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The AdVance Study: a Landmark Natural History Study of Adenovirus in Allogeneic Hematopoietic Cell Transplant Shows Strong Correlation Between Disease Burden and Mortality Risk
Prior to the AdVance study, data and evidence regarding AdV epidemiology after allo-HCT has been generally limited to single-center studies. As
“The AdVance study is the first of its kind to evaluate the impact of adenovirus infection in the transplant setting,” said
The multi-center, multinational study, conducted in 2017, examined the incidence, practice patterns, hospitalization and clinical outcomes of 4,276 (1,738 pediatric, 2,538 adults) allo-HCT recipients. The population of this study included allo-HCT performed at 50 centers in
“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
One in Three Pediatric Allo-HCT Recipients Impacted by Adenovirus
- In the AdVance study, 32 percent of pediatric allo-HCT recipients developed an AdV infection in the first six months following allo-HCT.
- Among pediatric allo-HCT recipients, 23 percent developed detectable AdV viremia (virus in the blood) and 14 percent developed greater than 1,000 copies/mL, a level previously associated with negative clinical outcomes.
- In adults, a much lower rate of 6 percent of transplant recipients were found to have AdV viremia, but only 36 percent of adult transplant centers employed regular screening protocols compared with 100 percent of pediatric centers. Thus, AdV infections in adult HCT may be under-diagnosed and underreported.
Greater than Ten-Fold Risk of Mortality with Highest AdV Burden
Among pediatric allo-HCT recipients:
- In patients with AdV viremia over 1,000 copies/mL in the first six months after transplant, there was an 18 percent mortality rate of any cause within 6 months.
- In a multivariate analysis, each 10-fold increase in AdV AAUC (total viral burden) was associated with almost a doubling (1.9 times) of the mortality risk.
- A patient with AdV level in the highest AdV AAUC quartile had a 12 times greater risk of dying than a patient with AdV in the lowest AAUC quartile.
- The highest mortality was observed in those with the greatest adenovirus burden, as measured by AdV AAUC. The highest AdV AAUC quartile had 52 percent 6-month mortality compared to 3 percent mortality in the quartile of lowest AdV AAUC.
- These data suggest that AdV AAUC is an appropriate endpoint to assess the potential benefits of antiviral therapies for the treatment of adenovirus.
- Adenovirus infection in pediatric allo-HCT recipients was also associated with significantly longer hospital stays.
- Incidence of Adenovirus Infections in Pediatric and Adult Allogeneic Hematopoietic Cell Transplant Recipients in
Europe; Sebastian Voigt, OS-9: Infectious Complications, 18:00 WET, Auditorium VIII
- Adenovirus Viral Burden is Associated with Mortality in Pediatric Allogeneic Hematopoietic Cell Transplant Recipients: Results from the Advance Study;
Marco Zecca, OS-9: Infectious Complications, 18:10 WET, Auditorium VIII
- Adenovirus Viremia is Associated with Substantially Prolonged Hospitalization in Pediatric Allogeneic Hematopoietic Cell Transplant Recipients; Antonio Pèrez-Martinez, B073, Infectious Complications poster session,
9:00 WET, Poster Area / Pavilion 1
- Screening, Monitoring, and Treatment of Adenovirus Infections in Pediatric and Adult Recipients of Allogeneic Hematopoietic Cell Transplants:
Multicenter Surveyof European Transplant Centers; Kanchan Rao, B043, Hematopoietic Stem Cells poster session, 9:00 WET, Poster Area / Pavilion 1
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that there may not be a viable continued development path for brincidofovir, that FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens, and that marketing approvals, if granted, may have significant limitations on their use. As a result, brincidofovir may never be successfully commercialized. In addition, Chimerix may be unable to file for regulatory approval for brincidofovir with other regulatory authorities. These risks, uncertainties and other factors could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company's filings with the Securities and Exchange Commission, including without limitation the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Source: Chimerix, Inc.