Shortly after the PPI disappointed and the Kaplan Fed warned of disinflation, the markets went up sharply, apparently following another Gilead press release stating that the mortality rate was down 62% from the “standard treatment” with using the drug Remdesivir COVID.
While the news looks encouraging, Gilead insists on this in a press release:
“This comparative analysis provides valuable additional information about the benefits of remdesivir compared to one standard of care,” said Susan Olender, MD, Columbia University Medical Center, Irving. “Although this analysis is not as strong as a randomized controlled trial, this analysis is largely based on the real world situation and serves as an important complement to clinical trial data, which contributes to our common understanding of the virus and reflects the extraordinary pace of the ongoing pandemic.”
Although he welcomed the results as an encouraging event, Dr. Scott Gottlieb noted that we had not yet achieved this and that most of these new results were obtained from a “retrospective analysis” of phase III data that has already been published.
This is very encouraging, but should be confirmed in a prospective study. This appears to be a retrospective analysis of phase III data using historically selected controls, suggesting the benefits of survival in patients with severe Covid. https://t.co/84dRMsInTA
– Scott Gottlieb, MD (@ScottGottliebMD) July 10, 2020
Like Moderna before, Gilead learns to extract every last drop of market success from its research data.
As well as shares of pharmaceutical giant Spike …
… we cannot help but wonder: is it time for Gilead to start a secondary proposal?
Read completely Press release below:
FOSTER CITY, Calif .– (BUSINESS WIRE) – Gilead Sciences, Inc. (Nasdaq: GILD) today announced additional data on remdesivir, an investigational antiviral drug for the treatment of COVID-19, which complements existing treatment knowledge. results with remdesivir. Data is presented at the Virtual COVID-19 conference as part of the 23rd International AIDS Conference (AIDS 2020: Virtual) and includes a phase 3 comparative analysis of an SIMPLE-Harsh and real retrospective cohort of patients with severe severity. COVID-19. In this analysis, remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in mortality risk compared to standard care — an important result that needs to be confirmed in prospective clinical trials.
Separate analyzes of the subgroups from phase 3 of the “SIMPLE-Difficult” study, including an assessment of the safety and efficacy of remdesivir in various racial and ethnic subgroups of patients treated in the United States, showed that the traditionally marginalized racial or ethnic groups receiving remdesivir in this study had experience similar clinical results as a general patient population in the study.
Gilead also presents a new analysis of the company’s compassionate use program, which showed that 83% of pediatric patients (n = 77) and 92% of pregnant and postpartum women (n = 86) recovered by day 28. There were no new safety signals. identified with remdesivir in these populations. To deepen understanding of these results in individual patient cases, Gilead recently announced the launch of a global open-label phase 2/3 study to evaluate the safety, tolerability and pharmacokinetics of remdesivir in pediatric patients from birth to less than 18 years of age. age. Gilead also collaborates in a study for pregnant women.
Due to the current public health emergency, the US Food and Drug Administration (FDA) has issued an emergency use of remdesivir for the treatment of hospitalized patients with severe COVID-19; please see below for additional important warnings and information on authorized use of remdesivir in the United States. In the United States, remdesivir is a test drug that has not been approved by the FDA, and the safety and effectiveness of remdesivir for the treatment of COVID-19 has not been established.
“We are working to expand our understanding of the full utility of remdesivir. In order to solve the urgent problem of the ongoing pandemic, we exchange data with the research community as quickly as possible in order to provide transparent and timely updates on new developments using remdesivir, ”said Merdad Parsi, MD, head physician, Gilead Sciences.
