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Gilead Drug Coronavirus

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Last Updated: 02 July 2021

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General | Latest Info

Remdesivir, first drug shown to be effective against Coronavirus, will be distributed under an unusual agreement with the federal government that establishes nonnegotiable prices and prioritizes American patients, health officials announced on Monday. Arrangement may serve as a template for distribution of new treatments and vaccines as pandemic swells, said Ernst Berndt, retired health economist at Massachusetts Institute of Technology Sloan School of Management. Remdesivir will be sold for 520 per vial, or 3 120 per treatment course, to hospitals for treatment of patients with private insurance, according to the Department of Health and Human Services and Gilead Sciences, drug manufacturer. The price will be set at 390 per vial, or 2 340 per treatment course, for patients on government - sponsored insurance and for those in other countries with National Health Care systems. Drug will be sold only in the United States through September, meaning American patients will receive almost the entirety of Gileads output, more than 500 000 treatment courses. Hhs and state health departments have been allocating Drug to hospitals nationwide based on need. After September, they will no longer have a role in determining where drugs are send. This is US - first policy, says Rena Conti, Health Care economist at Boston University. Access is guaranteed to US, but worldwide demand could potentially outstrip supplies. I am unaware of any other policies except perhaps in bioterrorism drugs where there might be country - specific supplies, she add. Remdesivir is so far the only treatment shown to speed recovery time in severely ill Coronavirus patients. A large clinical trial, sponsored by the National Institutes of Health, found that drugs modestly shorten recovery time by four days, on average, but do not reduce fatalities. Drugs ' eventual cost has always been uncertain. There is no playbook for how to price new medicine in a pandemic, Daniel ODay, chief executive of Gilead, said in a statement. Since drugs emergency authorization, Gilead has donated Remdesivir to hospitals for treatment of patients with COVID - 19, illness caused by Coronavirus. The last shipments of donated Drug were distributed on Monday. New pricing is not exorbitant, many experts say. Other promising drugs now in late - stage testing are already on the market for other purposes, Dr. Conti note, and cost several times more than Remdesivir. The Institute for Clinical and Economic Review, nonprofit group that calculates fair prices for drugs, estimates that Gilead would need to charge 1 600 per regimen to recoup its costs. But as much as 5 080 per treatment course would be still be a cost - effective price for insurers, given that patients would be able to leave hospital sooner. Critics have long accused Gilead of overcharging for groundbreaking drugs, including first hepatitis C cures and Truvada, daily pill to prevent HIV infection.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Important Information

Chicago hospital treating Severe COVID - 19 Patients with GILEAD Sciences antiviral Medicine Remdesivir in a closely watched clinical trial is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week, STAT has learn. Remdesivir was one of the first medicines identified as having potential to impact SARS - CoV - 2, novel coronavirus that causes COVID - 19, in lab tests. The entire world has been waiting for results from Gileads Clinical Trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies. If safe and effective, it could become the first approved treatment against disease. University of Chicago Medicine recruited 125 people with COVID - 19 into Gileads two Phase 3 Clinical Trials. Of those people, 113 had Severe Disease. All patients have been treated with daily infusions of Remdesivir. The best news is that most of our patients have already been discharge, which is great. Weve only had two patients perish, said Kathleen Mullane, University of Chicago Infectious Disease specialist overseeing Remdesivir studies for the hospital. Her comments were made this week during a video discussion about trial results with other University of Chicago faculty members. Discussion was recorded and STAT obtained a copy of the video. Outcomes offer only a snapshot of remdesivirs effectiveness. Same trials are being run concurrently at other institutions, and it is impossible to determine full study results with any certainty. Still, no other clinical data from GILEAD studies has been released to date, and excitement is high. Last month, President Trump touted the potential for Remdesivir as he has for many still - unproven treatments and said it seems to have very good result. In a statement Thursday, GILEAD say: What we can say at this stage is that we look forward to data from ongoing studies becoming available. Gilead had said it expect results for its trial involving severe cases in April. Mullane said during her presentation that data for the first 400 patients in the study would be lock by GILEAD Thursday, meaning that results could come any day. Mullane, while encouraged by University of Chicago Data, makes clear her own hesitancy about drawing too many conclusions. Its always hard, she say, because severe trial doesnt include placebo group for comparison. But certainly when we start drugs we see fever curves falling, she say. Fever is now not a requirement for people to go on trial,. We do see when patients do come in with high fevers, they do quite quickly. We have seen people come off ventilators the days after starting therapy. So, in that realm, overall, our patients have do very well. She add: Most of our patients are severe and most of them are leaving at six days, so that US duration of therapy doesnt have to be 10 days. We have very few that go out for 10 days, maybe three, she say.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Safety Information

