Тенофовир алафенамид оказался перспективен в терапии гепатита В
Gilead Sciences, Inc. announced detailed 48-week results from two large Phase 3 clinical trials (Studies 108 and 110) evaluating once-daily tenofovir alafenamide (TAF) 25 mg in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic hepatitis B virus (HBV) infection. Data were presented this week during two oral sessions (GS06 and GS12) at The International Liver Congres 2016 in Barcelona, Spain.
Both studies met their primary endpoints of non-inferiority to Gilead’s Viread (tenofovir disoproxil fumarate, TDF) 300 mg based on the percentage of patients with HBV DNA levels below 29 IU/mL at 48 weeks of therapy. In addition, TAF demonstrated improved renal and bone laboratory safety parameters compared to Viread. Discontinuations due to adverse events were uncommon in both treatment arms. The most commonly reported adverse events in both studies included headache, upper respiratory tract infection, nasopharyngitis and cough, and occurred at similar rates in patients receiving either TAF or Viread. A summary of the topline study results was disclosed in a press release dated January 5, 2016.
“Chronic hepatitis B infection is a life-threatening disease that can lead to liver failure, liver cancer and death,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “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.”