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Telbivudine Plus Adefovir Versus Lamivudine Plus Adefovir for Lamivudine-Resistant Chronic Hepatitis B: TeSLA Randomized Trial

Authors
Kim, Tae HyungKim, MinkooYim, Hyung JoonSuh, Sang JunJung, Young KulSeo, Yeon SeokUm, Soon HoIl Lee, JungLee, Sae HwanKim, Sang GyunKim, In HeeKim, Hyoung SuCho, Eun YoungKim, Tae YeobHwang, Seong Gyu
Issue Date
Nov-2021
Publisher
Kowsar
Keywords
Adefovir; Hepatitis B; Lamivudine Resistance; Rescue Therapy; Telbivudine
Citation
Hepatitis Monthly, v.21, no.11
Journal Title
Hepatitis Monthly
Volume
21
Number
11
URI
https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/20773
DOI
10.5812/hepatmon.121627
ISSN
1735-143X
1735-3408
Abstract
Background: In countries with unavailable tenofovir, a combination of lamivudine (LMV) and adefovir (ADV) is recommended for the treatment of LMV-resistant chronic hepatitis B (CHB). Considering that telbivudine (L-dT) was demonstrated to be superior to LMV in previous studies, L-dT and ADV combination therapy is expected to show better antiviral efficacy than the combination of LMV and ADV in patients with LMV-resistant CHB. Methods: This was a prospective randomized multicenter study. The primary endpoint was Hepatitis B Virus (HBV) DNA reduction after 52 weeks of treatment. The secondary endpoints were HBV DNA undetectability, hepatitis B e antigen seroconversion, the incidence of virological and biochemical breakthroughs, and safety during the study period. Results: A total of 43 LMV-resistant CHB patients were enrolled. Twenty-one were treated with LMV + ADV and 22 with L-dT + ADV. After 52 weeks of antiviral treatment, the HBV DNA reduction showed no significant intergroup difference (-4.54 +/- 1.23 log IU/mL in the LMV + ADV group, -4.24 +/- 1.46 log IU/mL in the L-dT + ADV group, P = 0.475). There were no significant intergroup differences in HBV DNA undetectability rates, mean HBV DNA level, or hepatitis B e antigen seroconversion rate at 13, 26, 39, and 52 weeks of treatment. In terms of safety, the mean creatine phosphokinase level was significantly higher in the L-dT + ADV group. Conclusions: In the treatment of LMV-resistant CHB, the combination of L-dT and ADV did not show any clinical benefit compared to the combination of LMV and ADV.
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