Covid researchers are racing the clock. They’ve made enormous progress on therapies and vaccines, but they aren’t far enough along to arrest the current surge of Covid infections as winter approaches. One of the biggest challenges is making sure the new treatments reach the patients who need them most.
The most immediate opportunity comes from antibody drugs that can be used both as treatment and prophylaxis. President Trump and former New Jersey Gov. Chris Christie both recovered after they received antibody combinations when their symptoms were worsening. These medications are likely to be most effective when used before or soon after symptoms begin.
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The Food and Drug Administration is reviewing evidence for the emergency authorization of these drugs, aiming to get them to Covid patients before they need to be hospitalized. We recently wrote on these pages about some important steps to ensure an adequate supply. Available medicine will need to be used wisely on the patients who need it most.
There are also practical challenges of administering these medicines intravenously and under medical supervision. Sending Covid patients to infusion clinics is a bad option, since those facilities are full of cancer patients and others with suppressed immune systems who may be at serious risk if infected.
The federal government is working on a system to control distribution, essentially sending limited supplies to states in proportion to their expected eligible patients. Governors would allocate the drugs to hospitals, as happened with the antiviral drug remdesivir.
This will require collaboration from states and hospitals in setting up special administration sites. Such sites might include emergency departments. But when Covid strikes a metropolitan area, stressed emergency wards may not have the space. Moreover, ideally the antibody drug would be given to patients who aren’t yet very sick. Healthy patients are often reluctant to take infused drugs, which feel riskier than swallowing pills. Having to spend three hours at a hospital will make that perception worse.
A more flexible approach would include modular sites or conversions of other hospital spaces. Health-care providers have also substantially expanded home infusion capabilities during the pandemic. It might be possible to treat some Covid patients at home, staffed by medical professionals trained to handle the small risk of allergic reactions. The FDA would need to authorize the drugs for delivery in home settings. The risk of managing reactions to the drug must be weighed against the risks that patients will avoid the hospital and forgo the therapy altogether.
A related issue is payment. Even if the antibody drug is free for patients, providers need reimbursement for the substantial costs of administering the
UC San Francisco released a preliminary analysis Thursday of data from a coronavirus testing effort in Oakland’s Fruitvale neighborhood and it confirmed what other similar studies have found: The novel coronavirus disproportionately affects the Latino community.
UCSF, in conjunction with local community groups, offered free, voluntary COVID-19 testing Sept. 26 and 27 in Fruitvale, a corner of Alameda County that has had the highest rates of COVID. Fruitvale is 50% Latino and home to one of the largest Mayan-speaking populations outside of Mexico, according to UCSF. Many residents live in multigenerational households.
The Food and Drug Administration (FDA) has approved the first treatment for Zaire ebolavirus (Ebola virus). The antibody medicine, called Inmazeb, is a cocktail of anti-viral antibodies made by Regeneron Pharmaceuticals to tackle the deadly disease, which continues to ravage the Democratic Republic of Congo (DRC).
The novel treatment helps stave off the Zaire ebolavirus infection in both adult and young patients, and has been approved for widespread use after a large 2019 trial deemed it safe and effective at reducing mortality in infected patients. The medication, called REGN-EB3 (commercially Inmazeb), is most effective when administered early on during Ebola infection.
It will now be used alongside Merck’s Ervebo, the first FDA-approved vaccine for Ebola, as a two-pronged defense against the outbreaks seen across Africa.
“We are incredibly proud that the FDA has approved Inmazeb, which is also known as REGN-EB3. This is the first time the FDA has approved a treatment specifically for Ebola, which has caused a number of deadly outbreaks,” said George D. Yancopoulos, president and chief scientific officer of Regeneron, in a statement.
On June 1, 2020, the DRC announced its 11th outbreak of Ebola virus, which is still ongoing. As of September 2, the outbreak had taken the lives of 47 people. The 10th outbreak was the second largest on record and took the lives of 2,299 people within the DRC.
Inmazeb contains antibodies that bind directly to the Zaire ebolavirus and blocks the molecules that allow the virus particles to attach to the human cells. These molecules, called glycoproteins, bind to human cell receptors and provide a pathway for the virus to enter the cell, where it replicates and wages war on the immune system. Instead, the cocktail of antibodies contained in Inmazeb attach to the virus glycoprotein, blocking the binding site (epitope). By blocking this method of entry, the antibodies can prevent the virus from spreading and doing damage to host cells.
The medicine does have notable side effects, including fever, chills, tachycardia (fast heart rate), tachypnea (fast breathing), and vomiting. While these symptoms were related to Inmazeb, they are also symptoms of the Ebola virus and could have been directly related to the infection instead of the medicine.
Now, Regeneron hopes to provide the life-saving medication for free to people living under the current Ebola outbreak in the DRC, as part of the Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) protocol for compassionate use. The USA has also ordered Inmazeb in preparation for any potential public health emergencies in the future.
However, Inmazeb is not the only project Regeneron has been working on. You may recognize the name from a different antibody medicine (REGN-COV2) taken by US President Donald Trump during his battle with Covid-19. The company is still actively working toward a safe and effective Covid-19 treatment, and whilst the REGN-COV2 looks promising, it is still in the experimental phase.