Switching to tenofovir vs continuing entecavir for hepatitis B virus with partial virologic response to entecavir: a randomized controlled trial

Hyung Joon Yim, I. H. Kim, S. J. Suh, Young Kul Jung, Ji Hoon Kim, Yeon Seok Seo, Jong Eun Yeon, C. W. Kim, S. Y. Kwon, S. H. Park, M. S. Lee, Soon-Ho Um, Kwan Soo Byun

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Abstract

Entecavir 0.5 mg (ETV) is widely used among treatment-naïve chronic hepatitis B (CHB) patients. However, 10%-30% of patients show partial virologic response (PVR) to the drug. If the hepatitis B virus (HBV) continues to replicate, the underlying liver disease may progress. Herein, we compared the efficacy of switching to tenofovir disoproxil fumarate (TDF) with that of continuing ETV in CHB patients with PVR to ETV. This was an open-label randomized controlled trial including CHB patients who had been receiving 0.5 mg of ETV for >12 months, but who still had detectable HBV DNA levels of >60 IU/mL without known resistance to ETV. Sixty patients were enrolled and 45 qualified for the study: Twenty-two patients were randomly assigned into the TDF group and 23 into the ETV group. After 12 months of treatment, the virologic response rate (HBV DNA <20 IU/mL) was significantly higher in the TDF group than in the ETV group, as measured using per-protocol analysis (55% vs 20%; P =.022) and intention-to-treat analysis (50% vs 17.4%; P =.020). The reduction in HBV DNA was greater (−1.13 vs −0.67 log10 IU/mL; P =.024), and the mean HBV DNA level was lower (1.54 vs 2.01 log10 IU/mL; P =.011) in the TDF group than in the ETV group. In conclusion, to achieve optimal response in CHB patients with PVR to ETV, switching to TDF would be a better strategy than continuing ETV. Appropriate modification of therapy would further improve the outcome of chronic HBV infection.

Original languageEnglish
Pages (from-to)1321-1330
Number of pages10
JournalJournal of Viral Hepatitis
Volume25
Issue number11
DOIs
Publication statusPublished - 2018 Nov 1

Fingerprint

Tenofovir
Hepatitis B virus
Randomized Controlled Trials
Chronic Hepatitis B
DNA
entecavir
Intention to Treat Analysis

Keywords

  • chronic hepatitis B
  • entecavir
  • partial virologic response
  • tenofovir
  • treatment

ASJC Scopus subject areas

  • Hepatology
  • Infectious Diseases
  • Virology

Cite this

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title = "Switching to tenofovir vs continuing entecavir for hepatitis B virus with partial virologic response to entecavir: a randomized controlled trial",
abstract = "Entecavir 0.5 mg (ETV) is widely used among treatment-na{\"i}ve chronic hepatitis B (CHB) patients. However, 10{\%}-30{\%} of patients show partial virologic response (PVR) to the drug. If the hepatitis B virus (HBV) continues to replicate, the underlying liver disease may progress. Herein, we compared the efficacy of switching to tenofovir disoproxil fumarate (TDF) with that of continuing ETV in CHB patients with PVR to ETV. This was an open-label randomized controlled trial including CHB patients who had been receiving 0.5 mg of ETV for >12 months, but who still had detectable HBV DNA levels of >60 IU/mL without known resistance to ETV. Sixty patients were enrolled and 45 qualified for the study: Twenty-two patients were randomly assigned into the TDF group and 23 into the ETV group. After 12 months of treatment, the virologic response rate (HBV DNA <20 IU/mL) was significantly higher in the TDF group than in the ETV group, as measured using per-protocol analysis (55{\%} vs 20{\%}; P =.022) and intention-to-treat analysis (50{\%} vs 17.4{\%}; P =.020). The reduction in HBV DNA was greater (−1.13 vs −0.67 log10 IU/mL; P =.024), and the mean HBV DNA level was lower (1.54 vs 2.01 log10 IU/mL; P =.011) in the TDF group than in the ETV group. In conclusion, to achieve optimal response in CHB patients with PVR to ETV, switching to TDF would be a better strategy than continuing ETV. Appropriate modification of therapy would further improve the outcome of chronic HBV infection.",
keywords = "chronic hepatitis B, entecavir, partial virologic response, tenofovir, treatment",
author = "Yim, {Hyung Joon} and Kim, {I. H.} and Suh, {S. J.} and Jung, {Young Kul} and Kim, {Ji Hoon} and Seo, {Yeon Seok} and Yeon, {Jong Eun} and Kim, {C. W.} and Kwon, {S. Y.} and Park, {S. H.} and Lee, {M. S.} and Soon-Ho Um and Byun, {Kwan Soo}",
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T1 - Switching to tenofovir vs continuing entecavir for hepatitis B virus with partial virologic response to entecavir

