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).
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.
Eligibility
Inclusion Criteria:
- Age 19-70 years
- Weight ≥ 45 kg
- Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment
- Eligible for Veterans Affairs healthcare
- If person with 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 (unable to participate) 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