Monday, 4 August 2014

Experimental drug likely saved Ebola patients - CNN

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STORY HIGHLIGHTS


  • Untested drugs can't be used in the midst of an outbreak, spokesman says

  • Ebola drug ZMapp given to Dr. Kent Brantly and Nancy Writebol

  • Experimental drug had only been tested in monkeys




(CNN) -- It's a story that could have come from a cinematic medical thriller: Two American missionary workers contract Ebola. Their situation is dire. Three vials containing a highly experimental drug are flown into Liberia in a last-ditch effort to save them.


And the drug flown in last week appears to have worked, according to a source familiar with details of the treatment.


Dr. Kent Brantly's and Nancy Writebol's conditions significantly improved after receiving the medication, sources say. Brantly was able to walk into Emory University Hospital in Atlanta after being evacuated to the United States last week, and Writebol is expected to arrive in Atlanta on Tuesday.


On July 22, Brantly woke up feeling feverish. Fearing the worst, Brantly immediately isolated himself. Writebol's symptoms started three days later. A rapid field blood test confirmed the infection in both of them after they had become ill with fever, vomiting and diarrhea.







Dr. Kent Brantly, right, gets out of an ambulance after arriving at Emory University Hospital in Atlanta on Saturday, August 2. Brantly was infected with the Ebola virus in Africa but was brought back to the U.S. for further treatment. Health officials say the Ebola outbreak centered in West Africa is the deadliest ever. The World Health Organization reports that the outbreak in Liberia, Sierra Leone and Guinea has infected more than 1,300 people and killed more than 700 this year.Dr. Kent Brantly, right, gets out of an ambulance after arriving at Emory University Hospital in Atlanta on Saturday, August 2. Brantly was infected with the Ebola virus in Africa but was brought back to the U.S. for further treatment. Health officials say the Ebola outbreak centered in West Africa is the deadliest ever. The World Health Organization reports that the outbreak in Liberia, Sierra Leone and Guinea has infected more than 1,300 people and killed more than 700 this year.

Nurses wearing protective clothing are sprayed with disinfectant on Friday, August 1, after preparing the bodies of several Ebola victims for burial in the isolation unit of the ELWA Hospital in Monrovia, Liberia.Nurses wearing protective clothing are sprayed with disinfectant on Friday, August 1, after preparing the bodies of several Ebola victims for burial in the isolation unit of the ELWA Hospital in Monrovia, Liberia.

A nurse disinfects the waiting area at the ELWA Hospital in Monrovia, Liberia, on Monday, July 28. A nurse disinfects the waiting area at the ELWA Hospital in Monrovia, Liberia, on Monday, July 28.

Liberian President Ellen Johnson Sirleaf, right, walks past an Ebola awareness poster in downtown Monrovia as Liberia marked the 167th anniversary of its independence Saturday, July 26. The Liberian government dedicated the anniversary to fighting the deadly disease. Liberian President Ellen Johnson Sirleaf, right, walks past an Ebola awareness poster in downtown Monrovia as Liberia marked the 167th anniversary of its independence Saturday, July 26. The Liberian government dedicated the anniversary to fighting the deadly disease.

In this photo provided by Samaritan's Purse, Dr. Kent Brantly, left, treats an Ebola patient in Monrovia. On July 26, the North Carolina-based group said Brantly tested positive for the disease. On Saturday, August 2, Brantly arrived by specially equipped plane in Georgia to be treated at an Atlanta hospital, becoming the first Ebola patient to knowingly be treated in the United States. In this photo provided by Samaritan's Purse, Dr. Kent Brantly, left, treats an Ebola patient in Monrovia. On July 26, the North Carolina-based group said Brantly tested positive for the disease. On Saturday, August 2, Brantly arrived by specially equipped plane in Georgia to be treated at an Atlanta hospital, becoming the first Ebola patient to knowingly be treated in the United States.

A 10-year-old boy whose mother was killed by the Ebola virus walks with a doctor from the aid organization Samaritan's Purse after being taken out of quarantine Thursday, July 24, in Monrovia.A 10-year-old boy whose mother was killed by the Ebola virus walks with a doctor from the aid organization Samaritan's Purse after being taken out of quarantine Thursday, July 24, in Monrovia.

A doctor puts on protective gear at the treatment center in Kailahun, Sierra Leone, on Sunday, July 20.A doctor puts on protective gear at the treatment center in Kailahun, Sierra Leone, on Sunday, July 20.

Doctors Without Borders staff members adjust tents in the isolation area in Kailahun, Sierra Leone, on July 20.Doctors Without Borders staff members adjust tents in the isolation area in Kailahun, Sierra Leone, on July 20.

Boots dry in the Ebola treatment center in Kailahun, Sierra Leone, on July 20.Boots dry in the Ebola treatment center in Kailahun, Sierra Leone, on July 20.

