A new emergency use authorization will put the spotlight on vilobelimab (Gohibic) to treat COVID-19 in hospitalized adults.
Vilobelimab blocks complement C5a...to reduce inflammation.
It’s only authorized to treat COVID-19 when started within 48 hours after beginning mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Explain that vilobelimab is given for up to 6 infusions while patients are hospitalized...on days 1, 2, 4, 8, 15, and 22.
Expect that vilobelimab will be touted to reduce mortality in patients requiring mechanical ventilation or ECMO...when added to a steroid.
But be aware of limitations. There isn’t a significant difference in mortality as the primary study outcome...benefit hinges on data reanalysis.
And this is a single study...with fewer than 400 patients.
Plus few patients got recommended steroid add-ons...the IL-6 inhibitor tocilizumab (Actemra) or the Janus kinase (JAK) inhibitor baricitinib (Olumiant).
Don’t update COVID-19 protocols to include vilobelimab yet.
Continue to use tocilizumab or baricitinib as your go-to add-on to steroids. Limited data suggest these meds also reduce mortality in critically ill COVID-19 patients.
Plus tocilizumab or baricitinib can be used in a broader range of patients...such as those on high-flow supplemental oxygen or noninvasive ventilation.
And either med may be more practical. For example, IV tocilizumab can be a single dose...or oral baricitinib is 14 days. A course of either is expected to cost less than vilobelimab.
Point out that all of these meds carry warnings about risk of serious infection...but there’s less experience with vilobelimab.
Use our resource, Treatments for COVID-19, to compare options...including evidence, adverse effects and place in therapy.
- https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products (5-30-23)
- https://www.covid19treatmentguidelines.nih.gov/about-the-guidelines/whats-new/ (5-30-23)
- Lancet Respir Med. 2022 Dec;10(12):1137-1146