Clin Mol Hepatol.  2016 Mar;22(1):152-159. 10.3350/cmh.2016.22.1.152.

Comparison of tenofovir plus lamivudine versus tenofovir monotherapy in patients with lamivudine-resistant chronic hepatitis B

• Park CH
• Jung SW
• Shin JW
• Bae MA
• Lee YI
• Park YT
• Chung HS
• Park NH

• KMID: 2363033
• DOI: http://doi.org/10.3350/cmh.2016.22.1.152

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.

Keyword

Tenofovir; Lamivudine; Resistance; Chronic hepatitis B

MeSH Terms

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
Antiviral Agents
DNA, Viral
Lamivudine
Tenofovir