Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection
This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir
 (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis
 C virus (HCV) infection as measured by the proportion of subjects with sustained virologic
 response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after
 discontinuation of therapy.
Inclusion Criteria:

 -  HCV RNA ≥ 10^4 IU/mL at screening

 -  Chronic genotype 4 or 5 HCV Infection

 -  Individuals may be treatment naive or treatment experienced

 -  Presence or absence of cirrhosis, a liver biopsy may be required

 -  Healthy according to medical history and physical examination with the exception of
 HCV diagnosis

 -  Agree to use two forms of highly effective contraception for the duration of the study

 Exclusion Criteria:

 -  History or current evidence of any condition, therapy, laboratory abnormality or other
 circumstance that might confound the results of the study, or interfere with the
 individual's participation for the full duration of the study or not be in the best
 interest of the individual in the opinion of the investigator

 -  Prior exposure to approved or experimental HCV specific direct acting antiviral(s)
 (DAA) other than NS3/4A protease inhibitors

 -  History of any other clinically significant chronic liver disease

 -  Evidence of or history of decompensated liver disease

 -  HIV or chronic hepatitis B (HBV) infection

 -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
 skin cancers)

 -  Chronic use of immunosuppressive agents or immunomodulatory agents