"The Evolution of HIV Testing: Then, Now and Beyond"


Uploaded by CDCStreamingHealth on 12.07.2011

Transcript:
>>> GOOD AFTERNOON, EVERYONE.
I'M THE DEPUTY DIRECTOR FOR BEHAVIORAL AND SOCIAL SCIENCE IN
THE DIVISION OF HIV/AIDS PREVENTION AND IT'S MY PLEASURE
THIS AFTERNOON TO BE ABLE TO WELCOME YOU ON BEHALF OF THE
DIVISION AND ON BEHALF OF THE NATIONAL CENTER FOR HIV/AIDS,
VIRAL HEPATITIS, STD AND TB PREVENTION.
I WANT TO THANK YOU FOR BEING HERE TODAY AND THANK YOU FOR
BEING PART OF WHAT I THINK IS GOING TO BE AN INTERESTING AND
STIMULATING DISCUSSION.
I WANT TO LET YOU KNOW IN ADDITION TO THOSE OF YOU HERE
WITH US IN THE AUDIENCE TODAY, WE'RE ALSO BEING JOINED BY
PEOPLE AROUND THE COUNTRY AND AROUND THE WORLD WHO ARE
WATCHING TODAY'S EVENT VIA LIVE WEB STREAM AND ARE TWEETING
ABOUT IT.
AS YOU KNOW, THIS MONTH MARKS 30 YEARS SINCE THE FIRST CASES OF
WHAT LATER BECAME KNOWN AS AIDS WERE REPORTED IN CDC'S MMWR.
TODAY'S SESSION IS ONE IN A SERIES OF LECTURES BEING
CONDUCTED THROUGHOUT THE SUMMER THAT COMMEMORATE THE UNWAVERING
COMMITMENT OF PUBLIC HEALTH OFFICIALS TO THE FIGHT AGAINST
HIV.
THIS LECTURE SERIES IS DESIGNED TO RAISE AWARENESS ABOUT THE
IMPORTANCE SUCCESSES THAT HAVE BEEN MADE OVER THE PAST 30 YEARS
AND TO PROVIDE AN OPPORTUNITY TO REFLECT ON THE HARD WON LESSONS
THAT WE HAVE LEARNED OVER THESE MANY DIFFICULT YEARS.
TODAY WE'LL HAVE A CHANCE TO HEAR FROM SOME OF THE PUBLIC
HEALTH LEADERS WHO HAVE MADE CRITICALLY IMPORTANT
CONTRIBUTIONS TO THE EVOLUTION OF HIV TESTING AND THE FIGHT
AGAINST HIV.
IT WOULD BE HARD TO OVERSTATE THE IMPORTANCE OF THEIR
CONTRIBUTIONS AND THE CONTRIBUTIONS THAT HIV TESTING
TO PUBLIC HEALTH, HEALTH CARE AND THE LIVES OF PEOPLE LIVING
WITH HIV AND AFFECTED BY HIV.
IN MY MIND, THE AVAILABILITY OF HIV TESTING IS CLEARLY ONE OF
THE TOP THREE CRITICAL BREAKTHROUGHS SINCE THE HIV
EPIDEMIC BEGAN.
THE AVAILABILITY OF HIV TESTING MADE IT POSSIBLE TO SCREEN BLOOD
PRODUCTS AND VIRTUALLY ELIMINATE HIV TRANSMISSIONS ASSOCIATED
WITH INFECTED BLOOD PRODUCTS.
HIV TESTING REDUCES RISK BEHAVIOR AMONG THOSE WHO ARE
LIVING WITH HIV AND IT'S A CRITICAL ELEMENT IN THE
PREVENTION OF MOTHER TO CHILD TRANSMISSION.
THE IMPORTANCE OF HIV TESTING IS EVIDENCED BY THE FACT THAT AFTER
TESTING WAS APPROVED BY THE FDA IN 1985 AND SCALED UP ALONG WITH
OTHER HIV PREVENTION PROGRAMS, WE SAW DRAMATIC DECREASE IN THE
NUMBER OF NEW HIV INFECTIONS IN THIS COUNTRY.
NOW HIV TESTING IS A CRITICAL FIRST STEP TO IMPROVING THE
HEALTH OF PEOPLE LIVING WITH HIV.
PEOPLE WHO DON'T KNOW THAT THEY'RE INFECTED, CAN'T GET THE
HEALTH CARE AND SERVICES THAT THEY NEED.
NOW, IN THIS ERA OF EFFECTIVE HIV TREATMENT, IT'S A LITTLE
HARD TO THINK BACK AND REMEMBER WHAT IT WAS LIKE IN THE EARLY
1980s BEFORE HIV TESTING BECAME AVAILABLE.
THE FEAR THAT EXISTED AT THAT POINT IN TIME WAS SOMETIMES
OVERWHELMING.
BEFORE WE HAD HIV TESTING, YOU HAD NO WAY OF KNOWING IF YOU,
SOMEONE YOU LOVED, OR SOMEONE YOU HAD MADE LOVE WITH HAD HIV
UNTIL YOU BECAME SICK AND DEVELOPED SYMPTOMS.
TESTING GAVE PEOPLE WHO WERE AT RISK FOR HIV A WAY TO TAKE
GREATER CONTROL OF THEIR DESTINY.
TO TAKE STEPS TO PROTECT THEMSELVES IF THEY WERE NEGATIVE
AND HOW TO MANAGE THEIR OWN HEALTH IF THEY WERE POSITIVE.
GETTING TESTED BACK IN THOSE DAYS WAS NOT WITHOUT
CONTROVERSY.
IT WAS A TIME WHEN WE DIDN'T HAVE NOT HAVE EFFECTIVE
TREATMENTS FOR HIV AND THERE WERE VERY REAL CONCERNS ABOUT
CONFIDENTIALITY AND WHAT MIGHT HAPPEN TO THOSE WHO TESTED
POSITIVE.
BACK THEN TESTING POSITIVE MEANT THAT YOU HAD TO FACE NOT ONLY
THE POSSIBILITY OF AN EARLY DEATH BUT ALSO THE WIDESPREAD
STIGMA, DISCRIMINATION AND REJECTION BY FRIENDS AND FAMILY
THAT WERE COMMON BACK IN THOSE DAYS.
IT'S IMPORTANT THAT WE DON'T FORGET ABOUT THE IMPORTANCE OF
HIV TESTING ON THE LIVES OF PEOPLE TODAY WHO ARE WORRIED
ABOUT THE RISK OF INFECTION AND ARE TRYING TO REDUCE THAT RISK
AS WELL AS THE IMPACT THAT HIV TESTING HAS ON THE LIVES OF
THOSE WHO WERE DIAGNOSED WITH HIV.
FOR THOSE OF US WHO HAVE TESTED POSITIVE, THAT TESTING EVENT AND
THAT BRIEF MOMENT IN TIME WHEN YOU LEARN THAT YOU ARE LIVING
WITH HIV IS ONE THAT STAYS WITH YOU FOR A LIFETIME AND IT
CHANGES YOUR LIFE FOREVER.
FEAR, STIGMA, AND DISCRIMINATION HAVE NOT COMPLETELY GONE AWAY,
BUT THEY'VE GOTTEN BETTER.
FORTUNATELY WE'RE NOW IN A TIME WHEN THERE'S EFFECTIVE TREATMENT
AND KNOWING YOUR STATUS AND ACTING ON THAT KNOWLEDGE MEANS
THAT INSTEAD OF FACING DEATH, PEOPLE LIVING WITH HIV ARE NOW
FACING THE POSSIBILITY OF HAVING LONG, HEALTHY AND PRODUCTIVE
LIVES.
THIS CHANGE HAS TRULY BEEN MIRACULOUS.
NOW, I WOULD LIKE TO TURN THE SESSION OVER TO MY COLLEAGUE,
DR. MICHELLE OWEN.
DR. OWEN IS THE LEADER OF THE HIV INCIDENTS AND DIAGNOSTICS
TEAM IN THE LABORATORY BRANCH OF CDC'S DIVISION OF HIV/AIDS AIDS
PREVENTION.
HER LABORATORY CONDUCTS RESEARCH TO DEVELOP, EVALUATE AND
IMPLEMENT NEW DIAGNOSTIC TECHNOLOGY AND SPECIFIC AREAS OF
RESEARCH INCLUDE EVALUATION AND DEVELOPMENT OF HIV DIAGNOSTICS
FOR DETECTION OF ANTIBODY, ANTIGEN AND DEVELOPMENT OF TESTS
TO DETERMINE RECENT FROM LONG-TERM INFECTION AND THEY ARE
INVESTIGATING NEW HIV TESTING TO IMPROVE DIAGNOSIS.
IN ADDITION TO THIS RESEARCH, DR. OWEN IS ALSO RESPONSIBLE FOR
THE OVERSIGHT OF CDC HIV CLEAR REFERENCE LABORATORY WHICH
PROVIDES HIV DIAGNOSTIC SUPPORT TO PUBLIC HEALTH LABORATORIES,
COMMERCIAL LABS AND PHYSICIANS.
DR. OWEN HAS WORKED IN RESEARCH AT CDC SINCE 1989 AND FROM 1989
TO 2003, HER RESEARCH WAS ON HIV AND IMMUNITY.
IN 2004, SHE ASSUMED THE ROLE OF DIAGNOSTIC ACTIVITY LEAD IN THE
LABORATORY BRANCH.
I'M GOING TO STOP THERE, MICHELLE.
I'M GOING TO LET YOU TAKE IT FROM HERE.
[ INAUDIBLE ] >> I'M GOING TO DOñr BRIEF
INTRODUCTIONS OF THE SPEAKERS.
I'LL INTRODUCE DR. COWEN FIRST AND LET HIM SPEAK.
I WILL ASK IF YOU HAVE QUESTIONS UNLESS IT'S A REAL CLARIFICATION
QUESTION, IF YOU CAN HOLD THEM UNTIL THE END, PLEASE, BECAUSE
WE HAVE A LOT OF INFORMATION TO GET THROUGH.
WE'LL HAVE ABOUT 30 MINUTES OF DISCUSSION SO I CERTAINLY HOPE
YOU'LL YOU WILLALL BE ABLE TO GET YOUR
QUESTION IN.
DR. COWEN HAS BEEN WORKING IN THE FIELD OF RETROVIRUSES FOR
QUITE A LONG TIME.
HE WORKED FOR NIH AND DID A LOT OF WORK IN HIS EARLY CAREER AND
THEN IN 1993 HE CAME TO FDA.
WELCOME, DR. COWEN, I THINK WE'LL TELL US ABOUT THE
SUCCESSES WITH SCREENING THE BLOOD SUPPLY.
>> THANK YOU, MICHELLE.
THANKS TO THE ORGANIZERS FOR INCLUDING FDA.
IT REALLY IS AN HAHNONOR TO BE HERE
AND I'M DELIGHTED TO BE THE ONE TO REPRESENT THE AGENCY.
I ALSO WANT TO POINT OUT THE TITLE OF THIS SESSION IS "THE
EVOLUTION OF HIV TESTING: THEN, NOW AND BEYOND."
GIVEN THERE ARE THREE SPEAKERS, I GUESS THAT MEANS THAT I AM
THEN.
I GUESS I'M THE OLD STUFF.
DR. BRANSON IS THE PRESENT AND DR. COHEN IS THE FUTURE.
WE'LL SEE HOW THIS PLAYS OUT.
HAVING SAID THAT, I THINK IT'S ALSO VERY IMPORTANT FOR US TO
UNDERSTAND REALLY WHERE IT IS THAT WE'VE COME FROM.
AND SO I'M GOING TO BE TALKING ABOUT HIV SCREENING AS IT FIRST
BEGAN AND GIVE YOU A BIT OF A HISTORY.
I THINK THAT THE HISTORY OF TESTING IS BEST DESCRIBED ON
THIS SLIDE RIGHT HERE, WHICH IS A GRAPH.
I USUALLY START OUT WITH BULLETS TO SAY WHAT I'M GOING TO TELL
YOU, BUT I THINK THIS SLIDE REALLY TELLS IT ALL.
I'LL TAKE YOU ON A JOURNEY WHICH IS GOING TO BEÑi SHOWN BY THIS
LITTLE BLOOD DROP THAT'S MOVING ALONG THAT'S INFECTED WITH HIV
AND WE'RE STARTING WITH THE FIRST CASES OF HIV REPORTED OF
COURSE IN 1981 WHICH IS WHY WE'RE HERE.
AND THEN THE FIRST CASE OF TRANSFUSION ASSOCIATED HIV
REPORTED IN 1982 AFTER WHICH HIGH RISK DONOR DEFERRAL WAS
INITIATED.
AS A RESULT OF THAT DEFERRAL, THEN THE PEAK WAS REACHED IN
1982 AND 1983 WITH THE DISCOVERY OF HIV AND THERE WAS A
PROSPROGRESSIVE IMPLEMENTATION.
I REALLY COULD STOP THERE.
THAT'S THE MESSAGE.
INSTEAD I WILL GO FILL OUT MY 15 MINUTES WITH A BIT MORE OF THE
HISTORY.
AGAIN, STARTING POINT HERE IF YOU NOTICE, THESE ARE CASES OF
TRANSFUSION ASSOCIATED AIDS REPORTED TO CDC BY YEAR AND WHAT
YOU CAN SEE BY 1983 THERE WERE A IN SOME CASES 700 TRANSFUSION
TRANSMISSIONS THAT WERE ASSOCIATE ED -- OF
HIV.
TO GIVE YOU OTHER NUMBERS, I'LL DROP IN OTHER DROPS HERE.
12,000.
12,000 WAS THE NUMBER OF HIV TRANSFUSION TRANSMITTED
INFECTIONS IN THE EARLY 1980s.
8,000 IS THE NUMBER OF HIV INFECTIONS THAT WERE TRANSMITTED
IN THE EARLY 1980s PRESUMABLY THROUGH CONTAMINATED BLOOD
PRODUCTS SUCH AS FACTOR 8 AND 1.1% REPRESENTS THE RISK OF
TRANSFUSION.
