Efficacy of treatment with Ombitasvir, Paritaprevir / r + Dasabuvir over 8 versus 12 weeks in chronic HCV hepatitis genotype 1B
Authors:   Gastroenterology & Hepatology Department, „Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania, Manuc Mircea ,   Fundeni Clinical Institute, Bucharest, Romania 3 Internal Medicine Department, „Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania, Preda Carmen Monica ,   Gastroenterology & Hepatology Department, „Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania,   Fundeni Clinical Institute, Bucharest, Romania 3 Internal Medicine Department, „Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania, Iliescu Laura ,   Fundeni Clinical Institute, Bucharest, Romania,   Internal Medicine Department, „Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania, Istratescu Doina ,   Fundeni Clinical Institute, Bucharest, Romania, Chifulescu Andreea Elena ,   Fundeni Clinical Institute, Bucharest, Romania, Pop Corina Silvia ,   Internal Medicine Department, „Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania,   University Emergency Hospital, Bucharest, Romania, Trifan Anca ,   Gastroenterology & Hepatology Department, “Gr.T. Popa“, University of Medicine and Pharmacy, Iasi, Romania,   Gastroenterology & Hepatology Institute, Iasi, Romania, Stanciu Carol ,   Gastroenterology & Hepatology Department, “Gr.T. Popa“, University of Medicine and Pharmacy, Iasi, Romania,   Gastroenterology & Hepatology Institute, Iasi, Romania, Popescu Corneliu Petru ,   Virology Department, „Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania,   “Victor Babes“ׅ Hospital, Bucharest, Romania, Diculescu Mircea-Mihai ,   Gastroenterology & Hepatology Department, „Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania,   Fundeni Clinical Institute, Bucharest, Romania, Manuc Teodora ,   Gastroenterology & Hepatology Department, „Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania,   Internal Medicine Department, „Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania, Tugui Letitia ,   Fundeni Clinical Institute, Bucharest, Romania, Cianga Elena ,   Fundeni Clinical Institute, Bucharest, Romania, Tieranu Cristian George ,   Gastroenterology & Hepatology Department, „Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania,   Elias Emergency Hospital, Bucharest, Romania, Stroie Tudor ,   Fundeni Clinical Institute, Bucharest, Romania, Gheorghe Liliana Simona ,   Gastroenterology & Hepatology Department, „Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania,   Fundeni Clinical Institute, Bucharest, Romania
Published: June 2021

Background and aims. For the 8-week OPrD regimen, real world data are insufficient. This study aims to compare the efficacy of the two types of regimens (12-week versus 8-week) in a real world cohort of patients with genotype 1b. Material and methods. We analysed a multicentric retrospective cohort enrolling 1436 patients who started HCV therapy in 2018-2019. Liver fibrosis was staged in all subjects by Fibromax. Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). Results. Out of the 1436 analysed patients, 112 received 8 weeks therapy and 1324 received 12 weeks. In this cohort the proportion of male patients was 25.2%, the median age 61 years, 28.2% were interferon pre-treated, and the rate of co-morbidities was 47%. 42% of the subjects had F2 fibrosis, 29% F1 fibrosis, 16% F3 and 12% F4. The SVR rate was comparable in both groups of patients (97% in those treated with OPrD 12 weeks vs 96.4% in those that received OPrD 8 weeks) (by intention-to-treat). In the 12 weeks arm, the drop-out rate was 0.8% and the rate of severe adverse events was 1%, while in the arm of 8 weeks therapy there were no severe adverse events reported and no drop-out (p = 0.25). The only predictive factor for non-response in both treatment arms was the male sex. Conclusions. OPrD 8 weeks proved to be highly efficient in our patients with a 96.4% SVR. No serious adverse events and no drop out were reported.