Tony Hagen is senior managing editor for The Center for Biosimilars®.
Monoclonal antibodies may play a frontline role in dealing with COVID-19 infections, according to Anthony S. Fauci, MD.
Much has been made of treatments for advanced coronavirus disease 2019 (COVID-19) infection, but early-stage treatments such as monoclonal antibodies (mAbs) and direct-acting antivirals (DAAs) are showing promise, said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infection Diseases, in a recent town hall meeting.
Among mAbs, for instance, the infliximab biosimilar Remsima is undergoing testing in the CATALYST study for treatment of COVID-19 related inflammation. The Celltrion Healthcare drug has previously been employed for inflammatory conditions, which investigators believe makes it a promising candidate for treatment of COVID-19.
DAAs target specific virus proteins and disrupt viral replication and infection. Also showing promise, Fauci said, are convalescent plasma and hyperimmune globulin, therapies that involve antibody-laden blood taken from patients who have recovered from COVID-19. “There’s a lot of drugs and interventions that are actually being tested right now,” he said.
Although those are largely experimental, there is sound progress in treatment of late-stage disease, Fauci noted. Two drugs have been shown in placebo-controlled trials to have a beneficial effect in advanced disease. One is the antiviral remdesivir, which has significantly reduced time to recovery and hospital discharge, and the second is dexamethasone, an anti-inflammatory that has reduced the death rate in patients with COVID-19 not yet on ventilators but who need supplementary oxygen. These drugs are already recommended by guidelines-setting authorities for treatment of COVID-19, Fauci said.
A Poster Child
Against the global backdrop, the United States has at times been exemplary for how not to manage the spread of COVID-19, but Fauci said he and others are in regular, weekly consults hosted by the World Health Organization to share information and experience.
“We have scientific collaboration with colleagues in the European Union, Australia, Canada, and Mexico. We have clinical trial networks in South Africa, Brazil, Chile, and Peru. So, there’s an awful lot of international activity going on. You don’t hear very much about that…, but it’s going on rather intensively," he noted.
Based on the progress, should schools be opening in the United States? Fauci said it all depends.
“The genuine default condition should be to try as best as you can to open up the schools for the reasons that the American Academy of Pediatrics has articulated very well: the psychological health of children, sometimes dependent on nutrition for breakfasts and lunches, and the secondary, downstream ripple effects that are negative for the families that might have to interrupt work to take care of the kids,” he said.
That said, it’s necessary to maintain the health of parents, relatives, and teachers as well as children, and “we live in a big country that has different levels of infection in different regions, states, cities, counties.” Some areas have less than 5% test-positivity for COVID-19 infection, and so you can open schools there “with relatively little impunity,” he said.
In areas with 5% to 10% test-positivity, there are CDC guidelines to help determine how to open schools and still protect school children and prevent the spread of infection. For areas in the “red zone” with greater than 10% test-positivity, “you really better think twice before you do that, because what might happen is you go in, people get infected, and—Boom!—they close them down,” he said.
“The bottom line is we live in a big country and we can’t take a unidimensional approach. Taking the country as a whole won’t work. We’re so heterogeneous,” Fauci said.
In other pandemic clinical developments, biosimilar interferon beta-1a (IFN-β-1a, ReciGen) has shown effectiveness in helping to reduce symptoms and achieve virological clearance in patients with COVID-19.