WE HAD SOME VERY, VERY SERIOUS THREATS TO THE SAFETY OF THE
BLOOD SUPPLY BACK IN '83.
NOW, FDA IS RESPONSIBLE FOR THE SAFETY OF BLOOD AND REGULATES
ALL ASPECT OF BLOOD SAFETY AND THERE'S AN APPROACH THAT WE HAVE
CALLED FIVE LAYERS OF SAFETY INCLUDING THE DONOR ELIGIBILITY
INCLUDING SELF-REFERRAL AND SCREENING AND FILLING OUT THE
DONOR QUESTIONNAIRE.
SECOND IS LABORATORY TESTING AND DEFERRAL AND THEN QUARANTINE
CONTROLS TO PREVENT UNIT RELEASE PENDING VERIFICATION OF DONOR
SUITABILITY AND INVESTIGATION AND CORRECTION WHEN MISTAKES ARE
MADE AND FOLLOW-UP INSPECTIONS TO MAKE SURE THAT THE DEVIATIONS
HAVE BEEN CORRECTED AND FINALLY DONOR DEFERRAL REGISTRY SO
PEOPLE WHO ARE$ UI9 ARE
RECOGNIZED AND NOT ALLOWED TO DONATE.
I'LL FOCUS ON NUMBER TWO HERE.
LABORATORY TEST AND REFERRAL.
I'LL TAKE YOU THROUGH A TIME LINE.
IT'S EMPTY BUT WILL BE FULL BY THE TIME WE GET TO THE END OF
IT.
IN 1983, WE START WITH PAPER INSTEAD OF TEST.
THE PAPER WAS RECOMMENDATIONS ISSUED BY PUBLIC HEALTH SERVICE
FOR DEFERRAL OF AT-RISK DENONORS FOLLOWED IN 1985 WITH FDA
APPROVAL OF THE FIRST ASSAY FOLLOWED A COUPLE YEARS LATER BY
THE FIRST WESTERN BLOT RECOGNIZING THE SCREENING TEST
APPROVED IN 1985 WAS ALLOWING -- WAS IDENTIFYING MORE PEOPLE THAT
WERE IDENTIFYING PEOPLE AS INFECTED WHEN THEY ACTUALLY
WEREN'T SO THE MANDATE WAS TO HAVE AN ADDITIONAL MORE SPECIFIC
TEST TO DETERMINE IF THE INITIAL SCREENING TEST WAS A TRUE
POSITIVE OR NOT AND WAS THE WESTERN BLOT APPROVED IN 1987.
THIS TAKES US TO 1988 WHEN THE SCREENING WAS IMPLEMENTED THERE
WAS A REQUIREMENT OF TESTING OF HIV AND PLASMA DONORS.
IN 1990 AND '91, THE FIRST TEST TO DETECT HIV 2 RECOGNIZING THAT
THE EXISTING TEST HAD SOME TROUBLE IN DETECTING HIV 2.
THE TEST THAT WERE LICENSED WERE EIAs DETECTED HIV ALONE OR
COMBINATION TEST TO DETECT BOTH HIV 1 AND HIV 2 ANTIBODIES.
THIS TAKES US TO 1995.
AT THAT POINT FDA WAS RECOMMENDING THE BLOOD
ESTABLISHMENTS IMPLEMENT DONOR SCREENING FOR HIV 1 ANTIGEN
USING LICENSED TEST KITS.
AT THAT TIME THERE WERE NO TESTS THAT WERE LICENSED.
THIS WAS DESIGNED TO HAVE RECOMMENDATIONS IN PLACE SO THAT
WHEN THE FIRST TEST WAS LICENSED IN 1996, THAT COULD BE IMPLEMENT
IMPLEMENTED IMMEDIATELY.
IN 1997, THE FIRST HIV ACID TEST WENT FORWARD FOR SOURCE PLASMA
AND IN 1989 STUDIES WERE INITIATED FOR THE U.S. BLOOD
SUPPLY.
THESE WERE INVESTIGATALE AL INVESTIGATIONAL
STUDIES DESIGNED TO COLLECT DATA FOR APPROVAL OF A LICENSE
APPLICATION FOR THESE TESTS.
WHILE IT WOULD SEEM THAT THE INVESTIGATIONAL STUDIES MAY BE
TRIVIAL, THEY WERE NOT BECAUSE WHAT HAPPENED WAS THAT ALL OF
THE BLOOD IN THE U.S. WAS BEING TESTED UNDER IND AND SO EVEN
THOUGH THERE WAS NOT A LICENSE TEST, THE INVESTIGATIONAL TEST
WAS USED TO SCREEN ALL OF THE BLOOD DONORS IN THE U.S. AND
THEREFORE THERE WAS BENEFIT TO BE GAINED AND I'LL GET TO WINDOW
PERIOD IN JUST A FEW MINUTES.
IN 2001 AND 2002, THEN THE STUDIES LED TO THE SUBMISSION OF
A LICENSE APPLICATION AND FDA AT THAT TIME LICENSED THE FIRST
TEST FOR POOL PLASMA TESTING AND FOR BLOOD DONOR SCREENING.
I TRIED TO COME UP WITH SOME SORT OF GRAPHIC FOR THIS AND I
DECIDED TO DO A VISUAL PUN AND THEREFORE YOU SEE A KITTY POOL
REPRESENTING A MINI POOL.
I TRIED.
IN 2003 FDA LICENSED THE FIRST TEST TO DETECT HIV 1 GROUP O
RECOGNIZING THE DIVERSITY OF HIV IN SOME CASES PROVED TO BE
DIFFICULT FOR SOME TESTS TO PICK UP AND SO GROUP O WAS ADDED TO
THE TEST.
SO WHERE DID THIS ACTUALLY GET US?
I'M GOING TO TALK NOW FOR A MINUTE ABOUT WINDOW PERIODS.
WITH HIV ANTIBODY TESTS, THIS SHOWS YOU THE CONNETTICS OF
ANTIBODY AND FIRST GENERATION AND SECOND GENERATION AND THIRD
GENERATION TEST.
FIRST GENERATION TEST HAD A WINDOW PERIOD OF 65 DAYS WITH
SECOND GENERATION TEST IMPROVEMENT IN TECHNOLOGY WINDOW
PERIOD WAS REDUCED TO ABOUT 45 DAYS AND WITH THIRD GENERATION
TEST WHICH ARE USED TO SCREEN BLOOD RIGHT NOW FOR HIV-1
ANTIBODIES AND GROUP 0, WINDOW PERIOD IS REDUCED TO ABOUT 22
DAYS.
IF WE LOOK AT HIV P-24 ANTIGEN, THE WINDOW PERIOD IS REDUCED TO
16 DAYS AND WHEN YOU LOOK AT HIV RNA WHICH IS STUDIED IN PLASMA
SPECIMENS IT'S REDUCED TO 11 DAYS AND IF INDIVIDUAL DONOR IS
USED, THAT'S REDUCED TO SEVEN DAYS.
THE WINDOW PERIOD IS REDUCED SO WE CAN IDENTIFY PEOPLE EARLIER
AND EARLIER DURING THE COURSE OF INFECTION DEPENDING ON THE
TECHNOLOGY THAT'S USED.
NOW, THIS GOES ACCORDING TO BIOLOGY OF THE VIRUS AND
RESPONSE TO THE VIRAL INFECTION.
HOW DOES THIS ACTUALLY PLAY OUT IN TERMS OF MAKING A DIFFERENCE
AND THAT'S SHOWN IN THIS SLIDE.
HERE YOU CAN SEE THAT AT THE BEGINNING IN 1983 AGAIN THE RISK
WAS 1/100 OF A TRANSFUSION TRANSMITTED INFECTION OF HIV.
WHEN THE CRITERIA WERE CHANGED, THE RISK DROPPED AND WHAT I'M
SHOWING IS THE RISK OF INFECTION PER UNIT TRANSFUSED.
WHEN HIV ANTIBODY SCREENING WAS GONE, THERE WAS MORE OF A DROP
AND WHEN P-24 BEGAN, THERE WAS MORE OF A DROP.
YOU CAN SEE THAT THE IMPLEMENTATION OF TESTING HAS
CERTAINLY MADE A TREMENDOUS DIFFERENCE IN THE SAFETY OF THE
BLOOD AND INTERDICTED A LARGE NUMBER OF INFECTIONS THAT
OTHERWISE WOULD HAVE GOTTEN THROUGH.
JUST TO PUT NUMBERS ON THIS FROM THE GRAPH, WE ARE DROPPING FROM
A RISK OF 140,000 OR SO NOW DOWN TO WHEN MINI POOL IS USED TO A
RESIDUAL RISK OF 1 IN 2 MILLION AND INDIVIDUAL A RISK OF 1 IN
1.3 MILLION.
A LOT OF US DEAL WITH VERY LARGE NUMBERS AND SO SOMETIMES I'M NOT
SURE WE REALLY HAVE A GOOD FEEL FOR WHAT THAT ACTUALLY MEANS SO
I'M GOING TO TRY TO PUT THIS IN PERSPECTIVE FOR YOU.
IF YOU WOULD IMAGINE A FULL FOOTBALL STADIUM AND THAT
EVERYONE IN THE STADIUM REPRESENTS SOMEONE THAT'S BEEN
TRANSFUSED.
THIS IS A PHOTO OF GILLETTE FIELD WHERE THE PATRIOTS PLAY.
THIS IS IN NO WAY AN ENDORSEMENT OF THE FDA FOR THE PATRIOTS.
IMAGINE EVERYONE IN THE STADIUM IS -- EVERYONE IN THE STADIUM IS
TRANSFUSION RECIPIENT, THE RISK IS GOING TO BE 1 IN 45 SELLOUTS.
THAT'S WHAT 1 IN 3 MILLION IS.
THAT PUTS IT IN PERSPECTIVE HOW EFFECTIVE THIS ACTUALLY IS.
THAT'S THE RESIDUAL RISK.
I ALSO WANT TO MAKE A COUPLE POINTS HERE THAT I THINK OFTEN
GO OVERLOOKED AND I CALL THESE UNDERAPPRECIATED FACTS AND THE
FIRST ONE IS AVAILABLE HIV TESTING TECHNOLOGY IS EXTREMELY
ACCURATE.çó THIS IS UNLIKE TESTS FOR SOME
OTHER INFECTIOUS AGENTS.
HIV TEST IN GENERAL TEND TO HAVE SENSITIVITIES THAT APPROACH
100%.
THIS IS UNHEARD OF IN THE TESTING ARENA.
I THINK WE OVERLOOK THAT A LOT.
WHEN I SPEAK WITH MY COLLEAGUES IN THE OFFICE AT THE CENTERS FOR
DEVICES AT FDA WHO DEAL WITH MOST OF THE DIAGNOSTICS OUT
THERE, WE TELL THEM WE ARE LOOKING AT NUMBERS LIKE THIS
APPROACHING 100%, THEY ARE AMAZED AT THE SENSITIVITY THESE
TESTS CAN ACHIEVE.
THE OTHER FACT I WANT TO MAKE YOU AWARE OF IS EVEN THOUGH HIV
CONTINUES TO MUTATE AT A VERY HIGH RATE, AND THERE ARE
NUMEROUS EMERGING VARIANTS, IT DOESN'T AFFECT THE VIRUS.
THE TECHNOLOGY IS SUCH THAT IT'S BEEN ABLE TO KEEP UP WITH IT.
AT THE SAME TIME WE DON'T WANT TO BE COMPLACENT ABOUT THIS.
WE RECOGNIZE THERE'S ALWAYS AN OPPORTUNITY FOR OTHER VARIANCES
TO COME INTO PLAY THAT MAY NOT BE RECOGNIZED BY EXISTING
TESTING AND SO THERE ARE ACTIVE RESEARCH PROGRAMS GOING ON RIGHT
NOW IN FDA LABS TO MONITOR EMERGING VARIANCE AND IMPACT OF
DIVERSITY ON DETECTION BY CURRENT AND FUTURE TESTS.
WE KEPT UP WITH HIV 2 AND GROUP 0 AND THERE'S ALSO N AND P
FLOATING AROUND OUT THERE AS WELL AS CIRCULATING REFORMS.
I WANT TO LET YOU KNOW THAT MANY DONOR SCREENING TESTS THAT WE
LICENSED WERE GIVEN DUAL CLAIMS FOR DIAGNOSTIC USE RECOGNIZING
THAT THE CLINICAL TRIALS THAT WERE DONE WERE SUFFICIENT TO
SUPPORT THE USE OF THESE IN A DIAGNOSTIC SETTING SO THAT LED
TO THE FIRST TEST USED IN THE DIAGNOSTIC SETTING.
BUT WE'VE ALSO GONE BACK THE OTHER WAY WHICH IS VERY
INTERESTING.
WE HAVE RECENTLY IN THE PAST YEAR OR SO APPROVED THE FIRST
HIV-1 COMBO TEST DETECTING BOTH HIV-1 ANTIBODY AND P-24 ANTIGEN
AT THE SAME TIME.
THERE IS VALUE IN GIVING A LIMITED CLAIM TO THAT SCREENING
TEST.
IF YOU WOULD ENCOUNTER A SITUATION WHEN A TRADITIONAL
BLOOD DONOR SCREENING TASTE MIGHT BE AVAILABLE, YOU CAN USE
A TEST LIKE THIS AS EMERGENCY DONOR SCREENING CLAIM AND WE'RE
IN THE PROCESS OF WORKING OUT RECOMMENDATIONS AND GUIDELINES
FOR HOW TESTS LIKE THIS CAN BE USED.
THIS IS THE FUTURE WE ARE PLANNING ON GIVING MORE CLAIMS
LIKE THIS IN THE FUTURE.
JUST TO REMIND YOU WHERE WE ARE NOW.
I TOLD YOU WHERE WE HAVE COME FROM.
WE'RE BACK IN THE PRESENT.
THERE'S POTENTIAL FOR REDUCING WINDOW PERIOD TO SEVEN DAYS
USUALLY INDIVIDUAL DONOR NET.
IT'S NOT BEING USED WIDELY FOR TECHNICAL AND EFFICIENCY AND
BLOOD DONOR SETTING YOU HAVE A VERY LOW PREVALENCE OF HIV
INFECTION AND THEREFORE MOST OF THOSE PEOPLE WILL NOT BE
INFECTED BY HIV.
