Tenofovir disoproxil fumarate monotherapy is superior to entecavir-adefovir combination therapy in patients with suboptimal response to lamivudine-adefovir therapy for nucleoside-resistant HBV: a 96-week prospective multicentre trial
- Authors
- Lee, Sae Hwan; Cheon, Gab Jin; Kim, Hong Soo; Kim, Sang Gyune; Kim, Young Seok; Jeong, Soung Won; Jang, Jae Young; Kim, Boo Sung; Jun, Baek Gyu; Kim, Young Don; Jun, Dae Won; Sohn, Joo Hyun; Kim, Tae Yeob; Lee, Byung Seok
- Issue Date
- 2018
- Publisher
- International Medical Press
- Keywords
- 의약학
- Citation
- Antiviral Therapy, v.23, no.3, pp 219 - 227
- Pages
- 9
- Journal Title
- Antiviral Therapy
- Volume
- 23
- Number
- 3
- Start Page
- 219
- End Page
- 227
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/6817
- DOI
- 10.3851/IMP3169
- ISSN
- 1359-6535
2040-2058
- Abstract
- Background: A complete virological response is closely related to the long-term outcome of patients with chronic hepatitis B and prevention of emerging HBV mutations. We aimed to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) monotherapy compared to entecavir-adefovir dipivoxil (ETV-ADV) combination therapy in patients with suboptimal responses to long-term lamivudine-adefovir dipivoxil (LAM-ADV) therapy for nucleoside analogue-resistant chronic hepatitis B. Methods: Patients (n=60) were randomized to TDF monotherapy or ETV-ADV combination therapy for 96 weeks. All patients had the rt204I/V mutation and serum HBV DNA was measured (>60 IU/ml) during LAM-ADV therapy. The primary end point was a complete virological response (HBV DNA <20 IU/ml) at week 96. Results: The median duration of prior LAM-ADV rescue therapy was 43 (7-108) months. A complete virological response was achieved in 86.6% and 53.3% of patients in the TDF and ETV-ADV groups, respectively, at week 96 (P=0.005). Reduction in serum HBV DNA was significantly greater in the TDF group than in ETV-ADV group (-3.2 +/- 1.2 versus -2.6 +/- 1.2; P=0.01). Hepatitis B e antigen loss (22.2% versus 16.6%; P=0.731) and biochemical responses (76.7% versus 73.3%; P=0.766) were not different between the TDF and ETV-ADV groups. No newly emerged mutations were detected. Both therapies demonstrated favourable safety profiles. Conclusions: TDF therapy achieved a better complete virological response than ETV-ADV therapy in chronic hepatitis B patients with suboptimal response to long-term LAM-ADV rescue therapy.
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