Final results of aAdVise study of brincidofovir for the treatment of adenovirus (AdV) infection in allogeneic hematopoietic cell transplant (HCT) recipients.-Chimerix.

Chimerix announced the presentation of final data from the AdVise trial of brincidofovir for the treatment of adenovirus (AdV) infection in allogeneic hematopoietic cell transplant (HCT) recipients at the BMT Tandem Meetings held February 22-26, 2017 in Orlando, FL. "The final data highlight the clinical benefit of the early antiviral effect of brincidofovir on adenovirus," said Dr. Vinod K. Prasad, Professor of Pediatrics, Duke University School of Medicine, and an investigator in the AdVise trial. "Rapid declines in adenovirus viral load were observed over the first four weeks of treatment, even in patients whose immune systems had not yet recovered. Importantly, patients who had a virologic response to brincidofovir showed higher survival, as did those who were treated earlier in the disease course. Adenovirus infection is a serious problem in HCT patients and this study showed encouraging results, particularly in children."

The AdVise trial was an open-label, multicenter study designed to evaluate the efficacy, safety and overall tolerability of oral brincidofovir for the treatment of adenovirus infection. Pediatric and adult subjects were assigned to one of three cohorts: �Cohort A, comprised of allogeneic HCT recipients with asymptomatic or limited adenovirus infection; �Cohort B, comprised of allogeneic HCT recipients with disseminated adenovirus disease; and � Cohort C, comprised of autologous HCT recipients, solid organ transplant recipients and other patients with serious adenovirus infections. All subjects were to receive 12 weeks of oral brincidofovir and were followed for at least 36 weeks. This final analysis includes 158 allogeneic HCT recipients assigned to Cohorts A (23 adult and 42 pediatric patients) and B (35 adult and 58 pediatric patients).

In the AdVise trial, declines in AdV viral load of greater than 2 log10 c/mL or below the limit of detection at Week 4 were observed in 76 percent of pediatric patients and 45 percent of adult patients. Notably, this antiviral effect was observed even in HCT recipients who did not yet have immune recovery. In Cohort A, 55 percent of patients with baseline low immunity (CD4 counts less than 50 cells/?L) achieved greater than 2 log10 c/mL decline or undetectable AdV at Week 4. In Cohort B, 52 percent of patients with baseline low immunity achieved greater than 2 log10 c/mL decline or undetectable AdV over the same period of time. In patients with disseminated disease, rapid virologic response, defined as undetectable AdV viremia at Week 6, was associated with nearly double the survival rate and lower adenovirus-associated mortality compared with subjects who did not have an antiviral response.