IT MAKES MORE SENSE TO DEVOTE RESOURCES TO TESTING.
INDIVIDUAL NAT IS NOT THE MOST SUFFICIENT WAY TO GO.
ALSO THE TECHNOLOGY NEEDS TO CATCH UP A BIT.
THERE ARE SOME SYSTEMS OUT THERE THAT CAN SCREEN USING INDIVIDUAL
DONOR NAT BUT THE HIGH PUT IS MORE AMENABLE TO MINI NAT POLL
TESTING.
THE INDIVIDUAL RISK OF HIV TRANSMISSION IN TRANSFUSED BLOOD
IS 1 IN 2 MILLION USING MINI PULL NAT AND 1 IN 43 MILLION FOR
I.D. NAT.
THERE ARE NEW FDA LICENSED APPROVED TOOLS FOR BLOOD
SCREENING FOR DIAGNOSTIC FOR VERY RAPID TESTING AND THERAPY
MONITORING.
THAT LEADS INTO WHAT BERNIE IS GOING TO TALK ABOUT AND TO
BRIDGE OVER WHAT MIKE IS GOING TO TALK ABOUT AND PROVE
PREVENTION AND TREATMENT ARE GAINED BY HAVING MORE PEOPLE
LEARN THEIR HIV STATUS.
WITH THAT I WOULD LIKE TO CONCLUDE BY CONGRATULATING CDC
FOR THE EXTRAORDINARY WORK THEY HAVE DONE WITH EXTRAORDINARY
PEOPLE AND WE AT FDA ARE PROUD TO BE A SISTER AGENCY TO YOU AND
LOOK FORWARD TO MORE AND EVEN BETTER TESTING IN THE FUTURE.
THANK YOU VERY MUCH.
[ APPLAUSE ] >> THANK YOU, ELLIOTT.
UNLESS THERE'S SPECIFIC CLARIFICATION QUESTIONS I THINK
WE'RE GOING TO GO AHEAD AND MOVE ON.
THE NEXT SPEAKER IS DR. BERNARD BRANSON.
ASSISTANT DIRECTOR FOR LABORATORY DIAGNOSTICS HERE AT
CDC.
DR. BRANSON HAS BEEN INVOLVED IN COUNSELING TESTING FOR MORE THAN
20 YEARS IN THE HIV FIELD.
HE WAS THE LEAD AUTHOR ON THE REVISED RECOMMENDATIONS FOR HIV
TESTING OF ADULTS, ADOLESCENTS, PREGNANT WOMEN AND HEALTH CARE
SETTING.
I THINK DR. BRANSON IS GOING TO GIVE YOU AN OVERVIEW OF HIV
DIAGNOSTIC TESTING.
>> THANKS A LOT, MICHELLE.
ELLIOTT TALKED A LOT ABOUT TESTS.
WHAT I WOULD LIKE TO TALK ABOUT IS TESTING IN ADDITION TO JUST
TESTS BECAUSE THAT'S IN PART AND PARCEL OF SOME PARALLEL
DEVELOPMENT.
AS ELLIOTT MENTIONED IN 1985, FDA LICENSED THE FIRST TEST AND
CDC DID SOMETHING THAT WAS UNPRECEDENTED AT THE TIME BY
ESTABLISHING PUBLICLY FUNDED TESTING SITES.
WHEN THE TESTS WERE LICENSED FOR USE IN BLOOD BANKS, THERE WAS
REAL CONCERN THAT PEOPLE WHO WOULD LIKE TO FIND OUT HIV
STATUS WOULD GO TO BLOOD BLANKS IN ORDER TO DO IT AND THEY
ESTABLISHED ALTERNATIVE TEST SITES FOR PEOPLE WHO WANTED AN
HIV TEST AS AN ALTERNATIVE TO GOING TO BLOOD BANKS AND SENT
CDC STAFF OUT ACROSS THE COUNTRY TO DIFFERENT CITIES IN ORDER TO
TALK ABOUT THE TESTS AND RECOMMENDATIONS FOR TESTING AND
RECOMMENDED TESTING BASED ON RISKS.
INTRODUCTION OF UNANIMOUS TESTING BECAUSE OF THE STIGMA
AND DISCRIMINATION THAT COULD BE ASSOCIATED WITH JUST SEEKING AN
HIV TEST AT THAT POINT IN TIME.
IMPORTANTLY IN 1985 THE IMPLICATIONS AND PROGNOSIS OF A
POSITIVE ANTIBODY TEST WEREN'T YET KNOWN.
THERE WAS THE SAN FRANCISCO CITY COHORT ESTABLISHED FOR LOOKING
AT HEPATITIS INFECTION AND FOLLOWED THOSE PEOPLE FOR HIV
AND WHEN THIS TEST FIRST CAME OUT, IT WAS BELIEVED THAT 10% OF
PEOPLE WHO TESTED POSITIVE WOULD EVER GO ON TO DEVELOP AIDS.
THEY WANTED TO ESTABLISH THE HIV TEST AND HAVING SYMPTOMS OF
AIDS.
IN 1987, CDC CONDUCTED A CONSULTATION ABOUT THE ROLE OF
VIRUS ANTIBODY TESTING AND PREVENTION AND CONTROL OF AIDS
AND AT THAT POINT IN TIME THE PROCESS THAT HAS BEEN IN PLACE
FOR MANY YEARS OF PRE AND POST-TEST COUNSELING HAS BEEN
DESIGNED TO EXPLAIN HIV AND HOW IT COULD BE PREVENTED BECAUSE
VERY PEOPLE KNEW ABOUT THAT IN THE COUNTRY AT THE TIME THEY
WERE SEEKING THE TEST.
YOU NEEDED TO EXPLAIN THE TEST, WHAT THE TEST RESULT MEANT AND
AS I POINTED OUT, A BIG EMPHASIS AT THE TIME WAS TO EXPLAIN THAT
HAVING HIV AND A POSITIVE TEST DID NOT NECESSARILY MEAN THAT
YOU HAD AIDS AND OF COURSE COUNSELING WAS CONDUCTED PRE-
PRE- AND POST-TEST TO EMPHASIZE CHANGES.
ONE OF THE CONCLUSIONS FROM THIS CONFERENCE WAS THAT TESTING WAS
ADJUNCTED TO EDED EDED TO COUNSELING.
THEY NEEDED TO BE PROVIDED WITH COUNSELING AND THERE WASN'T
THERAPY SO THERE WASN'T MUCH YOU COULD DO WITH A POSITIVE TEST
RESULT BUT COULD BE AN INCENTIVE TO CHANGE BEHAVIOR.
TECHNOLOGY REMAINED THE SAME.
THERE WERE STANDARDS FOR WHAT HAPPENED WITH TESTING ACROSS THE
COUNTRY.
THERE WAS REAL CONCERN ABOUT FALSE POSITIVE TESTS AND AS A
RESULT OF THAT CONCERN IN 1989 WHEN CDC CAME OUT WITH
RECOMMENDATIONS FOR HOW TO INTERPRET WESTERN BLOT, THEY
ALSO RECOMMENDED THAT NO POSITIVE TEST RESULTS BE GIVEN
OUT TO AN INDIVIDUAL UNTIL THE SCREENING TEST WAS REPEAT EDEDLY
REACTIVE AND A SUPPLEMENTAL TEST HAS BEEN USED TO VALIDATE THOSE
TEST RESULTS.
THESE WERE STRINGENT STANDARDS BEFORE GIVING OUT TEST RESULTS
AND ONE OF THE CONSEQUENCES OF THAT IS IN THE REST OF THE WORLD
PEOPLE BEGAN INTRODUCING RAPID TESTS AND IN THE U.S. THIS
RECOMMENDATION PRECLUDED THAT BECAUSE YOU COULD NOT GIVE A
POSITIVE TEST RESULT.
YOU COULD GIVE A NEGATIVE TEST RESULT AND TELL SOMEONE WHO HAD
A POSITIVE TEST I CAN'T TELL YOU ON THE BASIS OF THE RESULTS BUT
THAT REALLY WASN'T GOING TO WORK AND IT VIRTUALLY LIMITED THE
MARKET TO THE IEA AND WESTERN BLOT IN THIS COUNTRY.
AS TIME WENT ON, WE STARTED LOOKING AT WHAT HAPPENED BECAUSE
YOU HAD TO SEND A TEST TO A LABORATORY AND BECAUSE IT HAD TO
BE CONFIRMED BEFORE THE RESULTS CAME BACK, WE NOTICED THAT ONE
OF THE PROBLEMS WITH THIS CONVENTIONAL TESTING IS THAT
SINCE YOU HAD TO RETURN FOR YOUR TEST RESULT, MANY PEOPLE NEVER
DID SO.
MANY PEOPLE NEVER RECEIVED AN HIV POSITIVE TEST RESULT.
FROM 1995 IN RED IN STD CLINICS HALF OF PEOPLE RETURNED TO
RECEIVE THEIR TEST RESULTS.
THAT'S IN THE HIV NEGATIVE COLUMN AND EVEN WITH OUTREACH IN
ORDER TO TALK TO PEOPLE AND FIND PEOPLE WHO TESTED POSITIVE ABOUT
ONE-THIRD TO 40% OF PEOPLE WHO TESTED POSITIVE FOR HIV NEVER
RECEIVED THEIR POSITIVE TEST RESULTS.
WE BEGAN TO LOOK AT OTHER ALTERNATIVES IN ORDER TO HELP
IMPROVE THIS AND ONE OF THE CONCLUSIONS IS THAT WE NEEDED TO
BE ABLE TO USE RAPID TEST TO BE ABLE TO GIVE PEOPLE SAME-DAY
TEST RESULTS AND IN 1998, THE PUBLIC HEALTH SERVICE
RECOMMENDATION WAS CHANGED TO PROVIDE PRELIMINARY HIV POSITIVE
TEST RESULTS BEFORE THE CONFIRMATORY RESULTS ARE
AVAILABLE IN SITUATIONS WHERE TESTED PERSONS BENEFIT.
THIS INCLUDED CLINICS WHERE PEOPLE WENT TO SEEK THEIR HIV
TEST RESULTS AND INCLUDED CIRCUMSTANCES LIKE AFTER A
PERSON HAD AN OCCUPATIONAL EXPOSURE FROM A NEEDLE STICK OR
FOR A PREGNANT WOMAN WHERE YOU MIGHT WANT TO MAKE A THERAPEUTIC
DECISION IMMEDIATELY ON THE BASIS OF A PRELIMINARY POSITIVE
TEST RESULT.
AS A RESULT OF THE CHANGE IN THAT RECOMMENDATION, RAPID TESTS
CAME TO THE U.S. MARKET AND BETWEEN 2002 AND 2006, FDA
APPROVED SIX DIFFERENT RAPID TESTS FOR THE UNITED STATES.
IT WAS NOT ONLY RAPID TESTS THAT WERE IMPORTANT BUT THE CONCEPT
OF ANOTHER SYSTEM OF REGULATION FOR TESTING IN THE COUNTRY.
THEY CLASSIFY TEST ON THE ABOUT A BASIS OF HOW COMPLICATED THERE
ARE AND WHAT REQUIREMENTS THERE ARE FOR MONITORING AND FOUR OF
THE RAPID HIV TESTS APPROVED BY THE FDA AT LEAST SO FAR FOUR OF
THEM HAVE RECEIVED WAIVER PICTURED ON THIS SLIDE AND CAN
BE DONE AT POINT OF CARE AND YOU COULD PROVIDE RESULT BACK TO AN
INDIVIDUAL RELATIVELY QUICKLY AND THEY COULD BE DONE BY PEOPLE
WHO WERE NOT LABORATORY PROFESSIONALS SO THAT GREATLY
EXPANDED RANGE OF WHERE TESTING COULD HAPPEN IN THE COUNTRY.
BY 2009, OVER 61% OF ALL TESTING THAT IS CONDUCTED BY HEALTH
DEPARTMENTS PARTICULARLY AMONG HIGH-RISK PERSONS WERE
CLIA-WAIVED HIV RAPID TESTS.
THROUGH 2006, 2007, 2008, CONVENTIONAL TESTS IN BLUE AND
RAPID TESTS IN PURPLE.
RAPID TESTS OVERTOOK AND BECAME THE MAJOR FORM OF TESTING THAT
WAS USED.
AT THE SAME TIME IN CDC'S ORGANIZED PUBLICLY FUNDED
TESTING SITES, WHILE PROPORTION OF PEOPLE TESTED, 1.4 MILLION IN
1989 TO 2.1 MILLION TESTS IN 2004, THE PERCENTAGE OF PEOPLE
TESTED WENT UP BUT PEOPLE POSITIVE WENT DOWN.
HIGH RISK PEOPLE WERE SEEKING PEOPLE.
5% OF THOSE GETTING TESTED WERE TESTING POSITIVE FOR HIV.
BY 2004, IT WAS DOWN TO 1.2%.
IN RECENT YEARS IT'S DOWN TO .75%.
OUR PUBLICLY FUNDED SITES AND OUR TARGETED TESTING BASED ON
RISK WAS CONTINUING TO FIND INFECTED PEOPLE BUT FOUND FEWER
AND FEWER AND THAT LED TO THE CHANGE IN RECOMMENDATIONS.
FOLLOWING THE PATTERN OF THE NUMBER OF PEOPLE EVER TESTED,
THE NATIONAL INTERVIEW SURVEY ASKED PEOPLE EVERY YEAR ABOUT
WHETHER A PERSON HAD EVER BEEN TESTED FOR HIV.
IN THE PINK LINE ON THE SLIDE WHAT YOU CAN SEE IS THAT THE
NUMBER OF PEOPLE WHO SAY OR PERCENTAGE OF PEOPLE WHO HAVE
EVER BEEN TESTED INCREASED FROM 1987 AND 2002 TO AROUND 40% BUT
THEN IT STABILIZED.
IN 2002 THE SAME PROPORTION OF PEOPLE EVERY YEAR SAID THEY HAD
AN HIV TEST.
