Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19
-- Study Demonstrates Similar Efficacy with 5- and 10-Day Dosing Durations of Remdesivir --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 29, 2020-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with severe manifestations of COVID-19 disease. The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course (Odds Ratio: 0.75 [95% CI 0.51 – 1.12] on Day 14). No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.
“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”
Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19. This study sought to determine whether a shorter, 5-day course of remdesivir would achieve similar efficacy results as the 10-day treatment regimen used in multiple ongoing studies of remdesivir. Secondary objectives included rates of adverse events and additional measures of clinical response in both treatment groups. Patients were required to have evidence of pneumonia and reduced oxygen levels that did not require mechanical ventilation at the time of study entry. Clinical improvement was defined as an improvement of two or more points from baseline on a predefined seven-point scale, ranging from hospital discharge to increasing levels of oxygen support to death. Patients achieved clinical recovery if they no longer required oxygen support and medical care or were discharged from the hospital.
In this study, the time to clinical improvement for 50 percent of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. More than half of patients in both treatment groups were discharged from the hospital by Day 14 (5-day: 60.0%, n=120/200 vs.10-day: 52.3% n=103/197; p=0.14). At Day 14, 64.5 percent (n=129/200) of patients in the 5-day treatment group and 53.8 percent (n=106/197) of patients in the 10-day treatment group achieved clinical recovery.
Clinical outcomes varied by geography. Outside of Italy, the overall mortality rate at Day 14 was 7 percent (n=23/320) across both treatment groups, with 64 percent (n=205/320) of patients experiencing clinical improvement at Day 14 and 61 percent (n=196/320) of patients discharged from the hospital.
Impact of Earlier Treatment
In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms. Pooling data across treatment arms, by Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late.
“These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” said Aruna Subramanian, MD, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, and one of the lead investigators of the study. “While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective.”
Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events occurring in more than 10 percent of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests.
Key efficacy and safety results from the study are included in the table below.
About the SIMPLE Trials
Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection.
The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19. The initial phase of the study randomized 397 patients in a 1:1 ratio to receive remdesivir 200 mg on the first day, followed by remdesivir 100 mg each day until day 5 or 10, administered intravenously, in addition to standard of care. An expansion phase of the study was recently added and will enroll an additional 5,600 patients, including patients on mechanical ventilation. The study is being conducted at 180 trial sites around the world, including sites in the United States, China, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom.
A second SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in patients with moderate manifestations of COVID-19, compared with standard of care. The results from the first 600 patients of this study are expected at the end of May.
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS. In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
For more information on Gilead’s response to the coronavirus outbreak please visit the company’s dedicated page: https://www.gilead.com/purpose/advancing-global-health/covid-19.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. Remdesivir is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving remdesivir and the possibility that Gilead and other parties may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of remdesivir or that FDA and other regulatory agencies may not approve remdesivir, and any marketing approvals, if granted, may have significant limitations on its use. As a result, remdesivir may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s periodic reports filed with the U.S. Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200429005424/en/
Douglas Maffei, PhD, Investors
Sonia Choi, Media
Source: Gilead Sciences, Inc.
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Black Americans have more existing medical issues, less access to health care, and are more likely to work in unstable jobs -- all factors that have made the coronavirus pandemic disproportionately hurt blacks more.
While everyone is susceptible to Covid-19, black Americans are at higher risk, Surgeon General Dr. Jerome Adams said during an appearance on CBS This Morning on Tuesday.
That racial disparity has been evident in early data on coronavirus deaths in Louisiana, Illinois, Michigan and New Jersey. The federal government has not tracked coronavirus by demographic groups, but Adams and American Medical Association President Dr. Patrice Harris suggested they begin to do so.
"We have early evidence that we need to pay particular attention to race and ethnicity," Harris said Tuesday.
Click Louisiana Gov. John Bel Edwards said Monday that, of the 512 coronavirus deaths so far, more than 70 percent were African American patients, who make up just 32 percent of the state's population. to edit.
Click here toChicago, too, has seen similar numbers: Among those for whom race-ethnicity is known, 72% of the city's deaths have been among blacks, who make up just 30% of the city's population.
"This new data offers a deeply concerning glimpse into the spread of Covid-19 and is a stark reminder of the deep-seated issues which have long created disparate health impacts in communities across Chicago," said Chicago Mayor Lori Lightfoot.
A combination of structural factors means that black people are getting infected more and dying more of coronavirus, said Dr. Camara Phyllis Jones, a family physician and epidemiologist.
