The US Food and Drug Administration has approved ensitrelvir (XOCOVA) for postexposure prophylaxis of coronavirus disease 2019 in adults and adolescents aged 12 years and older following contact with an individual with coronavirus disease 2019, according to a press release from Shionogi. According to Shionogi, the approval introduces the first and only oral option to help prevent coronavirus disease 2019 following exposure.
The approval was based on results from the phase 3 SCORPIO-PEP trial, a global, randomized, double-blind, placebo-controlled study that enrolled 2,387 participants aged 12 years and older who had been exposed to a household member with symptomatic coronavirus disease 2019 (COVID-19) and tested negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection at enrollment. The primary analysis included 2,041 participants with a laboratory-confirmed negative SARS-CoV-2 test result at baseline.
Researchers reported that ensitrelvir reduced the risk of symptomatic COVID-19 by 67% through day 10 compared with placebo among uninfected participants following exposure to an infected household contact.
"It could be useful not only in household settings but also in other exposure circumstances, such as outbreaks in nursing homes, chronic or acute care facilities, and following travel-related exposures," stated Frederick Hayden, MD, Richardson Professor Emeritus of Clinical Virology and Professor Emeritus of Medicine, University of Virginia School of Medicine.
Participants began treatment within 72 hours of symptom onset in the household member with COVID-19. More than 99% of household contacts had evidence of prior SARS-CoV-2 infection, vaccination, or both.
Overall adverse event rates were similar between treatment groups, occurring in 15.1% of participants who received ensitrelvir and 15.5% of those who received placebo. The most common adverse events occurring in at least 1% of participants receiving ensitrelvir and at a higher frequency than placebo were headache, diarrhea, and cough. According to the company, no cases of dysgeusia attributed to ensitrelvir were reported in the trial.
Ensitrelvir is a SARS-CoV-2 main protease inhibitor. According to Shionogi, ensitrelvir suppresses SARS-CoV-2 replication by selectively inhibiting the viral main protease. XOCOVA is administered as a 5-day regimen consisting of three tablets on day 1 and one tablet daily on days 2 through 5, according to the company. The SCORPIO-PEP trial results were published in The New England Journal of Medicine.
Source: Shionogi