OUR PROGRESS HAD REALLY STALLED IN TERMS OF TESTING MORE PEOPLE
FOR HIV INFECTION.
SO IN 2006 AS A RESULT OF THIS OBSERVATION AND A RESULT OF
OBSERVATION THAT MANY PEOPLE WHO WERE GOING INTO HEALTH CARE
SETTINGS HAD HIV INFECTION BUT NEVER GOT DIAGNOSED, CDC ISSUED
REVISED RECOMMENDATIONS FOR TESTING ADULTS, ADOLESCENTS AND
PREGNANT WOMEN AND HEALTH CARE SETTINGS.
BEFORE THEY WERE BASED ON FACTORS ASSOCIATED WITH RISK FOR
HIV SO IT WAS TARGETED TESTING AND THESE RECOMMENDATIONS CALLED
FOR ROUTINE VOLUNTARY HIV SCREENING FOR ALL PERSONS AGE 13
TO 64 IN HEALTH CARE SETTINGS WHERE PREVALENCE OF UNDIAGNOSED
HIV WAS 1 IN 1,000.
THEY CALLED FOR REPEAT HIV SCREENING PERSONS WITH KNOWN
RISK FACTORS AT LEAST EVERY YEAR AND SPECIFICALLY INT KATED THAT
IN IN HEALTH CARE SETTINGS,
PREVENTION STANDARDS SHOULD NOT NECESSARILY BE REQUIRED FOR
PEOPLE WHO WERE RECEIVING AN HIV SCREENING TEST.
THIS SLIDE SUMMARIZES BASICALLY WHAT HAS HAPPENED OVER TIME WITH
HIV, THE NUMBER OF PEOPLE INFECTED AND THE PROPORTION WHO
FOUND OUT THEIR INFECTION.
WHAT YOU SEE IN GREEN ARE PROPORTION OF PEOPLE INFECTED
WITH HIV AND WHO KNOW THEY ARE INFECTED WITH HIV.
THAT NUMBER HAS INCREASED SO THAT RIGHT NOW OVERALL THERE ARE
ABOUT 1.1 MILLION PEOPLE WHO ARE INFECTED WITH HIV IN THE UNITED
STATES.
AT LEAST AS OF THE END OF 2008.
IN BLUE ARE THE PROPORTION OF PEOPLE WHO HAVE HIV INFECTION
AND DON'T KNOW IT AND LINE THAT'S GOING ACROSS THE SCREEN
INDICATES WHAT PERCENTAGE OF PEOPLE ARE UNAWARE OF THEIR HIV
INFECTION WHICH DECREASED FROM 90% BACK WHEN THE TEST FIRST
CAME OUT IN 1986 TO 20% IN THE MOST RECENT YEAR FOR WHICH WE
HAVE AN ESTIMATE BACK IN 2008.
PEOPLE ALWAYS FOCUS ON THE FACT THAT 20%ñr OF PEOPLE DON'T KNOW
THEY'RE INFECTED.
I THINK THE IMPRESSIVE FEATURE IS 80% OF PEOPLE DO KNOW THAT
THEY'RE INFECTED.
ONE OTHER THING WE SEE ON THIS SLIDE IS STARTING AROUND 1996
WHEN EFFECTIVE THERAPY BECAME AVAILABLE, THE NUMBER OF
INFECTED PEOPLE IN THE COUNTRY HAS CONTINUED TO INCREASE EVERY
YEAR BECAUSE SURVIVAL IS INCREASING FOR INDIVIDUALS AND
SO WE HAVE MADE SIGNIFICANT PROGRESS IN IDENTIFYING PEOPLE
WITH INFECTION AND GETTING THOSE PEOPLE ONTO EFFECTIVE TREATMENT.
THERE IS A CHANGING LANDSCAPE AND I WILL TALK A LITTLE BIT
ABOUT DIAGNOSTIC TESTS RECENTLY APPROVED BY THE FDA.
ORIGINALLY THERE WAS EIA THAT WAS DONE IN LARGE BATCHESñr AND
FOLLOWED BY THE WESTERN BLOT.
MORE RECENTLY THERE ARE PLATFORMS CALLED RANDOM ACCESS
ASSAYS AND THE NEW TESTS HAVE A DIFFERENT PRINCIPLE.
IN THESE TWO PLATFORMS ONE APPROVED IN 2006 AND ANOTHER IN
2008, THESE ARE MACHINES IN USE IN HOSPITALS AND LABORATORIES
WHERE THEY CAN STORE 30 DIFFERENT KINDS OF TESTS.
HIV, HEPATITIS B, HCG, WHICH IS A PREGNANCY TEST.
YOU CHECK WHICH ONE YOU WANT.
IT CAN DO ONE AT A TIME OR PUT IN A SPECIMEN AND GET AN
IMMEDIATE TEST RESULT BACK IN LESS THAN 60 MINUTES FROM ONE OF
THESE PROCEDURES.
THERE'S BEEN THE QUANTITATIVE RNA TESTING THAT CAN BE USED TO
DIAGNOSE ACUTE HIV INFECTION IN PEOPLE BEFORE THEY DEVELOP HIV
ANTIBODIES AND ALSO BE USED AS A CONFIRMATORY TEST WHO ARE HIV
POSITIVE.
THAT WAS THE FIRST RNA TEST APPROVED FOR DIAGNOSIS APPROVED
BY THE FDA IN 2006.
PREVIOUSLY THERE WERE TESTS USED FOR MONITORING AND NOT FOR HIV
DIAGNOSIS SO THIS GAVE US AN OPPORTUNITY TO IDENTIFY PEOPLE
EARLIER IN THE COURSE OF AN HIV INFECTION.
MOST RECENTLY AS ELLIOTT MENTIONED, FOURTH COMBINATION
ASSAYS HAVE BEEN APPROVED.
THEY RUN A RANDOM ACCESS PLATFORM I MENTIONED SO YOU CAN
DO ONE TEST AT A TIME AND YOU DON'T HAVE TO MATCH IT.
IN THIS PARTICULAR TEST THAT'S BEEN FDA APPROVED YOU CAN GET A
RESULT BACK IN HALF AN HOUR.
ONE OF THE KEY INGREDIENTS THAT MAKES THIS COMBINATION TEST
IMPORTANT IS THAT WHILE P-24 ANTIGEN SHOWS UP EARLY IN THE
COURSE OF INFECTION, IT ALSO DISAPPEARS WHEN ANTIBODY
DEVELOPS.
IF YOU ONLY TEST FOR ANTIGEN, YOU'LL FIND EARLY INFECTION.
IF YOU TEST FOR ANTIBODY YOU'LL FIND FOR LATE INFECTIONS BUT
WHEN YOU SCREEN FOR BOTH, YOU CAN USE A SINGLE TEST THAT'S A
LOT MORE PRACTICAL AND A LOT LESS EXPENSIVE THAN TESTING WITH
BOTH AN ANTI-TESTBODY TEST AND RNA
TEST.
THE WESTERN BLOT HAS BEEN THE LONG STAY OF POSITIVITY AND
THESE ARE DATA ACTUALLY FROM MICHELLE'S LABORATORY LOOKING AT
ALL OF THE FDA APPROVED TESTS WITH SPECIMENS IDENTIFYING
BASICALLY WHEN 50% OF THOSE SPECIMENS END UP TURNING
POSITIVE COMPARED WITH THE WESTERN BLOT.
ELLIOTT SHOWED YOU THE GRAPH OF DIFFERENT TESTS.
I'M GOING TO SHOW THE SPECIFIC TESTS SO FIRST TEST APPROVED
SECOND GENERATION IN USE UNTIL 2007 PICKED UP HIV INFECTION TWO
DAYS AFTER THE WESTERN BLOT TURNED POSITIVE.
THE SECOND GENERATION TEST, THIS BRAND WAS RLEB.
PICKED UP INFECTION FIVE OR SIX DAYS BEFORE THE WESTERN BLOT
TURNED POSITIVE.
THE RAPID HIV TEST PICK UP INFECTION AGAIN BETWEEN TWO AND
FIVE DAYS BEFORE WESTERN BLOT TURNS POSITIVE.
THE OTHER RAPID TEST IN THE LABORATORY PICK UP INFECTION A
LITTLE EARLIER.
UP TO TEN DAYS BEFORE THE TIME THE WESTERN BLOT TURNS POSITIVE.
AND THEN THE THIRD GENERATION TEST MOST WILDLY USED FOR
SCREENING AND TWO RANDOM ACCESS PLATFORMS THAT I MENTION PICK UP
INFECTION ABOUT TWO WEEKS BEFORE THE WESTERN BLOT TURNS POSITIVE
AND IF WE USE RNA TEST IT WILL PICK UP PEOPLE NEARLY FOUR WEEKS
BEFORE THE WESTERN BLOT TURNS POSITIVE.
SO AS YOU CAN SEE ON THIS SLIDE WHAT'S BEEN HAPPENING IS
SENSITIVITY TEST HAS BEEN MARCHING SO THAT INFECTIONS
DETECTED EARLIER AND EARLIER THE FOURTH GENERATION TEST WE HAVE A
LITTLE LESS EXPERIENCE WITH BUT PICKS UP INFECTION FOUR TO FIVE
DAYS AFTER RNA PICKS UP THE INFECTION.Ñi
WE'RE NOT ABLE TO DETECT INFECTION ALMOST AS SOON AS A
PERSON BECOMES INFECTIOUS WITH NEWEST KINDS OF TECHNOLOGIES.
IN SUMMARY I WANT TO REMIND US THAT 80% OF PEOPLE WHO ARE
LIVING WITH HIV IN THE UNITED STATES HAVE BEEN TESTED AND ARE
AWARE OF THEIR INFECTION.
IN ORDER TO CONTINUE THIS PROGRESS BOTH TARGETED TESTING
FOR PERSONS WITH RISK FACTORS AND ROUTINE SCREENING IN HEALTH
CARE SETTING REMAIN NECESSARY TO IDENTIFY THE INFECTIONS THAT WE
HAVE NOT YET DIAGNOSED.
THE TEST THAT WE HAVE AVAILABLE ARE REALLY GOOD.
THEY DETECT INFECTION EARLIER AND PRODUCE RESULTS A LOT MORE
QUICKLY SO THAT PEOPLE CAN RECEIVE THEIR RESULTS WHEN
THEY'RE IN THE HEALTH CARE SETTING AND FINALLY HIV TESTING
REMAINS AN ESSENTIAL FEATURE AS ENTRY POINT FOR EFFECTIVE
TREATMENT AND PREVENTION OF HIV.
THANKS VERY MUCH.
[ APPLAUSE ] >> THANK YOU, BERNIE.
WE APPRECIATE THAT.
THE NEXT SPEAKER IS DR. MIKE COHEN.
HE HAS A VERY DISTINGUISHED CAREER.
HE'S A PROFESSOR OF MEDICINE, DISTINGUISHED PROFESSOR OF
MEDICINE IN MICROBIOLOGY AND PUBLIC HEALTH.
HQú á
THE CENTER FOR HIV BACK IMMUNOLOGY ON THE SENIOR
LEADERSHIP GROUP AND CHAIR OF PREVENTION COMMITTEE.
WELCOME.
>> THANKS.
GOOD AFTERNOON.
I'M AMAZED THAT PEOPLE ARE HERE AT 3:00 IN THE AFTERNOON.
GOVERNMENT EMPLOYEES ARE UNDER DIFFERENT PRESSURES THAN WE ARE.
I'LL TRY TO BE BRIEF AND HOPEFULLY I'LL HAVE SLIDES.
I CONTROL THE SLIDES.
OKAY.
WE'RE GOING TO GO FROM A DISCUSSION OF DETECTION TO WHAT
DO YOU DO WITH INFORMATION ABOUT DETECTION AND GO TOWARD THE
FUTURE AS MUCH AS POSSIBLE IN THIS DISCUSSION.
ISSUES THAT I WANT TO TALK ABOUT ARE FACT THAT PEOPLE HAVE TO BE
LINKED TO CARE.
THE TEST RESULT ISN'T MEANINGFUL IF THE PERSON DOESN'T GET THE
RESULT OR FIND THEIR WAY INTO MEDICAL CARE.
THEY NEED ACCESS TO APPROPRIATE TREATMENT WHETHER IN THE UNITED
STATES OR SOMEWHERE ELSE ON THE PLANET.
IF WE SIMPLY FIND AND TREAT, WE CAN'T DEAL WITH THIS PROBLEM
WITH CURRENT TECHNOLOGY BECAUSE FOR EVERY PERSON WE DETECT AND
TREAT ME WHERE FROM TWO TO FOUR NEW INFECTIONS OCCUR.
MORE PEOPLE GET INFECTED.
IT'S A BIG PROBLEM AND ONE WE'VE BEEN WORKING 30 YEARS ON GETTING
A GRIP ON.
I WAS ASKED TO MAKE AN HISTORIC NOTE AND ANTIDOTES ARE GOOD AND
HISTORY IS GOOD.
WHAT'S IMPORTANT TO RECOGNIZE IS IN THE '80s WHEN SOME PEOPLE IN
THE ROOM PROBABLY WERE NOT BORN, IN THE '80s, THE DISEASE HELD
GREAT FEAR AND TERRIBLE PROGNOSIS AND BASICALLY DEATH.
100% OF THE PEOPLE WHO ACQUIRED THIS DIAGNOSIS DIED AND IN 1985,
I WORK AT THE UNIVERSITY OF NORTH CAROLINA, 10% OF ALL
ADMISSIONS WERE FOR HIV AND SO THAT'S A HUGE NUMBER.
IT'S 1,000-BED HOSPITAL.
AT ANY POINT TIME AT LEAST 100 PEOPLE WITH HIV IN THE HOSPITAL.
AT LEAST FIVE DEATHS A WEEK.
IT WAS A PRETTY TERRIBLE TIME.
PEOPLE DIDN'T REALLY WANT TO KNOW THEIR STATUS.
ESPECIALLY BECAUSE WE HAD NOTHING TO OFFER OTHER THAN
MODEST MANAGEMENT OF OPPORTUNISTIC INFECTIONS.
