Elsevier – Drug Monograph │ Nirmatrelvir; Ritonavir

NOTE: Information on medical conditions and factors associated with an increased risk for progression to severe COVID-19 can be obtained on the Centers for Disease Control and Prevention (CDC) website at www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Health care providers are advised to consider the benefit-risk for each individual patient.[67203]

NOTE: Health care providers should choose an authorized therapeutic option with activity against the circulating variants in their state, territory, or US jurisdiction. Current variant frequency data are available at: www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html. Nirmatrelvir; ritonavir is expected to be active against the Omicron SARS-CoV-2 variant (B.1.1.529), although clinical efficacy data are lacking.[65314]

NOTE: Due to the Omicron variant being the dominant variant in many parts of the United States, the National Institutes of Health (NIH) has issued a statement to provide guidance on treating nonhospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease. The NIH recommends using 1 of the following therapeutics:

  • Preferred therapies (listed in order of preference)
    • nirmatrelvir; ritonavir
    • remdesivir
  • Alternative therapies
  • bebtelovimab OR
  • molnupiravir

Before prescribing nirmatrelvir; ritonavir, the NIH recommends health care providers carefully review the patient’s concomitant medications (including over-the-counter medications and herbal supplements) to evaluate for potential drug interactions. If a significant drug interaction is identified, consider the risks and benefits of treatment. Consider expert consultation, especially for patients receiving highly specialized therapies such as antineoplastics, neuropsychiatric drugs, and certain immunosuppressants.[65314]

NOTE: There may be logistical or supply constraints that make it impossible to offer the available therapy to all eligible patients, making patient triage necessary. Health care providers should prioritize their use for patients at highest risk of clinical progression. Information on which individuals might receive the greatest benefit from anti-SARS-CoV-2 therapeutics for treatment or prevention can be obtained from www.covid19treatmentguidelines.nih.gov/therapies/statement-on-patient-prioritization-for-outpatient-therapies.[65314]

NOTE: Nirmatrelvir; ritonavir is NOT authorized for use in patients requiring hospitalization due to severe COVID-19; however, should a patient require hospitalization after starting treatment, the patient may complete the full 5-day treatment course at the discretion of the health care provider.[67203]

NOTE: Nirmatrelvir; ritonavir is NOT authorized for use as pre-exposure or post-exposure prophylaxis to prevent COVID-19.[67203]