Abstract
INTRODUCTION: The aim of this study was to investigate the sustained virological response (SVR) of the patients treated with new generation oral direct acting oral antiviral (DAA), the factors affecting to the treatment response, the treatment compliance of the patients and the side effects of the treatment.
METHODS: We enrolled 103 patients with HCV who received DAA from three tertiary hospitals between January 2016 to May 2017. The paitents were categorized as three gorups: Paitents in group-1 received Sofosbuvir plus Ledipasvir with or without ribavirin for 12 weeks, paitents in group-2 received Sofosbuvir plus Ledipasvir with or without ribavirin for 24 weeks and patiens in group-3 received Ombitasvir-Paritaprevir-Ritonavir plus Dasabuvir for 12 weeks. HCV-RNA levels, hcv genotype, hepatic fibrosis stage, hemogram and biochemical variables were recorded. The patients were followed up every 4 weeks during the treatment, and at the 4th week, 12th week and 24th week after the end of the treatment. Compliance to the treatment and side effects were recorded. SVR4, SVR12 and SVR24 datas and factors affecting to the SVR were analysed.
RESULTS: Demographic features of the patients have shown in Table-1. Side effects which could be related to DAAs were reported 15 patients in group-1, 3 patients in group-2 and 11 patients in group-3 (Table-2). There was significant difference between groups in terms of frequency of the side effects (p<0.001). The frequency of side effects is higher in group-1 than other groups. Only 1 patient has transfered to the group-1 from group-3 because of nausea and vomitting. All patients had complete compliance to the treatment. SVR4 was achieved in 22 patients (92%) in group-1, 45 patients (100) in group-2 and 34 patients (100%) in group-3. There was no significant difference between groups in terms of SVR4 (p:0.053). SVR12 was achieved in 22 (95) patients in group-1, 45 (100%) patients in group-2 and 34 (100%) patients in group-3. SVR12 rates in group-1 were lower than other groups but this difference wasn’t statically significant (p:0.053). 2 patients couldn’t achieve SVR12 in group-1. Both patients were treatment naive, had cirrhosis and genotype-1b hepatitis C infection. SVR24 was achieved in 22 (92%) patients in group-1, 45 (100%) patients in group-2 and 34 (100%) patients in group-3 but there was no significant difference between groups (p:0.053). Presence of cirrhosis, treatment experience, having genotype 1a or 1b hepatitis C infection, age or gender didn’t effect on treatment response. SVR4, SVR12 and SVR24 rates were 100% in treatment experienced and cirrhotic patients.
CONCLUSION: High virologic response rates have been achieved with new generation DAAs, even in cirrhotic and treatment experienced patients. Treatment compliance rates were quite good with DAAs. There were no relationship between age, gender, presence of cirrhosis or treatment experience and virologic response to the treatment.