed 48-week results of its two big phase three clinical trials to evaluate tenofovir alafenamide 25 mg in treatment-naïve and treat-experienced adults with HBeAg-negative, as well as, HBeAg-positive chronic hepatitis B infection. The company indicated that both the trial met their primary endpoints of non-interiority to its Viread 300 mg based on the percentage of patients with HBV DNA levels below IU/mL during the treatment period. Gilead Sciences disclosed that TAF demonstrated enhanced renal and bone laboratory safety parameters compared to Viread. According to the company, discontinuations as a result of adverse events were uncommon in both treatment arms. The medical firm said that the most commonly disclosed adverse events included a headache, upper respiratory tract infection, cough, and nasopharyngitis. The company also pointed out that the adverse events happened at similar rates in patients receiving either TAF or Viread. Gilead Science's EVP for R&D and Chief Scientific Officer, Norbert Bischofberger, commented that "Chronic hepatitis B infection is a life-threatening disease that can lead to liver failure, liver cancer and death". He went on to add that "With millions of people living with the disease, it remains a significant health concern worldwide. The TAF Phase 3 results presented this week demonstrate its potential to advance the treatment of HBV – offering a similar efficacy profile to Viread with improved bone and renal safety parameters." On Thursday, shares of the company ended with $1.06 gain.