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.