Glecaprevir/pibrentasvir safety in people taking prescription or illicit drugs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, real-world data study of participants who were prescribed an 8-week course of glecaprevir/pibrentasvir and are concurrently using one or more prescription or illicit drugs. Participants are treatment-naïve for their current HCV infection and are followed for safety, tolerability, and measures of effectiveness. Key exclusions include prior DAA treatment other than glecaprevir/pibrentasvir, decompensated cirrhosis, hepatitis B infection, or hepatocellular carcinoma. Data are collected at participating clinical sites in Canada to describe outcomes in routine care settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Prescribed 8 weeks of Glecaprevir/Pibrentasvir (G/P).
* Treatment-naïve (for the current infection, participants that may have had prior infections which were resolved with treatment are considered naive for current infection as long as they have not received any treatment for the current infection.)
* Is concomitantly on one or more prescription medications or illicit drugs.

Exclusion Criteria:

* Treated with DAAs other than G/P.
* History of decompensated cirrhosis.
* Had Hepatitis-B virus (HBV) infection.
* Had hepatocellular carcinoma (HCC).

Where it's running

• Vancouver Infectious Diseases Centre /ID# 275313
  Vancouver, British Columbia, Canada Recruiting
• St. Clair Medical Clinic /ID# 275334
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Dimitri Semizarov
• Email: dimitri.semizarov@abbvie.com
• Phone: +1 847-935-8741

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.