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理解無誤的話是指53例的小樣數據顯示對68%的患者臨床有效

April 10, 2020

Data on 53 Patients Treated With Investigational Antiviral Remdesivir Through
the Compassionate Use Program Published in New England Journal of Medicine
-- Remdesivir treatment resulted in clinical improvement in 68 percent of pati
ents in this limited data set --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 10, 2020-- Gilead Sciences, Inc. (N
asdaq: GILD) today announced results from a cohort analysis of 53 patients hos
pitalized with severe complications of COVID-19 who were treated with the inve
stigational antiviral remdesivir on an individual compassionate use basis. The
 majority of patients in this international cohort demonstrated clinical impro
vement and no new safety signals were identified with remdesivir treatment. Co
mpassionate use data have limitations and multiple Phase 3 studies are ongoing
 to determine the safety and efficacy of remdesivir for the treatment of COVID
-19. The detailed results of this analysis were published today in The New Eng
land Journal of Medicine.

Remdesivir is not yet licensed or approved anywhere globally and has not been
demonstrated to be safe or effective for the treatment of COVID-19.

Nearly two thirds of patients (64 percent, n=34/53) in this cohort were on mec
hanical ventilation at baseline, including four patients also on extracorporea
l membrane oxygenation (ECMO). Treatment with remdesivir resulted in an improv
ement in oxygen support class for 68 percent of patients (n=36/53) over a medi
an follow-up of 18 days from the first dose of remdesivir. More than half of p
atients on mechanical ventilation were extubated (57 percent, n=17/30) and nea
rly half of all patients (47 percent, n=25/53) were discharged from the hospit
al following treatment with remdesivir. After 28 days of follow-up, the cumula
tive incidence of clinical improvement, defined as discharge from the hospital
 and/or at least a two-point improvement from baseline on a predefined six-poi
nt scale, was 84 percent according to Kaplan-Meier analysis. Clinical improvem
ent was less frequent among patients on invasive ventilation versus noninvasiv
e ventilation (HR: 0.33 [95 percent CI 0.16, 0.68]) and among patients at leas
t 70 years of age (HR vs < 50 years: 0.29 [95 percent CI 0.11, 0.74]). Compass
ionate use data have limitations due to the small size of the cohort, the rela
tively short duration of follow-up, potential missing data due to the nature o
f the program and lack of a randomized control group.

“Currently there is no proven treatment for COVID-19. We cannot draw definiti
ve conclusions from these data, but the observations from this group of hospit
alized patients who received remdesivir are hopeful," said Jonathan D. Grein,
MD, Director of Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angele
s, and lead author of the journal article. “We look forward to the results of
 controlled clinical trials to potentially validate these findings.”

The overall mortality rate in this cohort was 13 percent (n=7/53). The mortali
ty rate was higher in the subgroup of patients on invasive ventilation (18 per
cent, n=6/34), compared with patients on noninvasive oxygen support (5 percent
, n=1/19). Factors associated with an increased risk of mortality included age
 greater than 70 years (HR vs < 70 years: 11.34 [95% CI 1.36, 94.17]) and high
er baseline serum creatinine levels (HR per mg/dL: 1.91 [95% CI 1.22, 2.99]),
indicating reduced kidney function.

Mild to moderate liver enzyme (ALT and/or AST) elevations (23 percent, n=12/53
) were observed in this cohort. No new safety signals were detected during sho
rt-term remdesivir therapy.

Given the limitations of this data set and analysis, data from ongoing, random
ized clinical studies of remdesivir are needed to provide a scientifically rob
ust understanding of the clinical impact of remdesivir treatment.

“While the outcomes observed in this compassionate use analysis are encouragi
ng, the data are limited,” said Merdad Parsey, MD, PhD, Chief Medical Officer
, Gilead Sciences. “Gilead has multiple clinical trials underway for remdesiv
ir with initial data expected in the coming weeks. Our goal is to add to the g
rowing body of evidence as quickly as possible to more fully evaluate the pote
ntial of remdesivir and, if appropriate, support broader use of this investiga
tional drug.”

Gilead is conducting two Phase 3 clinical trials of remdesivir, the SIMPLE stu
dies, in countries with high prevalence of COVID-19. Data from the SIMPLE stud
y in patients with severe disease are expected this month, followed by data fr
om the SIMPLE study in patients with moderate disease in May. In addition, Gil
ead is supporting multiple clinical trials led by other organizations, includi
ng two studies conducted in Hubei Province, China. Gilead has been informed th
at the study in China in patients with severe disease was terminated early due
 to low enrollment; the company awaits the publication of these data to enable
 an in-depth review of the results. The study in China in patients with mild-t
o-moderate disease is ongoing. A global study of remdesivir led by NIAID conti
nues to enroll patients and data from this study are anticipated in May. Final
ly, additional studies of remdesivir and other investigational treatments for
COVID-19, based on a master protocol by the World Health Organization, have al
so begun to enroll patients in countries around the world.

About the Compassionate Use Cohort Analysis

Since January 25, 2020, Gilead has been providing emergency access to remdesiv
ir for qualifying patients with severe complications of COVID-19 who are unabl
e to enroll in ongoing clinical trials. More than 1,800 patients have been tre
ated with remdesivir through individual compassionate use protocols.

This cohort evaluated data from 53 patients in the United States, Europe, Cana
da and Japan who received at least one dose of remdesivir on or before March 7
, 2020, through Gilead’s compassionate use program. All patients were hospita
lized with severe acute respiratory coronavirus 2 (SARS-CoV-2) infection and e
ither an oxygen saturation of 94 percent or less, or a need for oxygen. The me
dian duration of symptoms before initiation of remdesivir was 12 days. The maj
ority of patients (75 percent) were men over the age of 60 years with comorbid
 conditions, including hypertension, diabetes, hyperlipidemia and asthma. Comb
ined, all three of these factors have been associated with adverse outcomes of
 COVID-19.

The planned treatment was a 10-day course of remdesivir, consisting of a 200 m
g loading dose administered intravenously on day 1, followed by 100 mg daily f
or the remaining nine treatment days. Of the 53 patients included in the analy
sis, 75 percent received the full 10-day course of remdesivir, 19 percent rece
ived 5-9 days of treatment, and 6 percent received fewer than 5 days of treatm
ent. Follow-up continued through 28 days after initiation of remdesivir treatm
ent. Four patients discontinued remdesivir prematurely, one due to worsening o
f pre-existing renal failure, one due to multiple organ failure and two due to
 elevated liver enzymes, including one patient with a maculopapular rash.

There were no prespecified endpoints for this program. As part of the analysis
, rates of key clinical events were quantified, including change in oxygen sup
port requirements, hospital discharge, reported adverse events leading to disc
ontinuation of remdesivir treatment and mortality. In addition, the analysis e
valuated the proportion of patients with clinical improvement, defined as live
 discharge from the hospital and/or a clinical improvement of at least two poi
nts from baseline on a six-point scale reflecting hospitalization and oxygen s
upport status, as recommended by the World Health Organization R&D Blueprint G
roup.


https://reurl.cc/b5E05E


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