IN 1989, FRANK GRAHAM AND DENNIS MACKEY WROTE AN EDITOR AL
THATIAL THAT ATTRACTED A LOT OF NEGATIVE
ATTENTION AND THEY WERE FORCING PEOPLE TO KNOW THEIR STATUS AND
WHY BECAUSE THIS WAS FRAUGHT WITH NOT MUCH BENEFIT BUT
TREMENDOUS STIGMA WORST REALIZED IN RYAN WHITE WHO SUFFERED
TERRIBLY THROUGH NO FAULT OF HIS OWN AS HE ACQUIRED HIV FROM
BLOOD PRODUCTS IN THE EARLY 1980s.
PROBABLY ONE OF THE BIGGEST BIOMEDICAL EVENTS OF THE 20th
CENTURY, AZT AND 30 MORE DRUGS WERE DEVELOPED AND THIS SLIDE
GENERATED BY CDC WHICH IS ONE OF THE MOST SHOWN SLIDES EVER
ANYWHERE YOU SEE THAT AS SOON AS WE HAD ACCESS TO ANTIVIRAL
THERAPY, DEATHS PLUMMETED AND SO THIS BECAME A TOTALLY DIFFERENT
DISEASE.
MOST INFECTIOUS DISEASE CENTERS IN THE UNITED STATES DEVELOPED
OUT-PATIENT CLINICS TO CARE FOR PATIENTS WITH HIV.
THE ATTENTION OF THE COMMUNITY OF PHYSICIANS INVOLVED IN THIS
MOVED TO AFRICA AND OTHER PARTS OF THE WORLD WHERE THERE WAS NO
ACCESS TO THIS KIND OF THERAPY.
THE WORLD FOR MANY YEARS 1995 TO 2000, 2001, WAS DIVIDED INTO
PEOPLE WHO COULD GET ACCESS TO PILLS AND THOSE WHO COULD NOT
AND WOULD SIMPLY DIE.
IT WAS A VERY UNPLEASANT TIME.
WE'VE MOVED AWAY FROM THAT.
AS THIS PARTICULAR DISCUSSION TODAY FOCUSING MOSTLY
DOMESTICALLY, WE NEED TO BE CONCERNED THAT 80% OF THE
EPIDEMIC IS OUTSIDE OF THE UNITED STATES.
I WANT TO THANK THE ORGANIZERS BY THE WAY AND MY FRIEND FOR
INVITING ME TO BE HERE TODAY.
THAT KIND OF BRINGS US FORWARD.
NOW WE HAVE TREATMENT.
THE TREATMENT IS GOING TO BE IMPORTANT.
WE'LL TALK ABOUT THAT.
AND THEN WE ALSO HAVE TO DEAL WITH PREVENTION.
PREVENTION WE HAVE FOUR OPPORTUNITIES.
MOST OF OUR TIME HAS BEEN SPENT ON PEOPLE WHO ARE HIV NEGATIVE
CREATING OPPORTUNITIES FOR THEM TO REMAIN NEGATIVE.
AND THIS GRAPH YOU SEE THAT WE HAVE BEHAVIORAL CONSTRUCTIONAL
ACTIVITIES THAT MAY TAKE SOMEONE HIV NEGATIVE TO REMAIN NEGATIVE
AND ACTIVITIES FOR THOSE THAT ARE NEGATIVE BUT MAY BE HIGHER
RISK.
THESE ARE REALLY IMPORTANT TOOLS FOR PEOPLE WHO ARE NEGATIVE,
KNOW THEY'RE NEGATIVE, AND ARE AT SUBSTANTIAL RISK.
BUT THEN WE TWISTED AGGRESSIVELY TO WORRY ABOUT PEOPLE THAT ARE
HIV DETECTED.
THESE PEOPLE ARE RENDERED LESS CONTAGIOUS.
PROBABLY THE THING THAT'S ATTRACTED THE GREATEST ATTENTION
IN RECENT TIMES, FOR PEOPLE WHO KNOW THEY ARE INFECTED, WE ONLY
HAVE A COUPLE OPTIONS.
BEHAVIOR CHANGE SO PEOPLES ARE MORE RESPONSIBLE AND USE CONDOMS
AND GIVE THEIR STATUS.
THE OTHER THING WE CAN DO IS TREAT EVERYBODY.
IN TREATING EVERYBODY, THE IDEA WOULD BE IF THE TREATMENT IS
SOÑi EFFECTIVE IN PERSONAL HEALTH,
MAYBE IT RENDERS PEOPLE LESS CONTAGIOUS.
THIS IS AN OLD IDEA.
IT'S NOT BRAND NEW IDEA.
MOST OF US STARTED WORKING ON THE IDEA AS SOON AS AZT WAS
DEVELOPED TRYING TO DEMONSTRATE THAT DRUG WOULD RENDER PEOPLE
LESS CONTAGIOUS AND TOOLS THAT WERE USED WERE TRYING TO PROVE
THAT THE DRUG LED TO FEWER HIV PARTICLES IN GENITAL SECRETIONS.
THERE WAS OTHER STUDIES DONE AND THE OBSERVATIONAL STUDIES LOOKED
AT COUPLES AND THEY INDICATED WHEN THEY STUDIED COUPLES THAT
WHEN ONE PARTNER IN THE -- WHEN ONE WAS POSITIVE AND OTHER WAS
NEGATIVE AND THE POSITIVE WAS AFFORDED THERAPY, THE
ANTICIPATED TRANSMISSION EVENTS OCCURRED RARELY.
THESE OBSERVATIONAL STUDIES WERE CONNECTED WITH THE PLAUSIBILITY
WE THOUGHT EXISTED THAT IT WOULD LEAD TO REDUCED TRANSMISSION
EVENTS BUT WE FELT FOR A VARIETY OF REASONS THAT A TRIAL WAS
NECESSARY TO UNDERSTAND THE MAGNITUDE AND DURABILITY OF THE
BENEFIT TO THERAPY.
THE TRIAL THAT WAS LAUNCHED WAS LONG AND EXPENSIVE TRIAL CALLED
HIV PREVENTION TRIAL 052.
THIS HAD A STUDY THAT'S SHOWN ON THE SLIDE.
HALF OF THE COUPLES -- COUPLES ARE EXTREMELY WELL BALANCED.
EQUAL NUMBER OF MEN AND WOMEN.
THEY ARE ENROLLED WITH HIGH COUNT.
MEDIAN IS 446.
PEOPLE WOULD NOT REQUIRE THERAPY.
HALF OF THE COUPLES WERE FOLLOWED AND THERAPY WAS NOT
OFFERED FOR SOME PERIOD OF TIME.
THERAPY WAS DELAYED UNTIL SUCH TIME IT WAS MORE APPROPRIATE FOR
PERSONAL HEALTH AND THE OTHER HALF OF THE COUPLES VOLUNTEERED
TO RECEIVE IMMEDIATE THERAPY AT A COUNT HIGHER THAN WOULD BE
TRADITIONALLY USED FOR THERAPY.
THE PURPOSE OF THERAPY WAS NOT THEIR OWN PERSONAL HEALTH
ALTHOUGH THAT WAS IMPORTANT.
IT WAS TO DETERMINE WHETHER THAT THERAPY WOULD REDUCE THE
TRANSMISSION PROBABILITY TO THEIR SEXUAL PARTNER.
THAT STUDY WAS SUPPOSED TO GO -- THE STUDY WAS FULLY ENROLLED IN
MAY OF 2010 AND WAS SUPPOSED TO END IN MAY OF 2015 OR EARLY
2016.
ON APRIL 28th, A DATA SAFETY MONITORING BOARD INDICATED WHILE
THE STUDY COULD CONTINUE, THAT THE RESULTS HAD TO BE MADE
PUBLIC AND SO THIS IS A VERY UNUSUAL EVENT BECAUSE THE STUDY
IS ONGOING BUT THE DATA SAFETY MONITORING BOARD FELT THE
RESULTS WERE SO IMPORTANT TO THE HEALTH OF THE PUBLIC THAT IT WAS
IRRESPONSIBLE OR THAT THE RESPONSIBILITY OF THE SPONSOR
WAS TO MAKE THE RESULTS PUBLIC.
ON THE NEXT SLIDE I SHOW YOU THE RESULTS THAT THEY WERE CONCERNED
ABOUT.
OVER THE PERIOD OF 1.7 YEARS, THERE WERE 39 INFECTIONS
OBSERVED.
39 TRANSITION EVENTS OBSERVED.
NOW, THE TOTAL IS NOT REALLY IMPORTANT.
WHAT'S IMPORTANT IS THE LINKED CASES WHERE THE VIRUS COULD BE
LINKED FROM THE INFECTED PERSON TO THEIR SEXUAL PARTNER.
THERE WERE 28 OF THOSE.
THIS LINKAGE IS NOT SOMETHING YOU CAN DO AT HOME.
THIS IS HARD TO DO.
A LOT OF SOPHISTICATED TECHNOLOGY.
THERE WERE LINKED CASES.
THERE WAS ONLY ONE LINKED CASE IN SOMEONE RECEIVING ANTIVIRAL
THERAPY WHEREAS 27 LINKED CASES OCCURRED IN COUPLES WHO NO
THERAPY WAS PROVIDED.
THIS LED TO A CONCLUSION THAT OVER THIS PERIOD OF TIME THERE
WAS A 96% PREVENTION OF HIV TRANSITION.
NOW, WE DON'T KNOW WHETHER THIS WILL GO ON FOREVER BUT THIS IS
SUCH STRONG PREVENTION THAT IT WAS FELT THAT THE LICKPUBLIC
NEEDED TO KNOW THE PILLS WORKED IN THIS
WAY.
97% WERE HETEROSEXUAL COUPLES.
IT DOESN'T LEND ITSELF TO MEN HAVING SEX WITH MEN BUT TO
UNDERSTANDING OF HETEROSEXUAL COUPLES.
THE ONE TRANSMISSION CASE IS INTERESTING.
HOW IS IT POSSIBLE ONE PERSON WAS ABLE TO TRANSMIT EVEN THOUGH
THEY RECEIVED THERAPY.
THE ANSWER WILL BE REVEALED LATER THIS SUMMER WHEN ALL WILL
BE TOLD.
ALL DATA RELATED TO THE TRIAL HAS NOT BEEN TOLD TO EVERYBODY
AND THERE WILL BE AN AIDS INTERNATIONAL MEETING THAT WILL
HAVE AN ONLINE PORTION.
AN HOUR AND A HALF DEVOTED TO THIS WHOLE THING.
THEN THAT ONE CASE WILL BE DESCRIBED IN TREMENDOUS DETAIL.
SOMETHING HAS TO BE KEPT IN SECRET EVEN FROM MY FRIEND,
JOHN.
ALL RIGHT.
SO NOW THIS BECOMES THE INFRASTRUCTURE OF A BELIEF
SYSTEM.
NOW WE'RE CONCERNED ABOUT PREVENTION.
WE'RE TRYING TO FIND INFECTED PEOPLE AND NOW WE'RE IN A
POSITION TO TELL PEOPLE WHO ARE INFECTED IF YOU TAKE YOUR PILLS
RELIABLY, YOU'LL BECOME LESS INFECTIOUS ESPECIALLY IN A
HETEROSEXUAL RELATIONSHIP.
WHILE WE SPEAK, SOMEONE ON THE PLANET A MATHEMATICAL MODEL IS
BEING MODELED.
THERE'S PLENTY OF OPPORTUNITY.
THE ASSUMPTIONS PROVIDE THE ANSWERS.
IF I SHOW YOU THE NEXT SLIDE FROM A REVIEW ARTICLE WE WROTE
AND YOU ASK THE QUESTION IF YOU TREAT EVERYBODY, CAN YOU STOP
THE EPIDEMIC?
THE GREEN SAYS TREAT EVERYBODY AND YOU STOP THE EPIDEMIC.
THESE ARE MODELS.
THE RED IS TREAT EVERYBODY AND IT WILL HAVE NO BIG EFFECT.
DEPENDING ON YOUR ASSUMPTIONS, YOU CAN HAVE ANY ANSWER YOU LIKE
WHEN IT COMES TO MATHEMATICAL MODELING.
SO WE LOOK AT ECOLOGICAL STUDIES AND WE SEE TWO DIFFERENT KINDS
OF POINTS OF VIEW.
WE HAVE INVESTIGATORS FROM SAN FRANCISCO WHO TOLD US THEY FEEL
ENOUGH A.R.T. WAS USED IN THOSE COMMUNITIES THAT THEY SEE
REDUCED NEW CASES OF HIV OR REDUCED INCIDENTS CASES OF HIV
BUT MOSTLY LOOKING AT NEW DIAGNOSES WHICH IS PROBLEMATIC
AND OTHER COUNTRIES SAY WE USE A.R.T. AND WE DON'T SEE A
POPULATION BENEFIT.
I THINK WHAT ONE CAN CONCLUDE FROM ALL OF THIS AND THIS IS A
HUGE AMOUNT OF INFORMATION IS IT'S A REALLY INTERESTING TOPIC.
TREATMENT DEFINITELY REDUCES THE PROBABILITY OF TRANSMISSION FROM
ONE PERSON TO ANOTHER AND IN ORDER TO SEE THAT BENEFIT AT A
POPULATION LEVEL, WE'LL NEED MORE INFORMATION BOTH
OBSERVATIONAL INFORMATION, MODELING INFORMATION AND I LIKE
MODELING A LOT, I DON'T MEAN TO BE NEGATIVE, WE HAVE TO KNOW
THAT THE OUTCOME DEPENDS ON WHAT WE PUT IN AND WE'RE GOING TO
NEED EXPERIMENTS AND I'LL GET TO EXPERIMENTS IN A SECOND.
SO THE EXPERIMENTS.
HAVING SAID ALL THIS, THE HORSE IS WAY OUT OF THE BARN.
THE SPECIES WANTS TO KNOW WHETHER TREATMENT CAN SERVE AS
PREVENTION AND SO THERE ARE SEVERAL STUDIES GOING ON TRYING
TO TREAT LARGE GROUPS OF PEOPLE, TREAT ENOUGH PEOPLE TO STOP THE
TRANSMISSION OF HIV.
