For those suffering from COVID-19, the Paxlovid antivirus is a godsend.
The drug emerged as an antiviral treatment during the pandemic after the Food and Drug Administration granted it emergency use authorization in December 2021.
Now, there’s a new antivirus that’s better than Paxlovid — but Americans can’t get it, because it’s stuck in a long FDA approval process.
Ensitrelvir, marketed as Xocova in Japan — the only country where it is legally available — has several advantages over Paxlovid.
However, experts lament that newer and better drugs may not be available in the US until the end of 2024.
The FDA appears to be “slowing down” the approval process for ensitrelvir, infectious disease expert Dr. David Boulware, a professor of medicine at the University of Minnesota, told the Atlantic.
And because the COVID-19 emergency was declared over in May of this year, ensitrelvir may not be granted the same emergency use authorization that Paxlovid received.
However, the FDA has granted the new drug “fast track” status, meaning its review process will be expedited once the drug’s manufacturer, Shionogi of Osaka, Japan, submits the necessary documentation.
Paxlovid emerged as an antiviral drug in the early days of the COVID-19 pandemic.REUTERS
Encitrelvir vs. Paxlovid
Ensitrelvir has several advantages over Paxlovid and other antivirals.
People who took the drug tested negative almost two days earlier than people who took the placebo. Symptoms such as fever, congestion, sore throat, cough and fatigue disappear more quickly in some groups of people than with Paxlovid.
“Rebound” infections, in which symptoms subside and then appear to return – common among Paxlovid users – are rare among ensitrelvir users. In addiction, the taste of ensitrelvir is unusual, according to anecdotal reports, while patients on Paxlovid have described the aftertaste as “a mouthful of dirty pennies and rotten soy milk.”
Symptoms of COVID-19 such as fever, congestion, sore throat, cough and fatigue disappear more quickly with ensitrelvir.Getty Images/iStockphoto
And ensitrelvir is easier to take, as it only requires a once-a-day dose, while Paxlovid users must take three pills twice a day for five days.
The two drugs have never been compared in head-to-head trials, however, so physicians are keeping their enthusiasm for ensitrelvir until more data is available.
Loss of smell and taste
Despite this, a new study found that ensitrelvir effectively reduced one of the most annoying and problematic effects of the COVID infection: the loss of smell and taste.
After seven days, the percentage of study participants experiencing a loss of smell or taste was 39% lower in the group taking ensitrelvir compared to the placebo group.
Paxlovid and ensitrelvir have never been compared in head-to-head trials, so physicians are holding back their enthusiasm for ensitrelvir until more data are available.AP
“Most people will eventually recover on their own, but we know that some people have long-term problems with smell and taste,” Dr. Yohei Doi, an infectious disease researcher at Fujita Health University in Japan who worked on the ensitrelvir study, told Nature.
“When the omicron variant becomes dominant, loss of taste and smell starts to become less and less common,” explained Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, to Nature.
“But it still happens, and it’s a sad symptom,” Adalja added. “What we’re trying to do is not only minimize severe illness, hospitalizations and deaths, but also to minimize the disruption caused by infection to people’s activities.”
Drug manufacturer Shionogi continues to conduct clinical trials on the safety and efficacy of ensitrelvir among different groups of users.
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Source: thtrangdai.edu.vn/en/
