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Drug Trials Snapshots: VEKLURY

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the VEKLURY Package Insert for complete information.

VEKLURY (remdesivir)
VEK-lur-ee
Gilead Sciences, Inc.
Approval date: October 22, 2020


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

VEKLURY is for use in adult and pediatric patients 12 years and older weighing at least 40 kg (88 lbs) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization.

COVID-19 is an infectious, potentially serious or life-threating respiratory disease caused by a coronavirus called SARS-CoV-2 virus.

How is this drug used?

VEKLURY is an injection. It is given by a healthcare provider directly into the vein (intravenous infusion) once a day for 5 to 10 days.

What are the benefits of this drug?

In one trial in patients with mild, moderate and severe COVID-19, the time to recovery was shorter in patients who received VEKLURY than in patients who received placebo. In a different trial in patients with moderate COVID-19, treatment with VEKLURY was better in improving patients’ condition in comparison to standard of care.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: VEKLURY worked similarly in men and women.
  • Race: VELKURY worked similarly in all tested race groups.
  • Age: VEKLURY worked similarly in all tested age groups including patients 65 years and older.

What are the possible side effects?

VEKLURY may cause serious side effects including allergic reactions during and after the infusion, and increased liver enzymes in the blood.

The most common side effects of VEKLURY are nausea and increased liver enzymes in the blood.

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in men and women.
  • Race: The occurrence of side effects was similar in all tested race groups.
  • Age: The occurrence of side effects was lower in patients younger than 65 years of age.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the trials?

The FDA approved VEKLURY based primarily on evidence from three clinical trials (Trial 1/ NCT NCT04280705, Trial 2/ NCT04292899) and Trial 3/ NCT04292730) of 2043 hospitalized patients with COVID-19. The trials were conducted at 226 sites in 17 countries including the United States.

The figures below present combined patients from all three trials that provided data for the assessment of VEKLURY benefits (efficacy population).

Figure 1 summarizes how many men and women were in the clinical trials.

Figure 1. Demographics by Sex (efficacy population)

Pie chart summarizing how many men and women were in the clinical trials. In

FDA Clinical Review

Figure 2 summarizes the percentage of patients by race.

Figure 2. Demographics by Race (efficacy population)

Pie chart summarizing how many patients of different races were in the clinical trial.  In total, 1,170 patients were White (57%), 368 patients were Black or African American (18%), 282 patients were Asian (14%), 12 patients were American Indian or Alaska Native (1%), 8 patients were Native Hawaiian or other Pacific Islander (<1%), and 203 patients were Other (9%).

*Includes Multiple and Other

FDA Clinical Review

Figure 3 summarizes the percentage of patients by age.

Figure 3. Demographics by Age (efficacy population)

Pie chart summarizing how many individuals of certain age groups were in the clinical trial.  In total, 252 patients were less than 40 years old (12%), 1,080 patients were between 40-64 years old (53%), 420 patients were between 64-75 years old (21%), and 291 patients were 75 years and older (14%).

FDA Clinical Review

Figure 4 summarizes the percentage of patients by ethnicity.

Figure 4. Demographics by Ethnicity (efficacy population)

Pie chart summarizing how many individuals of certain ethnicity groups were in the clinical trial.  In total, 436 patients were Hispanic or Latino (21%), 1515 patients were not Hispanic or Latino (74%), and for 92 patients (5%) ethnicity has not been reported

FDA Clinical Review

How were the trials designed?

There were three trials that evaluated benefits and side effects of VEKLURY. Each trial was designed differently.

Trial 1 enrolled hospitalized adult patients with mild, moderate or severe COVID-19. Patients received at random either VEKLURY or placebo infusion every day for 10 days. Neither the patients nor the investigators knew which treatment was given. The benefit was evaluated by comparing the time to recovery within 29 days in VEKLURY-treated group to the placebo-treated group.

Trial 2 enrolled hospitalized adult patients with severe COVID-19. All patients had pneumonia. Patients received at random VEKLURY treatment once a day for either 5 or 10 days. The benefit was evaluated after 14 days of treatment by comparing the patients’ condition between the two groups. The patient’s condition was assessed on a 7-point scale going from “death” to “not hospitalized”.

Trial 3 enrolled hospitalized adult patients with moderate COVID-19. All patients had pneumonia. Patients received at random VEKLURY treatment once a day for either 5 or 10 days (in addition to standard of care), or the standard of care only. The benefit was evaluated after 11 days of treatment by comparing the patients’ condition among the three groups. The patient’s condition was assessed using the same scale as in Trial 2.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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