A multicenter study of entecavir vs. tenofovir on prognosis of treatment-naïve chronic hepatitis B in South Korea

Seung Up Kim, Yeon Seok Seo, Han Ah Lee, Mi Na Kim, Yu Rim Lee, Hye Won Lee, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Kwang Hyub Han, Seong Gyu Hwang, Kyu Sung Rim, Soon Ho Um, Won Young Tak, Young Oh Kweon, Beom Kyung Kim, Soo Young Park

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Abstract

Background & Aims: It is currently unclear which antiviral agent, entecavir (ETV) or tenofovir disoproxil fumarate (TDF), is superior for improving prognosis in patients with chronic hepatitis B (CHB). Here, we assessed the ability of these 2 antivirals to prevent liver-disease progression in treatment-naïve patients with CHB. Methods: From 2012 to 2014, treatment-naïve patients with CHB who received ETV or TDF as a first-line antiviral agent were recruited from 4 academic teaching hospitals. Patients with decompensated cirrhosis or hepatocellular carcinoma (HCC) at enrollment were excluded. Cumulative probabilities of HCC and death or orthotopic liver transplant (OLT) were assessed. Results: In total, 2,897 patients (1,484 and 1,413 in the ETV and TDF groups, respectively) were recruited. The annual HCC incidence was not statistically different between the ETV and TDF groups (1.92 vs. 1.69 per 100 person-years [PY], respectively; adjusted hazard ratio [HR] 0.975 [p = 0.852] by multivariate analysis). Propensity score (PS)-matched and inverse probability of treatment weighting (ITPW) analyses yielded similar patterns of results (HR 1.021 [p = 0.884] and 0.998 [p = 0.988], respectively). The annual incidence of death or OLT was not statistically different between the ETV and TDF groups (0.52 vs. 0.53 per 100 PY, respectively; adjusted HR 1.202 [p = 0.451]). PS-matched and ITPW analyses yielded similar patterns of results (HR 1.248 [p = 0.385] and 1.239 [p = 0.360], respectively). These findings were consistently reproduced in patients with compensated cirrhosis (all p >0.05). Conclusions: The overall prognosis in terms of HCC and death or OLT was not statistically different between the ETV and TDF groups. Further studies are needed to validate our results. Lay summary: It is currently unclear which antiviral agent, entecavir or tenofovir disoproxil fumarate, is superior for improving prognosis in patients with chronic hepatitis B virus infection. In this analysis we found that there was no difference in terms of overall prognosis, including risk of hepatocellular carcinoma, death, or the need for a liver transplant, in patients receiving either antiviral.

Original languageEnglish
Pages (from-to)456-464
Number of pages9
JournalJournal of Hepatology
Volume71
Issue number3
DOIs
Publication statusPublished - 2019 Sep

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Tenofovir
Republic of Korea
Chronic Hepatitis B
Multicenter Studies
Antiviral Agents
Hepatocellular Carcinoma
Transplants
Propensity Score
Liver
Therapeutics
Fibrosis
entecavir
Incidence
Virus Diseases
Hepatitis B virus
Teaching Hospitals

