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Clinical Data

The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of remdesivir to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, remdesivir, for the treatment of COVID-19.

Authorized Use

Remdesivir (GS-5734™) is authorized for use under an EUA only for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen, mechanical ventilation, and/or extracorporeal membrane oxygenation (ECMO). Remdesivir is authorized for adult or pediatric patients who are admitted to a hospital and for whom use of an IV agent is clinically appropriate. Remdesivir must be administered intravenously.

Clinical Data1

Remdesivir is an unapproved antiviral drug with available data from 2 randomized clinical trials and a compassionate use program in patients with COVID-19, and from clinical trials in healthy volunteers and patients with Ebola virus disease. The risks and benefits of the use of remdesivir for the treatment of COVID-19 are not yet known.

In healthy volunteers and in hospitalized patients with PCR-confirmed SARS-CoV-2 infection, graded elevations in ALT and AST have been observed with a loading dose of remdesivir 200 mg administered intravenously on Day 1, followed by 100 mg administered intravenously, once daily, for up to 9 days.

Preliminary Efficacy Data From the NIAID ACTT-1 Study

NIAID ACTT-1 Study: a randomized, double-blind, placebo-controlled clinical trial of remdesivir in hospitalized adult patients with COVID-19 (N=1063).

Patients were randomized in a 1:1 manner to receive remdesivir or placebo.

Remdesivir was administered as 200 mg on Day 1, followed by 100 mg on Days 2 to 10.

Primary clinical endpoint

Time to Recovery (all patients)

Mortality

Mortality Rate (all patients)

Efficacy and Safety Data From Study GS-US-540-5773

Study GS-US-540-5773: a randomized, open-label, multicenter study of patients with severe COVID-19 (N=397).

Trial arms

Primary clinical endpoint

Primary Endpoint

Study GS-US-540-5773 (N=397) 5-day regimen
(n=200)
10-day regimen
(n=197)
Time to clinical improvement for 50% of patients, days 10 11

These results suggest that patients receiving a 10-day treatment course of remdesivir had similar improvement in clinical status compared with those receiving a 5-day treatment course (odds ratio: 0.76 [95% CI, 0.51-1.13] on Day 14).

Results at Day 14

Study GS-US-540-5773 (N=397) 5-day regimen
(n=200)
10-day regimen
(n=197)
Clinical improvement, % 65 54
Clinical recovery, % 70 59
Mortality, % 8 11

Adverse Events

Study GS-US-540-5773 (N=397) 5-day regimen
(n=200)
10-day regimen
(n=197)
Adverse reactions (all grades), % 71 74
Serious adverse events, % 21 35
Adverse reactions (Grade ≥3), % 31 43
Discontinuation due to adverse event, % 5 10
All-cause mortality at Day 28, % 10 13

Hepatic Laboratory Abnormalities

5-day regimen
n/N (%)
10-day regimen
n/N (%)
Total
ALT Grade 3 8/194 (4) 11/191 (6) 19/385 (5)
Grade 4 4/194 (2) 5/191 (3) 9/385 (2)
AST Grade 3 11/194 (6) 7/190 (4) 18/384 (5)
Grade 4 3/194 (2) 4/190 (2) 7/384 (2)
Total bilirubin Grade 3 1/193 (1) 3/190 (2) 4/383 (1)
Grade 4 0 1/190 (1) 1/383 (<1)

Safety From a Compassionate Use Program

Remdesivir has been provided through a compassionate use multicenter, open-label program to over 1200 adult patients with confirmed SARS-CoV-2 infection by PCR and manifestations of severe disease. In addition, remdesivir has been provided to 76 pediatric patients <18 years of age and 96 pregnant women through the compassionate use program.

Patients were treated with remdesivir 200 mg once daily, followed by remdesivir 100 mg for 9 days intravenously, plus standard of care, for a total of up to 10 days of therapy.

In the compassionate use program in patients with severe or critical illness with COVID-19, liver function test abnormalities were reported in 11.7% (19/163) of patients. Time to onset from first dose ranged from 1 to 16 days. Four of these patients discontinued remdesivir treatment with elevated transaminases occurring on Day 5 of remdesivir treatment as per protocol.

Seven cases of serious liver-related laboratory abnormalities were identified. There was 1 serious adverse event (SAE) of blood bilirubin increased in a critically ill patient with septic shock and multiorgan failure. None of the other cases had reported adverse events suggestive of hyperbilirubinemia or symptoms of hepatitis.

