TerminatedPhase 4

ATTIC - Access To Treat in the Community

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

United Kingdom13 participantsStarted 2019-03-23

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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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.

What they're measuring

SVR

Timeframe: 24 months

Trial details

NCT IDNCT03797066

SponsorKing's College Hospital NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-28

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