
Clinical trial attempts to find protection against Ebola caused by Bundibugyo virus
RWAMPARA, Congo (AP) — More than 250 participants have been enrolled in a trial of a drug that could prevent them from contracting Ebola in Congoin what experts have described as a crucial step in trying to combat the the deadliest outbreak of the disease in this central African country.
The drug targets the Bundibugyo virus, which is responsible for the fast-moving outbreak and has no approved vaccine or treatment. The trial began in July and is one of several studies launched to find some protection and another way to at least slow the outbreak.
The Associated Press spoke this week with participants and doctors at the health center where the trial is taking place in the eastern province of Ituri, the epicenter of the outbreak. Participants include people who were exposed to the disease during this outbreak, including health workers and relatives of patients.
At least 8,300 confirmed casesincluding 4,000 deaths, have been recorded since the declaration of this Ebola epidemic in mid-May in eastern Congo. He has expanded to seven provinces and continues to outpace efforts to track and slow it, authorities say.
The trial is testing Gilead’s experimental antiviral pill, called obeldesivir, which is given shortly after suspected contact with the virus to prevent the disease from developing. This approach is called post-exposure prophylaxis, or PEP.
Drug aims to stop disease before it spreads
A participant in the trial known as EBO-PEP told AP she enrolled in the study in August after her husband tested positive for Ebola. She says so far no one in her family has developed symptoms.
She and other trial participants requested anonymity to protect their privacy due to the sensitive nature of the Ebola outbreak and the medical protocol involved.
“I realized that if I even touched my husband – and I touched him, his vomit, everything – (that meant that) I was a direct contact. I could also have transmitted this contagious disease. I could have been contaminated,” the participant said.
She said she knows of entire households that have been infected after a family member tested positive for Ebola. But so far, no one in her family has developed symptoms, she said.
Ebola disease only spreads once symptoms appear. People exposed to infected patients should wait to see if they become ill. Finding people at high risk of incubating the Bundibugyo virus – also known as contact tracing – has proven difficult in Congo.
Another participant said two members of his family had contracted Ebola and one of them had died. “This disease kills. It’s better to take precautions,” he said.
How the trial works
The trial, coordinated by ALIMA, a nonprofit medical organization, aims to recruit nearly 1,000 adults or children over the age of 12 who have been in contact with a confirmed case in the past five days but have no symptoms. Half will receive a placebo.
Participants are followed in person every day for 21 days, with a final phone call after 42 days, according to Dr. Godefroid Basara, who is working on the trial.
ALIMA said that if trial participants begin to develop symptoms, they will immediately receive supportive treatment, which has been shown to be helpful when symptoms are detected early.
If the pill proves effective, it could help break the chain of infection.
“It is different from a vaccine, which can take days or weeks to provide protection. It is also different from a curative treatment because it is intended for people who do not yet have symptoms,” said Dr. Guilavogui Jean Paul Yassa, ALIMA research coordinator.
Dr Jacques Zawadi, a medical investigator working with ALIMA at the trial center, said most participants were happy to take part in the study, but it had been difficult to encourage some people living far from the center to sign up.
He said the study was sometimes interrupted when participants discovered their family members had died from the disease.
“This is the biggest challenge we face. When a person is emotionally affected, it is not easy to reason with them and make sure they return to study,” he said.
Trial partners also include the National Institute of Biomedical Research of Congo and the French ANRS Institute for Emerging Infectious Diseases.
Frontline health workers are also at high risk
While new vaccines are being developed elsewhere, Congo has started vaccinating health workers with the Ervebo vaccine which has proven effective in previous Ebola outbreaks caused by a different, more common virus. The authorities said Ervebo could offer some protection against Bundibugyo, but whether the vaccine can actually prevent the disease is still under study.
On Thursday, humanitarian organization Doctors Without Borders said a member of its staff had tested positive for Ebola and was being evacuated to the Netherlands. In June, a humanitarian doctor from ALIMA also tested positive after returning to France from one of the virus hotspots.
The World Health Organization said the outbreak continues to outpace efforts to track and slow the spread, and is expected to surpass the regional outbreak in West Africa between 2014 and 2016 – the deadliest on record – which killed 11,000 people.
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Brennan reported from Dakar, Senegal. Lauran Neergaard contributed from Washington, D.C.
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