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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 VEKLURY (remdesivir) to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, VEKLURY, for the treatment of COVID-19.

Authorized Use

VEKLURY® (remdesivir) is authorized for use under an EUA only for the treatment of adult and pediatric patients hospitalized with suspected or laboratory-confirmed COVID-19, and for whom use of an intravenous (IV) agent is clinically appropriate. VEKLURY must be administered via IV infusion.

Clinical Data1

VEKLURY is an unapproved antiviral drug with available data from 3 randomized clinical trials in patients with COVID-19. The risks and benefits of the use of VEKLURY 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 VEKLURY 200 mg administered intravenously on Day 1, followed by 100 mg administered intravenously, once daily, for up to 9 days. The mechanism of these elevations is unknown.

Preliminary Efficacy and Safety Data From the NIAID ACTT-1 Trial

NIAID ACTT-1 Trial: a randomized, double-blind, placebo-controlled clinical trial of VEKLURY in hospitalized adult subjects with COVID-19 with evidence of lower respiratory involvement. Treatment with VEKLURY was stopped in subjects who were discharged from the hospital prior to the completion of 10 days of treatment.

The trial enrolled 1,062 subjects: 105 (9.9%) subjects with mild/moderate disease and 957 (90.1%) subjects with severe disease. Subjects were randomized in a 1:1 manner, stratified by disease severity at enrollment, to receive VEKLURY (n=541) or placebo (n=521) plus standard of care.

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

Primary clinical endpoint

Time to recovery within 29 days after randomization, defined as either discharged from the hospital or hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care.

Time to Recovery (all patients)

The odds of improvement in the ordinal scale were higher in the VEKLURY group at Day 15 when compared to the placebo group (odds ratio: 1.6 [95% CI, 1.3-1.9]; p<0.001).

Among subjects with mild/moderate disease at enrollment (n=105), the median time to recovery was 5 days in both the VEKLURY and placebo groups (recovery rate ratio: 1.22 [95% CI, 0.82-1.81]); the odds of improvement in the ordinal scale in the VEKLURY group at Day 15 when compared to the placebo group were as follows: odds ratio: 1.46 [95% CI, 0.71-2.97].

Among subjects with severe disease at enrollment (n=957), the median time to recovery was 11 days in the VEKLURY group compared to 18 days in the placebo group (recovery rate ratio: 1.31 [95% CI, 1.12-1.52]; p<0.001); the odds of improvement in the ordinal scale in the VEKLURY group at Day 15 when compared to the placebo group were as follows: odds ratio: 1.56 [95% CI, 1.24-1.95].

Mortality (interim analysis*)

14-Day Mortality Rate (all patients)

*The interim analysis was conducted after 607 recoveries were attained (N=1059; 538 VEKLURY, 521 placebo).

Adverse Events

% VEKLURY
(n=541)
Placebo
(n=522)
Serious adverse events (SAEs) 21 27
Grade ≥3 non-serious adverse events 29 33

The most common SAE was respiratory failure, reported in 5% of subjects treated with VEKLURY and 8% of subjects treated with placebo.

Most Common Grade ≥3 Non-Serious Adverse Events

n (%) VEKLURY
(n=538)
Placebo
(n=521)
Anemia or decreased hemoglobin 43 (8) 47 (9)
Acute kidney injury, decreased eGFR or creatinine renal clearance, or increased blood creatinine 40 (7) 38 (7)
Pyrexia 27 (5) 17 (3)
Hyperglycemia or increased blood glucose 22 (4) 17 (3)
Increased transaminases, including ALT and/or AST 22 (4) 31 (6)

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

Study GS-US-540-5773: a randomized, open-label, multicenter study of hospitalized patients at least 12 years of age with confirmed SARS-CoV-2 infection, oxygen saturation of ≤94% on room air, and radiological evidence of pneumonia (N=397).

Trial arms

Treatment with VEKLURY was stopped in subjects who were discharged from the hospital prior to completion of their protocol-defined duration of treatment.

Primary endpoint

Primary Endpoint

After adjusting for between-group differences at baseline, patients receiving a 10-day course of VEKLURY had similar clinical status at Day 14 as those receiving a 5-day course (odds ratio for improvement: 0.75 [95% CI, 0.51-1.12]).

Mortality

28-day mortality was 11.5% and 14.2% in the 5- and 10-day treatment groups, respectively.