All Science Journal Classification (ASJC) codes

  • Hepatology

Cite this

Kim, Seung Up ; Seo, Yeon Seok ; Lee, Han Ah ; Kim, Mi Na ; Lee, Yu Rim ; Lee, Hye Won ; Park, Jun Yong ; Kim, Do Young ; Ahn, Sang Hoon ; Han, Kwang Hyub ; Hwang, Seong Gyu ; Rim, Kyu Sung ; Um, Soon Ho ; Tak, Won Young ; Kweon, Young Oh ; Kim, Beom Kyung ; Park, Soo Young. / A multicenter study of entecavir vs. tenofovir on prognosis of treatment-naïve chronic hepatitis B in South Korea. In: Journal of Hepatology. 2019 ; Vol. 71, No. 3. pp. 456-464.
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title = "A multicenter study of entecavir vs. tenofovir on prognosis of treatment-na{\"i}ve chronic hepatitis B in South Korea",
abstract = "Background & Aims: It is currently unclear which antiviral agent, entecavir (ETV) or tenofovir disoproxil fumarate (TDF), is superior for improving prognosis in patients with chronic hepatitis B (CHB). Here, we assessed the ability of these 2 antivirals to prevent liver-disease progression in treatment-na{\"i}ve patients with CHB. Methods: From 2012 to 2014, treatment-na{\"i}ve patients with CHB who received ETV or TDF as a first-line antiviral agent were recruited from 4 academic teaching hospitals. Patients with decompensated cirrhosis or hepatocellular carcinoma (HCC) at enrollment were excluded. Cumulative probabilities of HCC and death or orthotopic liver transplant (OLT) were assessed. Results: In total, 2,897 patients (1,484 and 1,413 in the ETV and TDF groups, respectively) were recruited. The annual HCC incidence was not statistically different between the ETV and TDF groups (1.92 vs. 1.69 per 100 person-years [PY], respectively; adjusted hazard ratio [HR] 0.975 [p = 0.852] by multivariate analysis). Propensity score (PS)-matched and inverse probability of treatment weighting (ITPW) analyses yielded similar patterns of results (HR 1.021 [p = 0.884] and 0.998 [p = 0.988], respectively). The annual incidence of death or OLT was not statistically different between the ETV and TDF groups (0.52 vs. 0.53 per 100 PY, respectively; adjusted HR 1.202 [p = 0.451]). PS-matched and ITPW analyses yielded similar patterns of results (HR 1.248 [p = 0.385] and 1.239 [p = 0.360], respectively). These findings were consistently reproduced in patients with compensated cirrhosis (all p >0.05). Conclusions: The overall prognosis in terms of HCC and death or OLT was not statistically different between the ETV and TDF groups. Further studies are needed to validate our results. Lay summary: It is currently unclear which antiviral agent, entecavir or tenofovir disoproxil fumarate, is superior for improving prognosis in patients with chronic hepatitis B virus infection. In this analysis we found that there was no difference in terms of overall prognosis, including risk of hepatocellular carcinoma, death, or the need for a liver transplant, in patients receiving either antiviral.",
author = "Kim, {Seung Up} and Seo, {Yeon Seok} and Lee, {Han Ah} and Kim, {Mi Na} and Lee, {Yu Rim} and Lee, {Hye Won} and Park, {Jun Yong} and Kim, {Do Young} and Ahn, {Sang Hoon} and Han, {Kwang Hyub} and Hwang, {Seong Gyu} and Rim, {Kyu Sung} and Um, {Soon Ho} and Tak, {Won Young} and Kweon, {Young Oh} and Kim, {Beom Kyung} and Park, {Soo Young}",
year = "2019",
month = "9",
doi = "10.1016/j.jhep.2019.03.028",
language = "English",
volume = "71",
pages = "456--464",
journal = "Journal of Hepatology",
issn = "0168-8278",
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Kim, SU, Seo, YS, Lee, HA, Kim, MN, Lee, YR, Lee, HW, Park, JY, Kim, DY, Ahn, SH, Han, KH, Hwang, SG, Rim, KS, Um, SH, Tak, WY, Kweon, YO, Kim, BK & Park, SY 2019, 'A multicenter study of entecavir vs. tenofovir on prognosis of treatment-naïve chronic hepatitis B in South Korea', Journal of Hepatology, vol. 71, no. 3, pp. 456-464. https://doi.org/10.1016/j.jhep.2019.03.028

A multicenter study of entecavir vs. tenofovir on prognosis of treatment-naïve chronic hepatitis B in South Korea. / Kim, Seung Up; Seo, Yeon Seok; Lee, Han Ah; Kim, Mi Na; Lee, Yu Rim; Lee, Hye Won; Park, Jun Yong; Kim, Do Young; Ahn, Sang Hoon; Han, Kwang Hyub; Hwang, Seong Gyu; Rim, Kyu Sung; Um, Soon Ho; Tak, Won Young; Kweon, Young Oh; Kim, Beom Kyung; Park, Soo Young.

In: Journal of Hepatology, Vol. 71, No. 3, 09.2019, p. 456-464.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A multicenter study of entecavir vs. tenofovir on prognosis of treatment-naïve chronic hepatitis B in South Korea

