Clinical trial NCT05446857: Glecaprevir/Pibrentasvir for the Treatment of PTSD
Official title: Glecaprevir/Pibrentasvir for the Treatment of PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: PTSD
Keywords: PTSD
Antiviral
Hepatitis C
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2022-07-07
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility 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 Veterans Affairs healthcare.
5. If of 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 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

Primary outcomes:
measure: Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)
timeFrame: Change from Baseline CAPS score at 8 weeks
measure: World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)
timeFrame: Change from Baseline WHODAS score at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: White River Junction
country: United States
facility: White River Junction VAMC
state: Vermont
Study officials:
affiliation: White River Junction Veterans Affairs Medical Center
name: Bradley V Watts, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: