As you are likely aware, a couple of new oral antiviral COVID treatments were recently authorized.
While that’s good news, especially if you have COVID and are at high risk for complications, it is important to understand that these still aren’t a quick cure for COVID.
Oral Antiviral COVID Treatments
So what do these treatments do then?
“Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations.”Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19
If you have COVID, taking these medications will hopefully keep you out of the hospital or keep you from dying!
“In this analysis, 1,039 patients had received Paxlovid, and 1,046 patients had received placebo and among these patients, 0.8% who received Paxlovid were hospitalized or died during 28 days of follow-up compared to 6% of the patients who received placebo.”Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19
Paxlovid can be given to adults and children who are at least 12 years old with mild to moderate COVID-19 and who are at high risk of disease progression.
Each dose of Paxlovid consists of 2 pink tablets of nirmatrelvir with 1 white tablet of ritonavir. For each dose, you take all 3 pills at the same time. Paxlovid is given twice a day for 5 days.
Now, although ritonavir is included in Paxlovid to slow down the breakdown of nirmatrelvir, it can also affect other medications you might be taking.
That means Paxlovid is contraindicated if you are already taking any medication that is dependent on CYP3A for clearance or which induces CPY3A, including, but not limited to amiodarone, colchicine, clozapine, lovastatin, sildenafil, trazolam, carbamazepine, phenobarbital, phenytoin, rifamin, and St. John’s Wort. Ask your health care professional and pharmacist if you have any drug interactions before taking Paxlovid.
What about side effects?
In addition to liver problems and drug interactions, possible side effects of Paxlovid include dysgeusia (altered or impaired sense of taste), diarrhea, increased blood pressure, and myalgia (muscle aches).
There are also concerns about extra risks in those with uncontrolled or undiagnosed HIV-1 infection who take Paxlovid.
Where can you get Paxlovid?
Your health care professional can prescribe Paxlovid to those who meet the requirements of the EUA. And they have been distributed to many pharmacies, although you may have to call around to get your prescription filled.
Another oral medication, Molnupiravir, was also recently authorized and can be given twice a day for 5 days. Molnupiravir is a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis, targeting SARS-CoV-2 RNA-dependent RNA polymerase (RdRp).
“FDA has issued an EUA for the emergency use of the unapproved product molnupiravir for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate.”Frequently Asked Questions on the Emergency Use Authorization for Molnupiravir for Treatment of COVID-19
Unlike Paxlovid, Molnupiravir should only be prescribed when all other alternative COVID-19 treatment options authorized by FDA are not accessible
or clinically appropriate.
“Possible side effects of molnupiravir include diarrhea, nausea, and dizziness. Molnupiravir is not recommended for use during pregnancy because findings from animal reproduction studies showed that molnupiravir may cause fetal harm when administered to pregnant individuals.”Frequently Asked Questions on the Emergency Use Authorization for Molnupiravir for Treatment of COVID-19
You should not take molnupiravir if you are pregnant or breastfeeding.
“Females of childbearing potential are advised to use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for four days after the last dose of molnupiravir.”Frequently Asked Questions on the Emergency Use Authorization for Molnupiravir for Treatment of COVID-19
In addition to the warnings about pregnancy, you should not get pregnant while taking Molnupiravir. In fact, although the risk is thought to be low and studies are ongoing, to avoid pregnancy, sexually active males “with partners of childbearing potential are advised to use a reliable method of contraception correctly and consistently during treatment and for at least three months after the last dose of Molnupiravir.”
Your health care provider can prescribe Molnupiravir, but it will likely also be in short supply for a while.
What To Know About Oral Antiviral COVID Treatments
While it is great that we now have even more treatments available when folks get COVID, it is important to understand that these are still unapproved drugs that are authorized for use under Emergency Use Authorization.
More on COVID Treatments
- The Latest COVID-19 Treatment Regimens
- COVID-19 Vaccination Questions and Answers
- Get All of Your COVID-19 Questions Answered
- Treating Kids with COVID Monoclonal Antibodies
- The Truth About COVID-19 Vaccines
- I’m Not Anti-Vaccine, I Just Don’t Believe in the COVID-19 Vaccine
- FDA – Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19
- EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
- FDA – Fact Sheet for Patients, Parents, and Caregivers Emergency Use Authorization (EUA) of Paxlovid for Coronavirus Disease 2019 (Covid-19)
- FDA – Fact Sheet for Healthcare Providers: Emergency Use Authorization for Paxlovid
- FDA – Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment of COVID-19
- NIH – The COVID-19 Treatment Guidelines Panel’s Interim Statement on Patient Prioritization for Outpatient Anti-SARS-CoV-2 Therapies or Preventive Strategies When There Are Logistical or Supply Constraints
- Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)
- FDA – Frequently Asked Questions on the Emergency Use Authorization for Molnupiravir for Treatment of COVID-19
- FDA – Molnupiravir Checklist Tool for Prescribers: Patient Eligibility
- FDA – Fact Sheet for Patients And Caregivers Emergency Use Authorization (EUA) Of Molnupiravir For Coronavirus Disease 2019 (COVID-19)
Last Updated on January 3, 2022 by Vincent Iannelli, MD