THERE'S ONE IN UGANDA BY BRITISH AND ONE IN SOUTH AFRICA AND THEN
THE CDC AND NIH HAVE SEPARATE COMPETITIONS FOR VERY LARGE SUMS
OF MONEY THAT WILL BE GIVEN OUT THIS SUMMER TO USE COMBINATION
PREVENTION USING SOME COMBINATION OF BEHAVIORAL,
STRUCTURE, CIRCUMCISION AND ANTIVIRAL THERAPY TO STOP THE
SPREAD OF HIV.
THE COMBINATION TRIALS ARE THE WAY OF THE FUTURE.
THIS IS BEYOND MODELLING.
MODELING SAYS WE HAVE TO DO EXPERIMENTS.
THE EXPERIMENT -- THESE WILL BE COMMUNITY RANDOMIZED LARGE SCALE
EXPERIMENTS WHICH WILL TELL US WE CAN DO THIS OR WE CAN'T DO
IT.
IT'S GOING TO BE AN EXCITING TIME IN THE PREVENTION FIELD.
NOW, THIS IS -- I DON'T KNOW IF I CAN GO BACK.
APPARENTLY NOT.
THAT LAST SLIDE WAS A PICTURE OF NEW YORK OF THE COMMUNITY THAT'S
GOING TO PARTICIPATE IN 065.
UNFORTUNATELY AS WE TRY TO USE TREATMENT AS PREVENTION, THERE
ARE INCONVENIENT TRUTHS.
ACUTE INFECTIONS COME UP A BUNCH OF TIMES ALREADY.
I'LL SAY A WORD ABOUT THAT IN A SECOND.
DRUG RESISTANCE IS A BIG ISSUE.
IF WE TREAT MORE AND MORE PEOPLE WE CAN RUN INTO TROUBLE WITH
RESISTANCE AND CONVERT THE EP EPIDEMIC INTO MORE RESISTANT
VIRUSES.
THIS IS ACUTE INFECTION.
THIS IS A WINDOW OF TIME WHEN PEOPLE DON'T KNOW THEY'RE
INFECTED.
ANTIBODY IS NEGATIVE AND AS ANTIBODY BECOMES POSITIVE THE
PROCESS TRANSPIRES.
AS VIRUS GROWS TO HUGE CONCENTRATION THE PERSON IS
RENDERED VERY, VERY CONTAGIOUS.
EACH VIRAL PARTICLE DURING ACUTE INFECTION IS CONSIDERED TO BE
800 TIMES MORE CONTAGIOUS THAN VIRAL PARTICLE FROM SOMEONE WITH
CHRONIC INFECTION.
THERE ARE TWO SOCIAL FORCES.
SO THERE IS A LOT OF CONCERN ABOUT ACUTE INFECTION.
THE QUESTION IS PEOPLE ARE ANTIBODY NEGATIVE DURING ACUTE
INFECTION.
HARD TO FIND.
AND EVEN IF WE FIND THESE PEOPLE, WHAT DO WE TELL THEM?
WHAT DO WE TELL THEM ABOUT THEIR SEXUAL BEHAVIOR AND THUDSHOULD
THEY BE TREATED?
SHOULD WE TREAT PEOPLE DURING ACUTE INFECTION?
THERE'S NO RIGHT ANSWER TO THAT.
THIS IS A GRAPH FROM A PAPER PUBLISHED A FEW WEEKS AGO THAT
SHOWS ESTIMATES OF THE CONTRIBUTION OF SPREAD OF HIV
FROM PEOPLE WITH ACUTE INFECTION TO OTHER PEOPLE.
THE LOWEST YOU GET IS 9%.
GENERALLY SPEAKING.
HIGHEST YOU GET IS FROM OUR STUDY OF 38%.
YOU CAN EVEN GET HIGHER THAN THAT.
WE ARGUE THAT ABOUT ONE IN THREE NEW INFECTIONS COME FROM PEOPLE
WITH ACUTE INFECTION.
THIS KIND OF EMPHASIZES THAT EVEN IF WE FIND ALL PEOPLE WITH
CHRONIC INFECTION, WE STILL HAVE A PROBLEM WITH ACUTE INFECTION.
AND THEN THIS IS A STUDY PUBLISHED GIVING ALL OF THE
IDEAS THAT RELATE TO SHOULD WE TREAT PEOPLE WITH ACUTE
INFECTION?
WE FIND PEOPLE AND WE DON'T DO ANY PREVENTION ACTIVISTSTIES OR
TREAT.
TREATMENT TREATMENT, WHY DO WE WANT TO
FIND THEM?
WE NEED TO GET OUR ACT STRAIGHT ABOUT THIS.
LASTLY, AN ISSUE ABOUT REALITY.
A LOT OF PEOPLE ARE UNAWARE OF THEIR STATUS.
SOME PEOPLE ARE RECEIVING MEDICAL CARE.
SOME ARE GETTING THEIR PILLS.
SOME ARE FULLY DIAGNOSED AND IN VERY EXCELLENT CARE.
NOT IN CARE AND ENGAGED IN CARE BY THIS ARTICLE BY GARDNER.
WHAT'S STRIKING ABOUT THE ARTICLE, THE NUMBERS AREN'T
NECESSARILY 100% CORRECT, ABOUT YOU THEY HAVE VORACITY AND
THERE'S ANOTHER PAPER THAT SAYS THE SAME THING.
IF YOU LOOK AT THE ARGUMENT THAT THIS 1.1 MILLION PEOPLE ARE
INFECTED AND YOU ACCEPT THAT THERE'S 875,000 WHO KNOW THEIR
DIAGNOSIS AND LOOK AT THE NUMBER NOT LINKED TO CARE, IT'S A VERY
LARGE NUMBER NOT LINKED TO CARE OR LET'S SAY LINKED TO CARE IS
660,000.
THEN YOU LOOK AT THE NUMBER WHO REMAIN IN CARE AND ARE FULLY
SUPPRESSED ED SUPPRESSED.
GARDNER ARGUES IT'S ONLY 200 TO 300,000.
IF WE USE TREATMENT AS PREVENTION, HOW CAN THIS WORK IF
THE DENOMINATOR IS 1.1 MILLION AND NUMBER PEOPLE BENEFITING IN
THE RICHEST COUNTRY IN THE WORLD IS ONLY 300,000?
HOW DO WE DO THIS IN AFRICA AND AIRBORNE
ASIA?
WE NEED TO BE REALISTIC.
IT'S REALISM THAT HELPS US TO SUCCEED.
I'M GOING TO END BY SAYING THIS.
30 YEARS LATER I'VE BEEN WORKING ON THIS PROBLEM MY ENTIRE
CAREER.
'80 I SAW MY FIRST PATIENT AND IT'S NOW 2011.
I'M NOT ON THE FAST TRACK.
THIS HAS GONE ON A VERY LONG TIME.
WHAT I CAN SAY 100% FOR SURE IS THIS IS A DIFFERENT PROBLEM THAN
IT WAS 30 YEARS AGO.
THIS IS A TOTALLY DIFFERENT DISEASE AND TOTALLY DIFFERENT
PROBLEM AND TOTALLY DIFFERENT PLANET.
THERE'S NO DOUBT THAT HIV TREATMENT IS AMAZING.
IT PROLONGS LIFE AND WE'RE 100% SURE THAT WE CAN SLOW THE
TRANSMISSION WHEN WE FIND PEOPLE AND OFFER THEM TREATMENT.
THERE'S DOUBLE BENEFIT TO KNOWING YOUR STATUS AND BEING
TREATED.
THE CHALLENGE FOR US IS THE LAST STATEMENT.
TO ASSURE THAT HIV DETECTION THAT ALLOWS KNOWING YOUR STATUS
LEADS TO REMARKABLE PERSONAL AND PUBLIC HEALTH BENEFITS THAT ARE
POSSIBLE.
HOW DO WE AS A HUMAN BEING TAKE ALL OF THIS INFORMATION AND
TRANSLATE IT INTO THE MOST MEANINGFUL THING WE CAN DO FOR
HEALTH OF THE INDIVIDUAL AND HEALTH OF THE PUBLIC?
THANK YOU FOR LISTENING.
[ APPLAUSE ] >> THANK YOU.
NOW WE'LL TAKE QUESTIONS.
>> THERE'S JUST A COUPLE OBSERVATIONS.
FIRST, A QUOTE I'LL USE OFTEN IN THAT IT'S REALISM THAT HELPS TO
SUCCEED.
THANK YOU FOR THAT.
I'LL USE THAT A LOT.
ANOTHER SORT OF OBSERVATION I HADN'T NOTICED BEFORE IS WHILE
DEATHS DECREASED AFTER THE ADVENT OF HIV TREATMENT,
INCIDENTS STABILIZED AT THAT POINT AND I HADN'T NOTICED THAT
BEFORE.
THAT'S THE TIME IT STABILIZED IN '97 AND '98 WHEN WE STARTED
STABILIZING.
BUT IN TERMS OF DIAGNOSTICS AND TESTING IN THE ROLE OF ACUTE
INFECTION, I'M REALLY STRUCK BY THE COMMITMENT WE'VE HAD TO KEEP
THE BLOOD SUPPLY SAFE AND TREMENDOUS EXPENSE TO DO POOL
NAT TESTING FOR A SAFE BLOOD SUPPLY.
I'M CURIOUS WHAT THE IMPORTANCE IS OF DETECTING ACUTE INFECTION
FOR HIGH-RISK PEOPLE AND HOW MUCH TO COMMIT TO DOING THAT?
IT'S KIND OF A TOUGH QUESTION.
IS IT WORTH IT AS MUCH AS IT IS AS BLOOD SUPPLY AND SHOULD WE BE
GOING FOR IT?
>> I THINK BOTH MIKE AND I WILL TRY TO TACKLE THAT QUESTION
ABOUT ACUTE INFECTION.
IT'S NOT ALWAYS EASY WITH BLOOD SUPPLY.
IF YOU DETECT ACUTE INFECTION YOU DON'T TRANSMIT IT AND END OF
STORY.
ACUTE INFECTION AND MIKE AND I DON'T ALWAYS AGREE ON THE
IMPORTANCE BUT IN THE BEGINNING OF THE EPIDEMIC EVERYONE HAS
ACUTE INFECTION.
AND SO OBVIOUSLY IT WAS VERY IMPORTANT TO LOOK FOR IT.
AT CURRENT TIME WHAT WE RECOGNIZE IS THAT ACUTE
INFECTION AND ITS IMPORTANCE IS PROBABLY RELATED TO HOW MUCH OF
IT IS IN WHATEVER POPULATION ISÑi
EXPERIENCING IT.
IN MMWR ARTICLE ON MEN HAVING SEX WITH MEN THAT CAME OUT A
COUPLE WEEKS AGO, WHAT WE RECOGNIZE IS THAT NEARLY 20% OF
THE PEOPLE WHO WERE INFECTED BUT DIDN'T KNOW IT HAD THE TEST
WITHIN THE LAST THREE TO FOUR MONTHS AND WERE TOLD THEY WERE
NEGATIVE.
AND SO I SUSPECT THAT MANY OF THOSE PEOPLE WOULDN'T HAVE BEEN
DETECTED IF WE WERE LOOKING FOR ACUTE INFECTION AND BECAUSE WE
KNOW THAT'S A HIGH INCIDENT GROUP, IT'S PROBABLY VERY
IMPORTANT TO LOOK FOR ACUTE INFECTION.
ON THE OTHER HAND, FIRST OF ALL, IF THE PERSON GETS TESTED IF
THEY'RE INFECTED, WE WANT TO TELL THEM THEY'RE INFECTED SO
DETECTING ACUTE INFECTION WOULD BE IMPORTANT.
PEOPLE WHO FIND OUT THEY ARE IN INFECTED TEND TO CHANGE THEIR
BEHAVIOR AND ARE LESS LIKELY TO TRANSMIT AND IT MAKES A
DIFFERENCE IN TERMS OF EPIDEMIC AND THE BIG QUESTION IS WHETHER
TREATING PEOPLE WITH ACUTE INFECTION MAKES ANY DIFFERENCE
AND THAT IS SO FAR AN UNANSWERED QUESTIONS AND MAYBE I'LL TURN IT
OVER TO YOU AT THAT POINT.
>> THOSE ARE REALLY GOOD QUESTIONS TO BE HONEST.
THERE'S NO RIGHT ANSWER.
THE FIRST THING ABOUT INCIDENTS, WE HAVE A LOT OF TROUBLE --
MICHELLE HAS WORKED FOR MANY, MANY YEARS ON BETTER INCIDENTS
ASSAYS.
WE HAVE TROUBLE UNDERSTANDING NEW INCIDENTS.
IT'S OFTEN CONFUSED BY PEOPLE WHO SHOULD NOT CONFUSE IT.
TRUE INCIDENT CASES WITH HE HAVE A LOT OF TROUBLE WITH.
THE INCIDENTS IN THE UNITED STATES HAS BEEN ESTIMATED A LOT
OF DIFFERENT WAYS AT A LOT OF DIFFERENT NUMBERS OVER THE
YEARS.
I WOULD BE HESITANT AND WE'RE VERY INTERESTED IN REDUCING
INCIDENTS IN THE UNITED STATES BUT GIVEN HOW MUCH TROUBLE WE
HAVE IN MEASURING IT, WE HAVE TO BE VERY CAREFUL ABOUT DECLARING
SUCCESS OR FAILURE.
SO WHAT AM I SAYING?
WHEN I LOOK AT THE SLIDE IN THOSE NUMBERS, I'M NOT 100% SURE
HOW MUCH VARIABILITY THERE IS GIVEN OUR DIFFICULTY IN
DETECTING REALITY.
IN TERMS OF -- WE WOULDN'T DISAGREE.
IT'S VERY STRAIGHTFORWARD IN A SENSE.
PEOPLE WITH ACUTE INFECTIONS NO DOUBT THEY ARE VERY CONTAGIOUS.
THEIR CONTRIBUTION DEPENDS ON HOW MANY THEY ARE AND HOW MANY
SEX PARTNERS THEY HAVE AND HOW LONG THEY REMAIN CONTAGIOUS.
