[Efficacy of tenofovir-based rescue therapy for patients with drug-resistant chronic hepatitis B].

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.

• Authors: Kanghyug Choi, 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
• Journal: The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi (Korean J Gastroenterol) Vol. 65 Issue 1 Pg. 35-42 (Jan 2015) ISSN: 2233-6869 [Electronic] Korea (South)
• PMID: 25603852 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• DNA, Viral
• Nucleosides
• Tenofovir

Topics

• 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