Background & Aims: Treatment plan of chronic HCV infection has dramatically improved
after the introduction of different groups of Direct-Acting Antiviral (DAA) drugs. These
drugs have been found to be safe and effective. Sofosbuvir (SOF) plus simeprevir (SMV) regimen
has been shown to be tolerable and effective in treatment of patients with HCV genotype 1. The
aim of the study was to evaluate the safety and the efficacy of combined sofosbuvir plus simeprevir
treatment in genotype 4 chronic HCV patients.
Methods: This open-label multicenter prospective study was carried out on 381 Egyptian patients
with chronic hepatitis C virus- infection. Treatment experienced and treatment-naive patients were
included. Subjects administrated a regimen of sofosbuvir (400 mg/ day) plus semiprevir (150 mg
/day) for twelve weeks. Sustained Virological Response (SVR) was confirmed by undetectable
HCV RNA by quantitative PCR 3 months after the end of the treatment.
Results: 97.6% (372 /381) of patients had SVR. None of the studied clinical and demographic
characteristics were associated with the SVR status. However, patients who failed to achieve SVR
showed low albumin level and high total leucocyte. The most common side effects of the studied
regimen were headache, fatigue, itching, photosensitivity, and cough.
Conclusions: Twelve weeks’ regimen of sofosbuvir plus simeprevir was considered to be safe and
tolerable in the treatment of HCV genotype 4; also it was associated with high SVR (97.6%).