RCT of Glecaprevir/Pibrentasvir for the Treatment of PTSD

• Status: Not yet recruiting
• Trial end date: 2026-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this randomized control trial is to measure the effect of an antiviral medication, Glecaprevir/Pibrentasvir (GLE/PIB), on symptoms of post-traumatic stress disorder. The main questions this study will answer are: Is GLE/PIB effective in improving PTSD symptoms? What is the tolerability of GLE/PIB in those experiencing PTSD? Participants will be randomized into one of two study arms, active medication, or inactive medication (placebo), take active or placebo medication once a day for 8-weeks, provide blood samples at two time points, and complete surveys at eight time points during the eight-month study period.

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

Details

• Lead Sponsor: White River Junction Veterans Affairs Medical Center

Criteria

Inclusion Criteria:

1. Age 19-70 years

2. Weight more than 99 pounds

3. Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment

4. Eligible for VA 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 (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