Carvedilol Plus NUC for Patients With HBV-Compensated Cirrhosis Under Virological Suppression: A Randomized Open-Label Trial

• Published in: The American journal of gastroenterology Vol. 119; no. 4; pp. 700 - 711
• Main Authors: Wang, Bingqiong, Zhou, Jialing, Wu, Xiaoning, Sun, Yameng, Li, Lei, Li, Ping, Li, Minghui, Jiang, Wei, Xu, Mingyi, Feng, Bo, Xu, Xiaoyuan, Cheng, Jilin, Xie, Wen, Han, Tao, Wang, Xiaozhong, Li, Hai, Piao, Hongxin, Zhao, Xinyu, Chen, Shuyan, Meng, Tongtong, Guan, Qiushuang, Meng, Fandong, Kong, Yuanyuan, Ou, Xiaojuan, Jia, Jidong, You, Hong
• Format: Journal Article
• Language: English
• Published: United States Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins 01.04.2024
• Subjects: Antiviral Agents - therapeutic use; Ascites; Beta blockers; Blood pressure; Carvedilol - therapeutic use; Disease prevention; Endoscopy; Esophagus; Hepatitis B; Hepatitis B virus; Humans; Liver cancer; Liver cirrhosis; Liver Cirrhosis - drug therapy; Liver Neoplasms; Medical laboratories; Medical prognosis; Ultrasonic imaging; China
• ISSN: 0002-9270; 1572-0241; 1572-0241
• DOI: 10.14309/ajg.0000000000002569

Portal hypertension progression can be relieved after controlling the etiology of liver cirrhosis. Whether beta-blockers could additionally enhance the effects during treatment, particularly for small esophageal varices (EV), was unclear. This study aims to assess the efficacy of add-on carvedilol to delay EV progression during anti-hepatitis B virus (HBV) treatment in HBV-related cirrhosis. This randomized controlled trial enrolled patients with virologically suppressed HBV-compensated cirrhosis and small/medium EV. The participants were randomly assigned to receive nucleos(t)ide analog (NUC) or carvedilol 12.5 mg plus NUC (1:1 allocation ratio). The primary end point was the progression rate of EV at 2 years of follow-up. A total of 238 patients (small EV, 77.3%) were randomized into 119 NUC and 119 carvedilol plus NUC (carvedilol [CARV] combination group). Among them, 205 patients (86.1%) completed paired endoscopies. EV progression rate was 15.5% (16/103) in the NUC group and 12.7% (13/102) in the CARV combination group (relative risk = 0.79, 95% confidence interval 0.36-1.75, P = 0.567). Subgroup analysis on medium EV showed the CARV combination group had a more favorable effect in promoting EV regression (43.5% vs 13.1%, P = 0.022) than NUC alone, but not in small cases ( P = 0.534). The incidence of liver-related events (decompensation, hepatocellular carcinoma, or death/liver transplantation) within 2 years was similar between the 2 groups (11.2% vs 10.4%, P = 0.881). The overall results did not show statistically significant differences between the added carvedilol strategy and NUC monotherapy in preventing EV progression in patients with virologically suppressed HBV-compensated cirrhosis. However, the carvedilol-added approach might offer improved outcomes specifically for patients with medium EV (NCT03736265).