ATTIC - Access To Treat in the Community

  • STATUS
    Recruiting
  • days left to enroll
    20
  • participants needed
    150
  • sponsor
    King's College Hospital NHS Trust
Updated on 24 January 2021
interferon
cirrhosis
fibroscan
chronic hepatitis
hepatic decompensation
apri
chronic hepatitis c genotype 1

Summary

The study is looking at the potential of utilizing a "point of care" test and treat pathway; using the DDA called Zepatier for achieving SVR in an homeless population who have tested positive for genotype 1 or 4 HCV.

Description

Direct acting antivirals (DAA) are new medications that have been approved for the management of HCV. These drugs have proven to be very effective in curing the HCV, without the need for interferon injections which have always been used in the past. There are many combinations of DAAs, which treat specific types of HCV. Persons who test positive for the virus are typically referred to be seen and treated by a specialist hepatitis service based in hospital. This means that individuals may sometimes not attend the hospital to commence treatment or follow up on their management.

The study is designed to explore if testing and treating individuals close to their own "local" setting will be an improvement to the current treatment pathway and encourage better involvement with the health care team as well as looking at what the health care team can do to ensure participants in this test-and-treat trial receive the entire course of drug treatment prescribed to treat their HCV infection.

Participants infected with either genotype 1 or 4 HCV infection will be treated with Zepatier, a DAA which works by stopping the hepatitis C virus from (multiplying). The study medication is taken for 12 or 16 weeks depending on the genotype (or strain of HCV). Some participants will be given an additional drug called ribavirin. The study will examine the effectiveness of Zepatier at clearing the hepatitis C virus from the blood and body and also what particular effects may be experienced by participants who may also be taking treatment for other conditions. Participants affected with other genotypes (not 1 and 4)will be offered standard NHS treatment with the appropriate antiviral combination for these strains.

Details
Condition Chronic viral hepatitis C
Treatment ZEPATIER 50Mg-100Mg Tablet
Clinical Study IdentifierNCT03797066
SponsorKing's College Hospital NHS Trust
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 90 yrs?
Gender: Male or Female
Do you have Chronic viral hepatitis C?
Do you have any of these conditions: Do you have Chronic viral hepatitis C??
Participants 18 years or older with chronic hepatitis C genotype 1 or 4 will be eligible
Able and wiling to provide written informed consent
Both interferon treatment nave and experienced participants will be included
Participants without cirrhosis will be eligible if HCV RNA positive, documented chronic hepatitis C and a FibroScan of 12.5
Participants with cirrhosis (Fibroscan > 12.5 or APRI > 2) will be eligible if the serum albumin is > 3.5 g/dl, platelets > 100,000 and INR < 1.5 and there is no prior history of hepatic decompensation
Participants with well controlled HIV coinfection will be included, but should be stabilized on antiretrovirals for which no clinically significant interaction is expected
Participants who are HBsAg positive will be included, but will require antiviral prophylaxis for HepB. Anti- HbC positive participants will be included. Prophylaxis will not be given, but these participants will require careful monitoring of their ALT levels

Exclusion Criteria

Persons with prior HCV DAA treatment
Individuals younger than 18 years of age
Individuals infected with genotypes other than 1a or 1b or 4 HCV identified on screening; however such participants identified on screening will be offered appropriate NHS England standard of treatment for the genotype
Unable or unwilling to give informed consent
Active tuberculosis
Females who are pregnant, planning pregnancy or breastfeeding
Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within three months of study enrolment
Clinically-significant medical or psychiatric illness (other than chronic HCV) in the past, present, or being evaluated, that may interfere with participant treatment, safety, assessment or compliance with the protocol
Participants with cirrhosis (Fibroscan > 12.5 or APRI > 2) and serum albumin is < 3.5 g/dl, platelets <100,000 and INR > 1.5 or a prior history of hepatic decompensation
Severe renal impairment with eGFR <30 mL/min/1.73m2 or requiring dialysis
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