Background: Chronic Hepatitis C (CHC) is a common progressive healthcare challenge
that leads to liver cirrhosis, liver failure, and hepatocellular carcinoma. The optimum therapy was
a combination of pegylated interferon and ribavirin, which was associated with moderate response
and severe side effects. Sofosbuvir revolutionized CHC treatment, especially in combination with
other antiviral agents.
Objective: The aim of this study was to compare and evaluate the safety and efficacy of sofosbuvir/
daclatasvir versus sofosbuvir/ledipasvir for the treatment of non-cirrhotic naïve patients with
chronic Hepatitis C Virus (HCV) genotype 4 infection for 12 weeks.
Methods: One hundred CHC genotype 4 patients (70 females, 30 males) were recruited from the
hepatology clinic at the Beni-Suef general hospital. Patients were randomly allocated into two
groups that received a 12 weeks treatment of either sofosbuvir 400 mg/daclatasvir 60 mg or sofosbuvir
400 mg/ledipasvir 90 mg. The sustained virological response 12 weeks post-treatment
(SVR12) (HCV RNA < Lower Limit of Quantification (LLOQ)) was determined to evaluate efficacy.
The clinical laboratory tests and any reported adverse effects starting from the administration
of the first dose till 30 days after the last dose were assessed to evaluate safety.
The main outcome measure was the assessment of the safety, efficacy and compliance of sofosbuvir/
daclatasvir versus sofosbuvir/ledipasvir for the treatment of non-cirrhotic naïve CHC genotype
4 patients for 12 weeks.
Results: SVR12 was achieved by 98% and 96% of patients receiving sofosbuvir plus ledipasvir
and sofosbuvir plus daclatasvir, respectively. The most common adverse events reported were
headache, and fatigue. No patients discontinued treatment due to adverse events.
Conclusion: The findings from this study suggest that the 12 weeks treatment regimens of sofosbuvir
plus daclatasvir and sofosbuvir plus ledipasvir were both efficacious and well-tolerated in
patients with HCV genotype 4 infection.
Impact on Practice: In this paper, we report on the most recent approaches in the treatment of
Hepatitis C genotype 4 patients in Egypt. This is significant because this article focuses on comparing
the efficacy and tolerability of the most commonly used antiviral drugs in Egypt.