Glecaprevir/pibrentasvir safety in people taking prescription or illicit drugs
Retrospective Analysis of Glecaprevir/Pibrentasvir Safety and Concomitant Medications Through Integrated Real-World Data
This will see if an 8-week course of glecaprevir/pibrentasvir is safe and works for people with hepatitis C who are taking prescription or illicit drugs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 2 sites (Vancouver, British Columbia and 1 other locations) |
| Trial ID | NCT07419347 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people with hepatitis C who are treatment-naïve for the current infection, have been prescribed an 8-week glecaprevir/pibrentasvir regimen, and are concurrently using one or more prescription or illicit drugs without history of decompensated cirrhosis, HBV, or HCC.
Not a fit: Patients with prior DAA treatment other than glecaprevir/pibrentasvir, a history of decompensated cirrhosis, hepatitis B infection, or hepatocellular carcinoma are excluded and are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the results could support safe use of an 8-week glecaprevir/pibrentasvir regimen for people with HCV who are taking prescription or illicit drugs, potentially expanding treatment access.
How similar studies have performed: Previous clinical trials and real-world studies report high cure rates with 8-week glecaprevir/pibrentasvir in treatment-naïve patients, but data specifically focused on people using illicit drugs are more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vancouver, British Columbia and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.