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Taiwan National Health Insurance Administration of the Ministry of Health and Welfare Approves Vemlidy(R) (tenofovir alafenamide) for Reimbursement

- 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
2019-04-30 11:30 754

TAIPEI, , April 30, 2019 /PRNewswire/ -- Gilead Sciences, Inc. today 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.

There are around 2.2 million hepatitis B infections in Taiwan[1], and only 10 percent of the patient population are treated[2]. Untreated chronic hepatitis B can often lead to liver cirrhosis, liver cancer,  and death. Liver cancer is the second most common cause of cancer death in Taiwan[3].

"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."

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. In addition, no patient developed resistance to tenofovir during the studies through 96 weeks of therapy. The most commonly reported adverse events through 96 weeks in both studies included headache, abdominal pain, fatigue, cough, nausea and back pain and occurred at similar rates in patients receiving either Vemlidy or Viread.

Vemlidy received marketing approval from the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare in 2016, and marketing authorization from the European Commission in 2017. Vemlidy also received licence approval from the Taiwan Food and Drug Administration, Ministry of Health and Welfare, in 2017.

About Gilead Sciences, Inc. 
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with global headquarters in Foster City, California.

For more information on Gilead Sciences, please visit the company's website at www.gilead.com, or follow Gilead on Twitter (@GileadSciences).

References:

  1. CDA Foundation. Polaris Observatory, 2019, available online: http://cdafound.org/polaris-hepB-dashboard/ 
  2. Razavi-Shearer D et al. Global prevalence, treatment and prevention of hepatitis B virus infection in 2016: a modelling study. Lancet Gastroenterol Hepatol 2018, available online: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(18)30056-6/fulltext 
  3. Ministry of Health and Welfare, 2017 National Death Statistics, available online: https://www.mohw.gov.tw/cp-3795-41794-1.html

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Source: Gilead Sciences, Inc.
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