Long-term Efficacy of Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-Resistant Chronic HBV infection

Hye Won Lee, Jun Yong Park, Jin Woo Lee, Ki Tae Yoon, Chang Wook Kim, Hana Park, Young Seok Kim, Soon Ku Paik, Jung Il Lee, Beom Kyung Kim, Kwang Hyub Han, Sang Hoon Ahn

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9 Citations (Scopus)


Background & aims: There are no globally agreed upon treatment guidelines for patients with chronic hepatitis B virus (HBV) with multidrug resistance (MDR). We conducted a multicenter, prospective, real-world cohort study of effects of tenofovir disoproxyl fumarate (TDF) monotherapy and TDF-based combination therapy, as rescue therapy, in patients with multidrug-resistant chronic HBV infections. Methods: We recruited patients with chronic HBV infection with resistance to antivirals from 8 tertiary hospitals in Korea. Patients (n=423) received rescue therapy with TDF monotherapy (n=174) or TDF-based combination therapy (n=249). The median follow-up period was 180 weeks. A virologic response was defined as a serum HBV DNA level of <20 IU/mL. Results: Cumulative rates of virologic response did not differ significantly between the groups that received TDF monotherapy vs combination therapy at 48 weeks (71.7% vs 68.9%), 96 weeks (85.1% vs 84.2%), 144 weeks (92.1% vs 92.7%), 192 weeks (93.4% vs 95.7%), or 240 weeks (97.7% vs 97.2%). Serum levels of HBV DNA below 4.0 log10 IU/mL (odds ratio, 2.478; 95% CI 1.959–3.135; P < .001) and the absence of mutations associated with resistance to adefovir (odds ratio, 1.570; 95% CI 1.279–1.926; P < .001) were associated with virologic response in patients with MDR. There was no significant difference of virologic response among patients of different ages, sex, patients with vs without cirrhosis, positivity for hepatitis B e antigen, or renal function (all P > .05). Conclusion: In a multicenter, real-world cohort study, long-term use of TDF monotherapy showed non-inferior antiviral efficacy compared with that of TDF-based combination therapy in patients with MDR.

Original languageEnglish
Pages (from-to)1348-1355.e2
JournalClinical Gastroenterology and Hepatology
Issue number7
Publication statusPublished - 2019 Jun

Bibliographical note

Funding Information:
Funding This study was supported by an unrestricted grant from Gilead Sciences for the investigator-initiated trials. This research was supported by a fund ( 2016-ER5103-01 ) by Research of Korea Centers for Disease Control and Prevention .

Publisher Copyright:
© 2019 AGA Institute

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

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