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

Hepatitis C Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02460133
• Other study ID #: SAIL-001
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: October 2023

Study information

• Verified date: February 2023
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus

Intervention

Drug:
• Paritaprevir

• Ritonavir

• Dasabuvir

• Ombitasvir

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lisa Barrett	PEI Provincial Correction Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of subjects with sustained virologic response at 12 weeks post treatment		12 Weeks post treatment
Secondary	Change in fibrosis measured by transient elastography		From day 0 to the end of follow-up
Secondary	Global and HCV-specific T cell function before and after treatment with DAA therapy.		From day 0 to end of follow-up
Secondary	Global and HCV-specific B cell function before and after treatment with DAA therapy.		From day 0 to end of follow-up
Secondary	Global and HCV-specific NK cell function before and after treatment with DAA therapy.		From day 0 to end of follow-up