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

• Published in: Clinical and molecular hepatology Vol. 22; no. 1; pp. 152 - 159
• Main Authors: Park, Chan Ho, Jung, Seok Won, Shin, Jung Woo, Bae, Mi Ae, Lee, Yoon Im, Park, Yong Tae, Chung, Hwa Sik, Park, Neung Hwa
• Format: Journal Article
• Language: English
• Published: Korea (South) Korean Association for the Study of the Liver 01.03.2016; The Korean Association for the Study of the Liver; 대한간학회
• Subjects: Adult; Aged; Aged, 80 and over; Antigens; Antiviral Agents - pharmacology; Antiviral Agents - therapeutic use; Chronic hepatitis B; Clinical outcomes; Combination therapy; Creatinine; DNA, Viral - blood; Drug Administration Schedule; Drug Resistance, Viral - drug effects; Drug Therapy, Combination; Female; Genomes; Hepatitis B; Hepatitis B virus - genetics; Hepatitis B, Chronic - drug therapy; Humans; Kidney Function Tests; Laboratories; Lamivudine; Lamivudine - therapeutic use; Liver cancer; Liver cirrhosis; Liver Function Tests; Male; Middle Aged; Mutation; Original; Patients; Polymerase Chain Reaction; Polymorphism; Regression analysis; Resistance; Tenofovir; Tenofovir - therapeutic use; Treatment Outcome; Ultrasonic imaging; 내과학; United States > US; Resistance; Tenofovir; Lamivudine; Chronic hepatitis B
• ISSN: 2287-2728; 2287-285X
• DOI: 10.3350/cmh.2016.22.1.152

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. We investigated the antiviral efficacy of TDF monotherapy vs. TDF-LAM combination therapy in 103 patients with LAM-resistant CHB. 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. 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.