Glecaprevir/Pibrentasvir for the Treatment of PTSD

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

An open-label pilot study to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with posttraumatic stress disorder (PTSD) symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: White River Junction Veterans Affairs Medical Center

Criteria

Inclusion Criteria Summary

1. Age 19-70 years

2. Weight ≥ 45 kg

3. PTSD as determined by the CAPS within seven days of enrollment.

4. Eligible for VA healthcare.

5. If female 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 Criteria:

1. Pregnant or lactating woman

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 (HBV) 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. VA/DoD Clinical Practice Guideline first-line psychotherapy changes in the past two months

14. Evidence-based PTSD medication changes in the past two months