The use of experimental drugs and vaccines to fight Ebola in the Democratic Republic of the Congo is moving forward in the nation's latest outbreak, despite challenges of ongoing armed conflicts in the region, global health officials said.
At least five patients in the North Kivu area of the Democratic Republic of Congo, or DRC, have been treated with an experimental monoclonal antibody being developed by a research team at the U.S. National Institute of Allergy and Infectious Diseases, or NIAID, under a partnership with the U.S. Army Medical Research Institute of Infectious Diseases and the American military's Defense Advanced Research Projects Agency.
The NIAID said the antibody, dubbed mAb114, was isolated from a human survivor of the 1995 Ebola outbreak in Kikwit, DRC.
The same drug was also used in an earlier outbreak in the DRC, which erupted in May and was declared over on July 24.
The experimental medicine currently is being tested in a phase 1 study, which is examining the safety and tolerability of mAb114. The NIAID, part of the U.S. National Institutes of Health, has enrolled 13 healthy volunteers so far, spokeswoman Jennifer Routh told S&P Global Market Intelligence.
The agency is seeking to enroll up to 30 participants in the study, which is being conducted at the NIH's Clinical Center in Bethesda, Md.
The outcomes data from the DRC Ebola patients are being collected on site and will be relayed to the NIAID's Vaccine Research Center "in due course," Routh said. She had no further specifics on the timing on when those results are expected to be available.
During an Aug. 14 briefing with reporters, Tedros Adhanom Ghebreyesus, the director-general at the World Health Organization, or WHO, said other experimental treatments are also expected to be used during the current outbreak in North Kivu.
He noted those drugs — Mapp Biopharmaceutical's monoclonal antibody cocktail ZMapp; Gilead Sciences Inc.'s antiviral remdesivir, or GS-5734; Regeneron Pharmaceuticals Inc.'s fixed-dose monoclonal antibody combination treatment REGN3470-3471-3479; and FUJIFILM Holdings Corp.'s antiviral favipiravir, also known as Avigan — were also approved for use during the DRC outbreak that ended in July.
All five molecules — none of which have been approved by the U.S. Food and Drug Administration — have received clearance by health officials for use in the DRC during the outbreak, Tedros said.
The WHO chief said at least 216 healthcare workers and 20 people in the North Kivu community had been vaccinated with Merck & Co. Inc.'s experimental vaccine rVSV-ZEBOV Ebola.
Tedros noted there are about 3,000 doses of the vaccine available on the ground ready to be used in the DRC, with as many as 300,000 that could be moved to the area on short notice.
"I think we are OK. We are comfortable," he said.
NIAID Director Anthony Fauci told S&P Global Market Intelligence that Merck and other biopharmaceutical makers, including GlaxoSmithKline PLC and Johnson & Johnson, have remained committed and enthusiastic in the pursuit of a successful Ebola vaccine.
Tedros noted the Merck vaccine is being used in the DRC as part ring study, in which the contacts of infected patients and the contacts of the contacts are vaccinated. The idea is to create a ring of immunity around those contacts to stop the virus from spreading, according to WHO.
But Tedros said that strategy could change, with other measures taken, based on how the situation in the DRC unfolds.
As of Aug. 14, there were 66 cases of Ebola in the new outbreak — 39 confirmed and 27 probable — with 42 of those people dying, the DRC health ministry reported.
Tedros noted that seven of those who tested positive for Ebola were healthcare workers from one facility. Because of the concern the other 74 workers at that facility may have been exposed, all were sent home and are being monitored, he said. The facility, however, already has received replacement workers, Tedros added.
Another healthcare worker later in the day was deemed probable with Ebola.
The number of Ebola cases in the North Kivu area of the DRC has now surpassed those from the earlier outbreak, which Tedros said had him more worried for several reasons, though he acknowledged the numbers so far were nowhere near the more than 28,000 infected during the 2014-2016 West Africa epidemic.
He noted there were more Ebola infections this time in women and children than the earlier DRC outbreak and the virus also had spread faster in healthcare workers.
Most concerning, Tedros said, is the outbreak is occurring in a densely populated area, which is experiencing an active armed conflict, meaning less access for healthcare workers to patients. Such an environment is "really conducive" for a highly infectious disease like Ebola to transmit freely, he said.
Tedros noted there were more than 100 armed groups in the region, with frequent fighting engagements and kidnappings ongoing.
"So that makes it more difficult to manage," he said.
"We call on the warring parties for a cessation of hostilities, because the virus is dangerous to all. It doesn't choose between this group or that group," Tedros said.
He said that despite the challenges, WHO and the other health groups were not deterred and knew the situation meant they simply needed to be more aggressive to stop the North Kivu outbreak.