Reuters Health Information (2012-09-03): Raloxifene aids HCV therapy in some postmenopausal women
Drug & Device Development
Raloxifene aids HCV therapy in some postmenopausal women
Last Updated: 2012-09-03 12:00:24 -0400 (Reuters Health)
NEW YORK (Reuters Health) - The addition of raloxifene to standard treatment for hepatitis C virus (HCV) infection in postmenopausal women appears to improve outcome in many, according to Japanese researchers.
Dr. Jun Hayashi of Kyushu University Hospital and colleagues note that because pegylated interferon therapy is more effective in younger than older women it suggests a potential link to reduced estrogen secretion. In addition, early menopause has been reported to be the most predictive factor for failure to achieve a sustained viral response (SVR).
Raloxifene is an oral selective estrogen receptor modulator. Such agents have been suggested to function as estrogen agonists that directly protect hepatocytes and control liver fibrosis.
In a paper online August 13 in the Journal of Hepatology, the researchers report that to examine whether this might be of help, they studied 127 postmenopausal women with genotype 1b chronic HCV.
They were randomized to treatment with pegylated interferon alpha 2a and ribavirin with or without raloxifene 60 mg per day. Planned treatment duration was 48 weeks and all patients were followed for 24 weeks after cessation of treatment.
At this point, the SVR rate was significantly higher in the raloxifene group (61.3% vs. 34.4%, p=0.0051).This was also true of end of treatment response (88.7% versus 68.9%, p=0.0132).
Comparison by interleukin-28B genotype showed that response was significantly greater in the raloxifene patients with interleukin-28B TT compared to their counterparts who did not receive the agent (72.5% vs. 39.2%, p=0.0014). This was not true of carriers of the minor IL28B allele.
Summing up, Dr. Hayashi told Reuters Health by email that the raloxifene-mediated improvement in response is limited to patients homozygous for the major allele of IL28B, and studies are needed in other ethnic groups. Yet the agent "may be a promising candidate as an adjuvant in the antiviral treatment of postmenopausal women with chronic hepatitis C."
J Hepatol 2012.