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Published on: August 31, 2014
Clinical and Operational Implementation of Ansuvimab under Expanded Access for Ebola Patients in the Democratic
Sabue Mulangu1, Jepsy Yango2, Felicia Lipansky1
1Ridgeback Biotherapeutics LP, Miami, Florida, USA.
Background:
Ebola Virus Disease (EVD) is a zoonosis caused by Orthoebolavirus zairense (EBOV). Outbreaks of EVD have occurred in the Democratic Republic of Congo (DRC), and an Expanded Access Program (EAP) with ansuvimab was implemented.
Objectives:
The primary objectives were to treat individuals with EBOV infection and to provide post-exposure prophylaxis (PEP) to those with high-risk exposure.
Study Design:
We reported a descriptive expanded-access case series from the 11th, 12th, and 13th EVD outbreaks in the DRC. Following each outbreak declaration, the ansuvimab EAP protocol was updated and approved by the ethics committee. Eligible participants received ansuvimab intravenously.
Results:
Twenty-four participants with confirmed EBOV infection and three PEP participants received ansuvimab during the 11th, 12th, and 13th EVD outbreaks. Most treated participants received ansuvimab within 7 days of symptom onset. Three of 24 EBOV-infected participants died; all three had baseline high viral load. No PEP participant developed EVD. No serious adverse events or new safety signals were identified CONCLUSIONS: Rapid protocol adaptation, ethics review, and in-country product storage enabled ansuvimab delivery during EVD outbreaks. Favorable clinical outcomes were consistent with previous findings, although small sample size, lack of a comparator, and predominance of participants with lower viral load limited interpretation.