PEOPLE WITH CHRONIC INFECTION UNTREATED WILL ALWAYS OVERWHELM
A NUMBER OF PEOPLE WITH ACUTE INFECTION BUT LESS EFFICIENT IN
THEIR TRANSMISSION.
THEY'LL HAVE OPPORTUNITY TO HAVE MORE SEXUAL EPISODES WITHOUT A
TRANSITION TRANSPIRING.
THEY CAN CREATE A VERY LARGE PROBLEM.
WHAT HAPPENS AS EVERYBODY WOULD RECOGNIZE, EVERYBODY HAS ACUTE
INFECTION AT SOME POINT BUT MOST IS UNRECOGNIZED.
IF YOU LOOK AT COUPLES AND IT ALWAYS TAKES THREE PEOPLE WHEN
WE TALK ABOUT SEXUAL TRANSMISSION.
YOU HAVE A NEGATIVE COUPLE.
THEY ARE MINDING THEIR OWN BUSINESS.
A THIRD PERSON GETS IN THE RELATIONSHIP.
WHEN THAT THIRD PERSON GETS -- THAT'S EXACTLY WHAT HAPPENED.
THE THIRD PERSON -- HOPEFULLY NONE OF YOU ARE SUFFERING THAT.
OUR SPECIES IS CONFOUNDED BY THREE PEOPLE BEING IN A
RELATIONSHIP TOGETHER BUT DON'T KNOW THEY'RE ALL IN A
RELATIONSHIP.
WHEN A THIRD PERSON GETS IN A RELATIONSHIP AND A TRANSMISSION
EVENT OCCURS FROM THE CHRONIC PERSON TO THE UNRECOGNIZING
PARTNER, THEN THE TRANSMISSION EVENT OCCURS VERY QUICKLY TO THE
NEXT PARTNER RENDERING 80% OF COUPLES IN MOST PLACES POSITIVE
AND THAT TRANSMISSION EVENT OCCURS IN THE FIRST FIVE MONTHS
BY ALL ESTIMATES IT OCCURS QUICKLY.
IT EMPHASIZES THE IMPORTANCE OF ACUTE INFECTION.
ONE ARGUMENT WITH BERNIE.
AN ARTICLE THIS WEEK THAT HAS A VERY CHRONIC EPIDEMIC AND WE
CLAIM IN THAT ARTICLE THAT SAYS WE THINK A THIRD OF THE CASES
EVEN IN EPIDEMIC ARE DESCRIBED AS ACUTE INFECTION.
THAT HAS TO DO WITH THESE RELATIONSHIPS.
THESE SEXUAL RELATIONSHIPS.
IT'S A LONG WINDED ANSWER.
I APOLOGIZE.
LASTLY WE DON'T KNOW -- IN TERMS OF RESOURCES, I KNOW OF NO ONE
WHO COULD TELL THE RIGHT WAY TO ALLOCATE RESOURCES BECAUSE YOU
CAN WASTE A LOT OF MONEY TRYING TO FIND A FEW PEOPLE WITH ACUTE
INFECTION OR NOT.
AND THE BLOOD BANKERS SPENT ESTIMATED BY THE YALE PEOPLE IN
THE BEGINNING OF THE EPIDEMIC THAT THEY SPENT $80 MILLION IN
THE LAST EIGHT CASES OR SOMETHING.
VERY FAMOUS PAPER ABOUT WHAT WAS REQUIRED TO MAKE THE BLOOD
SUPPLY SAFE AND IT WAS ABSOLUTELY REQUIRED BUT IT WAS
TERRIFICALLY EXPENSIVE.
IS THAT TRUE, ELLIOTT?
THE LAST EIGHT CASES OR TEN CASES?
>> I DON'T KNOW.
IT'S VERY EXPENSIVE.
>> DO WE HAVE ANY QUESTIONS OUT IN CYBERSPACE FOR THE SPEAKERS?
NO QUESTIONS.
OKAY.
I HAVE A COUPLE OF QUESTIONS.
ACTUALLY, ONE JUST OCCURRED TO ME OFF THE TOP OF MY HEAD AND
YOU WERE ACTUALLY TALKING ABOUT WHEN YOU TALK ABOUT SUCCESS OF
052.
IT WAS GREAT.
IT WAS A VERY CONTROLLED STUDY LIKE YOU SAID.
YOU SAID YOU KNOW PEOPLE ARE ON THERAPY BECAUSE YOU CAN LOOK AT
THEM.
I HAVE A QUESTION THAT HAS TO DO WITH TESTING BUT KIND OF A
DIFFERENT TESTING QUESTION.
HOW VALUABLE DO YOU THINK IT WOULD BE TO HAVE A TEST THAT
COULD RAPIDLY DETECT WHETHER OR NOT SOMEONE IS COMPLIANT WITH
THEIR THERAPY?
SO YOU COULD ACTUALLY TEST -- INSTEAD OF JUST TESTING TO SEE
IF THEY ARE INFECTED BUT ARE THE MEDS PRESENT?
>> I MEAN, 100% FOR SURE A POINT OF CARE RAPID TEST THAT SHOWS
SPIRAL SUPPRESSION IS ONE OF THE HOLY GRAILS OF BOTH TREATMENT
AND PREVENTION.
IT'S EXTREMELY IMPORTANT.
IF IT'S NOT PRESENT, IT MEANS THAT THE PEOPLE ARE ADHERENT AND
THAT THEY HAVEN'T ACQUIRE RESISTANCE.
YOU GET TWO THINGS FOR ONE.
A LOT OF PEOPLE HAVE BEEN WORKING ON THIS FOR A LONG TIME.
THIS HOLY GRAIL DIP STICK TEST.
>> I'M SAYING NOT JUST HIV TEST BUT A TEST THAT CAN TELL YOU IF
THE DRUG WAS PRESENT AS WELL SO BASICALLY A TEST TO MEASURE
COMPLIANCE OF ACTUALLY TAKING DRUGS.
DO YOU THINK IT'S USEFUL?
>> I DON'T KNOW.
WHAT DO YOU THINK?
>> I THINK I AGREE WITH MIKE.
THE MORE IMPORTANT THING IN THE STUDY THAT ULTIMATELY WHAT WE
WANT TO LOOK AT IS WHETHER VIRUS IS UNDETECTIBLE IN PEOPLE.
IF THE DRUG IS THERE BUT VIRUS IS DETECTIBLE THAT DOESN'T HELP
YOU ANSWER THE QUESTION AND AS MIKE WAS POINTING OUT, NOT JUST
THIS IS HOLY GRAIL BUT WE'RE CLOSE.
THERE ARE SEVERAL PROTOTYPES OF POINT OF CARE TEST THAT WILL
LOOK AT WHETHER PEOPLE HAVE DETECTIBLE VIRUS AND THAT WILL
BE THE NEXT GAME CHANGER IN TERMS OF MONITORING THERAPY AND
HELPING TO LOOK FOR PEOPLE WITH ACUTE INFECTION.
>> THIS IS JONATHAN WITH CDC.
THANK YOU FOR WONDERFUL PRESENTATIONS.
ONE OF THE ISSUES, MIKE, THAT YOU HIGHLIGHTED WAS THE FACT
THAT TECHNOLOGICAL INNOVATION HAS PLAYED A LARGE ROLE IN THE
CHANGES WE'VE SEEN OVER THE LAST 30 YEARS IN THE HIV EPIDEMIC BUT
NOT ENOUGH.
FOR EXAMPLE CONDOMS PREVENT HIV INFECTION BUT NOT EVERYONE USES
THEM.
TESTS TO DETECT HIV BECAME AVAILABLE BUT THERE ARE STILL
ONE IN FIVE PEOPLE IN THE UNITED STATES THAT HAVE HIV AND DON'T
KNOW THEY HAVE AND ANTIVIRAL THERAPY IS SUCCESSFUL AT
PROLONGING SURVIVAL BUT NOT EVERYONE IS ACCESSING IT OR
TAKING IT.
I HAVE A QUESTION REGARDING RAPID ANTIGEN TESTS.
THE IDEA THAT WE'LL SOON HAVE IN THE MARKET AVAILABLE TO PEOPLE
SOMETIME IN THE NEXT FEW YEARS A TEST THAT WILL DETECT ANTIGEN AS
WELL AS ANTIBODY VERY CLOSE TO THE TIME OF INFECTION.
MY QUESTION FOR PEOPLE ON THE PANEL IS ONCE THAT TECHNOLOGY IS
AVAILABLE, HOW DO YOU THINK PEOPLE WOULD AND SHOULD USE THAT
TEST TO REDUCE TRANSITION AND ACQUISITION OF HIV?
>> A REALLY GOOD QUESTION.
I THINK IF SUCH A TEST BECOMES AVAILABLE, IT'S REALLY IMPORTANT
AND IT WILL FILTER -- FIRST OF ALL, THERE ARE 36 MILLION PEOPLE
WITH HIV INFECTION LIVING.
THEY ALL HAD ACUTE INFECTION.
THE NUMBER OF PEOPLE THAT KIND OF PRESENT TO A PHYSICIAN OR
HEALTH CARE PROVIDER WITH ACUTE INFECTION IS SMALL.
BUT THEN WHENEVER WE DO THESE RETROSPECTIVE STUDIES EVERY
SINGLE ONE SAYS THAT 90% OF THE TIME OR 93% OF THE TIME WHEN YOU
REALLY QUESTION THE PEOPLE, YOU COULD FIGURE OUT THE DAY THAT
THEY ACQUIRED INFECTION.
THEY WERE SICK.
HAD A FEVER AND RASH AND SO ON AND SO FORTH.
I SUSPECT THAT THIS IS UNKNOWN TO ME.
THIS IS A SUSPICION.
PEOPLE ACTUALLY ARE SICK WHEN THEY HAVE ACUTE HIV INFECTION
WITH A SELF-LIMITED ILLNESS.
I SUSPECT IF WE HAVE THE TEST YOU ARE DESCRIBING AND IT'S
APPROVED BY ELLIOTT AND IT'S IN A PHYSICIAN'S OFFICE, AND I
THINK FOR HIGHER RISK PATIENTS AND FOR GENERAL PATIENTS IT WILL
BE USED PRETTY READILY IN COMBINATION WITH ANOTHER EVENT
THAT WILL TRANSPIRE.
PHYSICIANS WILL BE AWARE THERE'S THIS TEST THEY CAN USE IN A
MODEL-LIKE ILLNESS.
LET ME MAKE SURE YOU DON'T HAVE THIS THING.
RECOGNIZING PEOPLE HAVE ACUTE INFECTION, WE'LL HAVE TO BE
AGGRESSIVE THEN.
THAT LENDS ITSELF TO THE FUTURE.
THERE ARE TWO PARTS OF THE FUTURE.
WE'LL TREAT PEOPLE WITH ACUTE INFECTION.
HOW STRONG WE BELIEVE IT'S A BENEFIT OR NOT, IT WILL HAPPEN
ANYHOW FOR A WHOLE BUNCH OF REASONS.
SECOND, WE'RE NOW INTO THE CURE AIDS WINDOW.
THIS WEEK OR NEXT WEEK THERE WILL BE MANY, MANY MILLIONS OF
DOLLARS, I THINK MAYBE $50 MILLION FOR A CURE AIDS GRANT.
THAT'S GOING TO REALLY GET A LOT OF ATTENTION.
WE'RE REALLY GOING TO TRY TO DO THIS.
EVEN IF WE DON'T CURE AIDS, THE WAY WE APPROACH THE PROBLEM WILL
BE APPLIED TO PEOPLE THAT MAKE HIV DISEASE MORE LIKE CANCER.
REMISSION IF YOU WILL.
THAT WHOLE MOVEMENT WILL FAVOR WHAT YOU JUST SAID.
THAT IS A TEST THAT DOCTORS CAN USE.
I BETTER KNOW THIS BECAUSE THIS PATIENT HAS ACUTE INFECTION
THEY'LL GO INTO THE CURE AIDS WINDOW.
IT'S ALL KIND OF COMING TOGETHER OVER THE NEXT 20 OR 30 YEARS.
THIS IS NOT THE FAST TRACK.
WE'VE BEEN IN THIS 30 YEARS.
THERE'S ANOTHER 30 YEARS AT LEAST IN FRONT OF US.
>> I THINK I HAVE DIFFERENT PERSPECTIVE ON THE QUESTION THAT
YOU'RE ASKING IN THAT I THINK THAT IT IS VERY UNLIKELY IF
SOMEONE MET A PERSON THEY WANTED TO HAVE SEX WITH THEY WOULD RUN
TO THE DOCTOR IN ORDER TO GET A TEST AT THAT POINT IN TIME.
WE HAD -- YOU ARE A DOCTOR SO THAT'S A DIFFERENT SITUATION.
ON FOCUS GROUPS LOOKING AT CONCEPT OF SELF-TESTING SEVERAL
YEARS AGO AND PEOPLE WERE INTERESTED IN DOING THAT.
ONE OF THE RECOMMENDATIONS WAS THEY SHOULD BE SOLD IN TWO
PACKS.
IF YOU WERE GOING TO DO IT BECAUSE BOTH PARTNERS NEED TO BE
TESTED.
BUT AT THAT POINT WHEN THERE WERE ONLY ANTIBODY TESTS
AVAILABLE PEOPLE WERE WORRIED ABOUT THE PERIOD AND PROSPECT
FOR INFECTION AT THAT TIME.
THERE CURRENTLY IS ONE MANUFACTURER THAT HAS APPLIED
FOR APPROVAL OF HOME USE OR SELF-TEST FOR ANTIBODY ONLY AND
PROSPECT YOU ARE RAISING OF AN ANTIGEN ANTIBODY TEST THAT WOULD
DETECT EVERYONE INFECTED EARLY ON WOULD ENLIGHT PEOPLEETGHTEN
PEOPLE ON WHAT ACTIONS TO TAKE TO PROTECT
THEMSELVES SO ASSUMING IT COULD BE DONE AFFORDABLY, PEOPLE COULD
TAKE CONTROL OF THEIR LIVES AND OPPORTUNITY FOR INFECTION.
