Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV
Background & Aims Premenopausal women who are HCV positive (HCV+) have failing ovarian function, which is likely to impact their fertility. Thus, we investigated the reproductive history, risk of infertility, and pregnancy outcomes in women of childbearing age who were HCV+. Methods Three different groups were studied: (1) Clinical cohort: 100 women who were HCV+ and also had chronic liver disease (CLD), age matched with 50 women who were HBV+ with CLD and with 100 healthy women; all women were consecutively observed in three gastroenterology units in hospitals in Italy; (2) 1,998 women who were HCV+ and enrolled in the Italian Platform for the Study of Viral Hepatitis Therapies (PITER)…
Incidence of DAA failure and the clinical impact of retreatment in real-life patients treated in the advanced stage of liver disease: Interim evaluations from the PITER network
Background: Few data are available on the virological and clinical outcomes of advanced liver disease patients retreated after first-line DAA failure. Aim: To evaluate DAA failure incidence and the retreatment clinical impact in patients treated in the advanced liver disease stage. Methods: Data on HCV genotype, liver disease severity, and first and second line DAA regimens were prospectively collected in consecutive patients who reached the 12-week post-treatment and retreatment evaluations from January 2015 to December 2016 in 23 of the PITER network centers. Results: Among 3,830 patients with advanced fibrosis (F3) or cirrhosis, 139 (3.6%) failed to achieve SVR. Genotype 3, bilirubin lev…
Real life data on elbasvir/grazoprevir efficacy, safety and drug-drug interaction profile in patients with chronic hepatitis C viral infection: a prospective analysis in the PITER cohort
Introduction: In a previous study, based on PITER cohort data, it was reported that of patients, undergoing direct acting antiviral (DAA) therapy, 30%-44%, are at risk of potential drug-drug interactions (DDI). Aim: We aimed to evaluate the prospective profile of elbasvir/grazoprevir (EBR/GZR) efficacy and safety combined with real life comedication profile. Method: Data from 312 patients (mean age 63 ± 10 years; 44% male, 90% of genotype 1.85% fibrosis stage ≤ F3, 15% with child A cirrhosis), enrolled in PITER by 15 clinical centers and treated with EBR/GZR, with at least three months of follow up after the end of treatment, were evaluated. Comedication profiles (no changes, drugs interrup…
Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data
OBJECTIVE:\ud We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy.\ud \ud METHODS:\ud A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulativ…