Safety and Efficacy of Sofosbuvir and Simeprevir Versus Sofosbuvir and Daclatasvir in Treatment of Na?ve Egyptian Patients with Chronic Hepatitis C Virus Infection

摘要

Hepatitis C infection considered to be one of the most important health problems in Egyp The treatment of chronic HCV was problematic due to lack of an effective and safe drugs. This study demonstrated that a virological response exceeding 90% in most genotypes. Aim: Study of safety and efficacy of combination between Sofosbuvir plus Simeprevir without ribavirin once daily versus combination of Sofosbuvir plus Daclatasvir without ribavirin once daily for 12 weeks in treatment of naive Egyptian patients with chronic HCV infection. Methods: this study included 60 patients divided into two groupsGroup I: Thirty patients received Sofosbuvir (SOF)400 mg plus Simeprevir(SMV) 150 mg once daily for 12 weeks. Group II: Thirty patients received Sofosbuvir 400 mg plus Daclatasvir 60 mg once daily for 12 weeks. All patients were subjected to detailed history taking and clinical examination. Assessment of liver fibrosis by FIB-4, Monitoring of treatment efficacy and endpoint at week 4, 8, 12 of treatment and a week at 12, 24 post treatment. Monitoring of treatment safety by complete liver profile, complete blood picture, creatinine each vist, and history taking about any side effects. Imaging by abdominal ultrasound. Results: There was no statistically significant difference in response rates to the combination of SOF/SMV regimen at week 4 of treatment (100%), at the end of treatment (96.7%) and post treatment at week 12(93.1%) and 24(96.2%) in comparison to the combination of SOF/DAC regimen at week 4 of treatment (100%), at the end of treatment (96.7%) and post treatment at week 12(96.5%) and 24(100%), but there was statistically significant increase in number of Relapsers who received SOF/SMV regimen (10%). There was highly statistically significant decrease in FIB-4 score in the responders of group-1 in comparison to the responders of group-2 before and post treatment (p<0.0001). The commonest adverse effects for both regimens were fatigue, headache and nausea, while with regimen SOF/SMV showed transient elevation of total bilirubin and cutaneous rash with prolonged exposure to sun. Conclusion: The oral regimen of SOF/SMV combination and SOF/DAC once daily for 12 weeks are an effective and well tolerated regimen and associated with high rate of sustained virological response (SVR) in na?ve patients with different stages of fibrosis. The regimen of SOF/DAC has lower relapse rate than the regimen of SOF/SMV. The Fib-4 score was significantly decreased at week 24 post treatment in patients who received the regimen SOF/SMV.