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TODAY'S CLINICAL CENTER GRAND
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CONCLUSION OF THE PRESENTATION.
TODAY WE ARE HONORED TO HAVE AS
OUR SPEAKER DR. JEANNE,
MARRAZZO, DIRECTOR OF THE
PHYSICIAN SCIENTIST, INFECTIOUS
DISEASE SPECIALIST.
DR. MARRAZZO, EARNED HER
BACHELOR ARTS FROM RAD CLIFF
UNIVERSITY, MEDICAL DEGREE FROM
JEFFERSON MEDICAL COLLEGE AND
COMPLETE RESIDENCY IN INTERNAL
MEDICINE AT YALE NEW HAVEN
HOSPITAL.
UPON HER TRAINING HE COMPLETED
FELLOWSHIPS AT THE UNIVERSITY OF
WASHINGTON AND A FELLOWSHIP IN
STD, HIV PREVENTION PUBLIC
HEALTH AND EPIDEMIOLOGY AT THE
CENTERS FOR CONTROL AND
PREVENTION AND LATEERA THE
UNIVERSITY OF WASHINGTON.
DR. MARRAZZO, BEGAN HER CAREER
AT THE UNIVERSITY OF WASHINGTON
RIDING TO BECOME PROFESSOR OF
MEDICINE AND INFECTIOUS
DISEASES, BEFORE JOINING FACULTY
HER SCHOOL OF MEDICINE AT
ALABAMA, AND ENDOWED SHARE AND
DIRECTOR OF INFECTIOUS DISEASES
IN 2016.
IN TWEMENT 23, SHE WAS SELECTED
AS THE SIXTH DIRECTOR AT THE
NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES.
THE JOURNAL OF SCIENCE WRITES
THAT DR. MARRAZZO, HAS
ESTABLISHED HERSELF AS AN TREND
SETTER, AND SHE LEADS PILLS AND
VAGINAL GELS TO PREVENT
INFECTION IN WOMEN.
SHE'S A NATIONALLY RECOGNIZED
STD, PUBLICATIONS, AND
UNDERSTANDING THE VAGINAL
MICROBIOME STD INFECTIONS AND
HIV PREEXPOSURE PROPHYLAXIS AND
SHE'S HELD LEADERSHIP ROLES IN
THE HIV PREVENTION TRIALS
NETWORK AND INFECTIOUS DISEASE
CLINICAL RESEARCH CONSORTIUM.
A DISTINGUISHED SCIENTIST,
CLINICIAN AND SCIENTIFIC
COMMUNICATOR, DR. MARRAZZO IS A
FELLOW OF THE AMERICAN COLLEGE
OF PHYSICIANS AND FELLOW OF THE
INFECTIOUS DISEASES SOCIETY OF
AMERICA AND IS A LEADING VOICE
AND WAS A LEADING VOICE IN
COMMUNICATING SCIENCE DURING
COVID-19 PANDEMIC.
THE TITLE OF HER PRESENTATION
TODAY IS CHEMO PROPHYLAXIS OF A
SEXUALLY TRANSMITTED INFECTIONS
IN HIV.
NOW PLEASE JOIN ME IN WELCOMING
OR SPEAKER DR. MAREFRESH -- MA.
>> THANK YOU VERY MUCH FOR THAT
KIND INTRODUCTION AND THANK YOU
TO ALL OF YOU FOR BEING HERE
TODAY BOTH IN-PERSON AND ONLINE.
SO WHEN DR. BURKLOW, ASKED ME TO
GIVE THIS PRESENTATION, HE
INITIALLY ASKED ME TO TALK ABOUT
DOCKS PSYCHE LYNN PROVE EXPOSURE
PROPHYLAXIS WHICH MANY OF YOU
KNOW OR WILL FIND OUT SOON WAS
RECENTLY FORMALLY RECOMMENDED BY
THE CENTERS FOR DISEASE CONTROL
FOR THE PREVENTION OF CERTAIN
STIs WHICH I WILL TALK ABOUT.
I CAN'T THINK THERE WAS REALLY
ENOUGH TO TALK ABOUT WITH
DOXY-PEP FOR A WHOLE HOUR.
SOME OF YOU MAY ARGUE WITH THAT.
MAYBE IT'S MY DESIRE TO TALK
ABOUT SOME OF THE REALLY
EXCITING THINGS IN HIV
PREVENTION, BUT I KEICIDED TO
BROADEN IT A LITTLE BIT TO TALK
ABOUT SOME OF THE MOST RECENT
ADVANCES IN HIV PREVENTION.
