Efficacy, Safety and Relapse of Sofosbuvir in Combination with Daclatasvir, Ledipasvir and Simeprevir for Treatment of Hepatitis C Virus in Egypt

Abstract

AbstractBackground: Hepatitis C Virus infects about 185 million people equating 2.8% of worldwide population and about 500,000 people die annually from hepatitis C related liver diseases. The most common clinical presentation of the disease is the chronic hepatitis and its complications such as: Com-pensated cirrhosis, portal hypertension, decompensated cir-rhosis and Hepatocellular Carcinoma (HCC). Therapeutic management of chronic HCV patients traditionally depended on combination of peg-interferon (IFN) with ribavirin but this regimen showed many serious side effects beside its non-satisfactory efficacy. In 2013, a second generation of Direct Acting Antiviral Agents (DAAs) gave a promising efficacy and safety. Although many IFN free regimens were approved, further evaluations are needed for these regimens.Aim: To compare sofosbuvir in combination with Da-clatasvir, Ledipasvir and Simeprevir in patients with chronic hepatitis C infection according to safety, efficacy, relapse and patient outcomes.Patients and Methods: This is a prospective study con-ducted on 150 patients of chronic HCV who were admitted to the Viral Hepatitis Center in Al-Ahrar Educational Hospital in Zagazig {National Committee for the Control of Viral Hepatitis (NCCVH) during the first 9 months of 2017 and were selected according to the inclusion and exclusion criteria set by the (NCCVH). 58% of overall participants had cirrhosis and 2.7% were treatment-experienced. Patients were assigned into three groups: 50 patients received Sofosbuvir + Daclatasvir ± Ribavirin (SOF/DCV ± RBV) therapy, 50 patients received Sofosbuvir + Ledipasvir ± Ribavirin (SOF/LDV ± RBV) therapy and 50 patients received Sofosbuvir + Simeprevir ± Ribavirin (SOF/SIM±RBV) therapy. Three regimens were given for 12 weeks. Primary end point was the rate of achieving SVR12 by HCV RNA PCR, while secondary end point was the occurrence of virologic relapse.Results: The SVR rate of three groups was 98%, 100% and 100% for SOF/DCV, SOF/LDV and SOF/SIM groups respectively. Only one patient had a virological failure and he was in SOF/DCV group but these results showed no statistical significance. Virological relapse occurred in only 1 patients (.67%) of the 149 patients. The patient who showed virological failure wasn't included, while the only one patient relapsed (2%) was in SOF/SIM therapy group. Results of virological relapse were statistically not significant. RVR showed a predictive value in SVR achievement and relapse occurrence was also confirmed in our study, in SVR (p=>.05) and in relapse (p=.9). Adverse events occurred in (22%) of SOF/DCV group, (26%) of SOF/LDV group and (40%) of SOF/SIM group (p=.153), thus SOF/SIM therapy showed a higher incidence of adverse events occurrence.Conclusions: Sofosbuvir based antiviral combination therapy with (DCV, LDV and SIM) showed a highly safety, tolerability and efficacy for treatment of chronic Hepatitis C Virus.