Tag Archives: Gilead Sciences

NIH starts clinical trial testing antibody treatments in COVID-19 patients

(Reuters) – The U.S. National Institutes of Health (NIH) said on Tuesday it has started a study to evaluate two antibody treatments in COVID-19 patients as part of the agency’s program to identify promising drugs to help tackle the new coronavirus.

The trial will test AbbVie Inc’s psoriasis drug risankizumab along with Gilead Sciences’ antiviral remdesivir, compared to a placebo and remdesivir.

The study will also test Humanigen’s experimental drug lenzilumab with remdesivir, compared to placebo and remdesivir.

“The goal here is to identify as quickly as possible the experimental therapeutics that demonstrate the most clinical promise as COVID-19 treatments and move them into larger-scale testing,” said NIAID Director and U.S. infectious diseases expert Anthony Fauci.

Gilead’s remdesivir, which was among the first to be used to treat COVID-19 and received emergency use authorization from the U.S. Food and Drug Administration in May, has since been authorized for use in several other countries.

Risankizumab and lenzilumab belong to a class of drugs known as monoclonal antibodies that are laboratory-made versions of proteins naturally produced by the immune system in response to invading viruses or other pathogens.

The treatment has come under the spotlight after U.S. President Donald Trump was treated with Regeneron Pharmaceuticals’ antibody drug earlier this month.

Regeneron and Eli Lilly have both applied to the U.S. FDA for emergency use of their antibody treatments.

(Reporting by Amruta Khandekar; editing by Ankur Banerjee and Ramakrishnan M.)

Exclusive: U.S. hospitals turn down remdesivir supplies, limit use to sickest COVID-19 patients

By Deena Beasley

(Reuters) – U.S. hospitals have turned down about a third of their allocated supplies of the COVID-19 drug remdesivir since July as need for the costly antiviral wanes, according to unpublished government statistics provided to Reuters by a U.S. pharmacists’ group.

Some hospitals said they are still buying the Gilead Sciences medicine to build inventory in case the pandemic accelerates over the winter. But they said current supplies are adequate, in part because they are limiting use to severely ill patients.

The Food and Drug Administration has allowed more liberal remdesivir use, but 6 out of 8 major hospital systems contacted by Reuters said they were not using it for moderate cases.

The slowdown suggests that a shortage of the drug is over and threatens Gilead’s efforts to expand use of remdesivir, which it sells under the brand name Veklury in some countries.

The U.S. Department of Health and Human Services (HHS) told hospitals and other healthcare organizations on Friday that between July 6 and September 8, state and territory public health systems accepted about 72% of the remdesivir they were offered, Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, told Reuters.

Hospitals in turn took only about two-thirds of what states and territories accepted, he added. It was not immediately clear what happened to the surplus supplies.

Neither Gilead nor HHS immediately responded to requests for comment.

A surplus of remdesivir – which costs $3,120 for a 6-vial intravenous course – marks a turnaround from earlier in the pandemic, when supplies of the drug had fallen short of demand in some regions.

Government-led distribution of remdesivir will expire at the end of September. Hospitals said they have little information on availability after that.

Remdesivir was first authorized by the FDA in May for emergency use in COVID-19 patients hospitalized and on oxygen support after data showed that it helped shorten hospital recovery time.

The agency last month expanded use to hospitalized patients who do not require oxygen support, based on data published in the JAMA medical journal showing that the drug provided a modest benefit for those patients.

The newer data has left many experts unconvinced.

Dr. Aneesh Mehta, chief of infectious diseases services at Atlanta’s Emory University Hospital, said Emory is focusing supplies on patients likely to benefit the most.

“I am not terribly impressed with the study,” said Dr. Adarsh Bhimraj, an infectious disease specialist at the Cleveland Clinic. He said he remains “skeptical” about using remdesivir in patients with moderate COVID, especially given the price.