AND REALLY THE COMMON THREAD
HERE IS THAT WE DON'T HAVE
VACCINES FOR ANY OF THESE
CONDITIONS, RIGHT?
THE ONLY VACCINE THAT WE HAVE
FOR SEXUALLY TRANSMITTED INFECTS
BESIDES HEPATITIS B IS HUMAN
PAPILLOMA VIRUS AND THAT'S BEEN
A RESOUNDING SUCCESS DESPITE THE
FACT THAT MANY PEOPLE REMAIN
UNVACCINATED FOR HPV.
SO WITH THAT, LET ME GO AHEAD
AND GET STARTED.
I WOULD LOVE TO HAVE THIS BE
MORE INTERACTIVE, SO IF PEOPLE
HAVE QUESTIONS OR THOUGHTS,
PLEASE JUMP IN, I DON'T HAVE ANY
CONFLICT ANDS I WILL DISCUSS
DOXYPEP WHICH DESPIED CDC
GUIDANCE IS NOT FDA APPROVED,
THAT'S NEVER STOPPED ANYBODY
FROM PRESCRIBING IT BUT JUST TO
LET YOU KNOW ABOUT THAT.
AND THE OBJECTIVE TO LOOK AT A
CURRENT OVERVIEW OF THE PREAND
POST EXPOSURE OF PROPHYLAXIS IN
HIV AND STD, AND ESPECIALLY IN
THE RECENT PURPOSE RESULT WHICH
MANY OF YOU HAVE HEARD OF AND
FOR INCREASING SUPPORT, BUT SOME
CAVEATS FOR DOXY-PEP I HAVE TO
SAY I WAS A DOXY-PEP PEP
SKEPTIC, I AM A CAUTIONARY
SUPPORT I REALLY OF DOXY-PEP AND
DR. BENNETT MAY TOLD ME HE FEELS
THE SAME BECAUSE HE TOLD ME HE
HAS QUESTIONS SO I WILL GET HIS
OPINION AS WE MOVE INTO THIS.
THE QUESTION IS WHY ARE WE IN
THIS STATE?
AS I THINK MANY OF YOU HAVE
HEARD ME SAY BEFORE, WE ARE
LOSING THE WAR AGAINST SEXUALLY
TRANSMITTED INFECTIONS WHETHER
YOU'RE TALKING ABOUT VIRAL OR
BACTERIAL, SEXUALLY TRANSMITTED
INFECTIONS AND THE WHO 2024
REPORT IS A VERY NICE IF
SOBERING COMPENDIUM OF WHERE WE
ARE WITH THESE INFECTIONS, I WAS
REALLY SURPRISED TO SEE THAT IN
2022, THERE WERE 220,000 CIVILIS
ASSOCIATED DEATHS.
IF YOU HAVEN'T SEEN A CIVILIS
ASSOCIATED DEATH, I WOULD
ENCOURAGE YOU TO THINK ABOUT
THINGS LIKE NEUROSYPHILIS WHICH
OFTEN GOES UNDIAGNOSED
UNFORTUNATELY, ALSO CONGENITAL
SYPHILIS WHICH I WILL SHOW YOU
DATA ON IN A MINUTE WHICH IS
REALLY SOBERING, SO A REALLY
STAGGERING COST, AND IF YOU LOOK
AT THE 4 CURABLE STIs THAT WE
THINK ABOUT FREQUENTLY,
SYPHILIS, GONORRHEA, CHLAMYDIA,
AND TRICK MONITOR SIS, AND ALL
WHICH ARE MAINLY CURABLE OFTEN
WITH A SINGLE DOSE OF AN
ANTIBIOTIC, THERE ARE OVER
1 MILLION INFECTIONS DAILY.
WE HAVE NOT CHANGED THIS SINCE
THE DAYS I BEIMAN MY FELLOWSHIP,
MANY, MANY YEARS AGO.
SO IT REALLY HAS BEEN A -- I
WOULD SAY A NEGLECTED FIELD,
RELEVANT TO THE INVESTMENTS IN
HIV, BUT WE'RE SORT OF PAYING
THE PRICE FOR IT NOW.
THE OTHER PROBLEM WITH GONORRHEA
IN PARTICULAR AND I WILL SHOW
YOU DATA ON THIS IS INCREASING
ANTIMICROBIAL RESISTANCE.
