Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection

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.