Raloxifene hydrochloride is an adjuvant antiviral treatment of postmenopausal women with chronic hepatitis C: a randomized trial.

Abstract

BACKGROUND & AIMS:

Early menopause in women with chronic hepatitis C virus (HCV) infection is associated with a low likelihood of a sustained virological response (SVR) in conjunction with their antiviral treatment. This is potentially related to their reduced estrogen secretion. The study was done to determine whether selective estrogen receptor modulator administration might improve the efficacy of the current standard of care (SOC) treatment, pegylated interferon (PegIFN) α2a plus ribavirin (RBV), for postmenopausal women.

METHODS:

One hundred and twenty-three postmenopausal women with genotype 1b chronic hepatitis C were randomly assigned to one of two treatment groups: raloxifene hydrochloride (RLX) (60 mg/day) plus SOC (PegIFNα2a 180 μg/week and RBV 600-1,000 mg/day) (n=62) or SOC only (n=61). Genotyping was performed of the polymorphism in the interleukin-28B (IL28B) gene region (rs8099917) of DNA collected from each patient.

RESULTS:

One RLX-treated patient discontinued RLX because of a systemic rash following 2 weeks of treatment. Twenty-four weeks after treatment, the SVR rate was significantly higher for RLX plus SOC patients (61.3%) than for SOC only patients (34.4%) (p=0.0051). Further, the SVR rate was significantly higher for RLX plus SOC patients with IL28B TT (72.5%) than for SOC only patients with IL28B TT (39.2%) (p=0.0014), but no such relationship was observed in patients carrying the minor IL28B allele.

CONCLUSIONS:

RLX improved the efficacy of SOC in the treatment of postmenopausal women with chronic hepatitis C. RLX shows promise as an adjuvant to the standard antiviral treatment of such patients.

• Authors: Norihiro Furusyo, Eiichi Ogawa, Masayuki Sudoh, Masayuki Murata, Takeshi Ihara, Takeo Hayashi, Hiroaki Ikezaki, Satoshi Hiramine, Haru Mukae, Kazuhiro Toyoda, Hiroaki Taniai, Kyoko Okada, Mosaburo Kainuma, Eiji Kajiwara, Jun Hayashi
• Journal: Journal of hepatology (J Hepatol) Vol. 57 Issue 6 Pg. 1186-92 (Dec 2012) ISSN: 1600-0641 [Electronic] Netherlands
• PMID: 22889955 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Chemical References

• Adjuvants, Pharmaceutic
• Antiviral Agents
• interferon-lambda, human
• Interferon-alpha
• Interleukins
• RNA, Viral
• Recombinant Proteins
• Selective Estrogen Receptor Modulators
• Polyethylene Glycols
• Ribavirin
• Raloxifene Hydrochloride
• Interferons
• peginterferon alfa-2a

Topics

• Adjuvants, Pharmaceutic (therapeutic use)
• Aged
• Antiviral Agents (therapeutic use)
• Female
• Genotype
• Hepatitis C, Chronic (drug therapy, virology)
• Humans
• Interferon-alpha (therapeutic use)
• Interferons
• Interleukins (genetics)
• Middle Aged
• Polyethylene Glycols (therapeutic use)
• Postmenopause
• Prospective Studies
• RNA, Viral (analysis)
• Raloxifene Hydrochloride (therapeutic use)
• Recombinant Proteins (therapeutic use)
• Ribavirin (therapeutic use)
• Selective Estrogen Receptor Modulators (therapeutic use)