Brincidofovir effective for adenovirus after liver transplant

SAN DIEGO — Preliminary clinical data showed brincidofovir reduced adenovirus infection viral load among adult and pediatric liver transplant recipients post-transplant, according to a poster presentation at IDWeek 2015.

Researchers, including Diana F. Florescu, MD, associate professor, Internal Medicine Division of Infectious Disease, University of Nebraska Medical Center, Omaha, evaluated 13 liver transplant recipients with adenovirus (AdV) infection following LT alone or as part of a multi-organ transplantation, identified from two studies known as the AdVise trial. Of these patients, 10 pediatric and three adult, all underwent treatment with brincidofovir (Chimerix) for a median of 79 days and were assessed for changes in AdV viral load from baseline, time to nadir viral load, survival and adverse events.

Diana F. Florescu

The median baseline serum of AdV viral load was 3.4 log¹⁰ c/mL, with a median change from baseline decreasing by 1.3 log¹⁰ c/mL (– 8.0-0.3 log¹⁰ c/mL). The median time to nadir viral load was 15 days. Ten patients were evaluated for more than 28 days and all were alive at time of evaluation, with a median decrease of 1.1 log¹⁰ c/mL in AdV viral load. The other three patients were followed for less than 28 days and one died.

Overall, one patient discontinued treatment due to diarrhea, which was deemed a brincidofovir-related adverse event. No brincidofovir-related clinical hepatobiliary adverse events were observed or reported, with aminotransferase levels remaining “stable or declining during treatment,” according to the abstract.

The median change from baseline increased by 4 U/L for alanine aminotransferase; decreased by 1 U/L for aspartate aminotransferase; decreased by 0.05 mg/dL for bilirubin; and increased by 0.1 mg/dL for creatinine.

W. Garrett Nichols, MD, MS, chief medical officer of Chimerix, said in a press release: “With no current FDA-approved treatment for adenovirus infection, there is a great unmet medical need for immunocompromised patients, including liver transplant recipients. These data support the continued study of brincidofovir for the prevention and treatment of double-stranded DNA virus infections, including adenovirus, in solid organ transplant recipients.”

The researchers concluded: “Preliminary pooled data from several LT patients with AdV infection suggest that treatment with [brincidofovir] can reduce viral burden and is associated with favorable survival. [Brincidofovir] was tolerated, with no clinical hepatobiliary AEs reported in these LT patients.”

Reference:

Florescu DF, et al. Abstract 1227. Presented at: IDWeek; Oct. 7-11, 2015; San Diego.

Disclosures: The researchers report no relevant financial disclosures.