Sunday, 16 June 2019

Taiwan Health Ministry approves Vemlidy for chronic hepatitis B

30 April 2019 | News

Vemlidy(R) has shown improved renal and bone safety profiles compared to TDF making it an important first-line treatment option for chronic hepatitis B

Gilead Sciences, Inc. has recently announced that with effect from 1 May 2019, Vemlidy (tenofovir alafenamide, TAF) 25 mg, a once-daily treatment for chronic hepatitis B in adults with compensated liver disease will be made available to patients via the National Health Insurance (NHI) scheme.

Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead's Viread® (tenofovir disoproxil fumarate, TDF) 300 mg, with better alanine aminotransferase normalization and improved bone and renal safety at one-tenth of the dose. Data show that because Vemlidy has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to Viread, it can be given at a lower dose, resulting in less tenofovir in the bloodstream.

Vemlidy's approval is supported by data from two international Phase 3 studies (Studies 108 and 110) among 1,632 treatment-naive and treatment-experienced adult patients with HBeAg-negative and HBeAg-positive HBV disease (including 120 treated in Taiwan). In an integrated analysis of both studies, patients receiving Vemlidy demonstrated improvements in certain bone and renal laboratory parameters compared to those treated with Viread.

"Today, patients living with hepatitis B face a wide range of challenges in their long-term treatment, including safety and increased resistance. The availability of Vemlidy means that healthcare professionals have access to a highly effective treatment that does not compromise their patients' bone or renal health. As leading experts in liver disease, we have developed cures for hepatitis C and are advancing compounds in pursuit of a cure for hepatitis B," said Pongo Peng, General Manager Gilead Taiwan. "We are committed to working with the Taiwan government to reduce the burden of hepatitis B and enhance health outcomes for patients."

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