Company says drug proved effective against virus in US study

A biotech company said Wednesday its experimental drug has proved effective against the new coronavirus in a major U.S. government study that put it to a strict test.

Posted: Apr 29, 2020 12:26 PM
Updated: Apr 30, 2020 7:33 AM

A biotech company said Wednesday its experimental drug has proved effective against the new coronavirus in a major U.S. government study that put it to a strict test.

Gilead Sciences’s remdesivir would be the first treatment to pass such a test against the virus, which has killed more than 218,000 people since it emerged late last year in China. Having a treatment could have a profound effect on the global pandemic, especially because health officials say any vaccine is likely a year or more away.

The study, run by the National Institutes of Health, tested remdesivir versus usual care in about 800 hospitalized coronavirus patients around the world. The main result is how long it takes patients to recover.

California-based Gilead gave no details on results Wednesday, but said an announcement is expected soon. NIH officials did not immediately reply to a request for comment.

A statement from the Food and Drug Administration says only that the agency has been talking with Gilead “regarding making remdesivir available to patients as quickly as possible, as appropriate.”

Remdesivir is among many treatments being tested against the coronavirus but was the farthest along in study.

The drug is given through an IV and is designed to interfere with the virus’s ability to copy its genetic material. In animal tests against SARS and MERS, diseases caused by similar coronaviruses, the drug helped prevent infection and reduced the severity of symptoms when given early enough in the course of illness. But it is not yet approved anywhere in the world for any use.

The NIH study quickly enrolled its original goal of 440 patients and then was expanded to give more answers on questions such as which subgroups may or may not benefit, and other factors that may affect success, such as how early in the course of illness the drug was given.

The study’s main goal also was altered. Originally, it was the percentage of patients having various outcomes such as needing a breathing machine, fully recovered or dying 15 days after starting treatment. The new main goal is time to recovery, such as no longer needing oxygen or hospitalization.

A less encouraging picture came from partial results from a separate study testing remdesivir in severely ill patients in China, published Wednesday in the British medical journal Lancet. Treatment did not speed recovery in that study, which was stopped after only 237 of a planned 453 patients were enrolled. Researchers gave 158 people the drug and 79 others got usual care.

Separately on Wednesday, Gilead announced partial results from its own ongoing study of the drug in severely ill, hospitalized COVID-19 patients. The company said patients treated for five days “achieved similar improvement” in health as others treated for 10 days. However, that result is hard to interpret because there is no comparison group of people getting usual care, so it’s impossible to know how much patients would have improved on their own.

The company also said no new safety problems emerged in that study, and that it would publish results in a medical journal soon.

Gilead also is testing remdesivir in a separate study of moderately ill coronavirus patients. No results have yet been announced from that study, which does have a comparison group getting usual care.

Besides these studies, Gilead also has given remdesivir to more than 1,700 patients on a case-by-case emergency basis.

In other treatment-related news this week, two studies gave updates on anti-inflammatory drugs that aim to tamp down the severe inflammation that often develops in later stages of severe COVID-19 and often proves fatal.

A French hospital consortium reported success with using Acetemra, a Roche drug sold for rheumatoid arthritis and some other conditions, in a study of 129 coronavirus patients where 65 got the drug and the rest, usual care. No details were released; doctors said they were preparing to publish results.

A similar drug, Kevzara, did not work as well at low doses in a study of severely ill coronavirus patients, its makers Sanofi and Regeneron said. They’re continuing to test it at higher doses in critically ill patients, though.

___

AP reporter Matthew Perrone in Washington contributed to this report.

__

Marilynn Marchione can be followed on Twitter at http://twitter.com/MMarchioneAP

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Terre Haute
Overcast
46° wxIcon
Hi: 48° Lo: 39°
Feels Like: 43°
Robinson
Overcast
44° wxIcon
Hi: 47° Lo: 39°
Feels Like: 40°
Indianapolis
Overcast
45° wxIcon
Hi: 49° Lo: 40°
Feels Like: 43°
Rockville
Overcast
46° wxIcon
Hi: 47° Lo: 37°
Feels Like: 43°
Casey
Overcast
39° wxIcon
Hi: 46° Lo: 37°
Feels Like: 33°
Brazil
Overcast
46° wxIcon
Hi: 48° Lo: 39°
Feels Like: 43°
Marshall
Overcast
46° wxIcon
Hi: 47° Lo: 37°
Feels Like: 43°
Rainy & Cold
WTHI Planner
WTHI Temps
WTHI Radar

