Open AccessEfficacy of treatment with Ombitasvir, Paritaprevir / r + Dasabuvir over 8 versus 12 weeks in chronic HCV hepatitis genotype 1B
Author(s) -
Mircea Mănuc,
Carmen Monica Preda,
Laura Iliescu,
Doina Istrătescu,
Andreea Elena Chifulescu,
Corina Silvia Pop,
Anca Trifan,
C Stanciu,
Corneliu Petru Popescu,
Mihai Mircea Diculescu,
Teodora Manuc,
Letiţia Tugui,
Elena Cianga,
Cristian Tieranu,
Tudor Stroie,
L. Gheorghe
Publication year - 2021
Publication title -
romanian journal of infectious diseases
Language(s) - English
Resource type - Journals
eISSN - 2069-6051
pISSN - 1454-3389
DOI - 10.37897/rjid.2021.1.6
Subject(s) - medicine , ombitasvir , adverse effect , cohort , regimen , paritaprevir , dasabuvir , retrospective cohort study , hepatitis c , gastroenterology , surgery , hepatitis c virus , ribavirin , immunology , virus
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.