Administer VEKLURY via intravenous infusion in total volume of up to 250 mL 0. 9% sodium chloride over 30 to 120 minutes. Do not administer intramuscular injection. Optimal dosing and duration of VEKLURY for treatment of COVID - 19 is unknown. The suggested dose under this EUA is described in Fact Sheet for Healthcare Providers. Suggest dose and duration may be updated as data from clinical trials becomes available. For pediatric patients with a body weight between 3. 5 kg and < 40 kg, only use VEKLURY for injection, 100 mg, lyophilized powder. Refer to Fact Sheet for Healthcare Providers for dosage and dose duration information for patients weighing < 40 kg. For pediatric patients 40 kg, VEKLURY can be dosed and administered according to instructions for adults provided on Fact Sheet for Healthcare Providers. Veklury should be used during pregnancy only if potential benefit justifies potential risk for mother and fetus. Veklury is not recommended in adult and pediatric patients with eGFR < 30 mL / min and in full - term neonates with serum creatinine 1 mg / dL unless potential benefit outweighs potential risk. Prior to Administration and daily during treatment with VEKLURY, all adult and pediatric patients must have eGFR determine; full - term neonates must have serum creatinine determine. Monitor renal function prior to initiating and daily during treatment with VEKLURY. It is not know if dose adjustment is needed in patients with hepatic impairment, and VEKLURY should only be used in patients with hepatic impairment if potential benefit outweighs potential risk. Do not initiate VEKLURY in patients with ALT 5x ULN; discontinue therapy in patients WHO develop ALT 5x ULN or ALT elevation accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR. Monitor hepatic function prior to initiating and daily during treatment with VEKLURY. Drug interaction Trials of VEKLURY and other concomitant medications have not been conducted in humans. Due to antagonism observed in vitro, concomitant use of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommend. Veklury for injection, 100 mg, lyophilized powder in single - dose vials. Unopened vials of lyophilized powder can be stored below 30C. Lyophilize powder must be reconstituted and diluted prior to use. Veklury injection, 100 mg / 20 mL, solution in single - dose vials. Unopened vials of concentrated solution must be refrigerate. Concentrated solution must be diluted prior to use. Once open, do not reuse or save unused VEKLURY lyophilize powder or solution for future use. This product contains no preservative.S Veklury must be administered intravenously. See Fact Sheet for Healthcare Providers for additional information on storage, handling, preparation, and Administration of VEKLURY IV solution. The Secretary of the Department of Health and Human Services has declared a public health Emergency that justifies Emergency Use of VEKLURY to treat coronavirus disease 2019 caused by SARS - CoV - 2 infection. In response, US Food and Drug Administration has issued an Emergency Use Authorization for an unapproved product, VEKLURY, for treatment of COVID - 19.


Authorized Use

- Authorization Enables Broader Use of Remdesivir to Treat Hospitalized Patients with Severe COVID - 19 Disease in the United States - based on Patients Severity of Disease, Authorization allows 5 - day and 10 - day Treatment Durations - FOSTER CITY, Calif. - Gilead Sciences, Inc. Today announced that US Food and Drug Administration has granted Emergency Use Authorization for investigational antiviral Remdesivir to Treat COVID - 19. Eua will facilitate Broader Use of Remdesivir to Treat Hospitalized Patients with Severe COVID - 19 Disease, enabling access to Remdesivir at additional hospitals across the country. Allocation of the currently limited available supply of Remdesivir will be made based on guiding principles that aim to maximize access for appropriate patients in urgent need of treatment, with direction from and in collaboration with government. Remdesivir is authorized for Treatment of Hospitalized Patients with Severe COVID - 19 Disease. The Optimal duration of treatment is still being studied in ongoing clinical trials. Under EUA, both 5 - day and 10 - day Treatment Durations are suggest, based on severity of disease. Authorization is temporary and does not take place of formal new drug application submission, review and approval process. Eua allows for distribution and Emergency Use of Remdesivir only for Treatment of COVID - 19; Remdesivir remains an investigational Drug and has not been approved by FDA. The US government will coordinate donation and distribution of Remdesivir to hospitals in cities most heavily impacted by COVID - 19. Give Severity of illness of Patients appropriate for Remdesivir Treatment and limited availability of drug supply, hospitals with intensive care units and other hospitals that the government deem most in need will receive priority in distribution of Remdesivir. Gilead is working with the US government on logistics of Remdesivir distribution and will provide more information when the company begins shipping drug under EUA. This EUA opens the way for the US to provide Emergency Use of Remdesivir to more patients with severe symptoms of COVID - 19, said Daniel ODay, Chairman and Chief Executive Officer of GILEAD Sciences. We will continue to work with partners across the globe to increase our supply of Remdesivir while advancing our ongoing clinical trials to supplement our understanding of drugs profile. We are working to meet the needs of patients, their families and healthcare workers around the world with the greatest sense of urgency and responsibility. Eua is based on available data from two global clinical trials - the National Institute for Allergy and Infectious Diseases placebo - control Phase 3 study in Patients with moderate to severe symptoms of COVID - 19, including those who were critically ill, and Gileads global Phase 3 study evaluating 5 - day and 10 - day dosing durations of Remdesivir in Patients with Severe Disease. Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of Remdesivir as Treatment for COVID - 19. Remdesivir must be administered intravenously. The Optimal dosing and duration of Remdesivir for Treatment of COVID - 19 is still unknown.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Rollercoaster ride

