Gilead CEO statement on remdesivir final report for the ACTT-1 Study Group for treatment of COVID-19

Statement from Gilead Sciences CEO: With publication of new data on remdesivir in the New England Journal of Medicine ( see citation below), we have the clearest picture yet of the medicine’s impact on COVID-19. Over the past months, we had already generated a wealth of clinical data on the benefits of remdesivir, providing much-needed hope to patients and healthcare providers worldwide. On the basis of this data, remdesivir has been approved or authorized for temporary use to treat COVID-19 in more than 50 countries worldwide. This peer-reviewed data come from the gold standard randomized, double-blind, placebo-controlled Phase III study led by the U.S National Institute of Allergy and Infectious Diseases (NIAID). They provide new information that expands on the benefits of remdesivir and offer greater hope than ever in the fight against COVID-19. The preliminary results from the global NIAID study were published in May, but now we have the final dataset covering approximately 1060 hospitalized patients worldwide. These data tell us three things. The first is that hospitalized patients receiving remdesivir recovered five days faster on average, and in patients with severe disease, seven days faster. These severely ill patients made up 85% of the total study population. The second key takeaway is that remdesivir reduced the likelihood of patients progressing to more severe stages of the disease where they would require new or additional oxygen support. And thirdly, in the largest group of patients in the study, those on low-flow oxygen, there was a significant reduction in mortality in a post-hoc analysis. In the overall population, the results showed a trend in mortality reduction. Each of these study outcomes is of critical importance to managing the pandemic and informing decisions made by healthcare workers on behalf of their patients. For patients who are hospitalized with COVID-19, the importance of speeding up recovery by five to seven days cannot be underestimated. Aside from the physical challenges, every day with the disease brings an emotional toll on patients and their families dealing with the separation and the worry. Some physicians have also raised the point that the longer a patient is in hospital, the greater the risk of getting a secondary infection. In the group of patients that required supplemental oxygen, those receiving remdesivir plus standard of care recovered one week faster than those treated with placebo plus standard of care. This represents a significant benefit in a disease where every day counts. The latest data also include new results on reducing disease progression. In the group of patients receiving remdesivir, fewer progressed to the need for supplementary oxygen or higher levels of respiratory support, such as mechanical ventilation. Remdesivir works by reducing the ability of the virus to replicate in the body and ideally, we want to stop the replication as early as possible in the course of the disease. We know that for patients on a ventilator, the chances of survival are lower. By reducing disease progression, remdesivir may keep patients from entering this critical stage of illness. The benefits of remdesivir in leading to faster recovery and a reduction in disease progression were seen broadly in the overall NIAID study results. In addition to the direct impact on patients, these outcomes represent clear benefit and value to healthcare systems. Remdesivir could help to lower the use of healthcare resources and reduce the number of days that patients are in the hospital. The question of whether remdesivir provides a mortality benefit is one we have been looking forward to answering with peer-reviewed, placebo-controlled clinical data. It is important to note that the study enrolled a broad range of patients so there was significant heterogeneity in disease severity at baseline. Although the prespecified analysis of mortality in the total population showed only a numerical trend toward a reduction, there are additional findings on mortality in this study that provide valuable new information. In a post-hoc analysis of mortality rates for patients receiving low-flow oxygen, there were 70% fewer deaths among patients receiving remdesivir compared with the placebo group. Patients on low-flow oxygen made up approximately 40% of the overall patient population. This information is critically important for understanding remdesivir’s potential impact on mortality and maximizing the benefit to patients. . See-"Remdesivir for the Treatment of Covid-19 — Final Report" ,John H. Beigel, M.D., Kay M. Tomashek, M.D., M.P.H., et al., for the ACTT-1 Study Group Members*-October 8, 2020DOI: 10.1056/NEJMoa2007764.