Efficacy of adefovir add-on lamivudine rescue therapy compared with switching to entecavir monotherapy in patients with lamivudine-resistant chronic hepatitis B

No study has reported on the comparative effect of adefovir (ADV) add-on lamivudine (LAM) versus switching to entecavir (ETV) in LAM-resistant patients with chronic hepatitis B. From October 2007 to September 2008, 92 consecutive LAM-resistant patients were enrolled (47 LAM + ADV and 45 ETV 1 mg). A...

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Published in:Journal of medical virology 2010-11, Vol.82 (11), p.1835-1842
Main Authors: Ryu, Han Jak, Lee, Jung Min, Ahn, Sang Hoon, Kim, Do Young, Lee, Myoung Ha, Han, Kwang-Hyub, Chon, Chae Yoon, Park, Jun Yong
Format: Article
Language:English
Subjects:
adefovir dipivoxil
Adenine - administration & dosage
Adenine - analogs & derivatives
Adenine - pharmacology
Adult
Aged
Antiviral Agents - administration & dosage
Antiviral Agents - pharmacology
Biological and medical sciences
chronic hepatitis B
Drug Resistance, Viral - drug effects
Drug Therapy, Combination
entecavir
Female
Fundamental and applied biological sciences. Psychology
Guanine - administration & dosage
Guanine - analogs & derivatives
Guanine - pharmacology
Hepatitis B virus - drug effects
Hepatitis B, Chronic - drug therapy
Hepatitis B, Chronic - virology
Human viral diseases
Humans
Infectious diseases
lamivudine
Lamivudine - administration & dosage
Lamivudine - pharmacology
Male
Medical sciences
Microbiology
Middle Aged
Miscellaneous
Organophosphonates - administration & dosage
Organophosphonates - pharmacology
resistant mutants
Treatment Outcome
Viral diseases
Virology
Young Adult
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Summary:No study has reported on the comparative effect of adefovir (ADV) add-on lamivudine (LAM) versus switching to entecavir (ETV) in LAM-resistant patients with chronic hepatitis B. From October 2007 to September 2008, 92 consecutive LAM-resistant patients were enrolled (47 LAM + ADV and 45 ETV 1 mg). All patients were followed for at least 12 months. The parameters assessed included normalization of ALT, HBeAg seroconversion, undetectable HBV DNA, reduction of HBV DNA, and predictors of virologic response. In the LAM + ADV and ETV groups, the baseline DNA levels were 7.61 (5.19-9.49) and 7.10 (5.43-9.74) log₁₀ copies/ml, respectively. At month 12, a virologic response occurred in 18/47 (38.3%) and 11/45 (24.4%; P = 0.182) patients; ALT normalization, in 39/41 (95.1%) and 36/40 (90.0%; P = 0.432); HBeAg seroconversion, in 5.1% and 2.4% (P = 0.606); and virologic breakthrough, in 2.1% and 11.1% (P = 0.107), respectively. The mean reduction from the baseline HBV DNA level was greater in the LAM + ADV group at month 12 (3.80 ± 1.12 vs. 2.72 ± 1.32 log₁₀ copies/ml; P < 0.001). In the multivariate analysis, the independent parameters related to a virologic response at month 12 were baseline ALT (OR = 1.003, 95% CI = 1.000-1.006, P = 0.026) and baseline HBV DNA (OR = 0.495, 95% CI = 0.298-0.823, P = 0.007). Compared with switching to ETV monotherapy, ADV add-on LAM therapy was more effective at reducing the viral load in patients with LAM resistance, and the baseline HBV DNA and ALT levels were independent predictors of the virologic response. However, ADV add-on therapy had limitations in patients with a higher baseline HBV DNA in LAM rescue therapy. J. Med. Virol. 82:1835-1842, 2010.
ISSN:0146-6615
1096-9071
DOI:10.1002/jmv.21898