Diabetes mellitus prevents an improvement in the serum albumin level during interferon-free sofosbuvir-based therapy for chronic hepatitis C patients: A multi-institutional joint study

Akira Kawano, Hirohisa Shigematsu, Koichiro Miki, Yasunori Ichiki, Chie Morita, Kimihiko Yanagita, Kazuhiro Takahashi, Kazufumi Dohmen, Hideyuki Nomura, Hiromi Ishibashi, Shinji Shimoda

Research output: Contribution to journalArticle

Abstract

Objective Interferon-free regimens of direct-acting antiviral agents have improved the treatment response for chronic hepatitis C virus (HCV) infection, and improvement in the serum albumin level during interferon-free therapy has been reported. The aim of this study was to identify the factors that influence the improvement in the serum albumin level in patients receiving interferon-free antiviral therapy. Methods This retrospective, multicenter study consisted of 471 Japanese patients with chronic hepatitis and compensated liver cirrhosis infected with HCV who completed 12-week interferon-free sofosbuvir (SOF)-based therapy [SOF plus ledipasvir for genotype 1 (n=276) and SOF with ribavirin for genotype 2 (n=195)]. We evaluated the changes in the serum albumin level from baseline to the end of treatment (ΔAlb). Results When compared with the normal-albumin group (baseline serum albumin >35 g/L, n=406), the low-albumin group (baseline serum albumin ≤35 g/L, n=65) showed a significant increase in the mean ΔAlb (5.5 g/L vs. 1.0 g/L, p<0.001). In the low-albumin group, a multivariate logistic regression analysis extracted diabetes mellitus as a negative predictive factor of median ΔAlb >5.0 g/L (odds ratio: 0.19, 95% confidence interval: 0.048-0.79, p=0.020). In the low-albumin group, the mean ΔAlb was significantly lower in the diabetic patients (n=14) than in the non-diabetic patients (n=51) (3.9 g/L and 5.7 g/L, p=0.049). Conclusion Interferon-free SOF-based therapy significantly improved the serum albumin in the low-albumin group patients with chronic HCV infection. However, the improvement in the serum albumin level was significantly lower in the diabetic patients than in the non-diabetic patients.

Original languageEnglish
Pages (from-to)1533-1542
Number of pages10
JournalInternal Medicine
Volume57
Issue number11
DOIs
Publication statusPublished - Jan 1 2018

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Chronic Hepatitis C
Serum Albumin
Interferons
Diabetes Mellitus
Albumins
Hepacivirus
Virus Diseases
Therapeutics
Antiviral Agents
Genotype
Ribavirin
Chronic Hepatitis
Sofosbuvir
Liver Cirrhosis
Multicenter Studies
Retrospective Studies
Odds Ratio
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Internal Medicine

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Diabetes mellitus prevents an improvement in the serum albumin level during interferon-free sofosbuvir-based therapy for chronic hepatitis C patients : A multi-institutional joint study. / Kawano, Akira; Shigematsu, Hirohisa; Miki, Koichiro; Ichiki, Yasunori; Morita, Chie; Yanagita, Kimihiko; Takahashi, Kazuhiro; Dohmen, Kazufumi; Nomura, Hideyuki; Ishibashi, Hiromi; Shimoda, Shinji.

In: Internal Medicine, Vol. 57, No. 11, 01.01.2018, p. 1533-1542.

Research output: Contribution to journalArticle

Kawano, Akira ; Shigematsu, Hirohisa ; Miki, Koichiro ; Ichiki, Yasunori ; Morita, Chie ; Yanagita, Kimihiko ; Takahashi, Kazuhiro ; Dohmen, Kazufumi ; Nomura, Hideyuki ; Ishibashi, Hiromi ; Shimoda, Shinji. / Diabetes mellitus prevents an improvement in the serum albumin level during interferon-free sofosbuvir-based therapy for chronic hepatitis C patients : A multi-institutional joint study. In: Internal Medicine. 2018 ; Vol. 57, No. 11. pp. 1533-1542.
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abstract = "Objective Interferon-free regimens of direct-acting antiviral agents have improved the treatment response for chronic hepatitis C virus (HCV) infection, and improvement in the serum albumin level during interferon-free therapy has been reported. The aim of this study was to identify the factors that influence the improvement in the serum albumin level in patients receiving interferon-free antiviral therapy. Methods This retrospective, multicenter study consisted of 471 Japanese patients with chronic hepatitis and compensated liver cirrhosis infected with HCV who completed 12-week interferon-free sofosbuvir (SOF)-based therapy [SOF plus ledipasvir for genotype 1 (n=276) and SOF with ribavirin for genotype 2 (n=195)]. We evaluated the changes in the serum albumin level from baseline to the end of treatment (ΔAlb). Results When compared with the normal-albumin group (baseline serum albumin >35 g/L, n=406), the low-albumin group (baseline serum albumin ≤35 g/L, n=65) showed a significant increase in the mean ΔAlb (5.5 g/L vs. 1.0 g/L, p<0.001). In the low-albumin group, a multivariate logistic regression analysis extracted diabetes mellitus as a negative predictive factor of median ΔAlb >5.0 g/L (odds ratio: 0.19, 95{\%} confidence interval: 0.048-0.79, p=0.020). In the low-albumin group, the mean ΔAlb was significantly lower in the diabetic patients (n=14) than in the non-diabetic patients (n=51) (3.9 g/L and 5.7 g/L, p=0.049). Conclusion Interferon-free SOF-based therapy significantly improved the serum albumin in the low-albumin group patients with chronic HCV infection. However, the improvement in the serum albumin level was significantly lower in the diabetic patients than in the non-diabetic patients.",
author = "Akira Kawano and Hirohisa Shigematsu and Koichiro Miki and Yasunori Ichiki and Chie Morita and Kimihiko Yanagita and Kazuhiro Takahashi and Kazufumi Dohmen and Hideyuki Nomura and Hiromi Ishibashi and Shinji Shimoda",
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T1 - Diabetes mellitus prevents an improvement in the serum albumin level during interferon-free sofosbuvir-based therapy for chronic hepatitis C patients