Safety From Studies of Healthy Volunteers and Patients With Ebola Virus Disease

Experience in Healthy Volunteers

Remdesivir was evaluated in four phase 1 studies in 138 healthy adult volunteers (Studies GS-US-399-1812, GS-US-399-1954, GS-US-399-4231, and GS-US-399-5505). In these studies, transient graded elevations in ALT and AST were observed at repeated once-daily doses of remdesivir.

Grade 1 and 2 transaminase elevations were observed in healthy volunteers in Study GS-US-399-5505 (200 mg followed by 100 mg dosing for 5 to 10 days) and Study GS-US-399-1954 (150 mg daily for 7 or 14 days), which resolved after discontinuation of remdesivir.

Experience in Patients With Ebola Virus Disease

Supportive safety data are provided from the PALM study, a phase 2/3, open-label, randomized, parallel-group study to assess the safety and efficacy of investigational treatments, including remdesivir, in patients with Ebola virus disease. In the study, 175 patients were randomized to receive remdesivir. A total of 9 SAEs judged by the site investigator as not related to underlying Ebola virus disease were reported for participants receiving remdesivir. Of these, an event of hypotension, which occurred during administration of the loading dose and led to fatal cardiac arrest, was considered related to remdesivir. The independent pharmacovigilance committee noted that the death could not be readily distinguished from underlying fulminant Ebola virus disease.

In the PALM Study, patients with Ebola virus disease were randomized to receive remdesivir. No SAEs of transaminase elevations or hepatic events were reported.

Twenty patients received remdesivir in a double-blinded, randomized, viral persistence study in the semen of Ebola survivors. Preliminary results indicated there were no SAEs for transaminase elevations.

ALT=alanine aminotransferase; AST=aspartate aminotransferase; NIAID=National Institute of Allergy and Infectious Diseases; PCR=polymerase chain reaction; SARS-CoV=severe acute respiratory syndrome coronavirus; SAE=serious adverse event.

Important Information

The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of remdesivir to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, remdesivir, for the treatment of COVID-19.

  • Remdesivir is an investigational drug that has not been approved by the FDA for any use. It is not yet known if remdesivir is safe and effective for the treatment of COVID-19.
  • The distribution of remdesivir has been authorized only for the treatment of hospitalized patients with severe COVID-19. It is not authorized for the treatment of any other viruses or pathogens.
  • This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the authorization is terminated or revoked sooner.
  • The FDA issued this EUA, requested by Gilead Sciences and based on their submitted data. The FDA Letter of Authorization for the EUA is available here.

Additonal Information for Healthcare Providers:

  • Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of remdesivir and mandatory requirements of the EUA.
  • Remdesivir must be administered intravenously. The optimal duration of treatment for COVID-19 is unknown. The suggested dose durations under this EUA are described in the Fact Sheet for Healthcare Providers, available here.

Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during remdesivir treatment and considered to be potentially attributable to remdesivir. These events must be reported within 7 calendar days from the onset of the event.

MedWatch adverse event reports can be submitted to the FDA online here, or by calling 1-800-FDA-1088.

  • For information about clinical trials that are testing the use of remdesivir for the treatment of COVID-19, please see www.clinicaltrials.gov.

Authorized Use

Remdesivir (GS-5734™) is authorized for use under an EUA only for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen, mechanical ventilation, and/or extracorporeal membrane oxygenation (ECMO). Remdesivir is authorized for adult or pediatric patients who are admitted to a hospital and for whom use of an IV agent is clinically appropriate. Remdesivir must be administered intravenously.

Overall Safety Summary

Remdesivir is an unapproved investigational product, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with remdesivir use.

Warnings: In clinical studies with remdesivir, infusion-related reactions and liver transaminase elevations have been observed. Remdesivir should not be used in patients who are hypersensitive to any ingredient of remdesivir. If signs and symptoms of a clinically significant infusion reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment. Do not initiate remdesivir in patients with ALT ≥5x ULN; discontinue therapy in patients who develop ALT ≥5x ULN or ALT elevation accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR.

Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with remdesivir; additionally monitor serum chemistries and hematology daily during therapy. The decision to continue or discontinue remdesivir therapy after development of an adverse event should be made based on the clinical risk/benefit assessment for the individual patient. For additional information and mandatory adverse event reporting, please see the Fact Sheet for Healthcare Providers.

Reference: 1. Remdesivir [EUA Fact Sheet]. Foster City, CA: Gilead Sciences, Inc.; 2020.

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Gilead is working closely with global health authorities and is focused on contributing our antiviral expertise and resources to help patients and communities impacted by COVID-19.