Pritelivir Demonstrated Superior Efficacy Compared to Investigator's Choice Treatment for Refractory Herpes Simplex Virus Infections In Immunocompromised Patients: PRIOH-1, Phase 3 Safety and Efficacy (TCT-ASTCT-CIBMTR 2026) - Feb 6, 2026 - Abstract #LBA-3; 906; Pres time: Feb 7, 2026; 03:45 PM - 04:00 PM; Location: Ballroom AB (Salt Palace Convention Center); "Methods In this randomized (1:1), controlled, open label trial, 101 IC patients (≥16 years) with R±R HSV mucocutaneous infection received oral pritelivir (100 mg daily; 400 mg loading dose) or ICT (IV foscarnet, IV/topical cidofovir, or topical imiquimod) for up to 28 days, extendable to 42 days. Eligibility criteria included hematopoietic cell transplant, solid organ transplant, HIV, malignancy, or chronic use of immunosuppressive treatment with refractory/clinical failure (defined as no clinical improvement of lesions after ≥7 days of standard of care nucleoside analogue therapy or confirmed acyclovir resistance)...Conclusions Pritelivir met the Phase 3 primary endpoint, demonstrating statistically superior efficacy compared with ICT, with a favorable safety and tolerability profile. These findings support pritelivir as a promising oral agent to address the unmet needs of refractory HSV infections in IC patients."
Clinical • Late-breaking abstract • P3 data • Herpes Simplex • Human Immunodeficiency Virus • Immunology • Infectious Disease • Primary Immunodeficiency • Solid Organ Transplantation
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Genovefa Papanicolaou; Robin Avery; Kimberly Workowski; Karl Peggs; Yeon Joo Lee; Jean-Michel Molina; Anum Abbas; Alma Perez-Rios; Jana Dickter; Sanjeet Dadwal; Stuart Cohen; Nicolas Issa; Palash Samanta; Alexander Birkmann; Cynthia Wat; Dilruwan Herath; Alessandra Marini; Bernadette Surujbally; Melanie Sumner; Anna Wald; Roy Chemaly
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