{"id":54131,"date":"2023-02-22T00:03:05","date_gmt":"2023-02-21T23:03:05","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/veklury-remdesivir-reduced-risk-of-mortality-in-hospitalized-covid-19-patients-across-all-variant-time-periods-in-a-real-world-study-of-more-than-500000-hospitalized-patients\/"},"modified":"2023-02-22T00:03:05","modified_gmt":"2023-02-21T23:03:05","slug":"veklury-remdesivir-reduced-risk-of-mortality-in-hospitalized-covid-19-patients-across-all-variant-time-periods-in-a-real-world-study-of-more-than-500000-hospitalized-patients","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/veklury-remdesivir-reduced-risk-of-mortality-in-hospitalized-covid-19-patients-across-all-variant-time-periods-in-a-real-world-study-of-more-than-500000-hospitalized-patients\/","title":{"rendered":"Veklury\u00ae (Remdesivir) Reduced Risk of Mortality in Hospitalized COVID-19 Patients Across all Variant Time Periods in a Real World Study of More than 500,000 Hospitalized Patients"},"content":{"rendered":"
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\n\u2013 <\/i>Real-World Evidence from Clinical Practice Demonstrates Use of Veklury was Associated with a Statistically Significant Reduction in Mortality in an Overall Patient Population, Including Immunocompromised Patients \u2013<\/i>\n<\/p>\n

\n\u2013 Separate Analysis Demonstrates <\/i>Those Receiving Veklury During COVID-19 Hospitalization had a Lower Likelihood of All-Cause Readmission Within 30 Days to the Same Hospital \u2013<\/i>\n<\/p>\n

\n\u2013 <\/i>Veklury Demonstrates Continued In Vitro Antiviral Activity Against Recent Omicron Subvariants of Concern \u2013<\/i>\n<\/p>\n

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive data from three retrospective real-world studies which demonstrated that initiation of Veklury\u00ae<\/sup> (remdesivir) within the first two days of hospital admission can help reduce mortality and hospital readmission rates among all patients hospitalized with COVID-19, regardless of disease severity. A reduction in mortality was also observed in vulnerable populations, such as people living with cancer or HIV. These studies evaluated routine clinical practice data from more than 800 hospitals throughout the United States to gain insights on patient outcomes as COVID-19 continues to evolve over time. These data will be presented at the 30th Conference on Retroviruses and Opportunistic Infections (CROI).\n<\/p>\n

<\/a><\/p>\n

\n\u201cEarly treatment with remdesivir led to better patient outcomes regardless of the predominant circulating variant of concern. We see this risk reduction consistently across all oxygen levels and disease severity, including in immunocompromised patients. This is indeed a paradigm shift in the way we think about treating our most vulnerable patients,\u201d said Chidinma Chima-Melton, study author and pulmonologist at UCLA Health, California, U.S.A. \u201cLarge studies utilizing real world clinical practice data are of great importance given the significant shifts that have occurred in the COVID-19 treatment landscape. These longitudinal analyses demonstrated the value of remdesivir in reducing mortality in all patients with COVID-19, and its positive impact on reducing readmission rates, which is an important consideration for hospitals.\u201d\n<\/p>\n

\nMortality Outcomes in Patients Hospitalized with COVID-19<\/span><\/b>\n<\/p>\n

\nTwo studies analyzed clinical practice information from the U.S. Premier Healthcare databases of more than 500,000 adult patients hospitalized with COVID-19. The overall analysis examined all-cause inpatient mortality rates at 14- and 28- days and demonstrated that initiation of Veklury within the first two days of hospital admission was associated with a statistically significant lower risk for mortality in all oxygen levels compared to matched controls that did not receive Veklury during their hospitalization for COVID-19. For patients with no documented use of supplemental oxygen at baseline, treatment with Veklury was associated with a 19% (p<0.001) lower risk of mortality at Day 28. Patients on low-flow or high-flow oxygen also had a 21% (p<0.001) and 12% (p<0.001) lower risk of mortality at Day 28, respectively. Patients on invasive mechanical ventilation\/ECMO at baseline had a 26% (p<0.001) reduced risk for mortality at Day 28. These findings were observed throughout all variant time periods, including Omicron, in patients who did not require supplemental oxygen and across all levels of supplemental oxygen use, including those on invasive mechanical ventilation (IMV)\/ECMO.\n<\/p>\n

