BREAKTHROUGHS BLOG

June 03, 2019

Research Roundup: An experimental Ebola cure may also protect against Nipah virus, gender inequality in clinical trials, and FDA authorizes first Zika diagnostic test for marketing

Ansley Kahn
Senior Program Assistant
GHTC
PATH/Georgina Goodwin

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An experimental drug, remdesivir, was shown to protect monkeys against infection with Nipah virus—an emerging pandemic threat for which there is no approved vaccine or cure. The only current treatment is a still experimental monoclonal antibody that was tested during an outbreak in India last year. Remdesivir is also being tested against the Ebola virus in the current outbreak in the Democratic Republic of Congo and has shown some effectiveness against Lassa fever, MERS coronavirus, and respiratory syncytial virus in other studies. In the new study performed by the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention, eight African green monkeys were given lethal doses of Nipah virus. The four monkeys who received intravenous remdesivir within 24 hours of infection and daily infusions for 12 days survived, while the four that did not died within eight days. If remdesivir wins approval, “it will give us an extra treatment that could be used relatively quickly,” said Emmie de Wit, a virologist at NIAID, noting that “the average person who reaches a hospital dies within two days, so it’s hard to protect them once they’re infected.” The next step is to test how long after infection the drug can be given and still cure the animals.

Women make up just over half of the 35 million people living with HIV worldwide but are underrepresented in clinical trials of potential HIV treatments, cures, and vaccines. A 2016 study performed by amfAR, the Foundation for AIDS Research, found that women represented a mean of only 11 percent of HIV cure trials, 19 percent of antiretroviral drug trials, and 38 percent of vaccine studies. Despite the well-known differences in how the immune systems of men and women respond to the HIV infection and how women respond to some drug treatments, clinical trials continue to rely heavily on the participation of gay men in particular. Further complicating women’s participation in clinical trials is the US Food and Drug Administration’s (FDA) strict rules for including women of childbearing age, leaving most researchers to opt for the easy way out and just enroll men, collecting data from women only after the drug is on the market. As scientists continue to pursue cures for HIV in light of reports of the second patient cured of the infection, researchers must reckon with the longstanding obstacle of the lack of women in clinical trials.

The FDA has authorized the first diagnostic test to detect Zika antibodies in human blood to be marketed in the United States. The diagnostic, known as ZIKV Detect 2.0 IgM Capture ELISA, detects the proteins produced by the body’s immune system when it tests for the Zika virus in blood. Though 18 other active tests to detect Zika exist, they have only been allowed under emergency use. This newly approved diagnostic test will only be usable by those with clinical signs and symptoms of Zika or on those who have traveled to regions with active Zika transmissions. FDA Acting Commissioner Ned Sharples noted that the marketing authorization of this Zika diagnostic demonstrates “FDA’s work to protect the public health in emergency response situations.”

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