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ATTIC - Access To Treat in the Community (ATTIC)

Primary Purpose

Hepatitis C, Chronic

Status

Terminated

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

ZEPATIER 50Mg-100Mg Tablet

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring hepatitis C virus, homeless

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 naïve 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

Sites / Locations

Kings College Hospital NHS Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

A phase 4, open label, non-randomised study, conducted in hostels and homeless shelters in London; as well as mobile clinics in collaboration with the Hep C trust and the NHS Find and Treat program. Treatment: 12 or 16 weeks of Zepatier, based on genotypes; with Ribavarin for certain subtypes. The study drug is administered as a single tablet; which is a combination of 100 mg of grazoprevir and 50 mg of elbasvir; as outlined below: Genotypes 1a/b and 4: once daily dose for 12 weeks, taken with / without food. Genotype 1a and 4: (HCV RNA> 800,000 iu/ml or baseline NS5A resistance): once daily dose for 16 weeks, taken with / without food. NO dose modifications with the study drug.

Outcomes

Primary Outcome Measures

SVR

The percentage of participants achieving an SVR, defined as an HCV RNA evel less than the lower limit of quantification by sensitive PCR; by means of a short directed test and treat program in the homeless community.

Secondary Outcome Measures

prevalence of HCV infection

Reduction in local prevalence of of viraemic hepatitis C, after a pilot trial of treatment in three to four homeless hostels.

Baseline knowledge evaluation

Participant knowledge of their hepatitis C status (disease, diagnosis, and current available approved treatments) will be assessed by means of a questionnaire completed at baseline. The researchers will also review participants willingness to engage in a test and treat protocol and correlate these findings with demographic and sociological data. This will be done using a questionnaire designed by the researchers; containing simple questions with respect to currently available testing and treatment of HCV infection.

Change From Baseline (BL) to SVR12 timepoint in 36-Item Short-Form Health Survey (SF-36) Scores

The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. The survey addresses eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Data will be analysed ffg the guidelines suggested by the developers https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html

Change From Baseline (BL) to SVR 12 in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)

Impact of a localized test and treat protocol on health related quality of life will be assessed using the CLDQ-HCV instruments. The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life

Percentage of Participants Who Were Compliant With Treatment According To Moriskey, Green And Levine Adherence Scale (MAS4)(Subset Analysis)

Adherence to treatment measured by Moriskey, Green and Levine Adherence scale. This is a 4 item questionnaire that is easy to administer and score (using a yes/no format); and quickly identifies barriers to adherence.An answer of yes to zero questions indicates high adherence behavior, answering yes to one or two questions indicates medium adherence behavior, and answering yes to three or four questions indicates low adherence behavior

Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)

Compliance will be calculated as the amount of dispensed medication minus the amount of medication returned by participants at each visit.

Full Information

NCT ID

NCT03797066

First Posted

October 30, 2018

Last Updated

May 2, 2023

Sponsor

King's College Hospital NHS Trust

Collaborators

Merck Sharp & Dohme LLC, Hepatitis C Trust

1. Study Identification

Unique Protocol Identification Number

NCT03797066

Brief Title

ATTIC - Access To Treat in the Community

Acronym

ATTIC

Official Title

Localized on -Site Testing and Treatment of Hepatitis C in Homeless Persons in South London: a Pilot Non-randomised Phase 4 Interventional Clinical Trial of Grazoprevir and Elbasvir ± Ribavirin in Participants With Genotype 1a, 1b or 4 to Measure Efficacy and Adherence to Treatment in a Homeless Population

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

Changing parameters in HCV management, resulted in poor recruitment; additionally onset of SARS CoV2 resulted in the cessation of all mobile clinical services.

Study Start Date

March 23, 2019 (Actual)

Primary Completion Date

July 28, 2020 (Actual)

Study Completion Date

November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

King's College Hospital NHS Trust

Collaborators

Merck Sharp & Dohme LLC, Hepatitis C Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

Keywords

hepatitis C virus, homeless

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

non-randomised, open label

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

ZEPATIER 50Mg-100Mg Tablet

Intervention Description

Zepatier 50/100 OD , with addition of Ribavarin in patients with Genotype 1a and 4 with HCV RNA> 800,000 iu/ml or baseline NS5A resistance.

Primary Outcome Measure Information:

Title

SVR

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

prevalence of HCV infection

Description

Reduction in local prevalence of of viraemic hepatitis C, after a pilot trial of treatment in three to four homeless hostels.

Time Frame

24 months

Title

Baseline knowledge evaluation

Description

Time Frame

24 months

Title

Change From Baseline (BL) to SVR12 timepoint in 36-Item Short-Form Health Survey (SF-36) Scores

Description

Time Frame

baseline, SVR 12 (twelve weeks post end of active treatment/ last dose of study drug)

Title

Change From Baseline (BL) to SVR 12 in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)

Description

Time Frame

baseline , SVR 12 (twelve weeks post end of active treatment/last dose of study drug)

Title

Percentage of Participants Who Were Compliant With Treatment According To Moriskey, Green And Levine Adherence Scale (MAS4)(Subset Analysis)

Description

Time Frame

12 or 16 weeks

Title

Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)

Description

Compliance will be calculated as the amount of dispensed medication minus the amount of medication returned by participants at each visit.

Time Frame

12 or 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 naïve 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

Facility Information:

Facility Name

Kings College Hospital NHS Trust

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

anonymised data sharing only, via publications

Learn more about this trial

ATTIC - Access To Treat in the Community

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