Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

Launched by WHITE RIVER JUNCTION VETERANS AFFAIRS MEDICAL CENTER · Nov 23, 2022

Keywords

ClinConnect Summary

N=92 patients with posttraumatic stress disorder (PTSD) will be enrolled into a double-blind randomized placebo-controlled trial to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with PTSD symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV). The research is intended to test the efficacy of GLE/PIB for PTSD symptom improvement in the absence of HCV.

Primary Aims:

Aim 1: Determine the efficacy of GLE/PIB for PTSD symptom improvement. Aim 2: Determine the efficacy of GLE/PIB for f...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 19-70 years
• • 2. Weight ≥ 45 kg
• • 3. Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment
• • 4. Eligible for Veterans Affairs healthcare
• • 5. If person with childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required.
• • 6. Able to read, understand, and sign the informed consent document.
• Exclusion (unable to participate) Criteria:
• • 1. Pregnant or lactating person
• • 2. Moderate or severe hepatic impairment (Child-Pugh B or C)
• • 3. History of prior hepatic decompensation
• • 4. Current use of drugs listed as having significant drug interactions on prescribing label
• • 5. Advanced liver disease
• • 6. Current or prior hepatitis B infection
• • 7. Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor
• • 8. Current HCV infection
• • 9. Current psychosis or mania
• • 10. Significant suicidal ideation
• • 11. Unstable medical conditions
• • 12. Current severe alcohol or substance use disorder (excluding nicotine)
• • 13. Evidence-based PTSD psychotherapy changes in the past two months
• • 14. Evidence-based PTSD medication changes in the past two months

Trial Officials