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

Sponsor

Lisa Barrett (Other)

Overall Status

Unknown status

CT.gov ID

NCT02460133

Collaborator

PEI Provincial Correction Centre (Other)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

This pilot study is crucial to determining whether treating individuals who are at high risk for transmission or re-infection will impact HCV reinfection rates. It will establish the feasibility of DAA treatment in corrections facilities, as well as delineate the underlying immune basis of HCV cure and reinfection.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus	Drug: Paritaprevir Drug: Ritonavir Drug: Dasabuvir Drug: Ombitasvir Drug: Ribavirin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment: A Pilot Project

Study Start Date :

Jul 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: HCV Genotype 1, with and without cirrhosis	Drug: Paritaprevir Drug: Ritonavir Drug: Dasabuvir Drug: Ombitasvir Drug: Ribavirin In genotype 1b individuals without cirrhosis, treatment will NOT include ribavirin.

Arm

Intervention/Treatment

Other: HCV Genotype 1, with and without cirrhosis

Drug: Paritaprevir

Drug: Ritonavir

Drug: Dasabuvir

Drug: Ombitasvir

Drug: Ribavirin

In genotype 1b individuals without cirrhosis, treatment will NOT include ribavirin.

Outcome Measures

Primary Outcome Measures

Re-infection rate in individuals treated with DAA therapy [1 year following treatment.]
This will require HCV quasispecies determination at baseline and in potentially re-infected individuals. Re-infection will require demonstration of HCV RNA above level of detection after SVR12 with a phyogenetically distinct HCV species.

Secondary Outcome Measures

Percentage of subjects with sustained virologic response at 12 weeks post treatment [12 Weeks post treatment]
Change in fibrosis measured by transient elastography [From day 0 to the end of follow-up]
Global and HCV-specific T cell function before and after treatment with DAA therapy. [From day 0 to end of follow-up]
Global and HCV-specific B cell function before and after treatment with DAA therapy. [From day 0 to end of follow-up]
Global and HCV-specific NK cell function before and after treatment with DAA therapy. [From day 0 to end of follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Lisa Barrett
PEI Provincial Correction Centre

Investigators

Principal Investigator: Lisa Barrett, MD PhD FRCPC, Department of Medicine, Division of Infectious Diseases, Nova Scotia Health Authority, Dalhousie University