Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

An offender at the PEI Provincial Correction Centre during the enrollment time
Male, 18 -70 years of age, inclusive, at time of screening
Chronic HCV genotype 1 infection
HCV infection, as demonstrated by positive HCV immunosorbant assay and detectable HCV viral load
No evidence of decompensated liver disease (refractory ascites, variceal bleed within 1 year, active hepatic encephalopathy or Child-Pugh score greater than 6)
HIV negative

Males must be abstinent from sexual intercourse, surgically sterile or agree to practice two effective forms of birth control from those listed below, throughout the course of the study, starting with Study Day 1 and for 7 months after the last dose of study drug (or per local RBV label):

Partner(s) using an IUD (intrauterine device),
Partner(s) using oral, injected, or implanted methods of hormonal contraceptives,
Subject and/or partner(s) using condoms, contraceptive sponge, or diaphragm with spermicidal jellies or creams.
Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements
Must voluntarily sign and date an informed consent form, approved by a Research Ethics Board prior to the initiation of any screening or study specific procedures

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.