Telbivudine Plus Adefovir Versus Lamivudine Plus Adefovir for Lamivudine-Resistant Chronic Hepatitis B: TeSLA Randomized Trial
- Kim, Tae Hyung; Kim, Minkoo; Yim, Hyung Joon; Suh, Sang Jun; Jung, Young Kul; Seo, Yeon Seok; Um, Soon Ho; Lee, Jung Il; Lee, Sae Hwan; Kim, Sang Gyun; Kim, In Hee; Kim, Hyoung Su; Cho, Eun Young; Kim, Tae Yeob; Hwang, Seong Gyu
- Issue Date
- Adefovir; Hepatitis B; Lamivudine Resistance; Rescue Therapy; Telbivudine
- Hepatitis Monthly, v.21, no.11
- Journal Title
- Hepatitis Monthly
- 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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- 2. Clinical Science > Department of Gastroenterology and Hepatology > 1. Journal Articles
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