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

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• 作者：Norihiro Furusyo¹ ; ² ; Eiichi Ogawa¹ ; Masayuki Sudoh³ ; Masayuki Murata¹ ; Takeshi Ihara² ; Takeo Hayashi² ; Hiroaki Ikezaki² ; Satoshi Hiramine² ; Haru Mukae² ; Kazuhiro Toyoda¹ ; Hiroaki Taniai¹ ; Kyoko Okada¹ ; Mosaburo Kainuma¹ ; Eiji Kajiwara⁴ ; Jun Hayashi¹ ; ² ; ^{hayashij@gim.med.kyushu-u.ac.jp}
• 关键词：HCV ; hepatitis C virus ; SVR ; sustained virological response ; SOC ; standard of care ; PegIFN ; pegylated interferon ; RBV ; ribavirin ; RLX ; raloxifene hydrochloride ; IL28B ; interleukin-28B ; SERM ; selective estrogen receptor modulator ; WBC ; white blood cell ; Hb
• 刊名：Journal of Hepatology
• 出版年：2012
• 出版时间：December, 2012
• 年：2012
• 卷：57
• 期：6
• 页码：1186-1192
• 全文大小：751 K

文摘

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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) ¦Á2a 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 (PegIFN¦Á2a 180 ¦Ìg/week and RBV 600-1000 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.