Tag Archives: antiviral

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allocated supplies of the COVID-19 drug remdesivir since July as need for the costly antiviral wanes, according to unpublished government statistics provided to Reuters by a U.S. pharmacists’ group.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)

Pfizer to make Gilead’s COVID-19 treatment remdesivir

(Reuters) – Pfizer Inc said on Friday it signed a multiyear agreement to make COVID-19 treatment remdesivir for developer Gilead Sciences Inc, which is under pressure to increase tight supplies of the antiviral drug.

Gilead is aiming to make enough of the drug by the end of the year to treat more than 2 million COVID-19 patients, and agreed to send nearly all of its remdesivir supply to the United States through September.

But hospital staffers and politicians have complained about difficulties in gaining access to the drug, which is one of only two to have demonstrated an ability to help hospitalized COVID-19 patients in formal clinical trials.

There are also fears of shortages outside the United States, and separately on Friday, Britain’s Hikma Pharmaceuticals PLC said it has started manufacturing remdesivir at its Portugal plant.

Gilead said its manufacturing network for the drug had grown to more than 40 companies in North America, Europe and Asia to add capacity.

Earlier this week, a bipartisan group of U.S. state attorneys general urged the federal government to allow other companies to make Gilead’s remdesivir, to increase its availability and lower the price of the antiviral drug.

Pfizer will provide contract manufacturing services through its McPherson, Kansas, plant, the drugmaker said. It was not immediately clear if Pfizer would supply only for the U.S. market.

The U.S. Food and Drug Administration sent a warning letter to Pfizer in 2017 saying that the process for manufacturing sterile injectable drugs at the Kansas plant was “out of control” and put patients at risk.

The FDA said several products were contaminated with multiple foreign particulates but a subsequent FDA inspection found that the issues had been resolved.

Pfizer, with Germany’s BioNTech, is also rushing to develop a vaccine against the coronavirus.

Pfizer has helped other drugmakers manufacture their products before. It makes EpiPen emergency allergy treatments through its Meridian Medical Technologies business and also operates a contract manufacturer called Center One.

(Reporting by Manas Mishra in Bengaluru; Editing by Anil D’Silva and Matthew Lewis)

UK’s Hikma making Gilead’s COVID-19 drug remdesivir to increase supply

By Pushkala Aripaka

(Reuters) – Britain’s Hikma Pharmaceuticals said on Friday it has started manufacturing Gilead’s antiviral drug remdesivir under contract in Portugal, as the U.S. company outsources to increase availability of the COVID-19 treatment.

Remdesivir is one of only two medicines to have shown to help hospitalized COVID-19 patients in clinical trials, making it a front-runner treatment for the illness caused by the new coronavirus.

Hikma’s Chief Executive Siggi Olafsson said the company will start supplying batches of the drug “soon,” and Gilead is expected to distribute it.

“The terms of the deal are confidential, we are simply a contract manufacturer for Gilead – they order products from us as they expect the sales to be,” Olafsson told Reuters in a telephone interview.

Remdesivir, which is administered intravenously, has been conditionally approved or supported in many regions to treat COVID-19, which has killed more than 800,000 people globally.

A pledge by Gilead to send nearly all of its supplies to the United States between July and September stirred concerns about availability elsewhere.

This week, a bipartisan group of U.S. state attorney generals urged Washington to allow other companies to make the treatment to increase availability and lower the price.

On Friday, Pfizer said it had signed a multi-year deal with Gilead to manufacture and supply remdesivir.

Gilead said on Thursday that its manufacturing network for the drug had grown to more than 40 companies in North America, Europe and Asia.

The company had said in June that it was aiming to supply enough of the drug by the end of the year to treat more than 2 million COVID-19 patients, more than double its prior target of 1 million.

Gilead has signed several pacts with generic medicine makers in Egypt, India and Pakistan to distribute remdesivir in 127 countries. The deals include those with Cipla Jubilant and privately held Hetero.

Hikma’s announcement of the deal with Gilead helped its shares jump more than 10% on Friday as it also reported a jump in first-half operating profit and lifted its sales outlook.

Analysts said the deal highlights Hikma’s “growing importance as a trusted source of essential medicines.”

(Reporting by Pushkala Aripaka in Bengaluru; Editing by Arun Koyyur/Josephine Mason/Susan Fenton)

Study panning anti-malaria drug Trump took against COVID faces new questions

By Michael Erman

NEW YORK (Reuters) – British medical journal the Lancet on Tuesday said it had concerns about data behind an influential article that found hydroxychloroquine increased the risk of death in COVID-19 patients, a conclusion that undercut scientific interest in the medicine championed by U.S. President Donald Trump.

Hydroxychloroquine – which has anti-inflammatory and antiviral properties – inhibited the coronavirus in laboratory experiments but has not been proven effective in humans, particularly in placebo-controlled, randomized clinical trials considered the gold standard for data.

The debate has become highly politicized, and many scientists have voiced concern.

Nearly 150 doctors signed an open letter to the Lancet last week calling the article’s conclusions into question and asking to make public the peer review comments that preceded publication.

“This is not some sideshow or minor issue,” said Dr. Walid Gellad, a professor at University of Pittsburgh’s medical school, who was not a signatory of the letter but has been critical of the study.

“We’re in an unprecedented pandemic. We’ve organized these enormous clinical trials to figure out if something works. And this study stopped or paused a couple of those trials, and changed the narrative around a drug that no one knows if it works or not,” he said.

The observational study published in the Lancet on May 22 looked at 96,000 hospitalized COVID-19 patients, some treated with the decades-old malaria drug that Trump said he took and has urged others to use.

Several clinical trials were put on hold after the study was published.

The study, using data provided by healthcare data analytics firm Surgisphere, was not a traditional clinical trial that would have compared hydroxychloroquine to a placebo or other medicine.

The Lancet’s editors said in a note that serious scientific questions about the study were brought to their attention and an independent audit of the data has already been commissioned.

Surgisphere said in a statement that the audit “will bring further transparency to our work (and) further highlight the quality of our work.”

Earlier on Tuesday, the New England Journal of Medicine (NEJM) said it was concerned about the quality of the data behind a different study it published in May that also used data from Surgisphere and had the same lead author.

Dr. Mandeep Mehra, the lead author and a professor of Medicine at Harvard Medical School, defended the use of the Surgisphere dataset as an intermediary step until clinical data is available.

“I eagerly await word from the independent audits, the results of which will inform any further action,” Mehra said in a statement after the Lancet note.

The World Health Organization (WHO) suspended hydroxychloroquine’s use in a large trial on COVID-19 patients after the Lancet study. Following the WHO trial suspension, the governments of France, Italy and Belgium halted the use of hydroxychloroquine for COVID-19 patients.

Among the critics of the study to sign the letter last week were several academics from the University of Oxford and Mahidol Oxford Tropical Medicine Research Unit (MORU) in Bangkok, which had been conducting the global “COPCOV” trial of hydroxychloroquine as a treatment of COVID-19.

The trial was paused last week, after the Lancet article.

In March, Trump, with little scientific evidence, said hydroxychloroquine used in combination with the antibiotic azithromycin had “a real chance to be one of the biggest game-changers in the history of medicine.” He later said he took the drugs preventively after two people who worked at the White House were diagnosed with COVID-19.

Trump and Brazilian President Jair Bolsonaro discussed a joint research effort on using hydroxychloroquine as both a prophylaxis and treatment for the coronavirus, the White House said on Tuesday.

(Reporting by Michael Erman; additional reporting by Alistair Smout, Editing by Bill Berkrot, Peter Henderson and Tom Brown)