Anthony S. Fauci
Preliminary findings from an ongoing randomized controlled trial of four investigational Ebola virus treatments being conducted amid the outbreak in the Democratic Republic of Congo, or DRC, showed favorable results for two of the drugs, officials announced today.
The findings resulted in the discontinuation of two of the drugs in the trial, remdesivir (Gilead Sciences) and ZMapp (Mapp Biopharmaceutical). Future patients will be randomly assigned to receive either REGN-EB3 (Regeneron) or mAb114 (Ridgeback Biotherapeutics) in an extension phase of the study, according to the officials from WHO and the National Institute of Allergy and Infectious Diseases.
The study’s independent data and safety monitoring board met most recently on Aug. 9 to review data collected on 499 of the 681 patients enrolled in the clinical trial, which is called PALM (Pamoja Tulinde Maisha, or “together we save lives”). That same day, the board notified the study investigators that REGN-EB3 had crossed the threshold of efficacy established to halt the study, which used ZMapp as the control after it displayed better outcomes in the West African Ebola epidemic than human-only care, according to National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD.
“Although these recommendations are based on preliminary study data, the encouraging, clear-cut findings are a ringing endorsement for conducting randomized controlled clinical trials to advance medical research and quickly provide better therapeutic options for patients based on sound scientific data,” Fauci said during a teleconference.
According to Fauci, the overall mortality rate among patients receiving ZMapp was approximately 49%. It was 53% for remdesivir, 29% for REGN-EB3 and 34% for mAb114. The results were “even more impressive” for patients with low viral loads who started treatment, Fauci added, with mortality rates of 24% for ZMapp, 33% for remdesivir, 6% for REGN-EB3 and 11% for mAb114.
Because the data were very close between REGN-EB3 and mAb114, the board concluded that both should be included in separate arms in an extension study, Fauci said.
“The news today is fantastic, but it doesn’t in itself stop Ebola,” Michael J. Ryan, MD, executive director of WHO Health Emergencies Programme, said during the teleconference. “What will stop Ebola is good surveillance, good infection prevention and control, good community engagement, excellent vaccination and the use of these therapeutics in the most effective way possible.”
More than 2,700 people have been infected and more than 1,800 have died in the ongoing outbreak in the DRC, which began over 1 year ago. – by Joe Gramigna
Disclosures: Fauci and Ryan report no relevant financial disclosures.