Focus: US provides Ebola treatment for outbreak in Congo, bringing trials closer
The U.S. government has provided experimental antibody drug doses from Mapp Biopharmaceutical for clinical trials against a Bundibugyo Ebola outbreak in the Democratic Republic of Congo, according to a Health Department spokesperson. This marks a policy shift, as the U.S. previously reserved the MBP134 treatment exclusively for American citizens.
Why is the U.S. providing the Mapp drug now?
The Department of Health and Human Services is making the drug available for compassionate use and to advance clinical trials in the outbreak region. A spokesperson stated the resulting data could inform future regulatory reviews and potential approval within the U.S.
The U.S. Centers for Disease Control and Prevention warned that this could potentially be the worst Ebola outbreak yet without a strong response. This contribution follows a period where the U.S. dismantled the U.S. Agency for International Development and reduced aid to the region.
While the U.S. has pledged hundreds of millions of dollars to the response, it is also constructing a quarantine center in Kenya for American citizens to prevent the virus from reaching the U.S.
What treatments are being tested for the Bundibugyo strain?
The World Health Organization (WHO) is sponsoring trials for Mapp’s MBP134, which the University of Oxford is leading alongside the governments of Congo and Uganda. MBP134 will be tested as a standalone treatment and in combination with Gilead Sciences’ antiviral remdesivir, also known as Veklury.
A second Gilead antiviral, obeldesivir, may begin testing this month as a preventive option. This specific trial is led by Congo, Uganda, and the Africa Centres for Disease Control and Prevention, with co-sponsorship from France’s ANRS Emerging Infectious Diseases agency and Congo’s National Institute for Biomedical Research.
WHO and Mapp officials noted that while these treatments showed safety in earlier trials, they have not yet been tested for efficacy against the Bundibugyo strain.
When will Ebola vaccines be available?
Vaccines will take longer to deploy than treatments, according to the WHO. Director-General Tedros Adhanom Ghebreyesus stated that doses must be manufactured and tested for safety and side effects before use in Congo hot spots.
Richard Hatchett, chief executive of the Coalition for Epidemic Preparedness Innovations (CEPI), said Phase 1 trials could begin in July. These trials are likely to occur in the UK and possibly Uganda.
CEPI has backed four candidates. The first to reach testing may be a vaccine developed by the Serum Institute of India and Oxford, or an mRNA-based candidate from Moderna.
What challenges face these clinical trials?
Global health officials said running trials in a conflict-hit region will be difficult. They cited disrupted supply chains, widespread mistrust, and attacks on health workers as primary obstacles.
The WHO also identified disease testing and contact tracing as significant challenges. The agency stated it is prioritizing these issues to ensure patients can access drugs if they are proven safe and effective.
Frequently Asked Questions
What is the current scale of the Bundibugyo Ebola outbreak?
According to the source, the outbreak has caused more than 1,000 cases in Congo, including more than 250 deaths, with a handful of cases and deaths reported in Uganda.
Which organizations are leading the drug trials?
The MBP134 trial is sponsored by the WHO and led by the University of Oxford and the governments of Congo and Uganda. The obeldesivir trial is led by Congo, Uganda, and the Africa Centres for Disease Control and Prevention.
How does the U.S. position on the Mapp drug change?
The U.S. previously stated that doses of the antibody treatment would only be available for Americans at high risk after exposure, but it is now providing doses for clinical trials and compassionate use in Congo.
How should global health organizations balance the need for speed with the necessity of clinical trials during an active outbreak?