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Comparative Study
. 2016 Mar;22(1):152-9.
doi: 10.3350/cmh.2016.22.1.152. Epub 2016 Mar 28.

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

Chan Ho Park  1 , Seok Won Jung  1 , Jung Woo Shin  1 , Mi Ae Bae  1 , Yoon Im Lee  1 , Yong Tae Park  1 , Hwa Sik Chung  1 , Neung Hwa Park  1
Affiliations
Comparative Study

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

Chan Ho Park et al. Clin Mol Hepatol. 2016 Mar.

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.

Keywords: Chronic hepatitis B; Lamivudine; Resistance; Tenofovir.

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Conflict of interest statement

Conflicts of Interest: The authors have no conflicts to disclose.

Figures

Figure 1.
Figure 1.
The cumulative VR rate did not differ significantly 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 test, p=0.652). VR, virologic response; TDF, tenofovir; LAM, lamivudine.
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