SAFETY OF OMBITASVIR/PARITAPREVIR/RITONAVIR+DASABUVIR IN CHRONIC HEPATITIS C PATIENTS WITH HCV GENOTYPE 1 INFECTION

Introduction The assessment of the safety profile of ombitasvir/paritaprevir/ritonavir+dasabuvir in adult chronic hepatitis C patients with confirmed HCV genotype 1 presence. Material and method Evaluation of clinical safety based on the results of primary studies found in the systematic review. The following literature databases were searched: Medline, Embase, Cochrane Library and others. Results Finally two clinical trial met the inclusion criteria. The study included untreated patients (SAPPHIRE I) or patients after unsuccessful therapy (SAPPHIRE II), with genotype 1 infection. In patients without prior treatment the prevalence of the reported adverse events was in general statistically significantly greater in the group on therapy 3D+RBV compared to the placebo group. No statistically significant differences were observed in relation to the risk of serious adverse events or therapy discontinuance due to adverse events. In patients after unsuccessful therapy the prevalence of the reported adverse events was statistically significantly greater in the group on therapy 3D+RBV compared to the placebo group. During the 3D+RBV itching was statistically significantly more frequently reported in the placebo group. Compared to the other adverse events, no statistically significant differences were observed. Conclusions Interferon-free therapies provide a safe therapeutic option in the population of adult patients with chronic genotype 1 hepatitis C, both those untreated and after unsuccessful two-drug PegIFNα-based therapy, patients with HIV co-infection and patients after liver transplantation.