Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

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

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).

Study Overview

• Status: Recruiting
• Conditions: PTSD
• Intervention / Treatment: Other: Placebo; Drug: Glecaprevir/pibrentasvir

Detailed Description

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 functioning improvement among patients with PTSD.

Aim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Bradley V Watts, MD, MPH; Phone Number: 5235 802-295-9363; Email: bradley.watts@va.gov
• Study Contact Backup: Name: Emily Colon, MS; Phone Number: 6131 802-295-9363; Email: emily.colon@va.gov

Study Locations

• United States
  • Vermont
    • White River Junction, Vermont, United States, 05001
      • Recruiting
      • White River Junction VAMC
      • Contact: Bradley V Watts, MD; Phone Number: 5235 802-295-9363; Email: bradley.v.watts@dartmouth.edu
      • Contact: Bradley V Watts, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Drug; Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.	Drug: Glecaprevir/pibrentasvir; Direct-acting antiviral, Food & Drug Administration (FDA) approved for the treatment of hepatitis C viral infection; Other Names: Mavyret
Placebo Comparator: Placebo; Placebo, 3 oral tablets once daily for 8 weeks.	Other: Placebo; Compounded, inactive pill equal in appearance to active study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)	Queries the frequency and intensity of symptoms of post-traumatic stress disorder (PTSD). The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.	Change from Baseline CAPS score at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)	A 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-180 with a higher score indicating worse functioning.	Change from Baseline WHODAS score at 8 weeks

Collaborators and Investigators

• Sponsor: White River Junction Veterans Affairs Medical Center
• Investigators: Principal Investigator: Bradley V Watts, MD, MPH, US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: PTSD; Hepatitis C; Antiviral
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 1698661; W81XWH22C0147 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No