Tag Archives: remdesivir

Gilead remdesivir study finds only marginal benefit for moderate COVID-19 patients

By Deena Beasley

(Reuters) – Moderately ill COVID-19 patients saw their condition improve after a 5-day course of Gilead Sciences Inc’s remdesivir, but the drug did not significantly shorten hospital stays and a 10-day course did not show a benefit, according to new data.

The drug, which was shown in a trial of severely ill COVID-19 patients to shorten their hospital recovery time, has been at the forefront of the battle against the pandemic.

The 600-patient analysis, published on Friday by the Journal of the American Medical Association, found that moderately ill patients treated with the antiviral drug for up to 5 days had significantly higher odds of improvement in certain areas, such as whether or not they needed supplemental oxygen, compared to patients given standard treatment.

Researchers said the clinical importance of the benefit for those patients was uncertain, however.

Remdesivir is currently sold under an emergency use authorization from the U.S. Food and Drug Administration for treating patients hospitalized with severe COVID-19, the disease caused by the new coronavirus. Gilead earlier this month filed an application seeking full FDA approval of the drug.

Differing trial results for remdesivir raise “the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” according to a JAMA editorial accompanying the study.

The new study in moderately ill COVID-19 patients showed that 11 days after starting treatment, 65% of the 10-day remdesivir patients, 70% of the 5-day patients and 60% of the standard care patients had left the hospital.

Side effects seen more frequently in the remdesivir groups included nausea, low blood potassium levels, and headache.

The JAMA editorial said important questions remain regarding the efficacy of remdesivir, including which patients are most likely to benefit from the drug, the optimal duration of therapy, the drug’s impact on clinical outcomes, and its relative effect if combined with generic steroid treatments.

(Reporting by Deena Beasley; Editing by Nick Tattersall and Sonya Hepinstall)

Drug costs for COVID-19 patients plunge at U.S. hospitals, but may rise

By Chad Terhune

(Reuters) – Medication costs for COVID-19 patients hospitalized in the United States have dropped sharply since May, reflecting advances in treatment, shorter stays and use of cheaper generic drugs.

But costs may rise again as hospitals start to pay for Gilead Sciences Inc’s remdesivir.

Research by the health data firm IllumiCare and exclusively shared with Reuters found that hospitals spent $1,090 per COVID-19 patient on medication in July. That was down from $3,011 in May among more than 50 hospitals in 10 states that were analyzed.

Several factors drove down the number. The average length of stay for COVID-19 patients declined by nearly 30%, from 9.6 days in April to 6.8 days in July, the hospital data show. And the number of medications used dropped by 22%, from nearly 20 individual drugs in April to 15.4 drugs in July.

Pharmacists say some of the decrease in medications may stem from reduced use of ventilators, which require painkillers for sedation.

“We were throwing the kitchen sink at these patients and now hospitals are getting better at treating these infections,” said G.T. LaBorde, chief executive of IllumiCare, a Birmingham, Alabama-based firm that works with hospitals and analyzes their electronic medical records.

Remdesivir, which helped speed up patients’ recovery in a U.S. trial, won emergency-use authorization in May from U.S. regulators. Gilead donated early doses but has begun charging. It has said the price for commercially insured patients is $3,120 per treatment course and $2,340 for patients on Medicare.

Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, said many of the medications being used on COVID-19 patients are not “budget busters” and drug shortages have often been a bigger problem than cost.

But Ganio said pharmacy costs could increase significantly in the months ahead because of remdesivir.

Overall, many U.S. hospitals continue to face significant financial pressure from the pandemic as new infections remain high across much of the country, including in California, Florida and Texas. And health officials have warned that the upcoming flu season could further stress the healthcare system.

“As healthcare professionals, we are holding our breath for what fall will bring with flu season and COVID,” Ganio said.

In addition to remdesivir, hospital costs also may rise because of the increased use of tocilizumab, an anti-inflammatory drug widely used to treat arthritis. Hospital use jumped 29% among COVID-19 patients during July compared with the month earlier.

