Half a year has passed since the FDA authorized Pfizer's at-home COVID-19 treatment Paxlovid for emergency use, and the two-pill regimen became the nation's No. 1 prescribed choice by the end of May.
Here are nine things to know:
The product
- Paxlovid is a regimen that involves swallowing two 150 milligram tablets of nirmatrelvir and one 100 milligram pill of ritonavir. The three pills are prescribed to be taken twice daily for five consecutive days.
- It's currently only authorized for those at high risk for COVID-19, including immunocompromised people and older populations. Pfizer dropped its clinical trials after failing to find statistically significant results among standard-risk populations.
- Among high-risk adults, Paxlovid proved an efficacy rate of 89 percent in reducing the risk of hospitalization and death, prompting the FDA to prefer it over Merck's molnupiravir, which lags behind with a 30 percent efficacy rate.
- Paxlovid is cleared for moderate renal impairment but not severe renal failure, according to the Institute for Safe Medication Practices.
Unclear consensus about rebound of COVID-19 symptoms
- The risk of symptoms rebounding after taking Paxlovid is still questionable. The CDC issued a warning May 24 about some patients experiencing mild symptoms two to eight days after taking the treatment and testing negative for COVID-19, but a Mayo Clinic study published two weeks later found less than 1 percent of people having symptoms rebound.
Access to the drug
- It has been tricky securing the treatment for consumers. In the first three months of 2022, more than 26 million people lived in Paxlovid "deserts" where pharmacies are scarce. The test-to-treat program, which launched in March with a difficult start, aims to curb this issue, with hundreds of pharmacy-based clinics prescribing and handing out free pills to eligible people.
- Another effort to close the distribution gap is the FDA allowing any state-licensed pharmacist to prescribe Paxlovid — a decision that sparked cheers and boos from the healthcare community.
On the horizon
- The vaccine manufacturer is gunning for the FDA to authorize the pills for people with severe COVID-19 symptoms.
- Researchers who evaluated how Paxlovid reacted to other prescribed drugs, such as antipsychotics for sleep or agitation, recommended deprescribing some drugs that aren't authorized to be used alongside Pfizer's treatment, according to a study published July 6 in JAMA Network. If the recommendation is employed, physicians could be adjusting people's prescriptions to safely administer Paxlovid.