A promising new Covid pill shows key advantages over Paxlovid being tested
An employee sorts drugs at a pharmacy in Huai’an, China on December 10, 2022.
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A new antiviral drug for Covid was found to be as effective as Paxlovid in limiting mild to moderate illness in people at high risk of severe illness in a Phase 3 trial in China.
Result, published Wednesday in the New England Journal of Medicine, suggesting that the treatment has fewer side effects than Paxlovid, an antiviral for high-risk patients. About 67% of those taking the experimental drug, known as VV116, reported side effects, compared with 77% of those taking Paxlovid.
The new drug is also less likely to cause unwanted side effects than Paxlovid from reactions with other drugs, such as drugs for insomnia, seizures or high blood pressure.
“You have a drug that looks just as good as Paxlovid, but less bulky,” said Dr. Panagis Galiatsatos, assistant professor of medicine at Johns Hopkins Medicine in Baltimore.
VV116 is similar to the antiviral remdesivir, which the Food and Drug Administration has approved as an IV infusion. But the team behind the new drug – pharmaceutical companies Junshi Biosciences and Vigonvita Life Sciences – have adapted the formula so that the body can absorb it in pill form, said Dr. Peter Gulick, an associate professor of medicine at State University Michigan said. Gilead ScienceThe company that developed remdesivir is testing a similar oral version.
Gulick said people who have received intravenous remdesivir so far have not seen it recovery symptoms for a few days or weeks after treatment everyone has with Paxlovid.
In trial VV116, more than 380 people took the experimental drug, while a similarly sized group took Paxlovid. Both treatments lasted five days.
The median time to recovery – defined as being without Covid symptoms for two consecutive days – was four days for VV116 recipients and five days for Paxlovid users. After four weeks, about 98% of all participants had recovered and none had developed severe Covid.
Study co-author Ren Zhao, a professor at Shanghai Jiao Tong University School of Medicine, called the trial a “huge success” in a press release Thursday.
When it comes to specific side effects, about 26% of trial participants taking Paxlovid said it changed their taste buds – foods that taste sour, sweet, bitter or metallic – but only 4% of those VV116 users report that experience. Although some people in both groups had high levels of triglycerides (fats in the blood that can increase the risk of heart disease or stroke), a smaller percentage of people in the VV116 group noticed the effects. that effect: 11% versus 21% of participants taking VV116. take Paxlovid.
Galiatsatos says the ability to reduce side effects is “a big deal”.
Three-quarters of the trial participants were vaccinated, although the study showed consistent results regardless of vaccine status.
US health experts say it is important to study the drug in a larger, more diverse group. Such trials could better capture rare side effects and test how the drug works against the newer omicron sub-variants that have emerged since the study period.
Galiatsatos said the FDA will likely require more data before considering emergency authorization.
But he added that the pill looks promising: “It looks like we might have another tool in the toolbox.”
Filling the gap in Covid treatment
Antiviral drugs are designed to prevent viruses from multiplying. According to Gulick, because they do not promote an antibody response like vaccines, the effectiveness of antiviral drugs is less sensitive to changes in the coronavirus as new variants and sub-variants develop. , according to Gulick.
“This whole group of agents will be very important for the future,” he said.
Besides remdesivir, the FDA has granted emergency authorization for two antiviral drugs: Paxlovid and molnupiravir. National Institutes of Health Recommendations Paxlovid, with molnupiravir as an alternative in situations when neither Paxlovid nor remdesivir is available or appropriate.
Paxlovid, although effective in preventing severe illness, also has some drawbacks. It contains a drug called ritonavir, which can cause liver damage — mainly in patients with pre-existing liver problems — and it can have negative interactions with other drugs such as statins or heart medications. .
“A lot of healthcare providers have been hesitant to give Paxlovid to many patients because of concerns about drug-drug interactions,” says Gulick.
Many of the patients most at risk of severe Covid-19 are taking multiple medications, he added.
“Paxlovid is still a great drug, but there are many reasons why it’s not really reaching the people it needs,” said Galiatsatos.
Experts hope that VV116 can fill some of these gaps, assuming it performs well in larger studies. Standard phase 3 drug trial with up to 3,000 participants, according to FDA. Paxlovid’s final testing including more than 2,200 people.
“The rare side effects you’ll only get when you hit the market in larger quantities,” says Galiatsatos. “It’s like playing the lottery: 1 in 100 people won’t win, but 1 in 1 million people will, because you increase the likelihood of seeing a rare event happen.”