Background: Adenovirus (AdV) infections cause significant morbidity and mortality in immunocompromised patients. Brincidofovir (BCV) is an investigational antiviral drug with high in vitro potency against all AdV subtypes. BCV was evaluated as a treatment for AdV infection in the AdVise trial (CMX001-304; NCT02087306). This abstract describes a subset of the trial (Cohort C) that included solid organ transplant recipients and other non-allogeneic hematopoietic cell transplant (HCT) patients. Methods: Patients were included if they had disseminated AdV disease, or were at risk of progression to disseminated AdV disease (asymptomatic viremia or localized infection). Patients were treated with oral BCV at 2 mg/kg (up to 100 mg) twice weekly for 12 weeks and followed for 36 weeks post-first dose. Descriptive patient characteristics and outcomes are presented. Results: Forty-three patients were enrolled, 63% male, 63% white, with a median age (range) of 4 y (0.4-76). Transplants included liver (9), intestine (6), pancreas (5), autologous HCT (5), kidney (3), lung (3), heart (1), thymus (1); 20 patients were immunocompromised for other reasons (eg, chemotherapy, congenital conditions). Thirty (70%) patients presented with disseminated AdV disease. Twelve (28%) patients had CMV and/or BKV co-infection (viremia) at baseline (pre-BCV). Thirty (70%) patients had AdV viremia at baseline (median 3.5 log₁₀ copies/mL, IQR 3.0-6.4). Of these, 22/30 (73%) cleared or had their AdV viremia decrease by ≥2 log within a median (IQR) of 15 (8-22) days; 18/30 (60%) had undetectable AdV viremia at end of treatment. Median (IQR) duration of BCV therapy during the prescribed 12 weeks was 28 (15-81) days. Diarrhea was the most common Grade 3 or higher adverse event reported in 5 (12%) patients and led to BCV discontinuation in 3 (7%) patients. Twenty-nine (67%) patients survived to Week 36. Conclusions: BCV treatment resulted in rapid decline in AdV viremia in the majority of patients and was generally tolerable in this diverse population of immunocompromised patients. These data support the development of BCV as a potential treatment for AdV.

CITATION INFORMATION: Florescu D., Grimley M., Papanicolaou G., Prasad V., Vainorius E., Chittick G., Brundage T., Nichols G. Brincidofovir Was Used to Successfully Treat Adenovirus Infections in Solid Organ Transplant Recipients and Other Immunocompromised Patients Am J Transplant. 2017;17 (suppl 3).

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