Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4.
OBJECTIVE
Egypt has the highest prevalence of chronic hepatitis C virus (HCV) infection in the world, and more than 90% of patients are infected with genotype 4 virus. We evaluated the efficacy and safety of the HCV polymerase inhibitor sofosbuvir in combination with ribavirin in HCV genotype 4 patients in Egypt.


METHODS
Treatment-naïve or treatment-experienced patients with genotype 4 HCV infection (n=103) were randomly assigned to receive either 12 or 24 weeks of sofosbuvir 400 mg and ribavirin 1000-1200 mg daily. Randomization was stratified by prior treatment experience and by presence or absence of cirrhosis. The primary endpoint was the percentage of patients with HCV RNA <25 IU/ml 12 weeks after therapy (SVR12).


RESULTS
Among all patients, 52% had received prior HCV treatment and 17% had cirrhosis at baseline. SVR12 rates were 90% (46/51) with 24 weeks and 77% (40/52) with 12 weeks of sofosbuvir and ribavirin therapy. Patients with cirrhosis at baseline had lower rates of SVR12 (63% 12 weeks, 78% 24 weeks) than those without cirrhosis (80% 12 weeks, 93% 24 weeks). The most common adverse events were fatigue, headache, insomnia, and anemia. Two patients experienced serious adverse events (cerebral ischemia, dyspnea). No adverse events resulted in treatment discontinuation.


CONCLUSIONS
Sofosbuvir plus ribavirin for 12 or 24 weeks is effective in treating both treatment-naïve and treatment-experienced Egyptian patients with genotype 4 HCV.
National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.
Wahid
W
Doss
Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt. Electronic address: g_shiha@hotmail.com.
Gamal
G
Shiha
National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.
Mohamed
M
Hassany
Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt.
Reham
R
Soliman
University of Cairo, Cairo, Egypt.
Rabab
R
Fouad
University of Cairo, Cairo, Egypt.
Marwa
M
Khairy
Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt.
Waleed
W
Samir
National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.
Radi
R
Hammad
Gilead Sciences, Inc., Foster City, CA, United States.
Kathryn
K
Kersey
Gilead Sciences, Inc., Foster City, CA, United States.
Deyuan
D
Jiang
Gilead Sciences, Inc., Foster City, CA, United States.
Brian
B
Doehle
Gilead Sciences, Inc., Foster City, CA, United States.
Steven J
SJ
Knox
Gilead Sciences, Inc., Foster City, CA, United States.
Benedetta
B
Massetto
Gilead Sciences, Inc., Foster City, CA, United States.
John G
JG
McHutchison
University of Cairo, Cairo, Egypt.
Gamal
G
Esmat
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D000069474:Sofosbuvir / Q000008:administration & dosage* / Q000009:adverse effects
D000998:Antiviral Agents; D012254:Ribavirin; D000069474:Sofosbuvir
Antiviral agents; Egypt; Genotype 4; Hepatitis C; Polymerase inhibitor; Sofosbuvir