SEATTLE, WASHINGTON There is a "slight hope" that this may help some people. It is a sober assessment of researchers from Ebola drug that made the first page news earlier this month when he was introduced as the first promising treatment for this deadly disease.
These media reports relied on preliminary data on a test of a new drug in Guinea that has been disclosed by a nongovernmental organization that helped conduct the study, the researchers say. The New York Times broke the story on February 4, and the same day, French President Francois Hollande issued a statement announcing the results as encouraging. "Healing is accelerated," read the statement. Guinean officials announced they wanted to make the drug more widely available.
Yesterday was the first time the French team discussed their data publicly talk media at the Conference on retroviruses and opportunistic infections (CROI) here.
at the press conference opening, the principal investigator of the trial, Denis Malvy of the University of Bordeaux, described the trial, called JIKI. Sixty-nine adults and adolescents participated in the study, from mid-December to mid-January. All participants received the drug, favipiravir, for up to 10 days. Their results were compared with patients receiving standard treatment in the same clinical for the 3 months before the start of the test. in all, 48% of participants died, which is similar to the death rate in the historical control group . But when the researchers analyzed the subgroup of patients who entered the clinic with lower levels of Ebola virus in their blood, they found an increase in survival.
Malvy, which intends to describe the data in detail during a presentation Wednesday morning, said that the trial did not initially intend to analyze patient outcomes by different viral loads. But the standard test used to diagnose the disease gave this information, and investigators have seen an interesting trend.
In 29 patients who arrived with high levels of virus, 27 dead. "It is very unlikely that favipiravir alone will reduce mortality in this population," said Malvy.
Among 40 patients who entered the trial with viral loads below, only 15% died compared with a 30% mortality rate in the historical control group. "We feel that the initial monotherapy favipiravir could improve survival in the group with less advanced disease," said Malvy, noting that the trial is ongoing. But Malvy also pointed out that even when the trial is over, it will not provide a clear answer as to whether favipiravir worked because, for ethical reasons, researchers enroll a control group untreated at the same time. He called it a "proof of concept" study that researchers hope to inform future trials.
The improvement in mortality in the group may have been linked to favipiravir, Malvy said. First, the quality of care in clinics may have improved during the study period, which makes the comparison misleading historical control. The researchers also relied on relatively crude measure of two different viral loads. Other studies that analyzed more carefully Ebola viral loads have found that at least four different levels correlated with different mortality rates, suggesting the supposed advantage of favipiravir seen could disappear if more accurate measures have were compared.
Xavier Anglaret, Malvy a colleague from the University of Bordeaux, which coordinates JIKI study, said their data "are not a high level of evidence" and that the goal of the group was modest from the start. "He just tries to find a signal," said Anglaret.
Anglaret said that researchers have submitted an abstract to the CROI meeting prior history New York Times appearing "We were all very angry" about the leak, he said "We wanted to share our global history."
* Ebola files. given the current Ebola outbreak unprecedented in terms of the number of people killed and the rapid geographic spread, science and science Translational Medicine have a collection of items research and news on the viral disease available for researchers and the general public.
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