Red Cross volunteers prepare to enter a house where an Ebola victim died in Pendembu, Sierra Leone, on Friday, July 18.Red Cross volunteers prepare to enter a house where an Ebola victim died in Pendembu, Sierra Leone, on Friday, July 18.

Dr. Jose Rovira, of the World Health Organization, takes a swab from a suspected Ebola victim in the town of Pendembu, Sierra Leone, on July 18.Dr. Jose Rovira, of the World Health Organization, takes a swab from a suspected Ebola victim in the town of Pendembu, Sierra Leone, on July 18.

Red Cross volunteers disinfect each other with chlorine after removing the body of an Ebola victim from a house in Pendembu, Sierra Leone, on July 18.Red Cross volunteers disinfect each other with chlorine after removing the body of an Ebola victim from a house in Pendembu, Sierra Leone, on July 18.

A dressing assistant prepares a member of Doctors Without Borders to enter an isolation ward on Thursday, July 17.A dressing assistant prepares a member of Doctors Without Borders to enter an isolation ward on Thursday, July 17.

A doctor works in the field laboratory at the Ebola treatment center in Kailahun, Sierra Leone, on July 17.A doctor works in the field laboratory at the Ebola treatment center in Kailahun, Sierra Leone, on July 17.

Doctors Without Borders staff prepare to enter the isolation ward at an Ebola treatment center in Kailahun, Sierra Leone, on July 17.Doctors Without Borders staff prepare to enter the isolation ward at an Ebola treatment center in Kailahun, Sierra Leone, on July 17.

A health worker with disinfectant spray walks down a street outside the government hospital in Kenema, Sierra Leone, on Thursday, July 10. A health worker with disinfectant spray walks down a street outside the government hospital in Kenema, Sierra Leone, on Thursday, July 10.

Dr. Mohamed Vandi, from the Kenema Government Hospital, trains community volunteers who will aim to educate people about Ebola in Sierra Leone, on July 10.Dr. Mohamed Vandi, from the Kenema Government Hospital, trains community volunteers who will aim to educate people about Ebola in Sierra Leone, on July 10.

Police block a road outside the town of Kenema, Sierra Leone, on Wednesday, July 9, in order to stop motorists for a body temperature check.Police block a road outside the town of Kenema, Sierra Leone, on Wednesday, July 9, in order to stop motorists for a body temperature check.

A woman has her temperature taken at a screening checkpoint on the road out of Kenema, Sierra Leone, on July 9.A woman has her temperature taken at a screening checkpoint on the road out of Kenema, Sierra Leone, on July 9.

A member of Doctors Without Borders puts on protective gear at the isolation ward of the Donka Hospital in Conakry, Guinea, on Saturday, June 28.A member of Doctors Without Borders puts on protective gear at the isolation ward of the Donka Hospital in Conakry, Guinea, on Saturday, June 28.

Airport employees check passengers in Conakry before they leave the country on Thursday, April 10.Airport employees check passengers in Conakry before they leave the country on Thursday, April 10.

CNN's Dr. Sanjay Gupta, left, works in the World Health Organization's mobile lab in Conakry. Gupta traveled to Guinea in April to report on the deadly virus.CNN's Dr. Sanjay Gupta, left, works in the World Health Organization's mobile lab in Conakry. Gupta traveled to Guinea in April to report on the deadly virus.

A Guinea-Bissau customs official watches arrivals from Conakry on Tuesday, April 8.A Guinea-Bissau customs official watches arrivals from Conakry on Tuesday, April 8.

Egidia Almeida, a nurse in Guinea-Bissau, scans a Guinean citizen coming from Conakry on April 8. Egidia Almeida, a nurse in Guinea-Bissau, scans a Guinean citizen coming from Conakry on April 8.

A scientist separates blood cells from plasma cells to isolate any Ebola RNA and test for the virus Thursday, April 3, at the European Mobile Laboratory in Gueckedou, Guinea.A scientist separates blood cells from plasma cells to isolate any Ebola RNA and test for the virus Thursday, April 3, at the European Mobile Laboratory in Gueckedou, Guinea.

Members of Doctors Without Borders carry a dead body in Gueckedou on Friday, April 1. Members of Doctors Without Borders carry a dead body in Gueckedou on Friday, April 1.

Gloves and boots used by medical personnel dry in the sun April 1 outside a center for Ebola victims in Gueckedou.Gloves and boots used by medical personnel dry in the sun April 1 outside a center for Ebola victims in Gueckedou.

A health specialist works Monday, March 31, in a tent laboratory set up at a Doctors Without Borders facility in southern Guinea.A health specialist works Monday, March 31, in a tent laboratory set up at a Doctors Without Borders facility in southern Guinea.

Health specialists work March 31 at an isolation ward for patients at the facility in southern Guinea.Health specialists work March 31 at an isolation ward for patients at the facility in southern Guinea.

