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MSF aims to start drug trials in Ebola clinics next month

Tue, 21st Oct 2014 17:24

* MSF says priority will be treatments already available

* Hopes trials can begin in November

* MSF would not approve use of placebo in drug trials

* Women and children should be included in tests

By Daniel Flynn

DAKAR, Oct 21 (Reuters) - The medical charity Medecines SansFrontieres (MSF) intends to start trials of experimental Eboladrugs in its treatment centres in West Africa next month, as itsteps up measures to tackle the worst outbreak of the disease onrecord.

Bertrand Draguez, medical director of MSF Belgium, saidacademics and the World Health Organization (WHO) were currentlyassessing which drugs to include in the tests. Meanwhile, a teamof experts in West Africa was assessing which treatments shouldbe tested in which MSF clinic, he said.

Ebola is known to have killed more than 4,500 people inLiberia, Sierra Leone and Guinea. But with at least half thecases going unreported and with an estimated 70 percent fatalityrate, the true toll may be more than 12,000, aid workers say.

With cases also recorded in the United States and Spain, theoutbreak has prompted pharmaceutical companies to fast-tracktrials of drugs to treat Ebola and vaccines to stop its spread.

The WHO said on Tuesday that tens of thousands of people inWest Africa should begin getting experimental Ebola vaccines byJanuary, chief among them drugs from GlaxoSmithKline andNewLink Genetics.

Successful vaccines would prevent people from getting Ebola.The MSF trials will test treatments for people who already havethe disease.

"It is the first time MSF will be involved in experimentalresearch," Draguez said. "But it's an unprecedented outbreak andall actors need to be flexible ... We are one of the fewproviding care to patients and to do these trials you needpatients."

Draguez said priority would be given to pharmaceuticals thatare already available - so called 'off-label' drugs that wereapproved for use on other diseases but that may have abeneficial effect on Ebola.

"To start the trials, I hope we are talking about weeks," Draguez said. "I hope it will be around the end of November."

TURN NO ONE DOWN

Draguez said MSF wanted to avoid having to turn down anypatient who wanted to be involved in the trials because of thelack of availability of drugs.

He said that while there were good supplies of Avigan, orfavipiravir, originally developed by Japan's Fujifilm to treat flu, and Chimerix's Brincidofovir, the ZMapptreatment developed by Mapp Biopharmaceutical was scarcer. Afourth treatment, TKM-Ebola, is being developed by Tekmira.

Before trials start, MSF will send a team to meet withcommunity leaders to seek their approval. Local resistancedogged early efforts to tackle the outbreak after it wasdetected in March deep in the forests of southeastern Guinea.

MSF staff will also seek individual consent from patients.Draguez said MSF staff would monitor the results themselves,given the high-risk conditions inside Ebola treatment units.

The trials are likely to be spread over MSF's six centres inthe three countries, with each site testing different drugs.Exact timing will depend on expected patient numbers, to avoidoverburdening staff and disturbing the quality of care.

Some of the procedures of clinical trials will have to beabandoned, Draguez said. MSF wants to avoid committing staff toheavy monitoring of patients, including blood samples.

"For us, it is also not acceptable to have a placebo,because we don't want patients asking 'why not me and why thisperson?'"

Instead of randomised testing, Draguez said patients wouldbe accepted for the trials sequentially as they arrived atclinics, with women and children included.

"MSF retains the right to veto this and say we will not gofor this trial," Draguez said. (Reporting by Daniel Flynn; Editing by Larry King)

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