Adding adefovir vs. switching to entecavir for lamivudine-resistant chronic hepatitis B (ACE study): a 2-year follow-up randomized controlled trial

被引：19

作者：

Yim, Hyung Joon ^{[1
]}

Seo, Yeon Seok ^{[2
]}

Yoon, Eileen L. ^{[1
]}

Kim, Chang Wook ^{[3
]}

Lee, Chang Don ^{[3
]}

Park, Sang Hoon ^{[4
]}

Lee, Myung Seok ^{[4
]}

Park, Choong Kee ^{[5
]}

Chae, Hee Bok ^{[6
]}

Kim, Moon Young ^{[7
]}

Baik, Soon Koo ^{[7
]}

Kim, Yun Soo ^{[8
]}

Kim, Ju Hyun ^{[8
]}

Lee, Jung Il ^{[9
]}

Lee, Jin Woo ^{[9
]}

Hong, Sun Pyo ^{[10
]}

Um, Soon Ho ^{[2
]}

机构：

[1] Korea Univ, Ansan Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Ansan, South Korea

[2] Korea Univ, Coll Med, Div Gastroenterol & Hepatol, Dept Internal Med,Anam Hosp, 126-1 Anam Dong,5 Ga, Seoul 136705, South Korea

[3] Catholic Univ Korea, Uijeongbu St Marys Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Uijongbu, South Korea

[4] Hallym Univ, Kangnam Sacred Heart Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Seoul, South Korea

[5] Hallym Univ, Sacred Heart Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Anyang, South Korea

[6] Chungbuk Natl Univ Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Cheongju, South Korea

[7] Yonsei Univ, Wonju Christian Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Wonju, South Korea

[8] Gachon Univ, Gil Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Inchon, South Korea

[9] Inha Univ Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Inchon, South Korea

[10] GeneMarix Inc, Yongin, South Korea

来源：

LIVER INTERNATIONAL | 2013年 / 33卷 / 02期

关键词：

adefovir; chronic hepatitis B; entecavir; lamivudine; resistance; THERAPY; MONOTHERAPY; DNA; DIPIVOXIL;

D O I：

10.1111/liv.12036

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background Management of lamivudine-resistant chronic hepatitis B (CHB) remains challenging, as inappropriate choice of treatment may cause multidrug resistance. Until now, randomized trials directly comparing adding adefovir and switching to entecavir monotherapy have not been reported. Aims This multicentre prospective randomized study was designed to compare the efficacy of these two strategies. Methods Two hundred and nineteen lamivudine-resistant CHB patients were randomized to either adefovirlamivudine combination group or entecavir monotherapy group (n = 110 vs. 109), and followed up for 24 months. Results One hundred and eighty patients completed this study. At month 24, virological response rate [hepatitis B virus (HBV) DNA <60 IU/ml] was higher in the adefovirlamivudine combination group compared with entecavir group (56.7% vs. 40%, P = 0.025), although biochemical and serological response rates were not significantly different. Genotypic resistance (9.2% vs. 24.6%, P = 0.005) and combined viral breakthrough (2.0% vs. 17.6%, P < 0.001) were more frequent in the entecavir group. However, by subgroup analysis, virological response rates were not significantly different between the two therapies in HBeAg-positive patients (44.9% vs. 35.7%, P = 0.268) or in patients with high baseline HBV DNA (=7 log IU/ml) (40.7% vs. 31.3%, P = 0.320) at month 24. Conclusion This study showed that adefovirlamivudine combination provides significantly higher antiviral efficacy and the lower resistance rate compared with the entecavir monotherapy in the management of lamivudine-resistant CHB. However, it had limited efficacy in HBeAg-positive patients or in patients with high baseline HBV DNA.

引用

页码：244 / 254

页数：11

共 31 条

[1] Add-On Adefovir Is Superior to a Switch to Entecavir as Rescue Therapy for Lamivudine-Resistant Chronic Hepatitis B [J].