Efficacy and safety of Ombitasvir/Paritaprevir/Ritonavir+ Dasabuvir and Ribavirin in patients with compensated HCV cirrhosis

Background and aim: Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir in association with ribavirin was the only interferon-free regimen available in 2015 in Romania for compensated HCV cirrhosis. The aim of our study is to reveal our experience with interferon-free therapy in compensated HCV cirrhosis. Materials and methods: We conducted a multicenter prospective study including 90 patients with compensated (Child-Pugh A) HCV cirrhosis treated with Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir and Ribavirin regimen for twelve weeks. The HCV infection was diagnosed using clinical, biological, and FibroMax tests. Each patient had follow-up visits at four, eight, twelve and twenty-four weeks after the initiation of the treatment. Results: 44 (49% of) patients were female and 46 (51 % of) were male. The mean age of patients in the study was 61 years old. All the patients had HCV genotype 1b infection. 22 patients were naive and 68 had previous antiviral therapies based on pegylated IFN-α and ribavirin. At the initiation of treatment 64 (71%) of patients had cytolysis, 38 (42%) had thrombocytopenia, 19 (21%) patients had hyperbilirubinemia and 11 (12%) patients had anemia. It was noticed a decreasing of cytolysis, only 10% of 64 patients still having cytolysis after four weeks of treatment. One patient (1%) died after four weeks of treatment by complications of cirrhosis. 89 (99%) of patients had a virologic response (VR) at the end of treatment (EOT) and sustained virologic response (SVR) twelve weeks after the last dose administration. Conclusion: The most common side effect among the patients in the study group was anemia (47% cases). Cytolysis disappeared after four weeks of treatment in 61% of patients. The interferon-free combination treatment was safe and highly effective in compensated HCV cirrhosis.