P-001. Real-world efficacy, safety and clinical outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin combination therapy in patients with hepatitis C virus genotype 1 or 4 infection: Turkey experience

Content Provider	Europe PMC
Author	Aygen, Bilgehan Demirtürk, Neşe Yıldız, Orhan Çelen, Mustafa Kemal Çelik, Ilhami Barut, Şener Ural, Onur Batırel, Ayşe Mıstık, Reşit Şimşek, Funda Asan, Ali Ersöz, Gülden Türker, Nesrin Bilgin, Hüseyin Hatipoğlu, Çiğdem Ataman Karakeçili, Faruk
Copyright Year	2019
Abstract	INTRODUCTION Clinical trials and real-world experiences evaluating ombitasvir/paritaprevir/ritonavir (OMV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) combination therapy have shown excellent rates of sustained virological response (SVR) and good safety profiles in patients with chronic hepatitis C virus (HCV) genotype 1 or 4 infections. We aimed to investigate the effectiveness and safety of OMV/PTV/r ± DSV ± RBV combination regimen in a real-world clinical practice. METHODS Data from HCV genotype 1 and 4 patients treated with OMV/PTV/r ± DSV ± RBV (n=862) in 34 centers across Turkey between April 1, 2017 and August 31, 2018 were recorded in a large national database. Study patients were treatment-naïve or interferon plus RBV-experienced with or without compensated cirrhosis. Follow-up (FU) ranged from 24 to 36 weeks depending on-treatment duration. Demographic, clinical and virological data were analyzed. Details of clinical and laboratory adverse events (AEs) were recorded. RESULTS The mean age of the patients was 55.63 and 430 (49.9%) were male. The majority had HCV genotype 1b infection (77.3%), and 66.2% were treatment-naïve. Non-cirrhosis was present at baseline in 789 patients (91.5%). The HCV RNA level was below 800.000 IU/mL in 442 of the cases. Of all patients, 18 had hepatitis B virus (HBV) co-infection. Sixty-five percent of the patients had an underlying disease. Out of the 862 analysed patients, 57 patients did not return for viral load FU at 12 weeks, 6 patients stopped antiviral therapy because of AEs, 7 patients had virological failure and 1 patient died. Virological rates by per protocol analysis was calculated in the patients. SVR12 rate was 99.1% in all patients. No significant differences were observed in SVR12 according to HCV genotypes (p= 0.410). HCV RNA was undectable at treatment week 4 in 90.9%, at treatment week 8 in 98.5%, and at end of treatment (EOT) in 98.9%. No significant differences were observed in at treatment week 8 and EOT virological response according to HCV genotypes (p= 0.630, p= 0.785, respectively). Rates of rapid virological response (RVR) were significantly higher in the patients infected with HCV genotype 1a or 1b than in the patients infected with genotype 4 (p< 0.001). RVR and SVR12 ratios were significantly higher in non-cirrhotic patients compared to compensated cirrhotic patients (p= 0.004, p=0.016). There was not significant difference in on-treatment or EOT or FU12 weeks responses between treatment-naïve and treatment-experienced patients (p= 0.599, p= 0.166, p= 1000, p=0.431). Rates of AEs and AEs-associated treatment discontinuation were 59.7% and 0.7% in the patients, respectively. HBV reactivation occurred in 13.3% of the patients. CONCLUSION The present real-life data of Turkey for OBV/PTV/r ± DSV ± RBV treatment of patients with HCV genotype 1b, 1a or 4 infection from 862 patients demonstrated high efficacy and a safety profile.
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ISSN	13004948
Volume Number	30
DOI	10.5152/tjg.2019.07
PubMed Central reference number	PMC7021020
Issue Number	supp1
PubMed reference number	PMC7021020
Journal	The Turkish Journal of Gastroenterology [Turk J Gastroenterol]
e-ISSN	21485607
Language	English
Publisher	Turkish Society of Gastroenterology
Publisher Date	2019-04-01
Access Restriction	Open
Rights License	Copyright 2019 by Turkish Society of Gastroenterology
Subject Keyword	Chronic hepatitis C HCV genotypes 1 and 4 ombitasvir paritaprevir dasabuvir real-world effectiveness
Content Type	Text
Resource Type	Article
Subject	Gastroenterology