Tocilizumab costs more than $2,200 per patient, and is one of a class of drugs that includes Roche’s Actemra.

The most frequently prescribed drug for COVID-19 patients was the anticoagulant enoxaparin. It was given to 50% of inpatients last month at a cost of $322 per patient, the data show.

Another treatment recently found to reduce mortality for some COVID-19 patients, the steroid dexamethasone, costs $8.78 per patient, according to IllumiCare, and it was given to 35.1% of hospitalized COVID-19 patients reviewed in July.

Overall, IllumiCare said it looked at data from March through July at health systems in 10 states, including California, Texas and Alabama. It found more than 4,000 patients who were hospitalized and under treatment primarily for a coronavirus infection, drawing on medical billing codes for respiratory infection, sepsis and related conditions.

The firm excluded some COVID-positive patients, such as pregnant women, who were hospitalized for other reasons.

(Reporting by Chad Terhune. Editing by Peter Henderson and Gerry Doyle)

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)

State attorneys general urge U.S. government to increase supply, lower price of remdesivir

(Reuters) – A bipartisan coalition of attorneys general on Tuesday urged the U.S. government to use its legal authority to increase the availability and lower the price of Gilead Sciences’ COVID-19 treatment, remdesivir.

Gilead has priced remdesivir, the antiviral drug at the forefront of the battle against the pandemic, at $2,340 per patient for wealthier nations and said will charge U.S. patients with commercial insurance, $3,120 per course, or $520 per vial.

The United States signed a deal with Gilead in June for more than 500,000 courses of the treatment, which shortened hospital recovery time in a U.S. trial, making up most of the company’s output through September.

In a letter sent to the U.S. health agencies, the coalition led by Louisiana Attorney General Jeff Landry and California Attorney General Xavier Becerra urged the federal government to ensure Americans can afford and have reasonable access to sufficient supply of remdesivir during this pandemic.

Under the Bayh-Dole Act, the National Institutes of Health and the U.S. Food and Drug Administration have the authority to license remdesivir to third-party manufacturers to scale up production and distribution and ensure its availability at a reasonable price, according to the letter.

Gilead was not immediately available for comment.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

India sees record 49,000 new coronavirus cases, drug shortages in places

By Zeba Siddiqui and Rajendra Jadhav

MUMBAI (Reuters) – India reported over 49,000 fresh cases of the novel coronavirus with 740 new deaths on Friday, marking the biggest daily surge in cases even as officials in some states complained of shortages of vital drugs for those hospitalized.

As the number of cases neared 1.3 million in India, local authorities scrambled to procure generic versions of remdesivir, the drug that has shown promise in clinical trials in treating severely-ill patients with COVID-19, the disease caused by the coronavirus.

“Demand is huge as cases are rising rapidly in the state,” said a senior drug regulatory official in the western state of Maharashtra. “Supplies of the drug are limited, but companies have assured us they will provide more in a week.”

India has reported 30,601 deaths from the disease, with more than 40% of these deaths coming from Maharashtra state.

The western state is the worst-affected, having recorded nearly 350,000 cases, of which almost 60% were reported in the country’s financial capital, Mumbai, and its satellite towns.

Remdesivir, made by the U.S. drugmaker Gilead Sciences Inc, has been in high demand globally amid the pandemic, and Gilead in May and June authorized six Indian companies, and three foreign ones, to make and sell generic versions of the drug in 127 developing nations.

Only three of these firms with operations in India – Hetero Labs Ltd, Cipla and Mylan NV have so far been able to start supplying. Others are either awaiting regulatory approvals or still setting up production.

Several hospitals have struggled to get the drug as patient numbers increased in a county whose public health system is one of the world’s most poorly-funded. India has the third-highest number of coronavirus cases after the United States and Brazil.

Drug industry and government officials in the country said that they are doing their best.

“These things cannot be done in a hurry,” said P.D. Vaghela, an official at India’s Department of Pharmaceuticals, adding the drug regulator was working on granting approvals to companies for generic remdesivir at the earliest.

