THANK YOU SO VERY MUCH. >>> I WANT TO GO NOW TO -- DR.
FAUCI WHAT HE JUST SAID IN THE
OVAL OFFICE ABOUT REMDESIVIR.
>> COMPARING THE GILEAD DRUG
REMDESIVIR WITH A PLACEBO.
IT WAS HIGHLY POWERED WITH ABOUT
1,090-PLUS INDIVIDUALS.
1,090-PLUS INDIVIDUALS. SO IT IS THE FIRST TRULY
HIGH-POWERED RANDOMIZED PLACEBO
CONTROL TRIAL.
CONTROL TRIAL. IT WAS AN INTERNATIONAL TRIAL
INVOLVING MULTIPLE SITES NOT
ONLY IN THE UNITED STATES BUT IN
VARIOUS COUNTRIES THROUGHOUT THE
WORLD, INCLUDING GERMANY,
DENMARK, SPAIN, GREECE, THE UK,
ET CETERA.
ET CETERA. THE PRIMARY END POINT WAS THE
TIME TO RECOVERY MAY LEAD TO THE
ABILITY TO BE DISCHARGED.
WHEN YOU HAVE A STUDY LIKE THIS,
WE HAVE A DATA AND SAFETY
MONITORING BOARD WHICH LOOKS AT
THE DATA.
THE DATA. AND THEY ARE INDEPENDENT SO
THERE’S NO PREJUDICE ON THE PART
OF THE INVESTIGATORS BECAUSE
THEY’RE DOING THE TRIAL OR THE
DRUG IS FROM A CERTAIN COMPANY.
THE DATA AND SAFETY MONITORING
BOARD ON MONDAY AFTERNOON
CONTACTED ME ON APRIL 27th --
FIRST ON FRIDAY THE WEEK BEFORE
AND THEN AGAIN ON APRIL 27th AND
NOTIFIED THE STUDY TEAM, MAINLY
THE MULTIPLE INVESTIGATORS WHO
ARE DOING THE STUDY THROUGHOUT
THE WORLD, THAT THE DATA SHOWS
THAT REMDESIVIR HAS A CLEAR-CUT
SIGNIFICANT POSITIVE EFFECT IN
DIMINISHING THE TIME TO
RECOVERY.
RECOVERY. THIS IS REALLY QUITE IMPORTANT
FOR A NUMBER OF REASONS, AND I
WILL GIVE YOU THE DATA.
IT’S HIGHLY SIGNIFICANT.
IF YOU LOOK AT THE TIME TO
RECOVERY BEING SHORTER IN THE
REMDESIVIR ARM, IT WAS IS HE11 D
COMPARED TO 15 DAYS.
THAT’S A P VALUE FOR THE
SCIENTISTS LISTENING OF .0.001.
THAT’S SOMETHING THAT A 31%
IMPROVEMENT DOESN’T SEEM LIKE A
KNOCKOUT 100%, IT IS A VERY
IMPORTANT PROOF OF CONCEPT.
BECAUSE WHAT IT HAS PROVEN IS
THAT A DRUG CAN BLOCK THIS
VIRUS.
VIRUS. AND I WILL GIVE YOU AN EXAMPLE
IN A MOMENT WHY WE THINK LOOKING
FORWARD THIS IS VERY OPTIMISTIC.
THE MORTALITY RATE TRENDED
TOWARDS BEING BETTER IN THE
SENSE OF LAST TESTS IN THE
REMDESIVIR GROUP.
REMDESIVIR GROUP. 8% VERSUS 11% IN THE PLACEBO
GROUP.
GROUP. IT HAS NOT YET REACHED
STATISTICAL SIGNIFICANCE BUT THE
DATA NEEDS TO BE FURTHER
ANALYZED.
ANALYZED. THE REASON WHY WE’RE MAKING THE
ANNOUNCEMENT NOW IS SOMETHING I
BELIEVE PEOPLE DON’T YET FULLY
APPRECIATE.
APPRECIATE. WHENEVER YOU HAVE CLEAR-CUT
EVIDENCE THAT A DRUG WORKS, YOU
HAVE AN ETHICAL OBLIGATION TO
IMMEDIATELY LET THE PEOPLE WHO
ARE IN THE PLACEBO GROUP KNOW SO
THEY COULD HAVE ACCESS.
AND ALL OF THE OTHER TRIALS THAT
ARE TAKING PLACE NOW HAVE A NEW
STANDARD OF CARE.
SO WE WOULD HAVE NORMALLY WAITED
SEVERAL DAYS UNTIL THE DATA GETS
FURTHER, DOT THE I AND CROSS THE
T, BUT THE DATA ARE NOT GOING TO
CHANGE.
CHANGE. SOME OF THE NUMBERS MAY CHANGE A
LITTLE BUT THE CONCLUSION WILL
NOT CHANGE.
NOT CHANGE. SO WHEN I WAS LOOKING AT THIS
DATA WITH OUR TEAM THE OTHER
NIGHT, IT WAS REMINISCENT OF 34
YEARS AGO IN 1986 WHEN WE WERE
STRUGGLING FOR DRUGS FOR HIV --
AND WE HAD NOTHING.
AND THERE WAS A LOT OF ANECDOTAL
ABOUT THINGS MAYBE THEY WORK,
MAYBE THEY NOT AND PEOPLE TAKING
DIFFERENT KINDS OF DRUGS.
AND WE DID THE FIRST RANDOMIZED
PLACEBO CONTROL TRIAL WITH AZT
WHICH TURNED OUT TO GIVE AN
EFFECT THAT WAS MODEST BUT THAT
WAS NOT THE END GAME.
BECAUSE BUILDING ON THAT EVERY
YEAR AFTER WE DID BETTER AND
BETTER.
BETTER. WE HAD BETTER DRUGS OF THE SAME
TYPE, AND WE HAD DRUGS AGAINST
DIFFERENT TARGETS.
DIFFERENT TARGETS. THIS DRUG HAPPENS TO BE BLOCKING
AN ENZYME THAT THE VIRUS USES.
AND THAT’S AN RNA RACE.
BUT THERE ARE OTHER ENZYMES THE
VIRUS USES THAT WILL BE TARGETS
FOR THIS.
FOR THIS. THIS WILL BE THE STANDARD OF
CARE.
CARE. IN FACT, WHEN WE LOOK AT THE
OTHER TRIALS WE’RE DOING, WE’RE
GOING TO DO A TRIAL WITH ANOTHER
ANTIVIRAL -- ACTUALLY, IT ISN’T
AN ANTIVIRAL, IT’S AN
ANTI-INFLAMMATORY.
ANTI-INFLAMMATORY. WE WILL NOW COMPARE THE
COMBINATION OF REMDESIVIR WITH
THIS SO THAT AS DRUGS COME IN,
WE WILL SEE IF WE CAN ADD ON
THAT.
THAT. SO BOTTOM LINE, YOU’RE GOING TO
BE HEARING MORE DETAILS ABOUT
THIS.
THIS. THIS WILL BE SUBMITTED TO THE
PEER REVIEW JOURNAL AND BE
PROCEDURE PEER REVIEWED.
BUT WE THINK IT’S AN OPENING