AU - Kim, Seung Up

AU - Seo, Yeon Seok

AU - Lee, Han Ah

AU - Kim, Mi Na

AU - Lee, Yu Rim

AU - Lee, Hye Won

AU - Park, Jun Yong

AU - Kim, Do Young

AU - Ahn, Sang Hoon

AU - Han, Kwang Hyub

AU - Hwang, Seong Gyu

AU - Rim, Kyu Sung

AU - Um, Soon Ho

AU - Tak, Won Young

AU - Kweon, Young Oh

AU - Kim, Beom Kyung

AU - Park, Soo Young

PY - 2019/9

Y1 - 2019/9

N2 - Background & Aims: It is currently unclear which antiviral agent, entecavir (ETV) or tenofovir disoproxil fumarate (TDF), is superior for improving prognosis in patients with chronic hepatitis B (CHB). Here, we assessed the ability of these 2 antivirals to prevent liver-disease progression in treatment-naïve patients with CHB. Methods: From 2012 to 2014, treatment-naïve patients with CHB who received ETV or TDF as a first-line antiviral agent were recruited from 4 academic teaching hospitals. Patients with decompensated cirrhosis or hepatocellular carcinoma (HCC) at enrollment were excluded. Cumulative probabilities of HCC and death or orthotopic liver transplant (OLT) were assessed. Results: In total, 2,897 patients (1,484 and 1,413 in the ETV and TDF groups, respectively) were recruited. The annual HCC incidence was not statistically different between the ETV and TDF groups (1.92 vs. 1.69 per 100 person-years [PY], respectively; adjusted hazard ratio [HR] 0.975 [p = 0.852] by multivariate analysis). Propensity score (PS)-matched and inverse probability of treatment weighting (ITPW) analyses yielded similar patterns of results (HR 1.021 [p = 0.884] and 0.998 [p = 0.988], respectively). The annual incidence of death or OLT was not statistically different between the ETV and TDF groups (0.52 vs. 0.53 per 100 PY, respectively; adjusted HR 1.202 [p = 0.451]). PS-matched and ITPW analyses yielded similar patterns of results (HR 1.248 [p = 0.385] and 1.239 [p = 0.360], respectively). These findings were consistently reproduced in patients with compensated cirrhosis (all p >0.05). Conclusions: The overall prognosis in terms of HCC and death or OLT was not statistically different between the ETV and TDF groups. Further studies are needed to validate our results. Lay summary: It is currently unclear which antiviral agent, entecavir or tenofovir disoproxil fumarate, is superior for improving prognosis in patients with chronic hepatitis B virus infection. In this analysis we found that there was no difference in terms of overall prognosis, including risk of hepatocellular carcinoma, death, or the need for a liver transplant, in patients receiving either antiviral.

AB - Background & Aims: It is currently unclear which antiviral agent, entecavir (ETV) or tenofovir disoproxil fumarate (TDF), is superior for improving prognosis in patients with chronic hepatitis B (CHB). Here, we assessed the ability of these 2 antivirals to prevent liver-disease progression in treatment-naïve patients with CHB. Methods: From 2012 to 2014, treatment-naïve patients with CHB who received ETV or TDF as a first-line antiviral agent were recruited from 4 academic teaching hospitals. Patients with decompensated cirrhosis or hepatocellular carcinoma (HCC) at enrollment were excluded. Cumulative probabilities of HCC and death or orthotopic liver transplant (OLT) were assessed. Results: In total, 2,897 patients (1,484 and 1,413 in the ETV and TDF groups, respectively) were recruited. The annual HCC incidence was not statistically different between the ETV and TDF groups (1.92 vs. 1.69 per 100 person-years [PY], respectively; adjusted hazard ratio [HR] 0.975 [p = 0.852] by multivariate analysis). Propensity score (PS)-matched and inverse probability of treatment weighting (ITPW) analyses yielded similar patterns of results (HR 1.021 [p = 0.884] and 0.998 [p = 0.988], respectively). The annual incidence of death or OLT was not statistically different between the ETV and TDF groups (0.52 vs. 0.53 per 100 PY, respectively; adjusted HR 1.202 [p = 0.451]). PS-matched and ITPW analyses yielded similar patterns of results (HR 1.248 [p = 0.385] and 1.239 [p = 0.360], respectively). These findings were consistently reproduced in patients with compensated cirrhosis (all p >0.05). Conclusions: The overall prognosis in terms of HCC and death or OLT was not statistically different between the ETV and TDF groups. Further studies are needed to validate our results. Lay summary: It is currently unclear which antiviral agent, entecavir or tenofovir disoproxil fumarate, is superior for improving prognosis in patients with chronic hepatitis B virus infection. In this analysis we found that there was no difference in terms of overall prognosis, including risk of hepatocellular carcinoma, death, or the need for a liver transplant, in patients receiving either antiviral.

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