Stock trading was briefly halt Thursday for California - base Gilead Sciences, after a draft report said the company's experimental coronavirus treatment disappointed in recent drug trial. Shares continue to slump, even after biotech company moved quickly to dispute the findings of World Health Organization study into the effectiveness of its anti - viral drug, remdesivir. Results were accidentally published online, before being taken down. We believe the post includes inappropriate characterizations of study. Importantly, because this study was terminated early due to low enrollment, it was underpowered to enable statistically meaningful conclusions, company said in a statement. It goes on to describe early results as inconclusive, and add: Trends in data suggest potential benefit for remdesivir, particularly among patients treated early in disease. According to earlier reporting by NBC News, study in New England Journal of Medicine found drugs improve breathing in some patients, though only 53 people were involved in the study. In majority of patients, 68 percent of doctors were able to reduce the amount of oxygen support needed. In addition, 17 out of 30 patients who had been on ventilators were able to come off those machines, key factor, since COVID - 19 patients who need to be put on ventilators appear to be more likely to suffer long - term health consequences, and may have worse outcomes. Gileads shares have taken a rollercoaster ride in recent weeks as Wall Street clings to any hope that treatment can be found for deadly virus. Last week, stock soared by 13 percent after STAT News reported that a Chicago hospital treating coronavirus patients with remdesivir in trial was recovering rapidly from severe symptoms. Covid - 19 does not have vaccine or treatment, and scientists are racing to figure out ways to assist patients suffering from previously unseen virus. Another treatment, hydroxychloroquine, promoted from White House by President Donald Trump, has seen mixed results and, in some cases, deaths. Investors have said that news of effective treatment or vaccine would be needed for stocks to mount a sustainable comeback. Remdesivir sounds like something that can get people out of hospitals quickly, CNBC's Jim Cramer said in a tweet last week. That allows our economy to have a fighting chance. I think that remdesivir would cut morbidity. Which would change how quickly we can open. And what we can do.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Small trials

