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

NCT02460133 | Active Not Recruiting Phase 4

• 1 other identifier: SAIL-001
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

• Re-infection rate in individuals treated with DAA therapy

  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.

  1 year following treatment.

Secondary Outcomes (5)

• 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

Study Arms (1)

HCV Genotype 1, with and without cirrhosis

OTHER

Drug: Paritaprevir; Drug: Ritonavir; Drug: Dasabuvir; Drug: Ombitasvir; Drug: Ribavirin

Interventions

Paritaprevir DRUG

HCV Genotype 1, with and without cirrhosis

Ritonavir DRUG

HCV Genotype 1, with and without cirrhosis

Dasabuvir DRUG

HCV Genotype 1, with and without cirrhosis

Ombitasvir DRUG

HCV Genotype 1, with and without cirrhosis

Ribavirin DRUG

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

HCV Genotype 1, with and without cirrhosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Provincial Correction Centre (PEI): collaborator

MeSH Terms

Conditions

Hepatitis C

Interventions

paritaprevir; Ritonavir; dasabuvir; ombitasvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Lisa Barrett, MD PhD FRCPC

  Department of Medicine, Division of Infectious Diseases, Nova Scotia Health Authority, Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: June 2, 2015
• Study Start: July 10, 2015
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08