Glecaprevir/Pibrentasvir for the Treatment of PTSD

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.

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