Title:Comparative Real Life Egyptian Experience of the Combination of Sofosbuvir
Plus Daclatasvir or Simeprevir for 12 Weeks in Naïve Cirrhotic Patients
Infected with HCV Genotype 4
Volume: 18
Issue: 2
Author(s): Sayed Ahmed, Essam Hassan, Ahmed Gomaa, Gamal Esamat, Ahmed Ramadan, Manar Ahmed, Aya Elsayed and Engy A. Wahsh*
Affiliation:
- Department of Clinical Pharmacy, Faculty of Pharmacy, October 6 University, Giza 12573, Egypt
Keywords:
Hepatitis C virus, sofosbuvir, daclatasvir, simeprevir, ribavirin, genotype-4.
Abstract:
Background: Chronic infection with HCV is progressive worldwide health problem and
the core reason for liver cirrhosis, portal hypertension, or hepatocellular carcinoma. HCV-G4 represents
the most common threat to transplantation of the liver in Egypt. New interferon-free regimens
have been started consuming direct-acting antiviral oral tablets for HCV cure.
Objectives: In the current study, comparing the safety and efficacy of DAAs combination regimens
including sofosbuvir with daclatasvir or sofosbuvir with simeprevir plus ribavirin for naïve cirrhotic
Egyptian patients infected with HCV-G4 was our main goal.
Methods: We recruited 150 naïve cirrhotic HCV patients from the Tropical patients’ clinic at Fayoum
General Hospital. They were classified randomly into two groups, group one (n=75 patients)
were administrated Sofosbuvir plus simeprevir (400 mg and 150 mg once daily respectively ) for
twelve weeks, and group two (n=75 patients) were administrated Sofosbuvir plus Daclatasvir (400
mg and 60 mg once daily respectively) with ribavirin (1-1.2 gm daily weight-based) for twelve
weeks. Clinical follow-up, laboratory investigations, and viral PCR were measured to detect treatment
efficacy, safety, and any adverse events.
Results: Sustained virological response rates (SVR12) were 92%and 90.7% in the first and second
groups, respectively. The major unfavorable events were fatigue, arthralgia, and weight loss without
statistically meaningful differences between study groups. However, anemia and headache
were significantly widespread in the second group (P=0.0161 and 0.0495, respectively). We observed
four patients with photosensitivity in group I and not observed in the second group.
Conclusion: The current study revealed that DAAs are safe and effective in the cure of naïve cirrhotic
patients chronically infected by HCV-G4 with better results in those treated with sofosbuvir
plus simeprevir regimen.
