Gilead's Hepatitis B Drug Vemlidy (TAF) Now Reimbursed in Taiwan's National Health Insurance Starting May 1, 2019
Apr 30, 2019 15:06
CST Updated
15:06
Gilead Sciences
Antiviral Drug Developer
April 30, 2019/Bio ValleyBIOON/--U.S. pharmaceutical giant Gilead Sciences recently announced that, effective May 1, 2019, the antiviral drug Vemlidy (tenofovir alafenamide fumarate, TAF, 25 mg) will be made available to patients in Taiwan through Taiwan’s National Health Insurance (NHI) program. Vemlidy is a once-daily medication indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease.
It is estimated that there are approximately 2.2 million hepatitis B patients in Taiwan, China, with only 10% of them receiving treatment. Untreated chronic hepatitis B often leads to liver cirrhosis, liver cancer, and death.Liver CancerIt is the second leading cause of cancer-related deaths in Taiwan.
Pongo Peng, General Manager of Gilead Sciences Taiwan, stated, “Today, patients with hepatitis B face extensive challenges during long-term treatment, including heightened concerns regarding safety and drug resistance. The availability of Vemlidy means that healthcare professionals have access to a highly effective therapy that does not compromise patients’ bone or renal health. As a leading expert in liver disease, Gilead has already developed curative treatments for hepatitis C and is currently developing compounds aimed at curing hepatitis B. We are committed to collaborating with the Taiwanese government to alleviate the burden of hepatitis B and improve patient health outcomes.”
Vemlidy is a novel nucleoside reverse transcriptase inhibitor (NRTI) and an upgraded version of Gilead’s marketed drug Viread (tenofovir disoproxil fumarate, TDF). InClinical Trial, TAF has been proven to achieve highly potent antiviral efficacy at one-tenth the dose of TDF, while demonstrating a better safety profile with improved renal and bone safety parameters.
Viread (TDF) is also a novel nucleoside reverse transcriptase inhibitor (NRTI) that is currently widely used in the treatment of HIV (AIDS) and HBV (hepatitis B). For hepatitis B patients who are suitable candidates for this medication, Viread represents an effective therapeutic option. However, like HIV/AIDS, hepatitis B is a chronic viral disease requiring long-term treatment. The launch of Vemlidy will provide the hepatitis B patient population with a treatment regimen featuring significantly improved safety, thereby promoting the long-term management of hepatitis B.
The approval of Vemlidy was based on data from two international Phase III studies (Study 108 and Study 110). Both were randomized, double-blind, 96-week Phase III clinical trials conducted in 1,632 adult patients with hepatitis B e antigen (HBeAg)-negative and HBeAg-positive chronic hepatitis B, including 334 patients from China, who were either treatment-naïve or treatment-experienced. These studies evaluated the efficacy and safety of Vemlidy relative to Viread.
The pooled analysis results demonstrated that the study data confirmed the non-inferiority of Vemlidy relative to Viread. Furthermore, compared with Viread, Vemlidy improved renal function and bone safety parameters. During the 96-week treatment period, no patients developed resistance to tenofovir. In the two studies, the most commonly reportedAdverse ReactionsIncluding headache, abdominal pain, fatigue, cough, nausea, and back pain, the incidence rates were similar between the Vemlidy treatment group and the Viread treatment group.
In the United States, Vemlidy is indicated only for adult patients with hepatitis B virus (HBV) infection and compensated liver disease. Its prescribing information includes a boxed warning regarding the risk of severe acute exacerbations following discontinuation of treatment. Vemlidy was approved in Japan and the United States in 2016 and in the European Union in 2017. In China, Vemlidy was approved in November 2018 as a once-daily medication for the treatment of chronic HBV infection in adults and adolescents (aged 12 years and older, weighing ≥35 kg).
It is estimated that there are as many as 350–400 million hepatitis B patients worldwide, and the disease can lead to cirrhosis, accounting for 80% of primary liver cancer cases globally.Liver Cancerthe direct cause. China is a country with a high prevalence of hepatitis B. Conservative estimates suggest that among the 1.3 billion people in China, 100 million are carriers of the hepatitis B virus (HBV), accounting for approximately one-third of the global total of HBV carriers. Moreover, the incidence of hepatitis B in China continues to rise, with approximately 300,000 deaths annually from HBV-related cirrhosis. The launch of Vemlidy in China enables clinicians to offer hepatitis B patients a new medication that retains the efficacy of tenofovir disoproxil fumarate (TDF) while demonstrating improved safety profiles regarding renal and bone parameters. (Bioon.com)