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Abstract Hepatitis C virus (HCV) infection is a serious healthcare problem with a wide prevalence of over 184 million people worldwide. It causes several progressive complications such as liver fibrosis, liver cirrhosis, and hepatocellular carcinoma leading to approximately 350,000 deaths every year. Egypt has the highest prevalence of HCV infection where 15 % of its population are infected. Hepatitis C virus (HCV) genotypes 4, 5 and 6 represent >20% of all HCV cases worldwide and have been the center of attention of most clinical trials. On the other hand, HCV‐4 is mainly seen in Egypt and represents more than 90 % of all HCV cases. Although some useful data are available for HCV‐4, many issues still need to be clarified and need further investigation. Chronic hepatitis C treatment have changed dramatically with development of sofosbuvir which is so far considered the most promising DAAs, that has been positioned as the backbone of several antiviral treatment regimens. The pan genotypic efficacy, and favorable safety profile of sofosbuvir make it an ideal drug for several CHC treatment regimens, however, each regimen limiting factor is the other combined drug potency and tolerability. One hundred non cirrhotic treatment naïve patients (70 females, 30 males) with confirmed CHC genotype 4 infection were recruited from hepatology clinic at Beni suef general hospital. Patients were randomly allocated into two treatment groups that either received a 12 weeks treatment of once daily oral dose of sofosbuvir 400 mg plus daclatasvir 60 mg or fixed-dose combination tablet of sofosbuvir 400 mg and ledipasvir 90 mg. The primary end point aimed to evaluate the efficacy of each treatment regimen by determining the sustained virological response 12 weeks post treatment (SVR12) (HCV RNA < LLOQ). Relapse is identified by confirmed HCV RNA ≥ LLOQ post treatment after first achieving HCV RNA <LLOQ at the end of treatment by quantitative polymerase chain reaction (PCR) for HCV RNA. The secondary endpoint aimed to evaluate the safety profile of each treatment regimen through assessing clinical laboratory tests and any reported adverse effects from the first dose administration till 30 days after the last dose. The study showed non-significant SVR12 was achieved by 98% and 96% of patients receiving sofosbuvir plus ledipasvir and sofosbuvir plus daclatasvir, respectively. In addition, both treatments were well tolerated and did not develop any severe side effects that may lead to therapy discontinuation. |