Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12),
 safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335,
 odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected
 subjects without cirrhosis.
This is a Phase 2b multicenter study. The study will include a screening period of maximum 6
 weeks, a treatment period of 6 or 8 weeks and a 24-weeks post-treatment follow-up period. The
 total study duration for each subject will be 36 to 38 weeks. This study investigates a 3
 direct-acting antiviral agent (DAA) combination of AL-335 (HCV NS5B inhibitor), odalasvir
 (ODV) (a second generation HCV NS5A inhibitor) and simeprevir (SMV) (HCV NS3A4 protease
 inhibitor). The results of this study will enable the selection of treatment and duration to
 be further developed.
Inclusion Criteria:

 -  Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection

 -  Documented as treatment naive or experienced with a prior regimen consisting of
 Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response

 -  Absence of cirrhosis

 -  Screening laboratory values within defined thresholds

 -  Must use specific contraceptive methods if female of childbearing potential or
 sexually active male

 Exclusion Criteria:

 -  Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)

 -  Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination
 with pegylated interferon (PegIFN) or IFN-free

 -  Current or prior history of clinical hepatic decompensation

 -  History of clinically significant illness or any other medical disorder including
 cardiovascular conditions that may interfere with individual's treatment, assessment
 or compliance with the protocol

 -  Pregnant or a nursing female