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

Abstract

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 interrupted, or modified as posology, or those added) were evaluated and the potential DDI were assigned according to HepC Drug Interactions. Results: The SVR12 was reached in 299 (96%) patients. Gender, age, fibrosis stage, previous interferon therapy, diabetes and fatty liver were not related to failure by logistic regression analysis. Of 312 treated patients, 187 (60%) had at least one comorbidity (median: 2 range: 1–6 comorbidities). Follow up data on comedications used were available in 182 patients (21% have taken 1 drug, 24% two drugs, and the remaining 55% from 3–10 drugs). Of 328 comedications used during the DAA therapy, 3% were modified in posology, 2% were interrupted and 3% were new drugs added. None of changes was due to potential DDI. None but statins (in 2% of patients) were reported to require monitoring by HepC Drug Interactions. EBR/GZR was well tolerated. An increase in ALT levels (lower than 3 times of normal levels), were observed in 12 (4%) patients during the DAA therapy. Conclusion: EBR/GZR demonstrated high cure rates and a good safety profile. No drug-drug interactions were recorded in this cohort of treated patients with different comorbidities and comedications used.