T2 - a randomized controlled trial

AU - Yim, Hyung Joon

AU - Kim, I. H.

AU - Suh, S. J.

AU - Jung, Young Kul

AU - Kim, Ji Hoon

AU - Seo, Yeon Seok

AU - Yeon, Jong Eun

AU - Kim, C. W.

AU - Kwon, S. Y.

AU - Park, S. H.

AU - Lee, M. S.

AU - Um, Soon-Ho

AU - Byun, Kwan Soo

PY - 2018/11/1

Y1 - 2018/11/1

N2 - Entecavir 0.5 mg (ETV) is widely used among treatment-naïve chronic hepatitis B (CHB) patients. However, 10%-30% of patients show partial virologic response (PVR) to the drug. If the hepatitis B virus (HBV) continues to replicate, the underlying liver disease may progress. Herein, we compared the efficacy of switching to tenofovir disoproxil fumarate (TDF) with that of continuing ETV in CHB patients with PVR to ETV. This was an open-label randomized controlled trial including CHB patients who had been receiving 0.5 mg of ETV for >12 months, but who still had detectable HBV DNA levels of >60 IU/mL without known resistance to ETV. Sixty patients were enrolled and 45 qualified for the study: Twenty-two patients were randomly assigned into the TDF group and 23 into the ETV group. After 12 months of treatment, the virologic response rate (HBV DNA <20 IU/mL) was significantly higher in the TDF group than in the ETV group, as measured using per-protocol analysis (55% vs 20%; P =.022) and intention-to-treat analysis (50% vs 17.4%; P =.020). The reduction in HBV DNA was greater (−1.13 vs −0.67 log10 IU/mL; P =.024), and the mean HBV DNA level was lower (1.54 vs 2.01 log10 IU/mL; P =.011) in the TDF group than in the ETV group. In conclusion, to achieve optimal response in CHB patients with PVR to ETV, switching to TDF would be a better strategy than continuing ETV. Appropriate modification of therapy would further improve the outcome of chronic HBV infection.

AB - Entecavir 0.5 mg (ETV) is widely used among treatment-naïve chronic hepatitis B (CHB) patients. However, 10%-30% of patients show partial virologic response (PVR) to the drug. If the hepatitis B virus (HBV) continues to replicate, the underlying liver disease may progress. Herein, we compared the efficacy of switching to tenofovir disoproxil fumarate (TDF) with that of continuing ETV in CHB patients with PVR to ETV. This was an open-label randomized controlled trial including CHB patients who had been receiving 0.5 mg of ETV for >12 months, but who still had detectable HBV DNA levels of >60 IU/mL without known resistance to ETV. Sixty patients were enrolled and 45 qualified for the study: Twenty-two patients were randomly assigned into the TDF group and 23 into the ETV group. After 12 months of treatment, the virologic response rate (HBV DNA <20 IU/mL) was significantly higher in the TDF group than in the ETV group, as measured using per-protocol analysis (55% vs 20%; P =.022) and intention-to-treat analysis (50% vs 17.4%; P =.020). The reduction in HBV DNA was greater (−1.13 vs −0.67 log10 IU/mL; P =.024), and the mean HBV DNA level was lower (1.54 vs 2.01 log10 IU/mL; P =.011) in the TDF group than in the ETV group. In conclusion, to achieve optimal response in CHB patients with PVR to ETV, switching to TDF would be a better strategy than continuing ETV. Appropriate modification of therapy would further improve the outcome of chronic HBV infection.

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KW - treatment

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