T2 - A multi-institutional joint study

AU - Kawano, Akira

AU - Shigematsu, Hirohisa

AU - Miki, Koichiro

AU - Ichiki, Yasunori

AU - Morita, Chie

AU - Yanagita, Kimihiko

AU - Takahashi, Kazuhiro

AU - Dohmen, Kazufumi

AU - Nomura, Hideyuki

AU - Ishibashi, Hiromi

AU - Shimoda, Shinji

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Objective Interferon-free regimens of direct-acting antiviral agents have improved the treatment response for chronic hepatitis C virus (HCV) infection, and improvement in the serum albumin level during interferon-free therapy has been reported. The aim of this study was to identify the factors that influence the improvement in the serum albumin level in patients receiving interferon-free antiviral therapy. Methods This retrospective, multicenter study consisted of 471 Japanese patients with chronic hepatitis and compensated liver cirrhosis infected with HCV who completed 12-week interferon-free sofosbuvir (SOF)-based therapy [SOF plus ledipasvir for genotype 1 (n=276) and SOF with ribavirin for genotype 2 (n=195)]. We evaluated the changes in the serum albumin level from baseline to the end of treatment (ΔAlb). Results When compared with the normal-albumin group (baseline serum albumin >35 g/L, n=406), the low-albumin group (baseline serum albumin ≤35 g/L, n=65) showed a significant increase in the mean ΔAlb (5.5 g/L vs. 1.0 g/L, p<0.001). In the low-albumin group, a multivariate logistic regression analysis extracted diabetes mellitus as a negative predictive factor of median ΔAlb >5.0 g/L (odds ratio: 0.19, 95% confidence interval: 0.048-0.79, p=0.020). In the low-albumin group, the mean ΔAlb was significantly lower in the diabetic patients (n=14) than in the non-diabetic patients (n=51) (3.9 g/L and 5.7 g/L, p=0.049). Conclusion Interferon-free SOF-based therapy significantly improved the serum albumin in the low-albumin group patients with chronic HCV infection. However, the improvement in the serum albumin level was significantly lower in the diabetic patients than in the non-diabetic patients.

AB - Objective Interferon-free regimens of direct-acting antiviral agents have improved the treatment response for chronic hepatitis C virus (HCV) infection, and improvement in the serum albumin level during interferon-free therapy has been reported. The aim of this study was to identify the factors that influence the improvement in the serum albumin level in patients receiving interferon-free antiviral therapy. Methods This retrospective, multicenter study consisted of 471 Japanese patients with chronic hepatitis and compensated liver cirrhosis infected with HCV who completed 12-week interferon-free sofosbuvir (SOF)-based therapy [SOF plus ledipasvir for genotype 1 (n=276) and SOF with ribavirin for genotype 2 (n=195)]. We evaluated the changes in the serum albumin level from baseline to the end of treatment (ΔAlb). Results When compared with the normal-albumin group (baseline serum albumin >35 g/L, n=406), the low-albumin group (baseline serum albumin ≤35 g/L, n=65) showed a significant increase in the mean ΔAlb (5.5 g/L vs. 1.0 g/L, p<0.001). In the low-albumin group, a multivariate logistic regression analysis extracted diabetes mellitus as a negative predictive factor of median ΔAlb >5.0 g/L (odds ratio: 0.19, 95% confidence interval: 0.048-0.79, p=0.020). In the low-albumin group, the mean ΔAlb was significantly lower in the diabetic patients (n=14) than in the non-diabetic patients (n=51) (3.9 g/L and 5.7 g/L, p=0.049). Conclusion Interferon-free SOF-based therapy significantly improved the serum albumin in the low-albumin group patients with chronic HCV infection. However, the improvement in the serum albumin level was significantly lower in the diabetic patients than in the non-diabetic patients.

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