Coming off a World Health Organization (WHO) recommendation for the use of Veklury in non-hospitalized COVID-19 patients, Gilead Sciences is touting real-world evidence that could help expand the WHO endorsement to those who are hospitalized with a severe infection.
While the FDA approved the infused antiviral for emergency use in patients with severe COVID in October of 2020 and more than 40 other countries have done the same, the WHO has not followed suit in a key area where options are limited.
But a look at the Premier Healthcare Database of 853,219 patients hospitalized in the U.S. for COVID suggests the increased use of Veklury has helped improve outcomes.
At the outset of the study in May of 2020, Veklury was used on 41% of patients within two days of hospitalization. By the end of the study period, in December of 2021, that figure had grown to 91%.
During those 19 months, the median length of patient hospital stays went from seven days to six. Among those who needed mechanical ventilation, the median improved from 15 days to 11. Additionally, the rate of those who needed high-flow oxygen/non-invasive ventilation decreased from 66% to 52%.
How much the improved outcomes can be attributed to Veklury is tough to determine.
“This a descriptive analysis just to look at patterns of utilization,” Fernando Bognar, Gilead’s vice president, global medical affairs, HIV, said in an interview. “It is a combination of factors with Veklury being a part of what is seen in this analysis.”
But Bognar said the results show Veklury is more effective when provided earlier in a patient’s hospital stay.
The findings were part of what Gilead is presenting on Veklury during the European Congress of Clinical Microbiology & Infectious Diseases Saturday though Tuesday in Lisbon, Portugal.
Another area in which Gilead hopes to expand Veklury’s usage is among those with mild to moderate COVID. Data from the phase 3 PINETREE study, which showed the antiviral was 87% effective in keeping at-risk patients out of the hospital, paved the way for an FDA approval in January, followed last week by the recommendation from the WHO.
Now, a post hoc analysis of the trial data shows that—as was the case with severe COVID patients—the earlier the treatment is administered the better it performs. When Veklury is administered within five days from symptom onset, it reduces the risk of hospitalization by 90%. When Veklury infusions begin six to seven days after symptom onset, they reduce the risk by 81%.
It's uncertain how much the FDA and WHO endorsements for Veklury in mild to moderate COVID will boost sales. Compared to Pfizer’s oral antiviral Paxlovid, Veklury measures up in efficacy but can’t match the latter’s price and convenience.
“It’s three days that patients have to return to site. That is not the ideal outpatient management,” Bognar said of Veklury. “However, given that options may at sometimes be limited, it is something for (doctors) to consider.”
Gilead is working on an oral version of Veklury, with early stage trials ongoing.
Gilead also presented interim data from a small trial of Veklury on hospitalized pediatric patients which showed by Day 10 that 75% of the participants had clinical improvement, with 60% discharged from the hospital.
Gilead recorded sales of $5.6 billion for Veklury in 2021, with $1.4 billion coming in the fourth quarter. The company projects a significant slowdown in sales to $2 billion in 2022.