Workers associated with Doctors Without Borders prepare isolation and treatment areas Friday, March 28, in Guinea. Workers associated with Doctors Without Borders prepare isolation and treatment areas Friday, March 28, in Guinea.



Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

Ebola outbreak in West Africa

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Photos: Ebola outbreak in West AfricaPhotos: Ebola outbreak in West Africa





Why isn't there an Ebola vaccine?




Second Ebola patient heading to U.S.




Doctors struggle to treat Ebola patients

It's believed Brantly and Writebol, who worked with the aid organization Samaritan's Purse, contracted Ebola from another health care worker at their hospital in Liberia, although the official Centers for Disease Control and Prevention case investigation has yet to be released.


As the Americans' conditions worsened, Samaritan's Purse reached out to a National Institutes of Health scientist who was on the ground in West Africa, according to the National Institute of Allergy and Infectious Diseases.


"The scientist was able to informally answer some questions and referred them to appropriate company contacts to pursue their interest in obtaining the experimental product," NIAID said.


The experimental drug, known as ZMapp, was developed by the biotech firm Mapp Biopharmaceutical Inc., which is based in San Diego. The patients were told that the treatment had never been tried before in a human being but had shown promise in small experiments with monkeys.


Questions about this new Ebola drug


According to company documents, four monkeys infected with Ebola survived after being given the therapy within 24 hours after infection. Two of four other monkeys that started therapy within 48 hours after infection also survived. One monkey that was not treated died within five days of exposure to the virus.


Brantly and Writebol were aware of the risk of taking a new, little-understood treatment and gave informed consent, according to two sources familiar with the care of the missionary workers. In the monkeys, the experimental serum had been given within 48 hours of infection. Brantly didn't receive it until he'd been sick for nine days.


The medicine is a three-mouse monoclonal antibody, meaning that mice were exposed to fragments of the Ebola virus and then the antibodies generated within the mice's blood were harvested to create the medicine. It works by preventing the virus from entering and infecting new cells.


The Ebola virus causes viral hemorrhagic fever, which refers to a group of viruses that affect multiple organ systems in the body and are often accompanied by bleeding.


Early symptoms include sudden onset of fever, weakness, muscle pain, headaches and a sore throat. They later progress to vomiting, diarrhea, impaired kidney and liver function -- and sometimes internal and external bleeding.


The ZMapp vials, stored at subzero temperatures, reached the hospital in Liberia where Brantly and Writebol were being treated Thursday morning. Doctors were instructed to allow the serum to thaw naturally without any additional heat. It was expected that it would be eight to 10 hours before the medicine could be given, according to a source familiar with the process.


Brantly asked that Writebol be given the first dose because he was younger and he thought he had a better chance of fighting it, and she agreed. However, as the first vial was still thawing, Brantly's condition took a sudden turn for the worse.


Brantly began to deteriorate and developed labored breathing. He told his doctors he thought he was dying, according to a source with firsthand knowledge of the situation.


Knowing his dose was still frozen, Brantly asked if he could have Writebol's now-thawed medication. It was brought to his room and administered through an IV. Within an hour of receiving the medication, Brantly's condition dramatically improved. He began breathing easier; the rash over his trunk faded away. One of his doctors described the events as "miraculous."


By the next morning, Brantly was able to take a shower on his own before getting on a specially designed Gulfstream air ambulance jet to be evacuated to the United States.


Writebol also received a vial of the medication. Her response was not as remarkable, according to sources familiar with the treatment. However, doctors on Sunday administered Writebol a second dose of the medication, which resulted in significant improvement.


She was stable enough to be evacuated back to the United States.


The process by which the medication was made available to Brantly and Writebol is highly unusual.


World Health Organization spokesman Gregory Hartl cautioned that health authorities "cannot start using untested drugs in the middle of an outbreak, for various reasons."


Doctors Without Borders similarly weighed in on the side of caution.


"It is important to keep in mind that a large-scale provision of treatments and vaccines that are in very early stages of development has a series of scientific and ethical implications," the organization said in a statement.


"As doctors, trying an untested drug on patients is a very difficult choice since our first priority is to do no harm, and we would not be sure that the experimental treatment would do more harm than good."


ZMapp has not been approved for human use and has not even gone through the clinical trial process, which is standard to prove the safety and efficacy of a medication. It may have been given under the U.S. Food and Drug Administration's "compassionate use" regulation, which allows access to investigational drugs outside clinical trials.


Getting approval for compassionate use is often long and laborious, but in the case of Brantly and Writebol, they received the medication within seven to 10 days of their exposure to the Ebola virus.


On July 30, the Defense Threat Reduction Agency, an arm of the military responsible for any chemical, biological, radiological, nuclear and high-yield explosive threats, allotted additional funding to MAPP Biopharmaceutical due to "promising results."


American Ebola patient 'seems to be improving'


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