Adverse Events

% 5-day regimen
(n=200)
10-day regimen
(n=197)
Adverse events (all grades) 72 75
SAEs 22 35
Adverse events (Grade ≥3) 32 43

The most common adverse events were nausea (10% in the 5-day group vs 9% in the 10-day group), acute respiratory failure (6% vs 11%), ALT increased (5% vs 8%), and constipation (7% in both groups). Nine (5%) subjects in the 5-day group and 22 (11%) subjects in the 10-day group discontinued treatment due to an adverse event.

Hepatic Laboratory Abnormalities

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

Efficacy and Safety Data From Study GS-US-540-5774

Study GS-US-540-5774: A randomized, open-label multicenter clinical trial of hospitalized subjects at least 12 years of age with confirmed SARS-CoV-2 infection and radiological evidence of pneumonia without an oxygen requirement during screening (N=584).

Trial arms

Treatment with VEKLURY was stopped in subjects who were discharged from the hospital prior to completion of their protocol-defined duration of treatment.

Primary endpoint

Primary Endpoint

The odds of improvement in clinical status were higher in the 5-day VEKLURY group at Day 11 when compared to those receiving only SOC (odds ratio: 1.65 [95% CI, 1.09-2.48]; p=0.017). The odds of improvement in clinical status with the 10-day treatment group when compared to those receiving only SOC were not statistically significantly different (odds ratio: 1.31 [95% CI, 0.88-1.95]; p=0.183).

Mortality

At Day 28, mortality was ≤2% in all treatment groups.

Adverse Events

% 5-day regimen
(n=191)
10-day regimen
(n=193)
SOC
(n=200)
Adverse events (all grades) 51 59 47
SAEs 5 5 9
Grade ≥3 adverse events 11 12 12

The most common adverse events in the 5-day, 10-day, and SOC groups, respectively, were nausea (10% vs 9% vs 3%), diarrhea (6% vs 5% vs 7%), hypokalemia (5% vs 7% vs 2%), and headache (5% vs 5% vs 3%). Four (2%) subjects in the 5-day group and 8 (4%) subjects in the 10-day group discontinued treatment due to an adverse event.

Hepatic Laboratory Abnormalities

n/N (%) 5-day regimen 10-day regimen SOC
ALT increased Grade 3 4/179 (2) 6/177 (3) 11/182 (6)
Grade 4 0 0 3/182 (2)
AST increased Grade 3 3/177 (2) 2/175 (1) 6/182 (3)
Grade 4 1/177 (<1) 0 5/182 (3)
Total bilirubin increased Grade 3 1/177 (<1) 3/176 (2) 1/181 (<1)
Grade 4 0 1/176 (<1) 1/181 (<1)

Safety From Studies of Healthy Volunteers

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 VEKLURY.

ALT=alanine aminotransferase; AST=aspartate aminotransferase; eGFR=estimated glomerular filtration rate; NIAID=National Institute of Allergy and Infectious Diseases; PCR=polymerase chain reaction; SARS-CoV=severe acute respiratory syndrome coronavirus.

Important Information

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

  • VEKLURY is an investigational drug that has not been approved by the FDA for any use. It is not yet known if VEKLURY is safe and effective for the treatment of COVID-19.
  • The distribution of VEKLURY has been authorized only for the treatment of hospitalized patients with COVID-19. 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 VEKLURY and mandatory requirements of the EUA.
  • VEKLURY 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 designees are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during VEKLURY treatment and considered to be potentially attributable to VEKLURY. 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.

Authorized Use

VEKLURY® (remdesivir) is authorized for use under an EUA only for the treatment of adult and pediatric patients hospitalized with suspected or laboratory-confirmed COVID-19, and for whom use of an intravenous (IV) agent is clinically appropriate. VEKLURY must be administered via IV infusion.

Safety Information

VEKLURY 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 VEKLURY use.

Warnings and precautions:

  • Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of VEKLURY. Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent symptoms of hypersensitivity. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of VEKLURY and initiate appropriate treatment. The use of VEKLURY is contraindicated in patients with known hypersensitivity to VEKLURY.
  • Transaminase elevations have been observed in healthy volunteers and patients with COVID-19 in clinical trials who received VEKLURY. Do not initiate VEKLURY 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.
  • Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine. Coadministration of VEKLURY and chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on in vitro data demonstrating an antagonistic effect of chloroquine on the intracellular metabolic activation and antiviral activity of VEKLURY.

Patient monitoring:

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 VEKLURY. The decision to continue or discontinue VEKLURY 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. VEKLURY. EUA Fact Sheet. Foster City, CA: Gilead Sciences, Inc.; 2020.

Information about the EUA:

Information about COVID-19:

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.