Entecavir Tablets (Baraclude) Approved in China for Expanded Indication in End-Stage Hepatitis B with Decompensated Liver Disease

According to the official WeChat account of Bristol-Myers Squibb, the company’s oral anti-hepatitis B virus drug Baraclude (entecavir tablets) has recently been approved by the National Medical Products Administration (NMPA) for an expanded indication, now applicable to antiviral treatment in patients with decompensated liver disease. This update to the indications will enhance treatment confidence among the broad population of Chinese patients with chronic hepatitis B complicated by decompensated cirrhosis.

Hepatitis B combined with decompensated cirrhosis belongs to the end-stage phase of hepatitis B, with approximately 8% progressing to hepatocellular carcinoma (HCC) annually and an annual mortality/transplantation rate exceeding 15%. Currently, for patients with chronic hepatitis B combined with decompensated cirrhosis, treatment principles mainly include comprehensive therapeutic regimens such as antiviral therapy, anti-inflammatory and liver-protective measures, and symptomatic treatment. As a key component of etiological treatment, antiviral therapy not only significantly improves liver function in patients with decompensated cirrhosis but also extends survival time and reduces mortality rates.

The approval of the expanded indication for Baraclude (entecavir tablets) is based on robust evidence from evidence-based medicine, including results from the Phase III clinical Study 048 and real-world studies. Furthermore, numerous real-world studies conducted both domestically and internationally have confirmed that Baraclude (entecavir tablets) can prolong survival in patients with chronic hepatitis B complicated by decompensated cirrhosis.

It is reported that entecavir has been on the market in China for 13 years, with over one million Chinese patients with chronic hepatitis B using it. In 2017, the drug was approved by the China Food and Drug Administration (CFDA) for the treatment of nucleoside-naïve pediatric patients aged 2 to less than 18 years with compensated liver disease due to chronic hepatitis B virus infection. It became the first nucleos(t)ide analogue approved in China for treating young children (<12 years old) with hepatitis B.

This drug has been supported by extensive evidence-based medicine demonstrating its favorable efficacy and tolerability in various special populations, including children, the elderly, patients with high viral load, liver cirrhosis, renal insufficiency, and hypophosphatemic bone disease. Therefore, it is recommended by major guidelines for use in these special populations.