Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

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.

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