Table 4e. Characteristics of Antiviral Agents, Including Antibody Products

Last Updated: July 21, 2023

This table contains drugs and products that have shown antiviral activity against SARS-CoV-2, including small-molecule antiviral drugs, CCP, and IFNs.
RDV and RTV-boosted nirmatrelvir (Paxlovid) are approved by the FDA for the treatment of COVID-19. RTV-boosted nirmatrelvir is currently only available from supplies obtained under the EUA, and its use must be consistent with the EUA terms and conditions.
MOV and CCP have received EUAs from the FDA for the treatment of COVID-19.
For drug-drug interaction information, please refer to product labels, EUA fact sheets, and Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications.
For the Panel’s recommendations on using the drugs listed in this table, refer to Antiviral Agents, Including Antibody Products; Therapeutic Management of Nonhospitalized Adults With COVID-19; Therapeutic Management of Hospitalized Adults With COVID-19; Therapeutic Management of Nonhospitalized Children With COVID-19; Therapeutic Management of Hospitalized Children With COVID-19; and Pregnancy, Lactation, and COVID-19 Therapeutics.

Table 4e. Characteristics of Antiviral Agents, Including Antibody Products
Drug Name	Dosing Regimens	Adverse Events	Monitoring Parameters	Drug-Drug Interaction Potential	Comments
Anti-SARS-CoV-2 Antiviral Drugs (Small-Molecule Antivirals)
Ritonavir-Boosted Nirmatrelvir (Paxlovid) Approved by the FDA for use in adults and authorized under an FDA EUA for use in children (aged ≥12 years and weighing ≥40 kg) for the treatment of mild to moderate COVID-19 in high-risk individuals.	FDA Prescribing Information/EUA Dose for COVID-19^1,2 eGFR ≥60 mL/min Nirmatrelvir 300 mg (two 150-mg tablets) with RTV 100 mg (one 100-mg tablet) twice daily for 5 days eGFR ≥30 to 60 mL/min Nirmatrelvir 150 mg (one 150-mg tablet) with RTV 100 mg (one 100-mg tablet) twice daily for 5 days eGFR <30 mL/min Not recommended (see comments) Severe Hepatic Impairment (Child-Pugh Class C) Not recommended	Dysgeusia Diarrhea Anaphylaxis, serious skin reactions, and other HSRs	Boxed warning: Monitor for potential AEs due to drug-drug interactions with concomitant medications. Weigh potential benefits of treatment against potential risks of drug-drug interactions. Use with caution in patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. Consider checking renal function in patients with suspected renal impairment. Monitor for HSRs.	RTV-boosted nirmatrelvir has significant drug-drug interactions. Before prescribing RTV-boosted nirmatrelvir, carefully review concomitant medications, including OTC medicines, herbal supplements, and recreational drugs. See Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications for additional guidance and resources to assist with identifying drug-drug interactions.	The FDA prescribing information/EUA does not recommend using RTV-boosted nirmatrelvir in patients with eGFR <30 mL/min. Both nirmatrelvir and RTV tablets can be taken with or without food. The FDA prescribing information/EUA advises against crushing nirmatrelvir and RTV tablets. However, some data indicate that the tablets can be split or crushed if necessary.³
Remdesivir Approved by the FDA for the treatment of COVID-19 in individuals aged ≥28 days and weighing ≥3 kg.	Dose for Adults and Children Weighing ≥40 kg RDV 200 mg IV on Day 1, then RDV 100 mg IV once daily from Day 2 Dose for Children Aged ≥28 Days and Weighing 3 kg to <40 kg RDV 5 mg/kg IV on Day 1, then RDV 2.5 mg/kg IV once daily from Day 2 Total Treatment Duration Nonhospitalized Patients 3 days Hospitalized Patients 5 days or until hospital discharge If a patient does not clinically improve, clinicians may extend the treatment course for ≤5 additional days, for a total duration of 10 days.	Nausea ALT and AST elevations HSRs Increases in prothrombin time	Monitor patients for infusion-related reactions during the infusion and observe them for ≥1 hour after the infusion as clinically appropriate. Monitor renal function, hepatic function, and prothrombin time as clinically indicated.	Clinical drug-drug interaction studies of RDV have not been conducted. In vitro, RDV is a minor substrate of CYP3A4; a substrate of OATP1B1 and P-gp; and an inhibitor of CYP3A4, OATP1B1, OATP1B3, and MATE1.⁴	RDV may be used without dose adjustment in patients with renal impairment, including those receiving dialysis.⁴
Molnupiravir Authorized under an FDA EUA for the treatment of mild to moderate COVID-19 in high-risk individuals aged ≥18 years.	Dose Recommended in FDA EUA MOV 800 mg (four 200-mg capsules) PO every 12 hours for 5 days MOV is not authorized for use in people aged <18 years due to potential effects on bone and cartilage growth.	Diarrhea Nausea Dizziness Per the EUA, the 5-day course of MOV has a low risk for genotoxicity.⁵ See Molnupiravir for details.	Before initiating MOV, assess the patient's pregnancy status as clinically indicated. Monitor for potential AEs.	Clinical drug-drug interaction studies of MOV have not been conducted. Drug-drug interactions related to hepatic metabolism are not expected.	People of reproductive potential who are sexually active should use effective contraception during and after treatment with MOV. If MOV is prescribed for a pregnant person, the clinician should document that the risks and benefits were discussed with the patient and that the patient chose to receive MOV. Pregnant patients should also be offered the opportunity to participate in the MOV pregnancy surveillance program. Lactating people should not breastfeed their infants during treatment with MOV and for 4 days after treatment. MOV can be taken with or without food. The EUA provides instructions for preparing and administering MOV capsule contents through OG or NG tubes.⁵
