CompletedNot Applicable

Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior

United States198 participantsStarted 2017-05-01

Plain-language summary

This is an open label, non-randomized, observational pilot study to evaluate a model of care for treatment of hepatitis C in people with ongoing injection drug use. Participants will be treated with direct-acting antivirals (DAA) as per standard of care and will concomittantly be offered pre-exposure prophylaxis for HIV prevention and buprenorphine for treatment of opioid use disorder when clinically indicated.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age 18 years old
✓. Able and willing to sign informed consent
✓. Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).
✓. Willing to have samples stored for future use
✓. Ongoing injection drug use, defined as self-report of either:
✓. Phase 1 (first 100 enrolled participants) Injection non-prescription drug use within three months of screening visit or
✓. Phase 2 (enrolled participants 101-200) Use of non-prescription opioids within twelve months of screening visit

Exclusion criteria

✕. Decompensated liver disease (Childs Pugh B or C)
✕. Unable to comply with research study visits
✕. Poor venous access not allowing screening laboratory collection
✕. Have any condition that the investigator considers a contraindication to study participation
✕. Pregnant or breastfeeding woman

What they're measuring

Hepatitis C Virus (HCV) Cure (Sustained Virologic Response)

Timeframe: 24 weeks

Trial details

NCT IDNCT03221309

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-01-22

Results submitted2023-04-19

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