Gohibic (vilobelimab) is now commercially available for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Gohibic is a monoclonal anti-human complement factor C5a antibody. The product was granted Emergency Use Authorization by the Food and Drug Administration based on data from the phase 3 PANAMO trial (ClinicalTrials.gov Identifier: NCT04333420).
The study included patients 18 years of age and older with COVID-19 who were receiving IMV in intensive care units (ICU). Patients were randomly assigned 1:1 to receive either vilobelimab (n=177) or placebo (n=191), in addition to standard of care (eg, anticoagulants, dexamethasone, other immunomodulators).
Results showed that the Kaplan-Meier estimated 28-day mortality rate (primary endpoint) was 31.7% in the vilobelimab arm compared with 41.6% in the placebo arm (hazard ratio, 0.67 [95% CI, 0.48-0.96]; P <.05), correlating to a 23.9% reduction in risk; similar results were reported at day 60. The percentage of patients alive and either discharged from the hospital or no longer requiring supplemental oxygen at day 28 were comparable in the vilobelimab and placebo arms (35.0% vs 36.1%, respectively).
The most common adverse reactions reported with vilobelimab were pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, increased hepatic enzymes, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash.
Gohibic is supplied as a 200mg/20mL solution in a single-dose vial for IV infusion after dilution. The recommended dosage is 800mg administered by IV infusion, given up to 6 times over the treatment period. Treatment should be started within 48 hours of intubation (day 1) followed by administration on days 2, 4, 8, 15 and 22 as long as the patient is hospitalized (even if discharged from ICU).
This article originally appeared on MPR
