Ebola Drug Trials to Start Without Placebos in Africa
By Makiko Kitamura and Simeon Bennett Nov 13, 2014 6:28 AM PT
The first human trials of experimental Ebola treatments will start next month in West Africa, as researchers seek to fast-track drugs to fight a disease that has killed more than 5,000 people and is threatening to spread in a fourth nation.
A trial of Fujifilm Holdings Corp.’s (4901) antiviral favipiravir involving about 200 patients will begin at a Doctors Without Borders treatment center in Guinea, and Chimerix Inc.’s (CMRX) drug brincidofovir will be tested in as many as 140 adults at a site yet to be determined, the medical charity said today. A third trial using antibody-rich blood from survivors to treat about 100 patients will start at the Donka Ebola Center in Conakry, Guinea.
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The studies, to be run by three different research groups, have been accelerated as doctors race to develop treatments against a disease that is killing about half of those it strikes, and for which there is no therapy but supportive care. More than 5,100 people have been killed in Liberia, Sierra Leone and Guinea, and four cases have been reported in Mali, raising concerns the virus may spread there as well.
Placebo Issue The Ebola Scourge
“We have these products which may or may not work in Ebola, and the only way we can test them is in an epidemic,” Peter Horby, a professor of tropical medicine and global health at the University of Oxford who will lead the brincidofovir trial, said at a briefing in Geneva today. “We’re going fast by clinical trial standards, maybe not fast enough for the people on the ground.”
Horby and colleagues will lead the trial of the Chimerix drug, while the favipiravir trial will be led by the French National Institute of Health and Medical Research. The Antwerp Institute of Tropical Medicine will lead the study involving survivors’ blood.
The trials won’t use placebos, partly because of uncertainty about whether traditional placebo-controlled trials are feasible in the midst of a humanitarian disaster, Horby said.
“There’s been a lot of discussion about the optimal trial design,” he said. “It’s a very difficult discussion because there’s no correct answer.”
Mortality RatesThe studies will be stopped if mortality remains above 50 percent, showing the drugs are having no effect, or if the survival rate of those receiving them rises to more than 80 percent, clearly demonstrating they work, Horby said.
In the favipiravir trial, about 60 patients will receive the drug within 48 hours of showing symptoms of Ebola, said Denis Malvy, who will lead that trial for France’s Inserm research group. Researchers will analyze data after every group of 20 patients to ensure the drug is not causing harm.
Doctors Without Borders has asked each of the research units to ensure they have indemnity insurance, said Annick Antierens, the charity’s manager for experimental Ebola products, said at the briefing today. The University of Oxford will provide indemnity cover for its brincidofovir trial. The researchers expect results by February or March and may move to larger trials if results are positive, Antierens said.
There are no approved drugs to treat Ebola, and care has mostly consisted of isolating patients and giving them rehydration therapy and antibiotics. Separate studies are under way to test vaccines to prevent people from catching Ebola.
Mali SpreadThe latest outbreak of Ebola has claimed most of its victims in Liberia, Guinea and Sierra Leone. The virus is threatening to spread in Mali, where a nurse died two days ago after treating a man from Guinea who died without being tested for Ebola and is thought to have spread the disease to members of his family, and a friend who has died.
The man died Oct. 27 and may have infected all four family members who drove him to Mali for treatment of kidney failure, as well as other relatives, according to the World Health Organization. The body of the man, a grand imam, was taken to a mosque in Bamako, Mali’s capital, for ritual washing and then returned to the border village of Kouremale in Guinea for burial.
The spread to Mali came as Ebola was nearly considered by Doctors Without Borders to be under control in that country, as there hadn’t been a case since a two-year-old girl brought to the country from Guinea died on Oct. 24.
To contact the reporters on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net; Simeon Bennett in Geneva at sbennett9@bloomberg.net
To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net Robert Valpuesta, David Risser |
