Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection
Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection
This study will look at the safety and efficacy of 8 week and 12 week treatment with
 Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic
 hepatitis C genotype 4.
Patients with confirmed absence of cirrhosis will receive 8 weeks of treatment with
 Sofosbuvir and Simeprevir. Patients with confirmed presence of cirrhosis will receive 12
 weeks of treatment with Sofosbuvir and Simeprevir. All patients will followed for 24 weeks
 post-treatment. Presence or absence of cirrhosis will be evaluated by FibroScan if no
 historical liver biopsy or FibroScan is available.
Inclusion Criteria:

 -  HCV genotype 4 infection

 -  HCV RNA >10,000 IU/mL at screening.

 Exclusion Criteria:

 -  Evidence of clinical hepatic decompensation (history or current evidence of ascites,
 bleeding varices or hepatic encephalopathy).

 -  Any liver disease of non-HCV etiology. This includes, but is not limited to, acute
 hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis,
 hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic
 steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease
 considered clinically significant by the investigator.

 -  Infection/co-infection with HCV non-genotype 4.

 -  Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2)
 (positive HIV-1 or HIV-2 antibodies test at screening).

 -  Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen [HBsAg] positive).

 -  Presence of significant co-morbidities or conditions that would compromise the
 subject's safety and could interfere with the subject's participation for the full
 duration of the study in the opinion of the investigator

 -  Previously been treated with any direct acting anti-HCV agent (approved or
 investigational) for chronic HCV infection.