Comparison of tenofovir plus lamivudine versus tenofovir monotherapy in patients with lamivudine-resistant chronic hepatitis B.
10.3350/cmh.2016.22.1.152
- Author:
Chan Ho PARK
1
;
Seok Won JUNG
;
Jung Woo SHIN
;
Mi Ae BAE
;
Yoon Im LEE
;
Yong Tae PARK
;
Hwa Sik CHUNG
;
Neung Hwa PARK
Author Information
1. Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan University Hospital, Ulsan, Korea. nhpark@uuh.ulsan.kr
- Publication Type:Comparative Study ; Original Article ; Research Support, Non-U.S. Gov't
- Keywords:
Tenofovir;
Lamivudine;
Resistance;
Chronic hepatitis B
- MeSH:
Adult;
Aged;
Aged, 80 and over;
Antiviral Agents/pharmacology/*therapeutic use;
DNA, Viral/blood;
Drug Administration Schedule;
Drug Resistance, Viral/drug effects;
Drug Therapy, Combination;
Female;
Hepatitis B virus/genetics;
Hepatitis B, Chronic/*drug therapy;
Humans;
Kidney Function Tests;
Lamivudine/*therapeutic use;
Liver Function Tests;
Male;
Middle Aged;
Polymerase Chain Reaction;
Tenofovir/*therapeutic use;
Treatment Outcome
- From:Clinical and Molecular Hepatology
2016;22(1):152-159
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND/AIMS: Tenofovir disoproxil fumarate (TDF) exhibits similar antiviral efficacy against treatment-naïve and lamivudine (LAM)-resistant chronic hepatitis B (CHB). However, there are few clinical reports on the antiviral effects of TDF-LAM combination therapy compared to TDF monotherapy in patients with LAM-resistant CHB. METHODS: We investigated the antiviral efficacy of TDF monotherapy vs. TDF-LAM combination therapy in 103 patients with LAM-resistant CHB. RESULTS: The study subjects were treated with TDF alone (n=40) or TDF-LAM combination therapy (n=63) for ≥6 months. The patients had previously been treated with TDF-based rescue therapy for a median of 30.0 months (range, 8-36 months). A virologic response (VR) was achieved in 99 patients (96.1%): 95.0% (38/40) of patients in the TDF monotherapy group and 96.8% (61/63) of patients in the TDF-LAM combination therapy group. The VR rates were not significantly different between the TDF monotherapy and TDF-LAM combination therapy groups (88.9 vs. 87.3% at month 12, and 94.4 vs. 93.7% at month 24, log-rank p=0.652). Univariate and multivariate analyses revealed that none of the pretreatment factors were significantly associated with VR. CONCLUSIONS: TDF monotherapy was as effective as TDF-LAM combination therapy for maintaining viral suppression in the vast majority of patients with LAM-resistant CHB, which suggests that TDF add-on therapy with LAM is unnecessary.
