Promising new Covid pill shows advantages over Paxlovid in trial

A Phase 3 trial in China found a new antiviral pill for Covid to be as effective as Paxlovid in controlling mild to moderate illness in people at high risk of severe illness.

The results, published Wednesday in The New England Journal of Medicine, show the treatment has fewer side effects than Paxlovid, the antiviral to use for high-risk patients. About 67% of those taking the experimental pill VV116 reported side effects compared to 77% of those taking Paxlovid.

The new pill was also less likely than Paxlovid to cause unexpected side effects due to insomnia, seizures, or reactions with other medications, such as high blood pressure.

D., assistant professor of Johns Hopkins Medicine in Baltimore. “You have a drug that looks as good as Paxlovid, but less burdensome,” said Panagis Galiatsatos.

VV116 is similar to the antiviral remdesivir, approved by the Food and Drug Administration as an IV infusion. But a professor of medicine at Michigan State University, Dr. Peter Gulick, the team behind the new drug – pharmaceutical companies Junshi Biosciences and Vigonvita Life Sciences – modified the formula so the body could absorb it in pill form. Gilead Sciences, which developed Remdesivir, is testing a similar oral version of its drug.

Gulick said that until now, people who took intravenous remdesivir had not seen their symptoms rebound in the days or weeks following treatment, as they did with Paxlovid.

In the VV116 trial, more than 380 people received the experimental drug, while a similarly sized group received Paxlovid. Both treatment courses lasted five days.

The mean recovery time, defined as two consecutive days of no symptoms of Covid, was four days for VV116 recipients and five days for Paxlovid recipients. After four weeks, about 98% of all participants had recovered and no one developed severe Covid.

Study co-author Ren Zhao, a professor at Shanghai Jiao Tong University School of Medicine, described the trial as a “huge success” in a news release on Thursday.

When it comes to certain side effects, about 26% of trial participants who took Paxlovid said it altered their sense of taste – the taste of food being sour, sweet, bitter or metallic – but only 4% of people taking VV116 reported the experience. Although some people in both groups had high triglyceride levels (blood fat that can increase the risk of heart disease or stroke), a smaller proportion of those in the VV116 group saw this effect: 21% versus 11% took Paxlovid.

Galiatsatos said the reduced chance of side effects is “a big problem.”

Three-quarters of trial participants were vaccinated, but the study found consistent results regardless of vaccine status.

US medical experts said it would be important to study the pill in a larger, more diverse group. Such trials could better capture rare side effects and examine how the drug stands up against newer omicron sub-variants that have emerged since the study period.

Galiatsatos said the FDA will likely ask for more data before considering emergency authorization.

But he added that the pill looks promising: “It looks like there may be another tool in the toolbox.”

Filling a gap in Covid treatments

Antiviral drugs are designed to stop a virus from multiplying. According to Gulick, the effectiveness of antivirals is less sensitive to changes in the coronavirus as new variants and sub-variants evolve, as they do not trigger an antibody response like vaccines.

“This whole group of agents will be very important for the future,” he said.

Alongside Remdesivir, the FDA granted emergency clearance for two antiviral pills: Paxlovid and molnupiravir. The National Institutes of Health recommends Paxlovid in combination with molnupiravir as an alternative when Paxlovid or remdesivir are unavailable or unsuitable.

While Paxlovid is effective at preventing serious illness, it comes with a few drawbacks. It contains a drug called ritonavir that can cause liver damage, mostly in patients with pre-existing liver problems, and may have adverse interactions with other drugs such as statins or heart medications.

“Many medical providers were very hesitant to use Paxlovid in many patients because they were concerned about drug-drug interactions,” Gulick said. Said.

He added that many patients at highest risk of severe Covid are using more than one medication.

“Paxlovid is still a great drug, but there are several reasons that prevent it from reaching everyone who really needs it,” Galiatsatos said.

Experts are hopeful that the VV116 can fill some of these gaps, assuming it performs well in larger studies. According to the FDA, standard Phase 3 drug trials involve up to 3,000 participants. More than 2,200 people took part in Paxlovid’s final phase trial.

“Rare side effects that you will only get when you start a larger population,” Galiatsatos said. “It’s like playing the lottery: It won’t win 1 in 100, but it will win 1 in a million because you increase the odds of a rare event occurring.”

Leave a Reply

Your email address will not be published. Required fields are marked *