Generics
Veklury Significantly Reduced Risk of Hospitalization in High-Risk Patients with COVID-19
23 September 2021 - - US-based Gilead Sciences, Inc. (NASDAQ: GILD) has posted positive results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury (remdesivir) for intravenous use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression, the company said.

This late-breaking data will be presented at the IDWeek 2021 virtual conference.

In an analysis of 562 participants randomly assigned in a 1: 1 ratio to receive Veklury or placebo, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008.

Results also showed an 81% reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by Day 28 for participants treated with Veklury (1.6% [4/246]) compared with placebo (8.3% [21/252]) p=0.002.

In the study, no deaths were observed in either arm by Day 28.

Enrollment for this trial was stopped prior to fulfilling enrollment targets in April 2021, reflecting the changing epidemiology and adoption of additional treatment options at the time; however, the study continued to collect data on enrolled participants and both investigators and participants remained blinded to their assignment of Veklury or placebo.

According to the company, these results complement positive results from ACTT-1 and other studies in hospitalized patients in which Veklury helped patients recover significantly faster and reduced the likelihood of disease progression.

The use of Veklury for the treatment of non-hospitalized patients with three days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency globally.

In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.

Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury.

The safety profile was similar between Veklury and placebo in this trial, with the most common treatment emergent adverse events in patients taking Veklury being nausea and headache.

Of the 279 participants who received Veklury, no new safety signals were identified.

One death was observed in the study at Day 59 (participant on placebo); no deaths occurred in either arm of the study by the Day 28 primary endpoint. Gilead is in the process of sharing the data with regulatory agencies.

Gilead said it continues to study the efficacy and safety of Veklury in hospitalized patient populations with ongoing unmet needs, such as patients with renal impairment, children and pregnant women, as well as through the support of a number of externally sponsored trials.

Gilead is also developing novel oral treatment options for non-hospitalized patients with COVID-19 and hopes to file investigational new drug applications with the Food and Drug Administration by early next year.

Study GS-US-540-9012 (PINETREE) was a Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of a three-day course of Veklury IV in reducing the rate of hospitalization or all-cause death among non-hospitalized COVID-19 patients at high risk for disease progression.

The primary study endpoint was the composite of COVID-19 hospitalization or all-cause death by Day 28. The composite endpoint of medical visits due to COVID-19 or all-cause death by Day 28 was a secondary outcome measure.

The study was designed to enroll 1,264 participants, randomized in a double-blind fashion so that half of enrolled participants would receive Veklury and the other half would receive a matched placebo.

Gilead decided to stop the study in April 2021, reflecting the evolution of the COVID-19 landscape and changing patient needs.

At the time that enrollment was terminated, 584 participants were enrolled. The study remained blinded and participants already enrolled in the study were followed according to the protocol until the last patient visit occurred, and at that point the study was closed.

This trial was designed to evaluate the potential role of Veklury in helping patients diagnosed with COVID-19 who were considered high-risk for disease progression based on comorbidities and age but had not recently been hospitalized due to the infection.

Common comorbidities in study participants included obesity, hypertension, and diabetes. A third of the participants were aged 60 or older.

Participants in the study must have received a positive diagnosis within four days of initiating treatment and experienced symptoms for seven days or less.

Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company's antiviral research. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19.

At this time, more than half of patients hospitalized with COVID-19 in the United States are treated with Veklury.

Veklury is approved or authorized for temporary use in approximately 50 countries worldwide and generic remdesivir, manufactured by our voluntary licensing partners, is provided to 127 middle- and low-income countries.
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