(Reporting By Deena Beasley; editing by Peter Henderson and Bill Berkrot)

Fauci says leak concerns fueled his White House revelation of Gilead drug results

By Julie Steenhuysen

CHICAGO (Reuters) – Concerns over leaks compelled the top U.S. infectious disease official to reveal data on Gilead Sciences Inc’s experimental drug remdesivir, the first in a scientifically rigorous clinical trial to show benefit in treating COVID-19.

The dramatic announcement by Dr Anthony Fauci in the Oval Office on Wednesday prompted concerns among scientists that the Trump administration was raising hopes about a coronavirus treatment before sharing the full data with researchers.

As a cautionary example of inflating the potential value of a therapy, some pointed to President Donald Trump’s repeated endorsements of malaria drug hydroxychloroquine as a treatment, with no evidence that it works.

Newer data suggests the malaria treatments may carry significant risks for some sufferers of the respiratory disease caused by the virus.

Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), which is running the trial, said he took the first opportunity to get the word out that patients taking a dummy treatment or placebo should be switched to remdesivir in hopes of benefiting from it.

He expressed concern that leaks of partial information would lead to confusion. Since the White House was not planning a daily virus briefing, Fauci said he was invited to release the news at a news conference with Louisiana Gov. John Bel Edwards(D). “It was purely driven by ethical concerns,” Fauci told Reuters in a telephone interview.

“I would love to wait to present it at a scientific meeting, but it’s just not in the cards when you have a situation where the ethical concern about getting the drug to people on placebo dominates the conversation.”

An independent data safety and monitoring board, which had looked at the preliminary results of the NIAID trial, determined it had met its primary goal of reducing hospital stays.

On Tuesday evening, that information was conveyed in a conference call to scientists studying the drug globally.

“There are literally dozens and dozens of investigators around the world,” Fauci said. “People were starting to leak it.” But he did not give details of where the unreported data was being shared.

Several scientists interviewed by Reuters felt the White House setting seemed inappropriate for the release of highly anticipated government-funded trial data on the Gilead therapy.

They had expected it to be presented simultaneously in a detailed news release, a briefing at a medical meeting or in a scientific journal, allowing researchers to review the data.

Information from various trials of remdesivir has been leaked to media in recent weeks. In a statement on Wednesday, Gilead said the NIAID’s much anticipated trial had met its primary goal, but gave no details.

Data in a separate NIAID statement after Fauci spoke detailed preliminary results showing that patients who got the drug had a 31 percent faster time to recovery than those who got a placebo, cutting hospital stays by four days.

The trial also came close to showing the drug helped people survive the disease, but the data fell just short of statistical significance.

“I want to see the full data. I want to understand the statistics. I want to understand the benefit and risk. I want to understand the structure of the study, and all of it,” said Dr. Steven Nissen, the chief academic officer at the Cleveland Clinic.

“Am I encouraged from what I’ve heard? Yes, I’m encouraged. But I want to get a full understanding of what happened here, and not get it via a photo opportunity from the Oval Office.”

Data Gilead released on its own trial of remdesivir drew less attention, as it did not compare outcomes between those receiving therapy and those who did not.

Results from a third study in China suggesting remdesivir failed to help COVID-19 patients were released in the British medical journal the Lancet after review by a peer group of scientists.

“That’s the only thing I’ll hang my hat on, and that was negative,” said Dr. Eric Topol, director and founder of the Scripps Research Translational Institute in La Jolla, California.

He was unimpressed by remdesivir’s modest benefit.

“It was expected to be a whopping effect,” Topol added. “It clearly does not have that.”

At the Oval Office news conference, Fauci compared the study findings to AZT, the first drug to show any benefit against HIV, decades ago.

“We know that was an imperfect drug. It was the first step,” Fauci said in the interview.

“Similar to AZT, it’s (remdesivir) the first baby step towards what hopefully will be a number of better drugs that will come in and be able to treat people with COVID-19.”

(This story has been refiled to correct spelling of “clinical” in paragraph one)

(Reporting by Julie Steenhuysen; Editing by Michele Gershberg and Clarence Fernandez)