\n\u201cThe real-world evidence presented at CROI is based on an analysis of the clinical practice data of hospitalized patient populations to help assess the treatment effects of Veklury in both the overall patient population, as well as subsets of patients that are considered high-risk for severe disease from COVID-19, like immunocompromised patient populations,\u201d said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. \u201cThese analyses demonstrate the consistent efficacy of Veklury across variant time periods of the pandemic, including its effect on mortality and likelihood of hospital readmission.\u201d\n<\/p>\n

\nThe second analysis demonstrated that a reduction in mortality was also associated in vulnerable patient populations, such as patients with immunocompromised conditions, who can experience repeat infections and breakthrough infections. Results demonstrated that at Day 28 mortality results showed that timely initiation of Veklury treatment within two days of hospital admission was associated with an overall 25% significantly lower risk compared to non-Veklury across all variant time periods [pre-Delta (35%), Delta (21%), Omicron (16%)].\n<\/p>\n

\nReadmission in Patients Hospitalized with COVID-19<\/span><\/b>\n<\/p>\n

\nA separate analysis found that hospitalized patients with COVID-19 treated with Veklury were also significantly less likely (27%) to be readmitted within 30 days to the same hospital. This finding was consistent across variant time periods of the pandemic. The lower rate of hospital readmission for patients treated with Veklury was observed even in patients who had higher supplemental oxygen requirements during initial hospitalization for COVID-19.\n<\/p>\n

\nIn vitro<\/span><\/i> Antiviral Activity Against Variants<\/span><\/b>\n<\/p>\n

\nBased on in vitro<\/i> analyses presented at CROI, Veklury retains potent antiviral activity against recent Omicron subvariants of concern, including XBB, BQ 1.1, BA.2.75, BA.4, BA 4.6 and BA.5. These data support the continued use of Veklury to treat patients with Omicron subvariants of SARS-CoV-2. Gilead continuously evaluates the activity of Veklury against new SARS-CoV-2 variants of concern as they emerge around the world.\n<\/p>\n

\nAbout Veklury Clinical and Real-World Evidence Studies<\/span><\/b>\n<\/p>\n

\nComplementing randomized clinical trials (RCTs), this new real-world evidence (RWE) of hospitalized patients with COVID-19 further demonstrates the value of Veklury to clinicians and patients. The clinical benefits of Veklury in hospitalized patients have been established in multiple randomized, controlled Phase 3 clinical trials, including ACTT-1. In 2020, results from ACTT-1 demonstrated that in the overall study population of hospitalized patients with COVID-19, Veklury-treated patients showed a trend toward reduced mortality compared with placebo (11% vs. 15%, HR:0.73, 95% CI:0.52 to 1.03); however, this result was not statistically significant.\n<\/p>\n

\nWhile RCTs remain the best tool for assessing the efficacy and safety of a medicine, RWE provides important data on a treatment\u2019s use in routine clinical practice that can complement data from RCTs. These studies take on greater incremental importance in a pandemic, where clinical management of a disease continues to evolve and can outpace the initiation of new clinical trials, and where frontline healthcare workers are eager to understand the effectiveness of treatments to guide and reinforce treatment decisions in real time. Such studies should be interpreted based on the type and size of the source datasets and the methodologies used to mitigate potential confounding or bias. Evidence from routine clinical practice needs to be considered in the context of all available data across the entire spectrum of patients, including different healthcare settings.\n<\/p>\n

\nThe reduction in mortality associated with Veklury from these real-world analyses are consistent with previous analyses<\/a> of real-world evidence conducted in 2021 which demonstrated improved survival among COVID-19 patients in the earlier phase of the pandemic. RWE analyses of Veklury from other sources are ongoing and may vary in their results or conclusions.\n<\/p>\n

\nAbout Gilead\u2019s COVID-19 Development Program<\/span><\/b>\n<\/p>\n

\nVeklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company\u2019s antiviral research. Veklury is a foundation for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury has an established safety profile and minimal known drug interactions in diverse populations. It can help reduce disease progression across a spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and saving healthcare systems money.\n<\/p>\n

\nVeklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to nearly 13 million patients around the world, including more than 8 million people in middle- and low-income countries through Gilead\u2019s voluntary licensing program. These licenses currently remain royalty-free, reflecting Gilead\u2019s existing commitment to enabling broad patient access to remdesivir.\n<\/p>\n

\nThere remains a significant need to develop new and effective oral treatment options for people with COVID-19. Gilead is also working to advance an investigational oral nucleoside prodrug, GS-5245, that when metabolized forms the same active metabolite as remdesivir.\n<\/p>\n

\nU.S. Indication for Veklury<\/span><\/b>\n<\/p>\n

\nVeklury\u00ae<\/sup> (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (\u226528 days old and weighing \u22653 kg) who are:\n<\/p>\n