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
- 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. (KCT0000627).
- All Author(s)
- S. H. Lee
; G. J. Cheon
; H. S. Kim
; S. G. Kim
; Y. S. Kim
; S. W. Jeong
; J. Y. Jang
; B. S. Kim
; B. G. Jun
; Y. Don Kim
; D. W. Jun
; J. H. Sohn
; T. Y. Kim
; B. S. Lee
- Issued Date
- 2018
- Type
- Article
- Keyword
- Adult; Aged; Antiviral Agents/administration & dosage/adverse effects/*therapeutic use; Biomarkers; *Drug Resistance, Viral; Drug Therapy, Combination; Female; Genotype; Hepatitis B virus/*drug effects/genetics; Hepatitis B, Chronic/diagnosis/*drug therapy/*virology; Humans; Male; Middle Aged; Tenofovir/administration & dosage/*therapeutic use; Time Factors; Treatment Outcome; Viral Load; Young Adult
- Publisher
- International Society for Antiviral Research
- ISSN
- 1359-6535
- Citation Title
- Antiviral Therapy
- Citation Volume
- 23
- Citation Number
- 3
- Citation Start Page
- 219
- Citation End Page
- 227
- Language(ISO)
- eng
- DOI
- 10.3851/imp3169
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/1461
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