“Some people were engaging in black marketing but we have taken strict action against them,” Vaghela said.

(Reporting by Zeba Siddiqui and Rajendra Jadhav in MUMBAI; Additional reporting by Anuron Kumar Mitra in BENGALURU; Editing by Euan Rocha)

Gilead says remdesivir reduced risk of death in COVID-19 patients, more studies needed

By Ankur Banerjee

(Reuters) – Gilead Sciences Inc. said on Friday additional data from a late-stage study showed its antiviral remdesivir reduced the risk of death and significantly improved the conditions of severely ill COVID-19 patients.

The company, which had initially released the data from the trial in April, said the finding requires confirmation in clinical trials.

Remdesivir has been at the forefront of the battle against COVID-19 after the intravenously administered medicine helped shorten hospital recovery times in a clinical trial.

Several countries have approved the use of the treatment in severe patients but there are concerns over supply of the drug, which is also being tested as an inhaled version.

Gilead said it analyzed data from 312 patients treated in a late-stage study and a separate real-world retrospective cohort of 818 patients with similar characteristics and disease severity as in the study.

Gilead’s late-stage study evaluated the safety and efficacy of five-day and 10-day dosing durations of remdesivir administered intravenously in hospitalized patients with severe manifestations of COVID-19, caused by the new coronavirus.

Dr. Susan Olender from Columbia University Irving Medical Center said in the Gilead statement that the analysis draws from a real-world setting and serves as an important adjunct to clinical trial data even as it is not as vigorous as a randomized controlled trial.

Findings from the analysis of its late-stage study showed that 74.4% of remdesivir-treated patients recovered by Day 14 versus 59.0% of patients receiving standard of care, the company said.

The mortality rate for patients treated with remdesivir in the analysis was 7.6% at Day 14, compared with 12.5% among patients not on remdesivir.

Gilead also said the rates and likelihood of recovery were lower in patients who received hydroxychloroquine as well as remdesivir compared with patients treated with remdesivir who did not receive hydroxychloroquine.

Gilead’s shares rose 2% to $76.21 in early trading.

(Reporting by Ankur Banerjee in Bengaluru; editing by Anil D’Silva and Maju Samuel)

Gilead prices COVID-19 drug candidate remdesivir at $2,340 per patient

(Reuters) – Gilead Sciences Inc has priced its COVID-19 drug candidate remdesivir at $2,340 for a five-day treatment in the United States and some other developed countries, it said on Monday, as it set the price for a single vial at $390.

The price for U.S. private insurance companies will be $520 per vial, the drug maker said, which equates to $3,120 per patient for a treatment course using 6 vials of remdesivir.

This is below the $5,080 per course recommendation by U.S. drug pricing research group, the Institute for Clinical and Economic Review, last week.

Gilead has entered into an agreement with the U.S. Department of Health and Human Services (HHS), with the agency and states set to manage allocation to hospitals until the end of September.

HHS has secured more than 500,000 treatment courses of the drug for American hospitals through September, the agency said on Monday.

This represents 100% of Gilead’s projected production for July of 94,200 treatment courses, 90% of production in August and September, in addition to an allocation for clinical trials, HHS said.

After this period, once supplies are less constrained, HHS will stop managing the allocation, Gilead said.

Remdesivir’s price has been a topic of intense debate since the U.S. Food and Drug Administration approved its emergency use in some COVID-19 patients in May. Experts have said that Gilead would need to avoid the appearance of taking advantage of a health crisis for profits.

Wall Street analysts have said the antiviral drug could generate billions of dollars in revenue over the next couple of years if the pandemic continues.

Gilead has tied up with generic drug makers based in India and Pakistan, including Cipla Ltd and Hetero Labs Ltd, to make and supply remdesivir in 127 developing countries.