>> ONE THING WE DIDN'T TALK ABOUT TO ADD TO WHAT BERNIE SAID
ABOUT HOME TESTING AND MUCH MORE BROAD EASY TO USE TEST, THE
PREEXPOSURE DEAL WE HAVEN'T TALKED ABOUT.
THOSE DRUGS WE HAVE THE DRUGS.
WE KNOW THAT THEY WORK AT SOME LEVEL.
WE KNOW CDC IS TRYING TO DEVELOP GUIDELINES OR RECOMMENDATIONS
BUT I THINK FOR SURE WHATEVER THOSE RECOMMENDATIONS END UP
BEING, MUCH MORE FREQUENT TESTING OF PEOPLE WHO CHOOSE TO
GO THAT ROUTE WILL BE ESSENTIAL.
IF YOU TAKE THOSE PILLS AND YOU DON'T TEST YOURSELF OR GET
TESTED VERY, VERY FREQUENTLY, THE CHANCE YOU'LL END UP WITH
RESISTANT VIRUS BECAUSE VERY, VERY HIGH.
I THINK ONE OF THE ISSUES ABOUT MUCH BETTER AVAILABILITY WHETHER
ANTIGEN OR ANTIBODY OR ANTIBODY TESTS THAT IF WE'RE GOING TO USE
PREEXPOSURE EFFECTIVELY, TESTING WILL BE A BIG PART OF IT.
WE REALLY DIDN'T GET INTO THAT.
DO YOU AGREE WITH THAT?
>> AND JUST, ELLIOTT, FROM YOUR PERSPECTIVE, WHAT LEVEL OF
SENSITIVITY AND NEGATIVE PREDICTED VALUE WOULD YOU NEED
OR WOULD FDA NEED TO SEE IN AN ACUTE HIV INFECTION TEST TO
ACTUALLY EVEN ENGAGE WITH DISCUSSIONS ABOUT IT BEING
AVAILABLE TO THE PUBLIC?
>> ARE YOU TALKING ABOUT A HOME USE TEST OR ARE YOU TALKING
ABOUT A PROFESSIONAL USE TEST?
>> PROBABLY HOME USE IS WHERE THE COMPLEXITIES EVOLVE MOST.
>> FOR HOME USE WE'VE ALREADY HAD PUBLIC MEETINGS TO TALK
ABOUT TYPE OF PERFORMANCE THAT WE WOULD EXPECT.
IT WAS A VERY INTERESTING DISCUSSION.
OBVIOUSLY THIS IS A VERY POLITICALLY CHARGED ISSUE.
WE HAVE PEOPLE WHO ARE VERY PASSIONATE ON BOTH SIDES OF IT.
MAKE HOME USE AVAILABLE, DON'T MAKE HOME USE AVAILABLE.
THE ADVISORY COMMITTEE HAS GIVEN US THE GREEN LIGHT OR
RECOMMENDED THAT FDA COULD ACTUALLY PROCEED ALONG THESE
LINES.
HAVING SAID THAT, WE TALKED TO THEM ABOUT PERFORMANCE LEVELS.
CURRENTLY THE PERFORMANCE ACCEPTABLE PERFORMANCE LEVELS
FOR PROFESSIONAL USE RAPID HIV TEST ARE 98% SENSITIVE AND 98%
SPECIFIC AS LOWER BOUND OF THE 95% CONFIDENCE INTERVAL.
TAKING THE STATISTICS OUT OF THE EQUATION WHAT THAT TRANSLATES
INTO IS SENSITIVITY 95% OR GREATER.
THAT'S WHAT WE WOULD EXPECT FOR A PROFESSIONAL USE TEST BE
ANTIBODIES AS THEY CURRENTLY EXIST.
NOW, WHEN WE GOT TO HOME USE SITUATION,Ñi WE HAD PROPOSED
THAT THE LEVELS BE DROPPED TOP 95% AS
THE LOWER BOUND.
THE REASON FOR THAT WAS WE DIDN'T WANT TO PUT TOO HEAVY A
BURDEN ON THE MANUFACTURERS TO DO SOMETHING WHICH WOULD BE MORE
REALISTIC RECOGNIZING ALSO THAT WHEN YOU TAKE A PROFESSIONAL USE
TEST AND PUT IT INTO THE HOME USE SETTING, YOU'RE GOING TO SEE
A DETERIORATION IN PERFORMANCE.
THAT WAS THE RATIONALE.
THERE WAS INTERESTING DISCUSSION AS I MENTIONED WITH THE ADVISORY
COMMITTEE IS ONE PERSON SUGGESTING WE DROP IT TO 90%
BECAUSE OF THE PERCEIVED NEED TO HAVE A TEST LIKE THIS AVAILABLE
BUT THE COMMITTEE DECIDED THAT 90% WAS TOO LOW.
WHERE WE ARE RIGHT NOW IS AT 95% AS LOWER BOUND.
THAT'S GOING TO TRANSLATE INTO HIGHER -- IT WILL BE ABOUT LOW
90s, SOMETHING LIKE THAT.
LOW 99s FOR SENSITIVITY.
THE OTHER INTERESTING THING THAT WE FOUND OUT WHEN WE DID A RISK
ANALYSIS IS THAT WHEN WE CONTACTED OUR COLLEAGUES AT CDC
TO ASK WHO WOULD BE MOST LIKELY TO USE A TEST LIKE THIS, THE
OVERWHELMING MAJORITY OF PEOPLE WHO WOULD BE USING A HOME USE
TEST WOULD BE LOW-RISK PEOPLE.
AND SO WHAT THAT DID WAS PUT EMPHASIS ON THE TEST.
IF YOU HAVE A SLIGHT DROP-OFF ON THE TEST, YOUR POSITIVE
PREDICTED VALUE JUST PLUMMETS.
IT'S LOOKING LIKE IT HAS TO BE VERY, VERY HIGH.
SENSITIVITY SHOULD BE HIGH ALSO BUT WE'RE GOING TO SEE A BIG
IMPACT ON SPECIFICITY.
RIGHT NOW WE'RE ON RECORD AS SAYING 95% IS THE LOWER BOUND
CRITERIA YOU HAVE TO MEET BUT WE'LL WORK WITH OUR RISK PEOPLE
SO PEOPLE UNDERSTAND WHAT THE IMPLICATIONS OF THAT ARE.
>> CAN I ASK YOU A QUESTION?
THE PROBLEM I HAVE FOR THAT AND JOHN MAY WANT TO COMMENT ON THIS
BUT THE PROBLEM I HAVE IS IF THE TEST IS USED LIKE TRADITIONALLY
IT WOULD BE WITH LOW-RISK PEOPLE, I UNDERSTAND IT EXACTLY.
IF IT BECOMES THE PREP TEST AND IT'S USED BY GAY MEN WHO ARE
TAKING PREEXPOSURE MEDICATIONS AND THERE ARE 500,000, THEN 95%
SOUNDS TO ME LIKE A TERRIBLE NUMBER BECAUSE THAT SENSITIVITY
IS WAY TOO LOW BECAUSE YOU'LL FORCE RESISTANCE AND THAT WILL
HAPPEN VERY QUICKLY IF THEY JUST TAKE IT AS PREP.
WOULD YOU RECONSIDER IT?
IF THE TEST IS USED, MAYBE YOU WOULD HAVE TO HAVE TWO DIFFERENT
KINDS OF TESTS.
>> WITH DIFFERENT INDICATIONS PERHAPS.
>> IT WOULD WORRY ME.
95% DOESN'T SOUND RIGHT IF PEOPLE ARE TAKING HIS AND
RETESTING THEMSELVES EVERY MONTH THAT THEY'RE NOT HURTING
THEMSELVES BY TAKING THE PILLS.
>> WE SHOULD TALK ABOUT THIS MORE AND BE PART OF THE GENERAL
DISCUSSION I THINK.
AT THE SAME TIME PART OF THAT DISCUSSION MIGHT INVOLVE LOOKING
AT HAVING DIFFERENT INTENDED USE CLAIMS.
>> INTERESTING IDEA.
THANK YOU.
>> GOOD AFTERNOON.
MY NAME IS BRITTANY HUGHES.
I HAVE A QUESTION FROM AN INDIVIDUAL FOLLOWING THE
DISCUSSION VIA TWITTER.
THEY WANT TO KNOW AS FAR AS HIV TESTING IS CONCERNED, CAN YOU
SPEAK ABOUT WHAT SUPPORT IS AVAILABLE FROM THE INSURANCE
INDUSTRY FOR THE PUBLIC?
>> CAN YOU REPEAT THE QUESTION?
>> THEY WANT TO KNOW, CAN YOU SPEAK ABOUT WHAT SUPPORT IS
AVAILABLE FROM THE INSURANCE INDUSTRY AS FAR AS I HAVEHIV
TESTING IS CONCERNED?
>> THE REGULATIONS FOR THE INSURANCE INDUSTRY IN TERMS OF
PROVIDING SUPPORT TO PEOPLE ARE STATE BY STATE AND STATES HAVE
SPECIFIC REQUIREMENTS IN DIFFERENT PLACES ABOUT WHAT THEY
REQUIRE INSURANCE COMPANIES TO DO AND IN MOST CASES THE
INSURANCE COMPANY WILL ONLY DO WHAT IS REQUIRED FOR THEM IN
TERMS OF HIV TESTING.
THERE ARE CERTAIN STATES THAT BASICALLY SAY YOU ONLY PROVIDE
HIV TEST RESULT IF THE PERSON REQUESTS IT.
AND IN GENERAL THEY DON'T HAVE STRINGENT REQUIREMENTS FOR
PROVIDING SUPPORT TO AN INDIVIDUAL AFTER THEY HAVE BEEN
TESTED WHETHER THEY TEST POSITIVE OR TEST NEGATIVE AS
ALMOST ANY OTHER ENVIRONMENT FOR TESTING DOES PROVIDE.
I THINK THAT AGAIN THAT'S A QUESTION THAT WE CAN'T ANSWER ON
A NATIONAL LEVEL BECAUSE EACH STATE MAKES ITS OWN DECISION
ABOUT WHAT THEY REQUIRE INSURANCE COMPANIES TO DO.
>> HAS THERE BEEN ANY DISCUSSION ON A NATIONAL LEVEL ABOUT
STANDARDS THAT WERE PUT IN PLACE FOR HIV TESTING FOR THE PUBLIC?
>> THERE'S NOT BEEN A DISCUSSION ON A NATIONAL LEVEL BECAUSE WE
CAN ISSUE A RECOMMENDATION BUT WE CAN'T SET A STANDARD OR PUT
IN A REGULATION THE WAY STATES CAN.
CDC LONG ENCOURAGED PEOPLE TO PROVIDE RESULTS AND SUPPORT AT
THE TIME OF RESULTS TO PROVIDE ACCESS TO FOLLOW-UP AS A
RECOMMENDATION AND CERTAINLY THAT RECOMMENDATION WON'T CHANGE
AND THAT APPLIES WHETHER YOU'RE AN INSURANCE COMPANY, A DOCTOR
OR BLOOD CENTER DOING THE SCREENING ACROSS THE BOARD.
>> THANK YOU.
>> HI.
BERNIE, MY QUESTION IS FOR YOU.
AS YOU WERE TALKING ABOUT ADVANCEMENTS IN THE TEST, I
WANTED TO KNOW IF WE WERE TO CHANGE OUR TESTING ALGARRISMS TO
WHAT POINTS WOULD THEY STOP CHANGES IN STATE TESTING?
>> THANKS FOR ASKING THAT QUESTION.
WE'VE ALL BEEN USED TO ONE WAY OF CONFIRMING TESTING WHICH IS
WITH THE WESTERN BLOT AND WE CLEARLY KNOW THAT NOW THAT THE
TESTS ARE A LOT BETTER THAT WE NEED TO DO SOMETHING DIFFERENT
THAN WE HAVE BEFORE.
IT WAS ACTUALLY A QUESTION MICHELLE PROMISED SHE MIGHT ASK
IS WHAT WOULD WE DO.
>> READ YOUR MIND.
>> THANKS FOR DOING THAT.
WHAT CDC IS IN THE PROCESS OF DOING IS LOOKING AT ALTERNATIVES
THAT WILL POTENTIALLY DO A BETTER JOB OF CONFIRMING THAT
WE'LL DO LESS EXPENSIVE JOB OF DOING CONFIRMATION AND WITH
FASTER TURNAROUND TIME IN MOST CASES.
WE HAVE BEEN IN COMMUNICATION WITH A SMALL NUMBER OF STATES
THAT HAVE VERY SPECIFIC REQUIREMENTS IN LEGISLATION.
IN OTHER WORDS, SOME STATES INSISTED YOU CAN ONLY DO WESTERN
BLOT FOR CONFIRMATION AND ILLINOIS JUST CHANGED THEIR
LEGISLATION THIS YEAR IN ORDER TO MAKE IT COMPATIBLE WITH WHAT
CDC RECOMMENDS.
PART OF OUR PROCESS IS TO, NUMBER ONE, RECOMMEND THE ALGRIT
AND THEN STATES TAKE STEPS TO MAKE SURE REGULATIONS ARE
CONSISTENT WITH THE NEWEST REGULATION THAT TAKES ADVANTAGE
OF THE BEST TECHNOLOGY.
>> THANK YOU.
>> DO WE HAVE ANY OTHER QUESTIONS FROM THE AUDIENCE OR
CYBERSPACE?
IT LOOKS LIKE WE'RE RIGHT AT OUR TIME AT 3:30.
IF NO ONE HAS ANY OTHER QUESTIONS, I WANT TO THANK ALL
OF THE PANELISTS AND ALL OF YOU FOR ATTENDING.
THANK YOU.
[ APPLAUSE ] I'M GOING TO SAY ONE LAST THING
AS YOU'RE LEAVING.
PLEASE DON'T FORGET THIS IS A LECTURE SERIES.
THE NEXT ONE WILL ACTUALLY BE ON JULY 14th AND IT'S GOING TO BE
AT MOREHOUSE AND YOU CAN GET MORE INFORMATION ABOUT THAT ON
THE 30th ANNIVERSARY