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A Frontline Perspective: Reviewing Clinical Data for an Antiviral Treatment for Patients Hospitalized With COVID-19

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ACTT-1 was the first Phase 3 clinical trial conducted in the US to evaluate an experimental treatment for COVID-19. Hear a viewpoint on the data.

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for Indication and Important Safety Information

  • Indication and Important Safety Information

    INDICATION

    VEKLURY is indicated for the treatment of COVID-19 in hospitalized adults and pediatric patients ≥12 years old and weighing ≥40 kg with positive results of SARS-CoV-2 viral testing.

    IMPORTANT SAFETY INFORMATION

    Contraindication

    • VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any of its components.

    Warnings and precautions

    • Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of VEKLURY; most occurred within 1 hour. Monitor patients during infusion and observe for at least 1 hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time of up to 120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue VEKLURY and initiate appropriate treatment (see Contraindications).
    • Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received VEKLURY; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing VEKLURY if ALT levels increase to >10x ULN. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation.
    • Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in the antiviral activity of VEKLURY.

    Adverse reactions

    • The most common adverse reaction (≥5% all grades) was nausea.
    • The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.

    Drug interactions

    • Drug interaction trials of VEKLURY and other concomitant medications have not been conducted in humans.

    Dosage and administration

    • Dosage: For adults and pediatric patients ≥12 years old and weighing ≥40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion. VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19.
    • Treatment duration: 
      -For patients who are hospitalized and require invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days.
      -For patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days, for a total treatment duration of up to 10 days.
    • Testing prior to and during treatmentPerform eGFR, hepatic laboratory, and prothrombin time testing prior to initiating VEKLURY and during use as clinically appropriate.
    • Renal impairment: VEKLURY is not recommended in individuals with eGFR <30 mL/min.
    • Dose preparation and administration: See full Prescribing Information.

    Pregnancy and lactation

    • Pregnancy: A pregnancy registry has been established. There are insufficient human data on the use of VEKLURY during pregnancy. COVID-19 is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death.
    • Lactation: It is not known whether VEKLURY can pass into breast milk. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 

    Please see full Prescribing Information for VEKLURY.
  • Overview

    COVID-19 is still an ongoing public health threat, and the continual emergence of concerning variants has resulted in ongoing hospitalizations. Joining us to review VEKLURY, the first and only FDA-approved treatment for COVID-19 in hospitalized patients, its antiviral mechanism of action, and efficacy and safety results from the ACTT-1 clinical trial, is frontline COVID-19 treater Dr Raj Dasgupta.

    Dr Raj Dasgupta is a quadruple board-certified pulmonary and critical care specialist at one of the largest hospitals in Los Angeles, California. He will be joined by Tom Oppelt, Senior Director of Medical Affairs at Gilead Sciences.

    COVID-19 is still an ongoing public health threat, and the continual emergence of concerning variants has resulted in ongoing hospitalizations. Joining us to review VEKLURY, the first and only FDA-approved treatment for COVID-19 in hospitalized patients, its antiviral mechanism of action, and efficacy and safety results from the ACTT-1 clinical trial, is frontline COVID-19 treater Dr Raj Dasgupta.

    Dr Raj Dasgupta is a quadruple board-certified pulmonary and critical care specialist at one of the largest hospitals in Los Angeles, California. He will be joined by Tom Oppelt, Senior Director of Medical Affairs at Gilead Sciences.

Schedule28 May 2022
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