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, KwangHyub Han, SangHoon Ahn

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Abstract

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
Volume17
Issue number7
DOIs
Publication statusPublished - 2019 Jun 1

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Tenofovir
Fumarates
Chronic Hepatitis B
Virus Diseases
Hepatitis B virus
Multiple Drug Resistance
Antiviral Agents
Cohort Studies
Therapeutics
Cohort Effect
Korea
Tertiary Care Centers
Guidelines

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Cite this

Lee, Hye Won ; Park, Jun Yong ; Lee, Jin Woo ; Yoon, Ki Tae ; Kim, Chang Wook ; Park, Hana ; Kim, Young Seok ; Paik, Soon Ku ; Lee, Jung Il ; Kim, Beom Kyung ; Han, KwangHyub ; Ahn, SangHoon. / Long-term Efficacy of Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-Resistant Chronic HBV infection. In: Clinical Gastroenterology and Hepatology. 2019 ; Vol. 17, No. 7. pp. 1348-1355.e2.
@article{b385113707724fd9947cdf8352b16269,
title = "Long-term Efficacy of Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-Resistant Chronic HBV infection",
abstract = "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.",
author = "Lee, {Hye Won} and Park, {Jun Yong} and Lee, {Jin Woo} and Yoon, {Ki Tae} and Kim, {Chang Wook} and Hana Park and Kim, {Young Seok} and Paik, {Soon Ku} and Lee, {Jung Il} and Kim, {Beom Kyung} and KwangHyub Han and SangHoon Ahn",
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Lee, HW, Park, JY, Lee, JW, Yoon, KT, Kim, CW, Park, H, Kim, YS, Paik, SK, Lee, JI, Kim, BK, Han, K & Ahn, S 2019, 'Long-term Efficacy of Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-Resistant Chronic HBV infection', Clinical Gastroenterology and Hepatology, vol. 17, no. 7, pp. 1348-1355.e2. https://doi.org/10.1016/j.cgh.2018.10.037

Long-term Efficacy of Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-Resistant Chronic HBV infection. / Lee, Hye Won; Park, Jun Yong; Lee, Jin Woo; Yoon, Ki Tae; Kim, Chang Wook; Park, Hana; Kim, Young Seok; Paik, Soon Ku; Lee, Jung Il; Kim, Beom Kyung; Han, KwangHyub; Ahn, SangHoon.

In: Clinical Gastroenterology and Hepatology, Vol. 17, No. 7, 01.06.2019, p. 1348-1355.e2.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Long-term Efficacy of Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-Resistant Chronic HBV infection

AU - Lee, Hye Won

AU - Park, Jun Yong

AU - Lee, Jin Woo

AU - Yoon, Ki Tae

AU - Kim, Chang Wook

AU - Park, Hana

AU - Kim, Young Seok

AU - Paik, Soon Ku

AU - Lee, Jung Il

AU - Kim, Beom Kyung

AU - Han, KwangHyub

AU - Ahn, SangHoon

PY - 2019/6/1

Y1 - 2019/6/1

N2 - 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.

AB - 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.

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