Drug trials in West Africa: Two possibly effective anti-Ebola drugs, plus immune plasma, will be trialed starting in December in West Africa. This is the first time that drug trials will be held in the middle of an area where an epidemic is in progress.
The New England Journal of Medicine describes how Brantly and Writebol, the first US Ebola victims evacuated from Liberia, were treated. Details of their symptoms treatment and eventual cure.
More below the snaky shepherd's crook virus.
Three experimental therapies that may be effective against Ebola will start trials in December in areas of West Africa. Two antiviral drugs that have shown some activity against Ebola (at least in the laboratory) will be used. Brincidofovir and favipiravir are the medications.
Brincidofovir is made in the US. It's being developed to treat cytomegalovirus and adenovirus infections. It's similar to cidofovir which is already in use, though not for Ebola. It was given to both Thomas Eric Duncan and Ashoka Mukpo.
Favipiravir, made in Japan, is active against influenza viruses, West Nile, yellow fever and several other virally caused diseases. It's been given to at least one human Ebola patient, who survived. Very limited studies in animals have shown that it is effective against Ebola if given very early in the course of the disease.
Both drugs are available in large enough amounts to begin use in trials and they are relatively inexpensive. This is not true for ZMapp, which takes more time to manufacture and is very expensive, as well.
Using plasma from Ebola survivors to treat Ebola victims has been tried in the past, but never on a large scale basis. Previously, some patients given the antibodies from the donors recovered and some died. If this therapy proves successful, it could be really dramatic. There might be a potential pool of thousands of donors, right where the epidemic is intense, able to donate for victims. No manufacture and shipping of drugs from thousands of miles away. The donors would be locally available and they could donate repeatedly with very little time between donations. Survivors of Ebola continue to produce antibodies against the disease for years after they have cleared the infection.
These trials will be unusual in a few different respects.
As mentioned previously, the trials will be done in an area where the disease is rampant, not in a laboratory designed for clinical drug trials. There may be problems with keeping the drug supply safe from persons not in the study who want the drug for themselves. There will also be difficulties with running a trial under those circumstances: the researchers will be at risk to contract the disease, there may be problems with on-site record keeping, drug supply and transport, and other associated problems.
An other major difference is that there will be no control group for any of the trials. Normally a control group, made up of people who are not taking the experimental drug, is used to compare how well the drug is working vs what happens to untreated patients. Because of the high fatality rate of untreated (and undertreated Ebola), the researchers will dispense with the control group.
Investigators will be observing the patients closely. If one of the drugs seems to be failing (not reducing mortality or actually harming patients) that drug will be stopped for all patients in that study. If that happens, the researchers may substitute a different drug from a group that has been pre-approved as possible Ebola therapies, another very unique feature of these clinical trials.
http://www.theguardian.com/...
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The New England Journal of Medicine has a report of how the first two US Ebola patients fared after being evacuated from Liberia. It discusses their symptoms, treatment and clinical courses both before they reached the US and while hospitalized and treated here.
This is the first account that I've seen that has a clear description of Brantly and Writebol's experiences from first symptoms through to cure. Interesting reading and not highly technical.
http://www.nejm.org/...