Data on the effectiveness and safety of Glecaprevir/Pibrentasvir for the treatment of HCV infection in a ‘field-practice’ scenario are still scant. This study (MISTRAL: MavIret SouTh italy ReAl Life), currently ongoing, evaluates this therapy in a large cohort of HCV-infected patients from Southern Italy.
All HCV-infected patients, consecutively treated with Glecaprevir/Pibrentasvir at 22 Centers all over Southern Italy were considered. Fibrosis was determined histologically or non-invasively, through liver stiffness measurement. We report here baseline characteristics of patients and available data on end of treatment (EOT). Efficacy of treatment was defined as undetectable HCV-RNA in patients’ blood sample obtained twelve weeks after the end of therapy (sustained virological response).
In total, 1178 patients were enrolled (mean age, 60±15 years; 581 males, 49.4%). Most common etiologies were HCV 1b (n=432; 36.8%) and HCV 2 (n=405; 34.5%). One hundred and twenty-three patients (10.5%) were infected from genotype-3 HCV. METAVIR score was F0 in 269 patients (22.9%), F1 in 477 (40.6%), F2 in 209 (17.8%), F3 in 92 (7.8%) and F4 in 103 (8.8%). The wide majority of patients showed normal (CKD1; n=572, 48.7%) or mildly impaired (CKD2; n=472, 40.2%) renal function; 28 subjects had kidney failure (CKD5; 2.4%). Ninety patients (7.7%) were diabetics. Laboratory parameters were as follows: creatinine, 1.02±1.17 mg/dl; bilirubin, 0.76±0.44 mg/dl; hemoglobin, 14.2±1.6 g/dl; platelets, 206874±64111/µl; ALT 45±38 U/L and AST 55±56 U/L. Most patients (n=918; 78.1%) were treatment-naïve. Planned duration of Glecaprevir/Pibrentasvir treatment was 8 weeks for 1067 patients (90.8%), 12 weeks for 102 (8.7%) and 16 weeks for 5 (0.4%). At the time of analysis, data concerning EOT were available for 1178 patients 100% of the total). Almost all of them reached EOT (99.5%). Data on sustained virological response at 12 weeks after EOT are not complete at the time of the present analysis we then here reported data on 885 patients showing a prevalence of 99.3% of SVR. SAE, not related to the drug, were documented in 1% of patients and 8.5% of AE (mostly pruritus).
The large MISTRAL study, conducted in a field-practice scenario, provides a still better prevalence, compared to registration trial, of SVR confirming the extraordinary efficacy and safety of Glecaprevir/Pibrentasvir association also for only 8 weeks treatment. Complete final results will be presented at the CROI meeting.