The FDA approved Paxlovid (Nirmatrelvir and Ritonavir) for the treatment of mild to moderate COVID-19 in adult and pediatric patients (aged 12 years and over 40 kg) in December 2021 and directly SARS-CoV- Showed a positive result. Two viral tests that are also at high risk of progressing to severe COVID-19, including hospitalization and death.

Paxlovid is now widely available in local pharmacies. Although the number of COVID-19 hospitalizations has dropped dramatically since early 2022, some high-risk patients are still ill enough to require hospitalization, and Paxlovid and other available approvals or approvals. Early treatment with the treatments given can make a difference.

In this CDER Conversation, Dr. John Farley, Director of the Department of Infectious Diseases, provides information to help healthcare providers make decisions about Paxlovid, the preferred treatment for the management of COVID-19 hospitalized adults. Offers.To National Institutes of Health COVID Treatment Guidelines..

What does “direct SARS-CoV-2 virus test” mean? Does the patient need a positive polymerase chain reaction (PCR) test to be treated with Paxlovid?

Direct SARS-CoV-2 virus test It is used to diagnose infection with SARS-CoV-2, the virus that causes COVID-19. The direct SARS-CoV-2 virus test includes two types of diagnostic tests, COVID-19.

• Molecular tests such as PCR tests to detect viral genetic material.
• A rapid antigen diagnostic test that detects a specific protein from a virus.

There are many rapid antigens Tests approved for home use.. Patients in the accredited population who reported to their provider that the rapid antigen diagnostic test was positive Emergency Use Authorization (EUA).. If the PCR test gives a positive result, it also meets the requirement that the EUA test result be positive. No additional direct SARS-CoV-2 virus testing, such as PCR, is required to confirm a positive home rapid antigen diagnostic test. Serological test It is not considered a direct SARS-CoV-2 virus test.

How should a healthcare provider rate a patient as “high risk of developing severe COVID-19”?

Patients in an approved population Risk factor For progress to severe COVID-19, united states of america Even if fully vaccinated. Patients do not have to have multiple risk factors to be considered “high risk”.

Risk factors change over time and we recognize that it is appropriate to consider vaccination status when assessing the risk of patients progressing to severe COVID-19.

For more information on the medical conditions and factors associated with the increased risk of progressing to severe COVID-19, please visit: Centers for Disease Control and Prevention (CDC) website..

Are there tools that help healthcare providers manage potential drug-drug interactions?

Yes. FDA recently updated Fact sheet for healthcare providers For Paxlovid to provide more specific recommendations for some medicines. also, Prescriber Patient Eligibility Screening Checklist.. This checklist is intended to support clinical decision making and may be helpful in adding it to the prescriber’s “toolbox”.

Paxlovid includes Nirmatorelville and Ritonavir. Ritonavir is a potent inhibitor of cytochrome P4503A. Potential drug-drug interactions are an important consideration. However, some commonly used medications with potential interactions, such as statins, oral contraceptives, and HIV medications, can be easily managed under the supervision of your provider. Recommendations are Healthcare provider fact sheet And that Eligibility Screening Checklist Tool With an alphabetical list of other drugs with potentially significant drug interactions.

Other resources on the management of drugs with potentially significant drug interactions with Paxlovid include:

Do patients with moderate renal dysfunction need dose adjustments for Paxlobid?

Yes. Paxlovid is currently available in two different dose packs. One is for standard administration and the other is for moderate renal dysfunction.

• In patients with moderate renal dysfunction (eGFR ≥30 to <60 mL / min), the dose of Paxlovid is 150 mg nirmatorelvir (1 tablet 150 mg) and 100 mg ritonavir (1 tablet 100). (Mg tablets) is administered twice daily for 5 days.
• Patients with mild renal dysfunction (eGFR ≥60 to <90 mL / min) receive standard doses of 300 mg nirmatorelvir (two 150 mg tablets) and 100 mg ritonavir (one 100 mg tablet) 2 daily. Must be taken orally once. 5 days.
• At this time, Paxlovid is not recommended for patients with severe renal dysfunction (eGFR <30 mL / min).

Health providers may rely on the patient’s medical history and access to the patient’s health records to make an assessment of the likelihood of renal dysfunction. Health providers may consider ordering serum creatinine or calculating the estimated glomerular filtration rate (eGFR) for a particular patient after a case-by-case evaluation.

How do I find a local pharmacy with Paxlovid in stock?

Paxlovid is now widely available in local pharmacies.U.S. government Locator tool For COVID-19 treatments that list pharmacies in the area where Paxlovid is in stock. Use the search glass icon to enter the patient’s zip code. Pharmacies are listed by proximity.

What do we know about case reports of patients who relapse after completing the Paxlovid course?

The FDA is aware of reports of some patients developing recurrent COVID-19 symptoms after completing a course of treatment with Paxlovid. In some of these cases, patients were negative on a direct SARS-CoV-2 virus test and then tested positive again.

The benefits of Paxlovid’s 5-day course of treatment have been demonstrated in clinical trials supporting EUA. This study showed that treatment with Paxlovid reduced the risk of hospitalization or death by 88% in non-hospitalized patients at high risk of progression to serious illness. Reduction of hospitalizations and mortality has been approved for other availability (Veklury) [remdesivir]) Or approved (Lagevrio) [molnupiravir]) Antiviral agent.

In light of these reports, additional analysis of Paxlovid clinical trial data was performed. In Paxlovid clinical trials, some patients (range 1-2%) had one or more SARS-CoV-2 PCR tests positive after a negative test, or SARS-CoV-2 detected by PCR. The amount of has increased. Treatment course. This finding was observed in patients who received drug treatment and those who received placebo, so it is not known at this time that this is related to drug treatment. Additional analysis showed that most patients were asymptomatic at the time of the positive PCR test after the negative test, and most importantly, there was no increase in hospitalization or death or development of drug resistance.

Therefore, these reports do not change the conclusions of the Paxlovid clinical trial, which showed a significant reduction in hospitalizations and mortality.

We will continue to review clinical trial data and provide additional information as it becomes available. However, at this time, there is evidence of benefit for longer treatment courses (eg, 10 days instead of the 5 days recommended in Paxlovid’s provider fact sheet) or repeated Paxlovid treatment courses in patients with relapsed COVID-19. is not. Symptoms after the completion of the treatment course.

In summary, Paxlovid reduces the risk of hospitalization and death in patients with mild to moderate COVID-19 who are at high risk of disease progression. Health providers should consider treatment with Paxlovid or other approved or approved treatments according to the approved label or the approved health provider fact sheet. Patients who test positive for symptomatic SARS-CoV-2 should discuss treatment options with their healthcare provider as soon as possible after testing positive.Healthcare providers and patients should refer CDC Recommendations for Patient Isolation, When Whether or not you are treated with antivirals, you should wear a mask and isolate if you have symptoms.

Thank you, Dr. Farley. Do you have a final opinion about Paxlovid that you would like to share with your healthcare provider?

I would like to reiterate that Paxlovid is now widely available in local pharmacies. There is strong scientific evidence to reduce the risk of hospitalization and death in patients with mild to moderate COVID-19 who are at high risk of developing severe disease. It is also expected to be effective against Omicron variants. For more information on Paxlovid’s EUA, including potential risks of use, Fact sheet for healthcare providersWhen Prescriber patient eligibility checklistPlease come FDA Emergency Authorization Web Page..