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Three Experimental Therapies To Be Tested With Ebola Patients In West Africa

There's no control group, so every patient at a research site is eligible for experimental treatment.

Posted on November 13, 2014, at 11:07 a.m. ET

The Doctors Without Borders Ebola treatment center in Monrovia, Liberia.
Stringer / Reuters

The Doctors Without Borders Ebola treatment center in Monrovia, Liberia.

NAIROBI, Kenya — Doctors Without Borders will host trials for three experimental Ebola therapies in its West African treatment centers, beginning as early as December.

The organization, which goes by the French acronym MSF, will host trials for two experimental drugs and an experimental transfusion therapy, according to Iza Ciglenecki, the deputy manager of the Investigational Platform for Experimental Ebola Products at MSF-Geneva.

The antiviral drug favipiravir will be tested in Guéckédou, Guinea, where the ongoing Ebola outbreak began. At the Donka Ebola Center in Conakry, the capital of Guinea, blood or plasma transfusions from survivors will be tested. Another antiviral drug, brincidofovir, will be tested at an as-yet-undetermined site in the region.

"Basically we looked at three criteria: how effective [a treatment] might be, safety data ... and if drug is at all available," Ciglenecki said. "The two antiviral drugs are basically the only ones available in quantities large enough to start the trial on a substantial number of patients."

The two drugs have been tested in humans to treat other diseases. Ciglenecki said the therapies will be tested on 100–200 patients each, depending on the design of the study.

There will be no control group in the studies, which means that all patients at the designated research site will be eligible for experimental treatment. But both drugs are orally administered, and vomiting is a common symptom of Ebola. Depending on a patient's individual condition, some may not be able to participate, Ciglenecki said.

The focus of the studies, however, is simple.

"Basically the only outcome we are interested in is the survival at day 14," she said. "It's just looking at the proportion of patients that survive at day 14 compared to the historical cohort of patients before at the same site."

The drug trials are due to start in early December. Conakry's blood bank currently does not have the capacity to extract plasma, and working through blood banks generally is more complicated, which will likely push the transfusion therapy experiment to late this year, she said.

MSF is hosting the trials, which are being run by three different institutions in partnership with the World Health Organization and national health ministries.

In August, WHO sanctioned experimental therapies, including those without safety data in human populations, in the context of the Ebola outbreak. At that time, Ciglenecki pointed out, virtually all the Ebola treatment centers across the region were being run by MSF.

"If MSF was not involved or willing to participate, these trials would be unlikely to happen fast," she said.

The trials themselves are being run by three different institutions. The French National Institute of Health and Medical Research (INSERM) will lead the favipiravir in Guéckédou; the Antwerp Institute of Tropical Medicine will lead the transfusion trials in Conakry; and the University of Oxford will lead the brincidofovir trials but has yet to make a final determination about where those trials will be held, according to MSF.

Patients at all three sites will be "given information about the drug as well as the fact that we don't know whether this works," Ciglenecki said, and asked to sign consent forms.

The three institutions behind the trials will also insure the trials. If anything should go wrong in the course of the trial, "that would be taken care of" by those institutions, she said.

That's a departure from legal procedures that governed the use of an experimental drug called ZMapp in Liberia, where the three medical professionals who received the last known doses of the drug were required to sign consent forms that indemnified the drug company and the Liberian government in the event of any complications.

The two drugs have not been used to treat Ebola before, but blood and plasma transfusions have been used on Americans infected with Ebola, mostly during treatment in the United States.

But those cases are too few, Ciglenecki said, to "tell us today that this is really working. That's why we are doing the trials."

She pointed out that Americans who received transfusion treatments also received other experimental treatments, as well as "a very high standard of care, with proper intensive care, which unfortunately our patients in Africa aren't getting." The confluence of factors makes it impossible to isolate which treatment method is behind the survival rate in the U.S.

With the exception of Patrick Sawyer, a Liberian who lived in Liberia but held U.S. citizenship and died of Ebola in Lagos, Nigeria, not a single American infected with Ebola has died.

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