Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

Description

A double-blind randomized placebo-controlled trial 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).

Conditions

PTSD

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Study Overview

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Study Details

Study overview

A double-blind randomized placebo-controlled trial 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).

Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder

Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

Condition
PTSD
Intervention / Treatment

-

Contacts and Locations

White River Junction

White River Junction VAMC, White River Junction, Vermont, United States, 05001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

19 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

White River Junction Veterans Affairs Medical Center,

Bradley V Watts, MD, MPH, PRINCIPAL_INVESTIGATOR, US Department of Veterans Affairs

Study Record Dates

2026-09-30