Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment

Exclusion Criteria

• •History of severe, life-threatening or other significant sensitivity to any drug
• •Positive test result at screening for Hepatitis B surface antigen
• •Prior therapy with direct acting antivirals for the treatment of HCV
• •Evidence of decompensated liver disease (current or past refractory ascites, variceal bleed within 1 year, active hepatic encephalopathy)
• •HIV positive screening test
• •Unwilling to follow up for 48 weeks after treatment completion
• •Use of any herbal supplements (including milk thistle) within 2 weeks or 10 half-lives of the respective supplement, whichever is longer, prior to the first dose of study drug
• •HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype
• •Use of any medications contraindicated for use with the study regimen
• •Clinically significant abnormalities, other than HCV-infection, based upon the results of a medical history, physical examination, vital signs, and laboratory profile that make the subject an unsuitable candidate for this study in the opinion of the investigator
• •Serum Alpha-Fetoprotein (AFP) \> 200 ng/mL at screening
• •Any cause of liver disease other than chronic HCV-infection, including but not limited to the following:
• •* Hemochromatosis
• •* Alpha-1 antitrypsin deficiency
• •* Wilson's disease
• •* Autoimmune hepatitis
• •* Alcoholic liver disease
• •* Nonalcoholic steatohepatitis
• •* Drug-related liver disease
• •Screening laboratory analyses showing any of the following abnormal laboratory results:
• •* ALT \> 5 × upper limit of normal (ULN)
• •* Aspartate aminotransferase (AST) \> 5 × ULN
• •* Calculated creatinine clearance (using Cockcroft-Gault method) \< 60 mL/min
• •* Albumin 25 g/L
• •* Prothrombin time/International normalized ratio (INR) \> 2.3.
• •* Hemoglobin \< LLN
• •* Platelets \< 60,000 cells per mm3
• •* Absolute neutrophil count (ANC) \< 1500 cells/μL
• •* Total bilirubin ≥ 51 umol/L
• •History of solid organ transplantation.
• •Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 6 weeks prior to study drug administration.
• •Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive paritaprevir, dasabuvir, ombitasvir, ritonavir and/or RBV.
• •Current enrollment in another clinical study, prior enrollment in this study, or previous exposure to paritaprevir, ombitasvir, or dasabuvir. Concurrent participation in a non-interventional, epidemiologic or registry trials may be permitted with approval of the principal investigator.
• •The use of colony stimulating factors, such as granulocyte colony stimulating factor (GCSF) or erythropoietin within 2 months of the screening period.
• •Uncontrolled clinically significant cardiac, respiratory (except mild asthma), hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness, which is unrelated to the hepatic disease.