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Table 2f. Characteristics of Antiviral Agents

Last Updated: December 16, 2021

  • RDV is the only antiviral drug that is approved by the FDA for the treatment of COVID-19. Some medications that are currently being evaluated in clinical trials for the treatment of COVID-19 are also included in this table. The inclusion of these drugs does not imply that the Panel approves of their use.
  • Information on CQ, HCQ, and LPV/RTV are available in the archived versions of the Guidelines. The Panel recommends against using these agents to treat COVID-19.
  • There are limited or no data on dose modifications for patients with organ failure or those who require extracorporeal devices. Please refer to product labels, when available.
  • There are currently not enough data to determine whether certain medications can be safely coadministered with therapies for the treatment of COVID-19. When using concomitant medications with similar toxicity profiles, consider performing additional safety monitoring.
  • The potential additive, antagonistic, or synergistic effects and the safety of using combination therapies for the treatment of COVID-19 are unknown. Clinicians are encouraged to report AEs to the FDA MedWatch program.
  • For drug interaction information, please refer to product labels and visit the Liverpool COVID-19 Drug Interactions website.
  • For the Panel’s recommendations on using the drugs listed in this table, please refer to the individual drug sections or Therapeutic Management of Hospitalized Adults With COVID-19.
Table 2f. Characteristics of Antiviral Agents
Dosing Regimens
The doses listed here are for approved indications or from reported experiences or clinical trials.
Adverse Events Monitoring Parameters Drug-Drug Interaction Potential Comments and Links to Clinical Trials
Remdesivir
Approved by the FDA for the treatment of COVID-19 in individuals aged ≥12 years and weighing ≥40 kg.

Please see Therapeutic Management of Hospitalized Adults With COVID-19 for the Panel’s recommendations on when to use RDV.

For Hospitalized Adults and Children (Aged ≥12 Years and Weighing ≥40 kg):

  • RDV 200 mg IV on Day 1, then RDV 100 mg IV once daily on Days 2–5. Administer RDV IV infusion over 30–120 minutes.

Dose Recommended in FDA EUA For Hospitalized Children Weighing 3.5 kg to <40 kg:

  • RDV 5 mg/kg IV on Day 1, then RDV 2.5 mg/kg IV once daily on Days 2–5. Administer RDV IV infusion over 30–120 minutes.
  • Nausea
  • ALT and AST elevations
  • Hypersensitivity
  • Increases in prothrombin time
  • Drug vehicle is SBECD, which has been associated with renal and liver toxicity. SBECD accumulation may occur in patients with moderate or severe renal impairment.
  • Each 100 mg vial of RDV lyophilized powder contains 3 g of SBECD, and each 100 mg/20 mL vial of RDV solution contains 6 g of SBECD.
  • Clinicians may consider preferentially using the lyophilized powder formulation (which contains less SBECD) in patients with renal impairment.
  • Infusion reactions
  • Renal function and hepatic function as clinically indicated
  • FDA does not recommend RDV when eGFR is <30 mL/min. See the Remdesivir section for information on using RDV in people with renal insufficiency.
  • Clinical drug-drug interaction studies of RDV have not been conducted.
  • In vitro, RDV is a minor substrate of CYP3A4, and a substrate of OATP1B1, and P-gp and an inhibitor of CYP3A4, OATP1B1, OATP1B3, and MATE1.1
  • No significant interaction is expected between RDV and oseltamivir or baloxavir (Gilead Sciences, personal and written communications, August and September 2020).
  • RDV should be administered in a hospital or a health care setting that can provide a similar level of care to an inpatient hospital.
  • A list of clinical trials is available: Remdesivir
Interferon Alfa
Not approved by the FDA and not recommended by the Panel for the treatment of COVID-19. Currently under investigation in clinical trials.

