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Entecavir plus adefovir versus adefovir plus lamivudine in hepatitis B virus e antigen-positive, lamivudine-resistant chronic hepatitis B.

Authors
 Jeong Heo  ;  Sang Hoon Ahn  ;  Young Oh Kweon  ;  Byung Ho Kim  ;  Henry L Y Chan  ;  Andrzej Horban  ;  Suchat Wongcharatrawee  ;  Cyril Llamoso  ;  Kwan Sik Lee 
Citation
 JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Vol.29(7) : 1485-1493, 2014 
Journal Title
JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY
ISSN
 0815-9319 
Issue Date
2014
MeSH
Adenine/administration & dosage ; Adenine/analogs & derivatives* ; Adolescent ; Adult ; Aged ; Antiviral Agents/administration & dosage* ; Drug Resistance, Viral ; Drug Therapy, Combination ; Female ; Hepatitis B e Antigens/immunology* ; Hepatitis B e Antigens/metabolism ; Hepatitis B, Chronic/drug therapy* ; Hepatitis B, Chronic/immunology* ; Hepatitis B, Chronic/virology ; Humans ; Lamivudine/administration & dosage* ; Male ; Middle Aged ; Organophosphonates/administration & dosage* ; Time Factors ; Treatment Outcome ; Young Adult
Abstract
Background and Aim: In areas of the world where tenofovir disoproxil fumarate is not marketed, adefovir (ADV) + lamivudine (LAM) is recommended and widely used for LAM-resistant chronic hepatitis B (CHB). This study hypothesizes that entecavir (ETV) + ADV, where both components are active against LAM-resistant hepatitis B virus (HBV), will provide greater antiviral potency than ADV + LAM where only ADV is active.
Methods: Open-label, randomized trial in hepatitis B virus e antigen-positive LAM-experienced CHB patients with LAM resistance treated with ETV 1 mg + ADV 10 mg (n = 138), ADV + LAM 100 mg (n = 137), or ETV (n = 140).
Results: At week 48, there was no significant difference in the primary endpoint of HBV-DNA < 50 IU/mL between the treatment groups (25.4% [ETV + ADV] vs 19.7% [ADV + LAM], P = 0.2619; vs 16.4% [ETV], P = 0.1336). However, at week 96, rates of HBV-DNA < 50 IU/mL were significantly greater with ETV + ADV than with ADV + LAM (43.5% vs 28.5%; P = 0.0095). Rates of virologic breakthrough and resistance to ETV or ADV were low through week 96 with both combinations. The delayed benefit of ETV + ADV is likely related to the high baseline viremia in this cohort relating to continued LAM exposure after treatment failure. All three therapies had favorable safety profiles.
Conclusions: In patients with LAM-resistant HBV, ETV + ADV demonstrated greater antiviral efficacy than ADV + LAM and comparable safety over 2 years, and may therefore be a preferable treatment option for LAM-resistant CHB, especially in regions where alternative rescue therapies are not available. In highly viremic patients, the benefit of ETV + ADV became apparent after a longer treatment duration.
Full Text
http://onlinelibrary.wiley.com/doi/10.1111/jgh.12567/abstract
DOI
10.1111/jgh.12567
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
Lee, Kwan Sik(이관식) ORCID logo https://orcid.org/0000-0002-3672-1198
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/138535
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