ATTIC - Access To Treat in the Community

NCT03797066 | Terminated Phase 4

• 1 other identifier: KCHATTIC01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C, Chronic

Keywords

hepatitis C virus; homeless

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (6)

• prevalence of HCV infection

  24 months

• Baseline knowledge evaluation

  24 months

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

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

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

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

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

  12 or 16 weeks

Study Arms (1)

Single arm

OTHER

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.

Drug: ZEPATIER 50Mg-100Mg Tablet

Interventions

ZEPATIER 50Mg-100Mg Tablet DRUG

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.

Single arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Merck Sharp & Dohme LLC: collaborator
• Hepatitis C Trust: collaborator

Study Sites (1)

Kings College Hospital NHS Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Model Details: non-randomised, open label

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: January 8, 2019
• Study Start: March 23, 2019
• Primary Completion: July 28, 2020
• Study Completion: November 30, 2020
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)