Telbivudine Plus Adefovir Versus Lamivudine Plus Adefovir for Lamivudine-Resistant Chronic Hepatitis B: TeSLA Randomized Trial
| Author | Tae Hyung Kim | en |
| Author | Minkoo Kim | en |
| Author | Hyung Joon Yim | en |
| Author | Sang Jun Suh | en |
| Author | Young Kul Jung | en |
| Author | Yeon Seok Seo | en |
| Author | Soon Ho Um | en |
| Author | Jung Il Lee | en |
| Author | Sae Hwan Lee | en |
| Author | Sang Gyun Kim | en |
| Author | In Hee Kim | en |
| Author | Hyoung Su Kim | en |
| Author | Eun Young Cho | en |
| Author | Tae Yeob Kim | en |
| Author | Seong Gyu Hwang | en |
| Orcid | Tae Hyung Kim [0000-0002-7747-4293] | en |
| Orcid | Hyung Joon Yim [0000-0002-6036-2754] | en |
| Orcid | Sang Jun Suh [0000-0003-4128-3732] | en |
| Orcid | Young Kul Jung [0000-0002-6566-1382] | en |
| Orcid | Soon Ho Um [0000-0002-4545-7907] | en |
| Issued Date | 2021-11-30 | en |
| 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. | en |
| DOI | https://doi.org/10.5812/hepatmon.121627 | en |
| Keyword | Adefovir | en |
| Keyword | Hepatitis B | en |
| Keyword | Lamivudine Resistance | en |
| Keyword | Rescue Therapy | en |
| Keyword | Telbivudine | en |
| Publisher | Brieflands | en |
| Title | Telbivudine Plus Adefovir Versus Lamivudine Plus Adefovir for Lamivudine-Resistant Chronic Hepatitis B: TeSLA Randomized Trial | en |
| Type | Research Article | en |
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