The nucleoside analogue entecavir has been approved by the U.S. Food and Drug Administration for treating chronic hepatitis B in adults with decompensated liver disease, the manufacturer announced.

Approval was based on data from an ongoing study that randomized patients with chronic hepatitis B and decompensated liver disease to treatment with entecavir, at a dose of 1 mg once daily, or the nucleotide analogue adefovir (10 mg once daily), according to a statement issued by Bristol-Myers Squibb (BMS).

Entecavir, first approved by the U.S. Food and Drug Administration (FDA) in 2005 for treating chronic hepatitis B in adults with compensated liver disease, is marketed as Baraclude by BMS.

The open-label, controlled, phase 3b study enrolled HBeAg-positive or HBeAg-negative patients with chronic hepatitis B and evidence of hepatic decompensation, who had never been treated for hepatitis B virus (HBV) or had been treated predominantly with lamivudine or interferon-alpha; 100 patients were randomized to receive entecavir, 91 to receive adefovir.

At 48 weeks, 57% of the patients in the entecavir arm had an undetectable HBV DNA viral load (less than 300 copies/mL), compared with 20% of those on adefovir, according to BMS. Among the patients with abnormal alanine aminotransferase levels at baseline, more of those treated with entecavir achieved normal levels at 48 weeks, compared with those treated with adefovir (63% vs. 46%, respectively). Loss of hepatitis B surface antigen was seen in 5% of those on entecavir, compared with none of those treated with adefovir.

However, slightly more patients on adefovir (67%) showed improvement, or no worsening, in their Child-Turcotte-Pugh scores, compared with 61% of those on entecavir.

The most common adverse events reported in patients treated with entecavir through 48 weeks were peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%), according to the company statement.

The study is the ETV-048 trial.

Approved in 2002, adefovir is indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

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百时美施贵宝公司近日宣布，美国食品药品管理局(FDA)已批准核苷类似物恩替卡韦(商品名博路定)用于治疗成年失代偿性肝病患者。

 

本研究是一项开放式对照3b期临床试验(编号ETV-048)，共纳入191例HBeAg阳性或阴性且存在失代偿性肝病症状的慢性乙型肝炎患者，其中100例被随机分配至恩替卡韦组(每日1次，每次1 mg)，另外91例被分配至阿德福韦组(核苷类似物，每日1次，每次10 mg)。

 

48周后，恩替卡韦组有57%患者乙肝病毒(HBV)DNA载量下降至检测水平之下(＜300拷贝/ml)，阿德福韦组患者中仅有20%患者达到此效果。在谷丙转氨酶基线水平异常的患者中，治疗48周后该数值达到正常水平的患者比例在恩替卡韦和阿德福韦组分别为63%和46%。恩替卡韦组患者有5%HBV表面抗原转阴，而阿德福韦无此疗效。CTP(Child-Turcotte-Pugh)评分表明，恩替卡韦组和阿德福韦组患者病情改善(或未发生恶化)率分别为67%和61%。

 

治疗48周后，恩替卡韦导致的最常见不良反应主要包括：外周性水肿(16%)、腹水(15%)、发热(14%)、肝性脑病(10%)和上呼吸道感染(10%)。

 

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