Ebola Drug Trial Is Halted for Lack of Patients
By ANDREW POLLACK
New York Times
FEB. 1, 2015
A clinical trial in Liberia of a drug to treat Ebola has been halted because of a sharp decline in the number of people infected with the virus, and studies in West Africa of other potential treatments are also facing problems finding patients.
The halted trial was testing the antiviral drug brincidofovir at a clinic in Monrovia, Liberia. The developer of the drug, Chimerix, announced late Friday that it would no longer participate in the study.
“Without having enough patients there to make any conclusions, it wasn’t feasible for us to push forward,” Dr. M. Michelle Berrey, chief executive of Chimerix, said in an interview Sunday.
She said the company had shipped enough of the drug to Liberia for 140 patients, but that fewer than 10 had been treated since the trial started on Jan. 2.
The World Health Organization reported last week that the number of new cases in the three most affected countries — Liberia, Guinea and Sierra Leone — had fallen below 100 a week for the first time since June. In Liberia, there were only four new cases in the seven days ending Jan. 25, the organization said.
Researchers said that, of course, the ebbing of the outbreak was a good problem to have.
“It’s more important to end the outbreak than to get the trial done,” said Dr. Armand Sprecher, a public health specialist at Doctors Without Borders, whose Ebola treatment center in Monrovia was the site of the brincidofovir trial.
Doctors Without Borders treatment centers are also being used to study the antiviral drug Avigan and also blood plasma collected from Ebola survivors. Avigan, also known as favipiravir, is a flu drug developed by Fujifilm of Japan.
Dr. Sprecher said the study of Avigan, which is taking place in Guinea, started before the one for brincidofovir and had already treated a “decent” number of patients. Organizers of that trial, however, are now looking for another clinic in order to find more patients, he said. The plasma trial has not really started yet, he said.
Organizers of a different trial of survivors’ plasma that has started in Liberia are now looking for collaborators to expand the testing into Sierra Leone, said Dr. William A. Fischer II, an assistant professor of medicine at the University of North Carolina and an investigator in that study. He said that besides testing the plasma as a treatment, the effort was aimed at improving the capacity of the health systems in West Africa to conduct safe blood donations and transfusions.
The falling number of patients could also affect other trials that are about to begin, including those for two vaccines and for the drug ZMapp, health authorities have said.
The Ebola outbreak has already sickened more than 22,000 people and has killed more than 8,800, according to the World Health Organization. It is possible that the outbreak could worsen again, as it did at least once before when experts thought it was ebbing.
Chimerix, which is based in Durham, N.C., said in its announcement that it would not participate in future Ebola trials.
“I think for now our plan is not to pursue clinical trials,” Dr. Berrey said. “We’ll wait and see how the outbreak goes.”
Dr. Berrey said the company, which has no drugs on the market, was small and had to concentrate its limited resources on finishing the trials needed to gain regulatory approval of brincidofovir to treat or prevent other types of viral diseases.
She said the decision to stop the trial in Liberia was made after discussions with the Food and Drug Administration, Doctors Without Borders and investigators at the University of Oxford.
New York Times
FEB. 1, 2015
A clinical trial in Liberia of a drug to treat Ebola has been halted because of a sharp decline in the number of people infected with the virus, and studies in West Africa of other potential treatments are also facing problems finding patients.
The halted trial was testing the antiviral drug brincidofovir at a clinic in Monrovia, Liberia. The developer of the drug, Chimerix, announced late Friday that it would no longer participate in the study.
“Without having enough patients there to make any conclusions, it wasn’t feasible for us to push forward,” Dr. M. Michelle Berrey, chief executive of Chimerix, said in an interview Sunday.
She said the company had shipped enough of the drug to Liberia for 140 patients, but that fewer than 10 had been treated since the trial started on Jan. 2.
The World Health Organization reported last week that the number of new cases in the three most affected countries — Liberia, Guinea and Sierra Leone — had fallen below 100 a week for the first time since June. In Liberia, there were only four new cases in the seven days ending Jan. 25, the organization said.
Researchers said that, of course, the ebbing of the outbreak was a good problem to have.
“It’s more important to end the outbreak than to get the trial done,” said Dr. Armand Sprecher, a public health specialist at Doctors Without Borders, whose Ebola treatment center in Monrovia was the site of the brincidofovir trial.
Doctors Without Borders treatment centers are also being used to study the antiviral drug Avigan and also blood plasma collected from Ebola survivors. Avigan, also known as favipiravir, is a flu drug developed by Fujifilm of Japan.
Dr. Sprecher said the study of Avigan, which is taking place in Guinea, started before the one for brincidofovir and had already treated a “decent” number of patients. Organizers of that trial, however, are now looking for another clinic in order to find more patients, he said. The plasma trial has not really started yet, he said.
Organizers of a different trial of survivors’ plasma that has started in Liberia are now looking for collaborators to expand the testing into Sierra Leone, said Dr. William A. Fischer II, an assistant professor of medicine at the University of North Carolina and an investigator in that study. He said that besides testing the plasma as a treatment, the effort was aimed at improving the capacity of the health systems in West Africa to conduct safe blood donations and transfusions.
The falling number of patients could also affect other trials that are about to begin, including those for two vaccines and for the drug ZMapp, health authorities have said.
The Ebola outbreak has already sickened more than 22,000 people and has killed more than 8,800, according to the World Health Organization. It is possible that the outbreak could worsen again, as it did at least once before when experts thought it was ebbing.
Chimerix, which is based in Durham, N.C., said in its announcement that it would not participate in future Ebola trials.
“I think for now our plan is not to pursue clinical trials,” Dr. Berrey said. “We’ll wait and see how the outbreak goes.”
Dr. Berrey said the company, which has no drugs on the market, was small and had to concentrate its limited resources on finishing the trials needed to gain regulatory approval of brincidofovir to treat or prevent other types of viral diseases.
She said the decision to stop the trial in Liberia was made after discussions with the Food and Drug Administration, Doctors Without Borders and investigators at the University of Oxford.
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