On Wednesday, the Food and Drug Administration authorized Paxlovid, the first prescription antiviral pill specifically designed to treat mild to moderate cases of COVID-19 in at-risk patients.
Paxlovid, which is made by Pfizer, should be given “as soon as possible” after someone has been diagnosed with COVID-19 and within five days after they developed symptoms of the virus, the FDA says.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally—a major step forward in the fight against this global pandemic,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”
You probably have lot of questions about Paxlovid and fair. Here’s everything you need to know about the COVID-19 pill.
What are the ingredients in Paxlovid?Paxlovid has two main ingredients—nirmatrelvir and ritonavir. Together, these ingredients work to inhibit a protein in SARS-CoV-2, the virus that causes COVID-19. Nirmatrelvir specifically stops the virus from replicating and ritonavir works to slow the breakdown of nirmatrelvir to help it stay in the body for longer periods of time at higher concentrations.
What does Paxlovid do?Paxlovid is not a preventative or prophylaxis medication. Meaning, you shouldn’t take it to try to keep yourself from getting COVID-19 or after you’ve been exposed to someone with the virus. It also shouldn’t be considered a first-line treatment for people who need to be hospitalized due to having a severe or critical form of COVID-19.
Instead, it’s designed to be given to people who test positive for COVID-19 and are considered high risk for serious complications of the virus. Once it’s taken, the drug helps prevent SARS-CoV-2 from replicating in your body. And, when it can’t replicate, it can’t make you sick or will only cause more mild symptoms, explains William Schaffner, M.D., an infectious disease specialist and professor at the Vanderbilt University School of Medicine.
The FDA made a point to stress in a press announcement about the authorization that Paxlovid is not a substitute for getting the vaccine and booster dose.
The medication is given via 30 tablets, broken down by three tablets swallowed twice daily for five days.
How much does Paxlovid cost?Paxlovid is priced at $530 per treatment course, according to Reuters. However, the U.S. government will cover the cost of the treatment, making it free to the public.
Are there drug interactions for Paxlovid?Yup—and there are a lot. “The list is huge,” says Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York. “It’s well over 100.”
There is a full list of potential drug interactions on the Emergency Use Authorization fact sheet for providers on Paxlovid. But, in general, “Paxlovid will have a slew of drug-drug interactions including cardiac medications, certain antibiotics, certain anti-epileptic drugs, and certain statins,” says infectious disease expert Amesh A. Adalja, M.D., a senior scholar at the Johns Hopkins Center for Health Security.
Who qualifies for Paxlovid?The exact list of qualifications won’t be created until the medication gets the thumbs up from the Centers for Disease Control and Prevention (CDC), but the FDA specifically says that Paxlovid is intended for “adults and pediatric patients—12 years of age and older weighing at least 40 kilograms or about 88 pounds—with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.”
“The eligibility criteria is likely to be very similar to that of monoclonal antibody treatments—meaning, those who are at severe disease risk,” Dr. Schaffner says. “But specifics still need to be sorted out.”
When can the general public expect to have access to Paxlovid?It could be a while. Doses are limited for the rest of 2021 and then Pfizer plans to ramp up production for 2022, Dr. Russo says. “It will likely be allocated carefully for quite a while,” Dr. Schaffner says. “At least for a couple of months.”
Overall, though, doctors say they’re glad to have another tool to help fight COVID-19, especially as two out of three monoclonal antibody treatments have been found to be ineffective against the Omicron variant of SARS-CoV-2. “The availability of this antiviral greatly improves the treatment of COVID-19,” Adalja says. “However, the supply is going to be constrained for some periods of time and optimal use depends on quick diagnosis.”
Dr. Russo echoes the importance of getting a quick diagnosis if you’re considered high risk for COVID-19. “React quickly if you develop symptoms,” he says. “This drug is going to be an effective tool for people who do get infected. This is very, very important.”
Korin Miller is a freelance writer specializing in general wellness, sexual health and relationships, and lifestyle trends, with work appearing in Men’s Health, Women’s Health, Self, Glamour, and more.
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