Chimerix has announced data from AdVance, the first large, multi-centre study of adenovirus (AdV) incidence, natural history, management and clinical outcomes in allogeneic haematopoietic cell transplant (allo-HCT) recipients.
These data will be presented at the 44th Annual Meeting of the European Society of Blood and Marrow Transplantation held 18–21 March in Lisbon, Portugal.
Prior to the AdVance study, data and evidence regarding AdV epidemiology after allo-HCT has been generally limited to single-centre studies. As Chimerix advances its brincidofovir development programme in serious adenovirus infections, the Company undertook the AdVance study to better characterise the real-world incidence and outcomes of these infections.
“The AdVance study is the first of its kind to evaluate the impact of adenovirus infection in the transplant setting,” said M Michelle Berrey, MD, MPH, President and Chief Executive Officer of Chimerix. “This groundbreaking study provides further evidence of the tremendous unmet need for an effective treatment for adenovirus, given an infection rate upwards of 32% in paediatric allo-HCT recipients and a strong correlation between adenovirus viral burden and mortality in the first year post-transplant. These results further strengthen our commitment to advance brincidofovir as the first potential treatment for serious adenovirus infections.”
The multi-centre, multinational study, conducted in 2017, examined the incidence, practice patterns, hospitalisation and clinical outcomes of 4276 (1738 paediatric, 2538 adults) allo-HCT recipients. The population of this study included allo-HCT performed at 50 centres in Europe from January 2013 to September 2015. The study also assessed AdV plasma viral burden, measured by time-averaged area under the curve (AAUC), and its correlation with overall and non-relapse-related mortality.
“The robust findings of the AdVance study are extremely important for transplant clinicians, as we seek to better understand the rates and clinical outcomes of adenovirus infection and assess ways to evaluate antiviral therapies,” said Marco Zecca, MD, paediatric haematologist and oncologist at Fondazione IRCCS Policlinico San Matteo and an investigator in the AdVance study. “Among paediatric allo-HCT recipients in the study, the highest mortality was observed in those with the greatest adenovirus burden, with 52% mortality in the quartile of highest adenovirus AAUC, compared to 3% mortality reported in the quartile of lowest AAUC. These data suggest that AdV AAUC is an appropriate endpoint to assess the potential benefits of antiviral therapies for the treatment of adenovirus.”