“These data, presented at the COVID-19 virtual conference, shed additional light on the use of remdesivir in certain groups of patients, including those that may be subject to higher levels of COVID-19 infection, as well as others that are especially vulnerable, including children and pregnant women and postpartum women. “
Comparative analysis of phase 3 SIMPLE-heavy study and a real retrospective cohort of patients diagnosed with severe COVID-19
Getting a standard of care
This comparative, pre-planned analysis included 312 patients treated in SIMPLE-Severe Phase 3 treatment, and a separate retrospective cohort of 818 patients with similar baseline characteristics and disease severity who received standard treatment over the same time period as SIMPLE. -Lots of learning. Patients were primarily located in North America (92 percent, remdesivir versus 91 percent, standard of care), Europe (5 percent versus 7 percent) and Asia (3 percent versus 2 percent). An analysis showed that treatment with remdesivir was associated with significantly improved clinical recovery and a 62 percent reduction in mortality risk compared to standard treatment. A comparative analysis showed that 74.4 percent of patients receiving remdesivir recovered by day 14 versus 59.0 percent of patients receiving standard care; recovery was defined as an improvement in clinical status based on a 7-point ordinal scale. The mortality rate among patients receiving remdesivir in the analysis was 7.6 percent on day 14 compared with 12.5 percent among patients not taking remdesivir (adjusted odds ratio 0.38, confidence interval 95% 0.22-0, 68, p = 0.001).
“This comparative analysis provides valuable additional information about the benefits of remdesivir compared to one standard of treatment,” said Susan Olender, MD, Columbia University Medical Center, Irving. “Although this analysis is not as strong as a randomized controlled trial, this analysis is important for real conditions and serves as an important complement to clinical trial data, complementing our general understanding of this virus and reflecting the extraordinary pace of the ongoing pandemic. “
The results of this comparative analysis complement the previously presented randomized, double-blind, placebo-controlled study of the National Institute of Allergy and Infectious Diseases (NIAID) in hospitalized patients with COVID-19, which showed that remdesivir on average shortened recovery time. four days compared with placebo (11 vs 15 days; p
Phase 3 Assays A SIMPLE SEVERE TEST
Phase 3 SIMPLE-Difficult study evaluated the safety and efficacy of 5-day and 10-day dosing times for remdesivir administered intravenously in hospitalized patients with severe COVID-19. At the initial stage of the study, 397 patients were randomized in a 1: 1 ratio to receive a 5-day or 10-day course of treatment with remdesivir in addition to standard treatment. The results were published in the New England Medical Journal in May. An extension phase of the study was added to cover up to 5600 additional patients, including those on mechanical ventilation; Expected results of the expansion phase.
Additional new evidence on the safety and efficacy of remdesivir presented at the Virtual COVID-19 conference includes analysis of subgroups, including race and ethnicity of patients being treated in the United States, as well as global baseline characteristics related to clinical improvement and concomitant use hydroxychloroquine.
In this study, 229 patients were enrolled in test centers in the United States; clinical improvement was defined as an improvement of ≥ 2 points on a 7-point ordinal scale. Among these patients, clinical improvement rates on day 14 were 84 percent in African American patients (n = 43), 76 percent in Latin American white (HW) patients (n = 17), 67 percent in Asian patients (n = 18), 67 percent in non-Hispanic white (NHW) patients (n = 119) and 63 percent in patients who did not identify with any of these groups (n = 32). The main results for efficacy and safety in the treatment of remdesivir depending on race and ethnicity in the United States are included in the following table.
Among the 397 patients treated with remdesivir worldwide, black races, under 65 years of age, treatment outside Italy, and low-flow or room-level oxygen support at baseline were significantly associated with a clinical improvement of at least two points per day. fourteen.
After obtaining in vitro data demonstrating that chloroquine inhibits the antiviral activity of remdesivir in a dose-dependent manner, Gilead analyzed the clinical outcomes of patients receiving both remdesivir and hydroxychloroquine compared with patients receiving remdesivir and not receiving concomitant hydroxychloroquine. By means of a median follow-up period of 14 days, the frequency and probability of recovery were lower in patients receiving concomitant hydroxychloroquine compared with patients receiving remdesivir who did not receive hydroxychloroquine (57 percent versus 69 percent, HR adjusted for covariate) [95% CI] 0.61 [0.45, 0.83]p = 0.002). The concomitant use of hydroxychloroquine was not associated with increased mortality in the 14-day analysis window. The analysis also showed that patients in the concomitant group of hydroxychloroquine showed overall higher side effects. After adjusting for the baseline variables, this difference was significant for side effects of grade 3-4.
