Clinical trial NCT03797066: ATTIC - Access To Treat in the Community
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C virus
homeless
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Hepatitis C Trust
First posted: 2019-01-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: non-randomised, open label
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Participants 18 years or older with chronic hepatitis C genotype 1 or 4 will be eligible.
2. Able and wiling to provide written informed consent.
3. Both interferon treatment naïve and experienced participants will be included.
4. Participants without cirrhosis will be eligible if HCV RNA positive, documented chronic hepatitis C and a FibroScan of ≤ 12.5.
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.
6. Participants with well controlled HIV coinfection will be included, but should be stabilized on antiretrovirals for which no clinically significant interaction is expected.
7. 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

Primary outcomes:
measure: SVR
timeFrame: 24 months
Secondary outcomes:
measure: prevalence of HCV infection
timeFrame: 24 months
measure: Baseline knowledge evaluation
timeFrame: 24 months
measure: Change From Baseline (BL) to SVR12 timepoint in 36-Item Short-Form Health Survey (SF-36) Scores
timeFrame: baseline, SVR 12 (twelve weeks post end of active treatment/ last dose of study drug)
measure: Change From Baseline (BL) to SVR 12 in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)
timeFrame: baseline , SVR 12 (twelve weeks post end of active treatment/last dose of study drug)
measure: Percentage of Participants Who Were Compliant With Treatment According To Moriskey, Green And Levine Adherence Scale (MAS4)(Subset Analysis)
timeFrame: 12 or 16 weeks
measure: Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)
timeFrame: 12 or 16 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Kings College Hospital NHS Trust
Study officials:
References: