All Oral Antiviral Treatment with Paritaprevir/Ombitasvir/Ritonavir and Dasabuvir in Chronic HCV Infection - Real Life Experience

Introduction All oral antiviral treatment in chronic HCV infection is one of the most important breakthroughs in hepatology. While clinical trials have revealed maximum efficacy with minor side-effects, its use in real life raises questions about drug-drug interaction and use in patients with comorbidities. Methods We performed an observational prospective study on 442 patients who underwent treatment with OMB/PTV/r + DSV during December 2015-June 2018. Inclusion criteria were: patients with compensated liver cirrhosis (F4 fibrosis, clas Child A), patients with F3 fibrosis, patients with F2 fibrosis and HCV related comorbidities or indication for kidney transplant and patients with HCV relapse after liver transplant. Clinical and biologic parameters were evaluated at initiation of therapy, at the end of therapy and at 12 weeks after the end of therapy. Results All patients have reached the end of treatment checkpoint and in 397 patients we determined presence of sustained virologic response. Four patients had detectable HCV-RNA at the end of treatment and three patients did not achieve SVR. Serious adverse events occurred in four cases (2 patients with B-cell lymphoma and hematologic decompensation died during treatment, one p patients presented variceal bleeding and one patient presented acute pancreatitis). The most common adverse reactions were nausea and fatigue. None of the patients discontinued antiviral therapy. In patients with cardiovascular comorbidities, diabetes mellitus or autoimmune manifestations concurrent medication had to be adjusted. In patients after solid organ transplantation doses of tacrolimus were drastically reduced, with frequent monitoring of tacrolinemia. Conclusion Real life experience with OMB/PTV/r + DSV proves its efficacy in achieving SVR in patients with compensated cirrhosis or chronic HCV hepatitis. We did not identify treatment-related adverse reactions. Close monitoring is required in patients with comorbidities and concurrent medication.