Additional Data from Gilead’s Merciful Program for Remdesivir
Gilead previously reported safety and efficacy results in 53 patients hospitalized with severe COVID-19 who were treated with remdesivir as part of a compassionate use program with the company. Additional analyzes from the compassion program will be presented at the conference, including data on the use of remdesivir in children and in pregnant women and women in the postpartum period. In these analyzes, recovery was defined as improvement in indoor air for patients who needed oxygen support at the initial stage, and extracts for those who did not need oxygen support at the initial stage.
An analysis of 77 pediatric patients receiving remdesivir in the compassionate program showed that the vast majority improved in clinical status by day 28, 73% were discharged from the hospital. By day 28, 12 percent remained in the hospital, but in the air, and four percent died. Of the 39 pediatric patients who required invasive mechanical ventilation at the start of the study, 80 percent of these critically ill patients recovered; Of the 38 patients not requiring invasive ventilation, 87 percent recovered.
Of the 86 pregnant and postpartum women who received remdesivir as part of a compassionate program (average age 33 years), 96 percent of pregnant women and 89 percent of postpartum women had improved levels of oxygen support. Pregnant and postpartum women, who had a more severe disease at baseline, achieved equally high rates of clinical recovery – 93% and 89%, respectively. Pregnant women who did not receive invasive oxygen support at the start of the study had the shortest average recovery time (5 days), while pregnant and postpartum women who had invasive ventilation at the start of the study had an average recovery time (13 days). No new safety signals were detected; the most common AEs were caused by the underlying disease, and the majority of laboratory abnormalities were 1-2 degrees.
Remdesivir is an antiviral drug that has been studied in numerous international clinical studies. Recognizing the current public health emergency and based on available clinical data, approval status for remdesivir varies from country to country. In countries where remdesivir has not been approved by the regional health authority, remdesivir is the study drug, and the safety and effectiveness of remdesivir have not been established.
Important Information About Remdesivir in the United States
In the United States, remdesivir (GS-5734 ™) is approved for emergency use (EUA) only for patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. Severe illness is defined as patients with oxygen saturation (SpO2) ≤ 94% in indoor air or requiring additional oxygen or requiring mechanical ventilation, or requiring extracorporeal membrane oxygenation (ECMO). Remdesivir is approved for adults or children admitted to the hospital and it is clinically advisable to use the drug for intravenous administration, since remdesivir should be administered intravenously.
Remdesivir is a research drug that has not been approved by the FDA for any use, and the safety and effectiveness of remdesivir for the treatment of COVID-19 have not been established. This authorization is temporary and may be revoked and does not replace the formal process of submitting, reviewing and approving a new application for a medicine. For information on permitted use of remdesivir and mandatory EUA requirements in the United States, please see the FDA’s Newsletters and Written Permission to www.gilead.com/remdesivir,
Limited clinical data are available for remdesivir. Serious and unexpected side effects may occur that have not been previously reported with remdesivir. Hypersensitivity reactions, including infusion and anaphylactic reactions, were observed during and after taking remdesivir. The use of remdesivir is contraindicated in patients with known hypersensitivity to remdesivir. An increase in transaminases was observed in healthy volunteers and patients with COVID-19 in clinical trials receiving remdesivir. Patients should have proper clinical and laboratory monitoring to help in the early detection of any potential side effects. Monitor renal and hepatic function prior to and daily during therapy with remdesivir; additionally monitor serum chemistry and hematology daily during therapy. Do not start taking Remdesivir in patients with ALT ≥5x ULN or with GFR
Due to the risk of a decrease in antiviral activity, the simultaneous administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended.
Healthcare providers and / or their appointees are responsible for informing the FDA MedWatch of any medication-related errors, as well as serious adverse events or deaths that occur during treatment with remdesivir and are considered to be potentially associated with remdesivir. These events must be reported within 7 calendar days of the start of the event. MedWatch Adverse Event Reports can be sent to the FDA online at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
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Source: Gilead of Sciences