Cipla’s version is priced at less than 5,000 Indian rupees ($66.24), while Hetero Lab’s version is priced at 5,400 rupees.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Arun Koyyur)

What you need to know about the coronavirus right now 6-02-20

(Reuters) – Here’s what you need to know about the coronavirus right now:

Inhaled remdesivir

Gilead Sciences Inc is developing easier-to-administer versions of its antiviral treatment remdesivir for COVID-19 that could be used outside hospitals, including versions that can be inhaled after trials showed moderate effectiveness for the drug given by infusion.

Remdesivir is the only drug so far that has been shown to help patients with COVID-19, but Gilead and other companies are looking for ways to make it work better.

Sell, stow or dump?

Forget fast or slow fashion, now it’s ground to a halt.

A mountain of apparel stock has been piling up in stores, distribution centres, warehouses and even shipping containers during months of COVID-19 lockdowns. As retailers reopen around the world, they have to work out how to get rid of it.

Their main options? Keep it in storage, hold a sale, offload it to “off-price” retailers like TJ Maxx which sell branded goods at deep discounts, or move it to online resale sites.

Save the crabs

Wildlife advocates are pushing drugmakers to curb the use of prized horseshoe crab blood by switching to a synthetic alternative for safety tests that detect bacterial contamination in intravenous drugs or implants, including those needed before a COVID-19 vaccine can be used on humans.

This shift could save 100,000 horseshoe crabs annually on the U.S. East Coast alone and help threatened migratory birds that depend on crab eggs for survival say the National Audubon Society, Defenders of Wildlife and other groups.

Horseshoe crabs’ milky-blue copper-rich blood has helped the species to survive for 450 million years – and made it a source of one of the drug industry’s most unusual raw materials because it clots in the presence of bacterial endotoxins.

Mockery over coronavirus “sex ban”

The British government faced mockery on Tuesday over coronavirus rules which were cast by some media as a “sex ban”, though a junior minister said the regulations were aimed at keeping people safe.

Under amendments introduced to English rules on Monday, no person may participate in a gathering which takes place in a public or private place indoors and consists of two or more people. Britain’s tabloid media cast it as a “bonking ban” while #sexban was trending in the United Kingdom on Twitter.

“What this is about is making sure we don’t have people staying away from home at night,” junior housing minister Simon Clarke told LBC radio when questioned about the ban.

(Compiled by Karishma Singh and Nick Tattersall; Editing by Nick Macfie)

Gilead study shows shorter five-day course of remdesivir works as well as 10-day one

By Deena Beasley

(Reuters) – Gilead Sciences Inc, which has suggested that a shorter treatment duration could extend limited supplies of its drug remdesivir, on Wednesday published results of a study showing no significant difference in outcomes between 5- and 10-day courses of the drug for patients with severe COVID-19.

Gilead announced “top-line” findings from the trial on April 29. The full results were published in the New England Journal of Medicine.

Gilead’s trial involved 397 patients hospitalized with severe COVID-19, most of whom were not on ventilators. The company said the study, which did not include a placebo comparison, showed that 14 days after treatment with the intravenous drug, 64% of patients treated for 5 days and 54% treated for 10 days showed some clinical improvement.

At the 14-day mark, 8% of patients in the 5-day group and 11% of patients in the 10-day group had died.

Gilead said the results should not be interpreted as indicating that the shorter duration worked better since evidence of improved outcomes occurred early on, leading investigators to attribute the difference to imbalances inpatient status at enrollment.

Adverse events included nausea and worsening respiratory failure. The company said 2.5% of patients in the 5-day group and 3.6% in the 10-day group discontinued treatment due to elevated liver enzymes.

The U.S. Food and Drug Administration granted emergency use authorization to remdesivir on May 1, citing results from a different study run by the National Institutes of Health showing that the drug reduced hospitalization stays by 31% compared to a placebo treatment.

Gilead has said it anticipates results from a company study of remdesivir in patients with more moderate COVID-19 around the end of this month.

Gilead has pledged to donate 1.5 million doses of remdesivir – or enough to treat at least 140,000 patients – to fight the global pandemic.

(Reporting By Deena Beasley; Editing by Sonya Hepinstall)