COVID-19 Antibodies Raise Unanswered Clinical Questions
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While monoclonal antibody treatment may hold promise for COVID-19, its clinical benefit has yet to be proven, said experts from the Infectious Diseases Society of America (IDSA).

In a media briefing, IDSA experts discussed that while manufacturers of monoclonal antibody treatment, Regeneron and Eli Lilly, both applied for emergency use authorization (EUA) from the FDA to treat COVID-19, the data on both so far have yet to demonstrate any impact on patient care.

Reviewing the data, Adarsh Bhimraj, MD, co-chair of the IDSA COVID-19 Treatment and Management Guidelines Expert panel, noted how the endpoints of both trials examined decreases in viral load for patients.

Bhimraj compared these antibody therapies to the saga of hydroxychloroquine, which was also shown to have "a very fast reduction in viral load" in early studies, "but randomized controlled trials did not translate into patients getting better or not dying."

He pointed to the situation with convalescent plasma, which received an EUA outside the context of a randomized clinical trial. He emphasized how important it was to "let science and let objectivity ... determine the decision-making rather than any kind of political pressure."

Helen Boucher, MD, member of the IDSA Board of Directors, noted that even if an EUA is issued, that's only half the battle, given how much manufacturers would need to scale up to meet demand.

"Any kind of authorization or approval doesn't necessarily mean the drug is available to anyone who needs it," Boucher said.

Using the example of 50,000 people who may be infected with COVID-19 on any particular day, even 20% of those patients ending up in the hospital would require more product than the companies are prepared to produce right now. Boucher said it would take "months" to manufacture enough to treat everyone in this country who needs it.

In addition, the treatment was only shown to be effective in a limited population. Bhimraj pointed out the drug was effective was for patients with mild or moderate disease who were not hospitalized, and were "antibody-negative."

Safety is another issue, with concerns about antibody-mediated worsening of the disease, though Bhimraj said based on the data in the press releases, these drugs seem to be safe and well-tolerated.

Source: https://www.medpagetoday.com/infectiousdisease/covid19/89065
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