COVID-19 Convalescent Plasma
High-Titer COVID-19 Convalescent Plasma Authorized under an FDA EUA for the treatment of COVID-19 in patients who are immunocompromised or who are receiving immunosuppressive treatment.	Dose Recommended in FDA EUA Administer 1 high-titer CCP unit (about 200 mL) IV. Administer an additional CCP unit IV based on the prescribing provider’s judgment and the patient’s clinical response.	TRALI TACO Allergic reactions Anaphylactic reactions Febrile nonhemolytic reactions Hemolytic reactions Hypothermia Metabolic complications Transfusion-transmitted infections⁶ Thrombotic events Theoretical risk of antibody-mediated enhancement of infection and suppressed long-term immunity	Before administering CCP to patients with a history of severe allergic or anaphylactic transfusion reactions, consult a transfusion medicine specialist who is associated with the hospital’s blood bank. Monitor for transfusion-related reactions. Monitor vital signs at baseline and during and after transfusion.	Drug products should not be added to the IV infusion line for the blood product.	In patients with impaired cardiac function and heart failure, it may be necessary to reduce the CCP volume or decrease the transfusion rate.
Interferons
IFN Beta Not approved by the FDA and not recommended by the Panel for the treatment of COVID-19. Currently under investigation in clinical trials.	Various doses and durations for IFN beta-1a and IFN beta-1b are being studied in clinical trials.	Flu-like symptoms (e.g., fever, fatigue, myalgia) Leukopenia, neutropenia, thrombocytopenia, lymphopenia Liver function abnormalities (ALT > AST) Injection site reactions Headache Hypertonia Pain Rash Worsening depression Induction of autoimmunity	Monitor CBC with differential and liver enzymes. Monitor for worsening CHF. Monitor for signs of depression and suicidal ideation.	Low potential for drug-drug interactions Use with caution with other hepatotoxic agents. Reduce dose if ALT is >5 times ULN.	Inhaled IFN beta-1a is not approved by the FDA for use in the United States.
PEG-IFN Lambda Not approved by the FDA and not recommended by the Panel for the treatment of COVID-19.	Dose for COVID-19 in Clinical Trials Single dose of PEG-IFN lambda 180 µg SUBQ	Liver function abnormalities (ALT > AST) Injection site reactions	CBC with differential Liver enzymes Monitor for potential AEs.	Low potential for drug-drug interactions Use with caution with other hepatotoxic agents.	PEG-IFN lambda is not approved by the FDA for use in the United States.
Key: AE = adverse event; ALT = alanine transaminase; AST = aspartate aminotransferase; CBC = complete blood count; CCP = COVID-19 convalescent plasma; CHF = congestive heart failure; CYP = cytochrome P450; eGFR = estimated glomerular filtration rate; EUA = Emergency Use Authorization; FDA = Food and Drug Administration; HSR = hypersensitivity reaction; IFN = interferon; IV = intravenous; MATE = multidrug and toxin extrusion protein; MOV = molnupiravir; NG = nasogastric; OATP = organic anion transporting polypeptide; OG = orogastric; OTC = over-the-counter; the Panel = the COVID-19 Treatment Guidelines Panel; P-gp = P-glycoprotein; PEG-IFN = pegylated interferon; PO = oral; RDV = remdesivir; RTV = ritonavir; SUBQ = subcutaneous; TACO = transfusion-associated circulatory overload; TRALI = transfusion-related acute lung injury; ULN = upper limit of normal

References

Ritonavir-boosed nirmatrelvir (Paxlovid) [package insert]. Food and Drug Administration. 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217188s000lbl.pdf.
Food and Drug Administration. Fact sheet for healthcare providers: Emergency Use Authorization for Paxlovid. 2023. Available at: https://www.fda.gov/media/155050/download.
BC COVID Therapeutics Committee COVID Therapy Review and Advisory Working Group. Therapeutic brief: crushing nirmatrelvir/ritonavir (Paxlovid). 2022. Available at: http://www.bccdc.ca/Health-Professionals-Site/Documents/COVID-treatment/Crushing_Paxlovid.pdf.
Remdesivir (Veklury) [package insert]. Food and Drug Administration. 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s019lbl.pdf.
Food and Drug Administration. Fact sheet for healthcare providers: Emergency Use Authorization for Lagevrio (molnupiravir) capsules. 2023. Available at: https://www.fda.gov/media/155054/download.
Food and Drug Administration. Fact sheet for health care providers: Emergency Use Authorization (EUA) of COVID-19 convalescent plasma for treatment of coronavirus disease 2019 (COVID-19). 2021. Available at: https://www.fda.gov/media/141478/download.