Efficacy of Tenofovir-based Rescue Therapy for Patients with Drug-resistant Chronic Hepatitis B.
- Author:
Kanghyug CHOI
1
;
Han Min LEE
;
Baek Gyu JUN
;
Sae Hwan LEE
;
Hong Soo KIM
;
Sang Gyune KIM
;
Young Seok KIM
;
Boo Sung KIM
;
Soung Won JEONG
;
Jae Young JANG
;
Young Don KIM
;
Gab Jin CHEON
Author Information
- Publication Type:Original Article ; Research Support, Non-U.S. Gov't
- Keywords: Hepatitis B; Drug resistance; Tenofovir; Virologic response
- MeSH: Adult; Aged; Antiviral Agents/pharmacology/*therapeutic use; Cohort Studies; DNA, Viral/blood; Drug Resistance, Viral; Drug Therapy, Combination; Female; Hepatitis B virus/drug effects/genetics/isolation & purification; Hepatitis B, Chronic/*drug therapy/virology; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Nucleosides/chemistry/therapeutic use; Retrospective Studies; Sex Factors; Tenofovir/*therapeutic use; Treatment Outcome; Young Adult
- From:The Korean Journal of Gastroenterology 2015;65(1):35-42
- CountryRepublic of Korea
- Language:Korean
- Abstract: 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.
