High Rates of Viral Suppression Shown in Gilead Hepatitis B Treatment

Gilead presents data at the International Liver Congress 2017 supporting the efficacy and safety of Vemlidy in patients with chronic hepatitis B after 96 weeks, and also after switching from Viread.

Gilead Sciences, Inc. has announced 96-week results from two ongoing Phase 3 studies evaluating the safety and efficacy of daily Vemlidy (tenofovir alafenamide, TAF 25mg) in immune active patients and in patients switching from Gilead’s Viread (tenofovir disoproxil fumarate, TDF 300mg).

Vemlidy is a once-daily treatment approved for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. In addition, Gilead presented data from preclinical studies of investigational compounds being studied for their potential role in HBV cure strategies. Data are being presented this week at The International Liver Congress 2017 (EASL) in Amsterdam.

Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy that is noninferior to that of Viread at Week 48 in patients with chronic HBV. Vemlidy treatment at the same time point also demonstrated a beneficial impact on renal and bone laboratory safety parameters compared to Viread.

Analyses now conducted at Week 96 of treatment demonstrate continued benefits of Vemlidy including high rates of viral suppression, with no evidence of resistance, and less impact on renal and bone safety parameters as compared to Viread (#PS-042, #FRI-153). Additionally, patients switching from Viread to Vemlidy after Week 96 demonstrated maintenance of viral suppression, improvement in serum alanine aminotransferase (ALT) normalization rates, and improvement in bone and renal parameters 24 weeks after switching to Vemlidy (#PS-041: “Hepatitis B and D: emerging treatment options”).

“The results observed in these studies reinforce Vemlidy as an important treatment option for patients living with chronic HBV infection,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “Additionally, the preclinical data presented at this EASL meeting illustrate our scientific approach to evaluating compounds with distinct mechanisms of action aimed at curing HBV infection.”

Vemlidy has a boxed warning in its U.S. product label regarding the risk of post-treatment severe acute exacerbation of hepatitis B.

(Source: Business Wire)