"What's happening is black folks are getting infected more because they are exposed more, and once infected they're dying more because they have their bodies -- our bodies -- have born the burden of chronic disinvestment (and) active neglect of the community," she said. "When I look at it is because of structural racism, which puts us in the forward facing jobs so that we are exposed and less valued and don't have the protection that we need."
President Donald Trump recognized the issue during the White House's coronavirus news briefing on Tuesday.
"We're actively engaging on the problem of increased impacts -- this is a real problem and it's showing up very strongly in our data -- on the African-American community," Trump said. "And we're doing everything in our power to address this challenge. It's a tremendous challenge. It's terrible."
Existing Chronic Diseases
People with underlying conditions are more affected by Covid-19, and in the United States, black people are more likely to have underlying health issues like diabetes, heart disease and lung disease, Adams said.
"I've shared myself personally that I have high blood pressure. That I have heart disease and spent a week in the (intensive care unit) due to a heart condition. That I actually have asthma and I'm pre-diabetic, and so I represent that legacy of growing up poor and black in America," Adams said. "I and many black Americans are at higher risk for Covid. It's why we need everyone to do their part to slow the spread."
Adams added "it breaks my heart" to hear about higher Covid-19 death rates among the black community -- and he emphasized that the recommendations to stay at home and follow mitigation measures to slow the spread of the coronavirus are for everyone.
Some of these health issues are related to the environment, such as the water quality in Flint, Michigan state Rep. Tyrone Carter said.
"This pandemic just magnifies what we already knew: Access to health care, environmental issues in certain communities, air quality, water quality. We think about Flint and think about my district who has air issues, asthma," he said.
Access to Health Care
Compared to white people, blacks have lower levels of health insurance coverage and are less likely to have insurance coverage through an employer.
A 2015 report from the Kaiser Commission on Medicaid and the Uninsured explained why having access to health care is so important for receiving proper care, pandemic or not.
"The access barriers facing uninsured people mean they are less likely to receive preventive care, are more likely to be hospitalized for conditions that could have been prevented, and are more likely to die in the hospital than those with insurance," the report said.
That lack of access exacerbates the impact of the outbreak, said Carter, who himself tested positive for coronavirus.
"When we talk about health care, it's easy to say that it's accessible, but to people that don't have a job, a service job that has health care, sometimes they use urgent care or the emergency room as their primary care physician," he said. "So what this has done is magnified those issues to show that there is still a huge gap between races when it comes to health care."
Loss of Jobs
The widespread shutdown of non-essential businesses has hurt black and Hispanic workers at a higher rate.
William Rodgers, chief economist at the Heldrich Center for Workforce Development at Rutgers University, estimated that the true rate of unemployment is likely 20.7% percent for African Americans rather than the official rate of 4.1%, and 18.7% for Hispanic workers, as opposed to the official rate of 6%.
He said that the higher unemployment rates for minorities and young workers is primarily because the sectors in which they typically work will be more affected by current lockdown policies in much of the country.
"Those groups' jobs were at greater risk going into this downturn," he said.
Black and Hispanic workers are also "much less likely" to be able to work from home, said Heidi Shierholz, senior economist and director of policy at the Economic Policy Institute in Washington, and fellow economist Elise Gould.
"It just comes down to the fact that in the United States there's still a lot of occupational segregation by race and ethnicity," said Shierholz, who was the Department of Labor's chief economist from 2014 to 2017.
For example, she said, there's a large concentration of Hispanic workers in construction and a large concentration of black workers in service sector jobs. The economists' analysis notes that most low-wage workers can't telework.
Coronavirus spreads faster in locations with higher density, such as cities. Black Americans are more likely to live in urban counties than suburban or rural ones, according to a Pew analysis. And within those areas, black Americans are more likely to have lower incomes, which may press them into crowded living situations, CNN's Van Jones writes.
While health officials have recommended that infected people isolate from others, that may not be possible for people living in housing projects, homeless shelters or prisons and jails -- all places with disproportionate black populations.
Data in Chicago, for example, shows that black non-Latino people were more likely to be infected with coronavirus and to die of it. Black non-Latino people made up 52% of all coronavirus cases in the city, and adjusted for population, this group was more than twice as likely to be infected as white non-Latino people.Allison Arwady, Commissioner of the Chicago Department of Public Health, said that these racial health disparities were evident in Chicago before the covid-19 outbreak.
"As a City, under the Mayor's leadership, we've been facing these huge, historic problems head-on. But our COVID-19 data is a clear reflection of these underlying inequities," she said in a statement. "This is true in Chicago, and true around the U.S."
CNN's Gina Yu, Maegan Vazquez, Pierre Meilhan, Konstantin Toropin, Fernando Alfonso III, Chris Isidore and Catherine Shoichet contributed to this report.
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