ATTIC - Access To Treat In the Community

Localized on site testing and treatment of hepatitis C in homeless persons in 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 - ATTIC - Access To Treat in the Community

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002251-14-GB

Enrollment

150

Registered

2018-11-05

Start date

2019-01-02

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatitis C viral infection MedDRA version: 20.0 Level: LLT Classification code 10008914 Term: Chronic hepatitis C without mention of hepatic coma System Organ Class: 100000004862

Interventions

Trade Name: Zepatier Product Name: Zepatier Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Elbasvir CAS Number: 1370468-36-2 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants 18 years or older 2. Infected with genotype 1a, 1b or 4 HCV identified on screening 3. Able and willing to provide written informed consent. 4. Both interferon treatment naive and experienced participants will be included. 5. Participants without cirrhosis will be eligible if HCV RNA positive, documented chronic hepatitis C and a FibroScan of = 12.5. 6. 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 =65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

Exclusion criteria: 1. Persons with prior HCV DAA treatment will be excluded. 2. 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 3. Participants with active TB infection will be excluded. 4. Refusal to practice effective contraception.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To evaluate the percentage of patients achieving sustained virological response (SVR 12), assessed by the percentage of participants achieving SVR [defined as HCV RNA <lower limit of quantification when tested by sensitive polymerase chain reaction (PCR)] 12 weeks after the end of all study therapy of the fixed dose combination of elbasvir and grazoprevir; given for 12 or 16 weeks in homeless persons with hepatitis C. 2. To demonstrate the suitability of immediate diagnosis of infectious and progressive hepatitis C in homeless shelters; by directly testing for HCV RNA and concurrent staging of the liver disease by transient elastography (fibroscan) and APRI testing (AST to platelet ratio index). ;Secondary Objective: 1. To demonstrate the comparable safety to other DAA treated populations 2. To reduce the viraemic interval in infected homeless persons by introducing a short, directed testing-to-treatment pathway – to virological cure (SVR). 3. To evaluate the safety and efficacy of this regimen in homeless participants with hepatitis C many of whom will be using drugs of potential abuse or will be on Opioid Substitution 4. To reduce the prevalence of viraemic hepatitis C, after a pilot trial of treatment in three to four homeless hostels (depending upon recruitment). 5. To evaluate participant knowledge of their hepatitis C status and willingness to engage in a test and treat protocol and to correlate the findings with demographic and sociological data;Primary end point(s): The primary outcome will be the percentage of participants achieving an SVR, defined as an HCV RNA level less than the lower limit of quantification by sensitive PCR; by means of a short directed test and treat program in the homeless community. ;Timepoint(s) of evaluation of this end point: Evaluation will be done at end of study (end of all clinical interventions as specified in the protocol)	—

Measure

Time frame

Main Objective: 1. To evaluate the percentage of patients achieving sustained virological response (SVR 12), assessed by the percentage of participants achieving SVR [defined as HCV RNA <lower limit of quantification when tested by sensitive polymerase chain reaction (PCR)] 12 weeks after the end of all study therapy of the fixed dose combination of elbasvir and grazoprevir; given for 12 or 16 weeks in homeless persons with hepatitis C. 2. To demonstrate the suitability of immediate diagnosis of infectious and progressive hepatitis C in homeless shelters; by directly testing for HCV RNA and concurrent staging of the liver disease by transient elastography (fibroscan) and APRI testing (AST to platelet ratio index). ;Secondary Objective: 1. To demonstrate the comparable safety to other DAA treated populations 2. To reduce the viraemic interval in infected homeless persons by introducing a short, directed testing-to-treatment pathway – to virological cure (SVR). 3. To evaluate the safety and efficacy of this regimen in homeless participants with hepatitis C many of whom will be using drugs of potential abuse or will be on Opioid Substitution 4. To reduce the prevalence of viraemic hepatitis C, after a pilot trial of treatment in three to four homeless hostels (depending upon recruitment). 5. To evaluate participant knowledge of their hepatitis C status and willingness to engage in a test and treat protocol and to correlate the findings with demographic and sociological data;Primary end point(s): The primary outcome will be the percentage of participants achieving an SVR, defined as an HCV RNA level less than the lower limit of quantification by sensitive PCR; by means of a short directed test and treat program in the homeless community. ;Timepoint(s) of evaluation of this end point: Evaluation will be done at end of study (end of all clinical interventions as specified in the protocol)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Reduction in local prevalence of of viraemic hepatitis C, after a pilot trial of treatment in three to four homeless hostels. 2. Participant knowledge of their hepatitis C status and willingness to engage in a test and treat protocol and correlation of these findings with demographic and sociological data. 3. Impact of a localized test and treat protocol on health related quality of life. ;Timepoint(s) of evaluation of this end point: Evaluation will be done at end of study (end of all clinical interventions as specified in the protocol)	—

Measure

Time frame

Secondary end point(s): 1. Reduction in local prevalence of of viraemic hepatitis C, after a pilot trial of treatment in three to four homeless hostels. 2. Participant knowledge of their hepatitis C status and willingness to engage in a test and treat protocol and correlation of these findings with demographic and sociological data. 3. Impact of a localized test and treat protocol on health related quality of life. ;Timepoint(s) of evaluation of this end point: Evaluation will be done at end of study (end of all clinical interventions as specified in the protocol)

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Countries

United Kingdom

Contacts

Public ContactLiver Research Office

King's College Hospital NHS Foundation Trust

kosh.agarwal@nhs.net02032992038

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026