Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C
Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C
Menopause represents a critical period in a woman's life as the hormonal changes and the
 failing ovarian function not only determine relevant modifications in the reproductive
 function but also in many other conditions and organs that apparently are scarcely linked
 with hormones. The PI's centre has among its main goals the treatment of chronic liver
 disease; in the last years, a increasing interest in gender-related issues has grown.

 Goal of this study is to verify the impact of menopause on response to antiviral therapy for
 CHC and in determining more severe fibrosis in comparison with age-matched men. To achieve
 this goal a database of all the PEG IFN/Ribavirin patients treated in the GI Unit of the
 University of Modena and Reggio Emilia in the last 7 years will be set up. Demographic,
 clinical and biochemical data as well data regarding the reproductive history, time, type,
 length of estrogen deprivation and of hormone-replacement therapy will be collected.
The study is designed retrospective epidemiological cohort study. Overall, a group of 442
 women (168 still in fertile age; 274 menopausal) with HCV-positive CAH who underwent PEG IFN
 treatment in the last 5 years will be evaluated. For comparison, a group of 548 HCV-positive
 males with CAH will be evaluated. Liver biopsies before undergoing standard antiviral therapy
 will be scored for fibrosis, inflammation and steatosis. In women the presence, type and
 timing of menopause, associated hormonal/metabolic features and serum interleukin-6 (IL-6)
 and hepatic tumor necrosis factor-α (TNF-α) levels will be evaluated.

 The primary endpoint will be evaluation of SVR in females (in fertile and menopausal age) and
 in males.
Inclusion Criteria:

 -  All women treated for HCV chronic hepatitis, at the Unit Gastroenterology, University
 of Modena and Reggio Emilia, in the last 7 years.

 -  Control group is a cohort matched for age (ratio 1:1) selected from a group of 558 men
 with chronic HCV treated in the same period

 Exclusion Criteria:

 -  No exclusion criteria aret pre-defined as the study includes all patients who were
 treated for chronic HCV hepatitis; exclusion was made upstream of the constitution of
 this cohort.