Glecaprevir/Pibrentasvir for the Treatment of PTSD

Study Overview
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Brief Summary
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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).

Detailed Description
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To perform an open-label pilot study (N=10) 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). The specific research described in this proposal is intended to pilot GLE/PIB for N=10 patients with PTSD in the absence of HCV. Primary Aims: Aim 1: Determine the feasibility of testing GLE/PIB for PTSD symptoms. Aim 2: Determine the feasibility of testing GLE/PIB for functioning among patients with PTSD. Aim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV. Exploratory Aim: Investigate the possible biological mechanism of GLE/PIB for PTSD via blood bio-marker analyses.

Official Title
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Glecaprevir/Pibrentasvir for the Treatment of PTSD

Conditions
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PTSD

Intervention / Treatment
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* Drug: Glecaprevir / Pibrentasvir Pill


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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Drug<br>All enrolled participants will receive Glecaprevir/Pibrentasvir | Drug: Glecaprevir / Pibrentasvir Pill<br>* Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.<br>* Other names: Mavyret;|

What is the study measuring?
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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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Antiviral, Hepatitis C