The US has its first and solely oral COVID-19 post-exposure prophylaxis (PEP) on its means, after a Section III trial of the drug ensitrelvir met targets required for approval by the US Meals and Drug Administration (FDA).
Ensitrelvir, which will likely be offered below the model title Xocova within the US, was developed by Japanese pharmaceutical firm Shionogi. It has been accredited to be used in Japan since 2024.
As an anti–SARS-CoV-2 drug, ensitrelvir is designed to chop the danger of contracting the virus following publicity. The remedy is a five-day routine of tablets, with three taken up entrance after which one tablet every day for the remaining interval.
“The FDA approval of Xocova offers an vital new strategy to stopping COVID-19, which continues to influence lives,” mentioned Frederick Hayden, MD, a medical professor on the College of Virginia College of Medication, in a Shionogi assertion. “COVID-19 can turn into extreme, and even when gentle or reasonable, it could possibly worsen or exacerbate continual circumstances or set off new ones, together with lengthy COVID.
“Ensitrelvir inhibits viral replication, serving to defend individuals who have been uncovered to COVID-19 from growing sickness,” he added. “The PEP technique has the potential to profit anybody who doesn’t wish to get COVID-19. It could possibly be helpful not solely in family settings but in addition in different publicity circumstances, corresponding to outbreaks in nursing houses, continual or acute care services and following travel-related exposures.”
Within the SCORPIO-PREP Section III trial,1,030 contributors acquired ensitrelvir inside 72 hours of household exposure to a symptomatic shut contact, whereas 1,011 took a placebo.
Xocova decreased the danger of symptomatic COVID-19 by 67% following publicity to an contaminated particular person by Day 10, in contrast with the management.
Uncomfortable side effects, mostly headache, diarrhea and cough, have been low – 15.1% within the ensitrelvir group and 15.5% within the placebo group – with the danger of great opposed occasions extraordinarily uncommon, at 0.2% for each cohorts.
Critically, not one of the COVID-19 infections required hospitalizations.
“Xocova is the primary and solely oral possibility clinically confirmed to assist forestall symptomatic COVID-19 after publicity amongst research contributors no matter vaccination standing or baseline immunity from prior an infection,” mentioned Nathan McCutcheon, President and CEO, Shionogi Inc. “With Xocova, people who find themselves uncovered to COVID-19 can act early to assist defend themselves.”
Whereas antiviral drugs corresponding to molnupiravir (model title Lavegrio) have been out there to scale back the severity of the virus in sufferers, ensitrelvir turns into the primary drug available on the market to assist forestall an infection.
Xocova will likely be out there for all adults and people aged 12 years and older.
The outcomes of the research have been revealed within the New England Journal of Medicine.
Supply: Shionogi
Reality-checked by Mike McRae