The Remdesivir clinical Trial program was designed to answer multiple scientific questions in parallel, to rapidly evaluate the potential for remdesivir to treat COVID - 19 patients. Gilead SIMPLE Trials Gilead is conducting two randomized, open - label, multicenter, Phase 3 clinical studies to evaluate safety and efficacy of two dosing durations - 5 days and 10 days - of remdesivir in adults diagnosed with COVID - 19. The first of two SIMPLE studies evaluated safety and efficacy of both 5 - day and 10 - day dosing durations of remdesivir, in patients with severe COVID - 19. The Study initially enrol 400 patients and subsequently allowed for enrollment of 5 600 additional patients, including those on mechanical ventilation, in the expansion phase of study. Topline results from the initial study Phase were announced on April 29, and full results from the initial phase were published in the New England Journal of Medicine on May 27. Data from the expansion phase of the study is expected in the near future. The second SIMPLE study is evaluating safety and efficacy of 5 - day and 10 - day dosing regimens of remdesivir, compared with standard of care alone, in patients with moderate COVID - 19. This study initially enrol 600 patients and subsequently allowed for enrollment of 1 000 additional patients in expansion Phase of study. Topline results from the initial study Phase were announced on June 1. Pediatric Trial Gilead is conducting a Phase 2 / 3 clinical Trial that will investigate the use of remdesivir in treating pediatric patients with COVID - 19. The study will evaluate safety, tolerability, pharmacokinetics and efficacy of remdesivir in the younger population hospitalized with the virus, including newborns through adolescents. The single - arm, open - label study will enroll approximately 50 patients under the age of 18, beginning in June. Patients will be treated for up to 10 days, with dosing determined based on age and weight. Remdacta Trial Gilead is working in collaboration with Roche to evaluate the safety and efficacy of remdesivir in combination with tocilizumab, anti - inflammatory drug, compared to remdesivir plus placebo in patients with severe COVID - 19 pneumonia. Phase 3, double - blind, placebo - control trial is expected to begin enrolling in June, with a target of approximately 450 patients globally. Other Trials US National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, conducted Phase 2 Adaptive, randomize, double - blind, placebo - control Trial evaluating remdesivir as potential treatment for hospitalized adult patients diagnosed with COVID - 19. Gilead provides study Drug at no charge and provides input on study design and conduct. Study enrol 1 063 participants at 47 US and 21 international sites. Preliminary findings were announced on April 29 and full data were published in the New England Journal of Medicine on May 22. Niaid is conducting second Adaptive Trial with remdesivir. Phase 3, double - blind, randomize, control trial is evaluating the safety and efficacy of remdesivir in combination with anti - inflammatory drug baricitinib compared to remdesivir alone. The study was initiated in May and is expected to enroll more than 1 000 patients at approximately 100 US and international sites.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Many drugs needed

Since the first cases were reported in December 2019, infection with severe acute respiratory coronavirus 2 has become a worldwide pandemic. 1 2 COVID - 19 illness caused by SARS - CoV - 2 is overwhelming health care systems globally. 3 4 symptoms of SARS - CoV - 2 Infection vary widely, from asymptomatic disease to pneumonia and life - threatening complications, including acute respiratory distress syndrome, multisystem organ failure, and ultimately, death. 5 - 7 Older patients and those with preexisting respiratory or cardiovascular conditions appear to be at greatest risk for severe complications. 6 7 in the absence of proven effective therapy, current management consists of supportive care, including invasive and noninvasive oxygen support and treatment with antibiotics. 8 9 in addition, many patients have received off - label or compassionate - use therapies, including antiretrovirals, antiparasitic agents, antiinflammatory compounds, and convalescent plasma. 10 - 13 remdesivir is a prodrug of nucleotide analogue that is intracellularly metabolized to analogue of adenosine triphosphate that inhibits viral RNA polymerases. Remdesivir has broad - spectrum activity against members of several virus families, including filoviruses and coronaviruses and has shown prophylactic and therapeutic efficacy in nonclinical models of these coronaviruses. 14 - 17 in vitro testing has also shown that remdesivir has activity against SARS - CoV - 2. Remdesivir appears to have a favorable clinical safety profile, AS reported on the basis of experience with approximately 500 persons, including healthy volunteers and patients treated for acute Ebola virus Infection, 18 19 and supported by our data. In this report, we describe outcomes in cohort of patients hospitalized for severe COVID - 19 who were treated with remdesivir on a compassionate - use basis. To date, NO therapy has demonstrated efficacy for patients with COVID - 19. This preliminary report describes clinical outcomes in a small cohort of patients who were severely ill with COVID - 19 and were treated with remdesivir. Although data from several ongoing randomize, control trials will soon provide more informative evidence regarding safety and efficacy of remdesivir For COVID - 19, outcomes observed in this compassionate - use program are the best currently available data. Specifically, improvement in oxygen - support status was observed in 68% of patients, and overall mortality was 13% over median follow - up of 18 days. In a recent randomized, control trial of lopinavir - ritonavir in patients hospitalized for COVID - 19 28 - day mortality was 22%. 10 It is important to note that only 1 of 199 patients in that trial were receiving invasive ventilation at baseline. In case series and cohort studies, largely from China, mortality rates of 17 to 78% have been reported in severe cases, defined by need for admission to intensive Care unit, invasive ventilation, or both. 23 - 28 For example, among 201 patients hospitalized in Wuhan, China, mortality was 22% overall and 66% among patients receiving invasive mechanical ventilation. 7 by way of comparison, 13% mortality observed in this remdesivir compassionate - use cohort is noteworthy, considering the severity of disease in this patient population; However, patients enrol in this compassionate - treatment program are not directly comparable to those studied in these other reports.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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