Latest Video

Image

Seasonal Affective Disorder

Image

Indiana National Guard set to help long term care facilities

Image

Country Legend J.T. Corenflos dies at 56

Image

Golden Apple: Erin Hardy

Image

Women leaving the workforce at an alarming rate, hear one local mother's struggles amid the pandemic

Image

Tuesday: Showers early, cloudy. High: 48

Image

Noble Johnson

Image

How to protect yourself from scammer

Image

Daviess County government center opens for business

Image

Monday Evening Forecast

WTHI Events

 

Illinois Coronavirus Cases

(Widget updates once daily at 7 p.m. CT)

Confirmed Cases: 383687

Reported Deaths: 9792
CountyConfirmedDeaths
Cook1774655433
DuPage23099606
Lake20815511
Will18621427
Kane16903347
Winnebago10340180
St. Clair7993220
Madison7221154
McHenry6452121
Champaign617229
Unassigned4778270
Peoria462273
McLean420934
Rock Island407090
Sangamon406763
Kankakee342180
Macon316052
Kendall270430
Tazewell268756
LaSalle242663
DeKalb239942
Coles193539
Adams188820
Williamson188859
Boone187825
Clinton178926
Vermilion174110
Jackson154826
Whiteside146027
Knox131716
Randolph128315
Ogle12187
Effingham11834
Marion102819
Stephenson10187
Franklin9869
Grundy9777
Morgan93424
Monroe92530
Bureau91316
Jefferson90748
Henry8537
Christian82529
Macoupin81611
Union78725
McDonough77120
Lee7402
Shelby69112
Fayette68524
Douglas6849
Crawford6516
Livingston64610
Woodford63714
Montgomery61516
Logan5994
Saline5679
Fulton5271
Jo Daviess5127
Bond5079
Warren5068
Iroquois49519
Wayne48612
Jersey47521
Cass46311
Perry44716
Carroll41911
Moultrie4154
Johnson3620
Pike3586
Lawrence3368
Richland33516
Clay31413
Hancock3144
Clark31017
Washington3102
Mason3091
Greene29515
Cumberland2946
Mercer2706
White2704
De Witt2646
Jasper26410
Piatt2540
Pulaski2401
Wabash2285
Ford19814
Menard1861
Edgar15710
Marshall1573
Massac1552
Henderson1290
Hamilton1262
Alexander1241
Brown1110
Edwards1090
Gallatin1072
Scott1070
Putnam920
Schuyler901
Stark863
Calhoun660
Hardin540
Pope421
Out of IL50

Indiana Coronavirus Cases

(Widget updates once daily at 8 p.m. ET)

Confirmed Cases: 164581

Reported Deaths: 4143
CountyConfirmedDeaths
Marion26055792
Lake14436358
St. Joseph9606168
Elkhart9271138
Allen8647231
Hamilton6400115
Vanderburgh617162
Tippecanoe396715
Porter347550
Hendricks3418134
Monroe335638
Johnson3286130
Delaware311575
Clark306263
Vigo275340
Madison250896
LaPorte239261
Cass229724
Warrick205065
Kosciusko201127
Floyd187468
Howard169466
Bartholomew147958
Marshall147428
Dubois146426
Wayne142031
Grant133539
Henry133030
Boone129150
Hancock124744
Noble122935
Jackson121018
Dearborn103128
Morgan100340
Lawrence96838
Gibson94412
Clinton92416
Daviess92334
Shelby90632
LaGrange82815
Knox81810
Harrison81024
Posey7767
Putnam77616
Fayette76719
DeKalb76011
Jasper6885
Miami6715
Steuben6608
Montgomery63122
White62316
Greene57838
Adams5607
Scott55413
Decatur52839
Ripley4838
Whitley4836
Clay4617
Sullivan45714
Wells45611
Huntington4455
Starke4438
Wabash4439
Orange42425
Spencer4176
Randolph39210
Jennings38713
Washington3873
Franklin38325
Fulton3785
Perry36914
Jefferson3655
Pike35718
Carroll34313
Jay3386
Fountain3293
Tipton28423
Vermillion2721
Parke2564
Rush2464
Blackford2394
Newton23711
Owen2151
Martin2050
Pulaski1783
Crawford1631
Brown1473
Ohio1337
Union1140
Benton1130
Switzerland980
Warren911
Unassigned0236