IFN Alfa-2b

Dose for COVID-19 in Clinical Trials:
  • Nebulized IFN alfa-2b 5 million international units twice daily; the optimal duration of treatment is unclear.
  • AEs that are associated with inhaled therapy (e.g., throat irritation, cough, bronchospasm)
  • Systemic effects of IFN are expected to be minimal.
  • Respiratory symptoms after inhalation
  • Low potential for drug-drug interactions
  • The nebulized formulation of IFN alfa has been the formulation most commonly used in clinical trials for the treatment of COVID-19. IFN alfa is usually included as part of a combination regimen.
  • A list of clinical trials is available: Interferon Alfa

Availability:

  • Nebulized IFN alfa-2b is not approved by the FDA for use in the United States.
Interferon Beta
Not approved by the FDA and not recommended by the Panel for the treatment of COVID-19. Currently under investigation in clinical trials.

IFN Beta-1a

Dose for COVID-19 in Clinical Trials:
  • IFN beta-1a 44 µg SQ or IV every other day for up to 3 or 4 doses

IFN Beta-1b

Dose for COVID-19 in Clinical Trials:
  • IFN beta-1b 8 million international units SQ every other day for up to 7 days total
  • 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
  • CBC with differential
  • Liver enzymes
  • Worsening CHF
  • Depression, suicidal ideation
  • Low potential for drug-drug interactions
  • Use with caution with other hepatotoxic agents.
  • Reduce dose if ALT >5 times ULN.

Availability:

Brand Names of IFN Beta-1a Products:
  • Avonex, Plegridy, Rebif
Brand Names of IFN Beta-1b Products:
  • Betaseron, Extavia
Interferon Lambda
Not approved by the FDA and not recommended by the Panel for the treatment of COVID-19. Currently under investigation in clinical trials.

PEG-IFN Lambda-1a

Dose for COVID-19 in Clinical Trials:
  • Single dose of PEG-IFN lambda-1a 180 µg SQ
  • Liver function abnormalities
  • 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.

Availability:

  • PEG-IFN lambda-1a is not approved by the FDA for use in the United States.
Ivermectin
Not approved by the FDA and not recommended by the Panel for the treatment of COVID-19. Currently under investigation in clinical trials.
Dose for COVID-19 in Clinical Trials:
  • IVM 0.2–0.6 mg/kg PO given as a single dose or as a once-daily dose for up to 5 days
  • Dizziness
  • Pruritis
  • GI effects (e.g., nausea, diarrhea)
  • Neurological AEs have been reported when IVM has been used to treat parasitic diseases, but it is not clear whether these AEs were caused by IVM or the underlying conditions.
  • Monitor for potential AEs.
  • Minor CYP3A4 substrate
  • P-gp substrate
  • Generally given on an empty stomach with water; however, administering IVM with food increases its bioavailability.2
  • A list of clinical trials is available: Ivermectin
Nitazoxanide
Not approved by the FDA and not recommended by the Panel for the treatment of COVID-19. Currently under investigation in clinical trials.
For Adults:
  • Doses studied for COVID-19 range from NTZ 500 mg PO 3 times daily to 4 times daily.
  • Higher doses are being studied.
  • Doses used for antiprotozoal indications range from NTZ 500 mg–1 g PO twice daily.
  • Abdominal pain
  • Diarrhea
  • Headache
  • Nausea
  • Vomiting
  • Urine discoloration
  • Ocular discoloration (rare)
  • Monitor for potential AEs.
  • Drug-drug interactions may occur if NTZ is administered concurrently with other highly plasma protein-bound drugs due to competition for binding sites.3
  • If NTZ is coadministered with other highly protein-bound drugs with narrow therapeutic indices, monitor the patient for AEs.
  • NTZ should be taken with food.
  • The oral suspension is not bioequivalent to the tablet formulation.
  • A list of clinical trials is available: Nitazoxanide

References

  1. Remdesivir (Veklury) [package insert]. Food and Drug Administration. 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214787Orig1s000lbl.pdf.
  2. Ivermectin (Stromectol) [package insert]. Food and Drug Administration. 2009. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s024s025lbl.pdf.
  3. Nitazoxanide (Alinia) [package insert]. Food and Drug Administration. 2017. Available at: https://www.alinia.com/wp-content/uploads/2017/08/prescribing-information.pdf.