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KMID : 0614620150650010035
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Korean Journal of Gastroenterology
2015 Volume.65 No. 1 p.35 ~ p.42
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Efficacy of Tenofovir-based Rescue Therapy for Patients with Drug-resistant Chronic Hepatitis B
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Choi Kang-Hyug
Lee Han-Min
Jun Baek-Gyu
Lee Sae-Hwan
Kim Hong-Soo
Kim Sang-Gyune
Kim Young-Seok
Kim Boo-Sung
Jeong Soung-Won
Jang Jae-Young
Kim Young-Don
Cheon Gab-Jin
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Abstract
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Background/Aims: Tenofovir disoproxil fumarate (TDF) plays a pivotal role in the management of drug-resistant chronic hepatitis B. However, it remains unclear whether TDF-nucleoside analogue combination therapy provides better outcomes than TDF monotherapy. This study aimed to compare the efficacy of TDF monotherapy with that of TDF-nucleoside analogue combination therapy in patients with drug-resistant chronic hepatitis B.
Methods: This retrospective cohort study included 76 patients receiving TDF-based rescue therapy for more than 12 months. Suboptimal response was defined as serum HBV-DNA level of ＞60 IU/mL during prior rescue therapy. Multi-drug resistance was defined as the presence of two or more drug resistance-related mutations confirmed by mutation detection assay. The relationship between baseline characteristics and virologic response (HBV DNA ＜20 IU/mL) at 12 months were evaluated using logistic regression analysis.
Results:Fifty-five patients (72.4%) were suboptimal responders to prior rescue therapy, and 26 (34.2%) had multi-drug resistance. Forty-two patients (55.3%) received combination therapy with nucleoside analogues. Virologic response at 12 months was not significantly different between the TDF monotherapy group and TDF-nucleoside analogue combination therapy group (p=0.098). The serum HBV DNA level was reduced to ?4.49±1.67 log10 IU/mL in the TDF monotherapy group and to ?3.97±1.69 log10 IU/mL in the TDF-nucleoside analogue combination therapy group at 12 months (p=0.18). In multivariate analysis, female sex (p=0.032), low baseline HBV-DNA level (p=0.013), and TDF monotherapy (p=0.046) were predictive factors for virologic response at 12 months.
Conclusions:TDF monotherapy showed similar efficacy to that of TDF-nucleoside analogue combination therapy in patients with drug-resistant chronic hepatitis B.
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KEYWORD
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Hepatitis B, Drug resistance, Tenofovir, Virologic response
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