The U.S. Food and Drug Administration (FDA) has approved the new antiviral medication ensitrelvir (Xocova), developed by the Japanese pharmaceutical company Shionogi, for the post-exposure prophylaxis (PEP) of COVID-19 in individuals 12 years of age and older.<\/p>\n
Ensitrelvir acts as a SARS-CoV-2 main protease (Mpro) inhibitor. This enzyme is critical for viral replication; consequently, its selective inhibition suppresses viral propagation within the body. The drug is already approved in Japan for both the post-exposure prophylaxis of COVID-19 and the treatment of mild-to-moderate COVID-19. It is important to note that, in the United States, the drug is not approved for the treatment of COVID-19.<\/p>\n
The FDA\u2019s decision is based on the results of the Phase III SCORPIO-PEP clinical trial, which is the only Phase III trial for an oral antiviral to have met its primary efficacy endpoint in preventing symptomatic COVID-19 following exposure to an infected individual. According to the study results, Xocova significantly reduced the risk of developing COVID-19 symptoms in people who had been in contact with an infected person. Specifically, within 10 days of starting the medication, 67% fewer people developed the disease compared to the placebo group (ensitrelvir n=1,030; placebo n=1,011).<\/p>\n
The drug’s safety profile was evaluated as clinically acceptable. The incidence of adverse events was nearly identical between the treatment and placebo groups (15.1% in the Xocova group (n=1,190) and 15.5% in the placebo group (n=1,187)). The most common adverse effects (regardless of causality) reported in the Xocova group in \u22651% of participants, and occurring at a higher frequency than in the placebo group, included headache, diarrhea, and cough. No cases of taste disturbance (dysgeusia) were reported during the study. The drug is recommended for use within 72 hours of exposure, and the treatment course lasts for 5 days. The dosage regimen consists of three 125 mg tablets on the first day, followed by one 125 mg tablet daily from day 2 through day 5.<\/p>\n
Despite its high efficacy, strict adherence to limitations regarding the medication’s use in clinical practice is required. Ensitrelvir is contraindicated in patients with a known allergy to ensitrelvir or any of its components. Furthermore, Xocova must not be used concomitantly with several medications, including apalutamide, carbamazepine, colchicine, dihydroergotamine, enzalutamide, eplerenone, ergotamine, finerenone, ivabradine, lomitapide, lumacaftor\/ivacaftor, lurasidone, methylergonovine, phenytoin, pimozide, quinidine, rifampin, St. John\u2019s wort, simvastatin, triazolam, and voclosporin, as these combinations may lead to severe or life-threatening adverse reactions. Additionally, the drug requires special caution in women of reproductive age and pregnant individuals, as potential harm to the fetus cannot be ruled out; furthermore, it is recommended that breastfeeding be suspended during the treatment course and for two weeks following its completion.<\/p>\n
Sources: medpagetoday.com<\/a><\/p>\n