AND OF COURSE, THE HIV
SITUATION, IS REALLY NOT THAT
MUCH BETTER DESPITE SOME OF THE
PROMISES THAT I'M GOING TO TALK
ABOUT, WE STILL HAVE OVER
1.3 MILLION NEW INFECTIONS OVER
A YEAR, OVER 630,000 DEATHS AND
OF COURSE THOSE OF YOU WHO DO
CLINICAL WORK HERE KNOW WHO
THESE NEW INFECTIONS ARE,
THEY'RE OCCURRING IN VERY
VULNERABLE POPULATIONS WHO OFTEN
DON'T HAVE ACCESS TO SOME OF THE
BEST PREVENTIVE MEASURES,
LARGELY BECAUSE OF FINANCIAL
ISSUES, IMMIGRATION ISSUES,
STIGMA ISSUES, LOTS OF THINGS
THAT INFORM INABILITY TO GET
CARE AND JUST A REMINDER,
SEXUALLY TRANSMITTED VIRAL
HEPATITIS NOT TO BE DISCOUNTED
DESPITE THE FACT THAT WE HAVE A
VERY EFFECTIVE VACCINE FOR HEAP
TITIS B, WE STILL HAVE
1.3 MILLION DEATHS ASSOCIATE
WIDE VIRAL HEPATITIS A YEAR, AND
OF COURSE WE HAVE A CURATIVE
REGIMEN FOR HEPATITIS C.
I MENTIONED THE PROBLEM WITH
SYPHILIS, ANYBODY SEEN A CASE OF
CONGENITAL SYPHILIS IN THIS
ROOM, IF YOU HAVE RACE YOUR
HANDS, OKAY, SO NOT SO MUCH
HERE, I SAW A CASE IN LIMO,
ACTUALLY IN KUSCO, PERU NOT TOO
LONG AGO BUT BEFORE WE I LEFT
ALABAMA WE HAD 22 CASES FROM THE
YEAR I LEFT AND THAT WENT UP
FROM HAVING 0 EXPW WE WENT FROM
HAVING 335 CASES IN 2012 TO OVER
3700 LAST YEAR.
THIS WAS ACCOMPANIED BY
APPROXIMATELY 270 KNOWN FETAL
DEATHS TUE TO THIS INFECTION.
AND WHEN YOU LOOK AT WHY THIS IS
OCCURRING, IT'S NOT JUST DUE TO
AN INABILITY TO MAKE THE
DIAGNOSIS CORRECTLY, IT'S ALSO
DUE TO INCORRECT TREATMENT, AND
THERE'S A VERY NICE OVERVIEW ON
THE CDC WEBSITE THAT DEALT INTO
THE REASONS FOR THIS WHICH RANGE
FROM VERY DISENFRANCHISED PEOPLE
WHO DON'T ACCESS PRENATAL CARE
PARTICULARLY IN NATIVE AMERICAN
AND AMERICAN INDIAN POPULATIONS,
THE INCIDENCE IN THAT GROUP IS
OVER 4
TIMES RELATIVE THAT TO OTHERS.
SO THIS A PROBLEM THAT GETS AT
ALL THE VULNERABILITIES OF OUR
HEALTHCARE SYSTEM IN THE UNITED
STATES.
THE SIN DEMICS OF LACK OF
INSURANCE, LACK OF ACCESS,
SUBSTANCE USE, MENTAL HEALTH,
AND A LACK OF REPRODUCTIVE
HEALTHCARE, FRANKLY, O IT'S A
REALLY, REALLY BIG CHALLENGE.
NOT GOING TO TALK ABOUT THAT
MUCH TODAY, BUT I DON'T WANT TO
LET IT GO BY TO POINT OUT THAT
WE DO HAVE A LOT GOING ON IN
THIS SPACE AND IF YOU HAVE SEEN
OUR RECENT PRESS RELEASE FROM
DMID, WE ANNOUNCED SEVERAL
EFFORTS INCLUDING SOME RAPID
POINT OF CARE DIAGNOSTIC
STUDIES.
THOSE OF YOU WHO DO CONSULTS,
SPECIALLY IN THE HIV CARE
SETTING, KNOW THAT SOME OF THE
THORNIEST PROBLEMS YOU GET ON
INTERPRETATIONS OF CIVILIS
SERIES POINTSOLOGYYS, HOW DO YOU
HANDLE SYPHILIS SERIES
POINTSOLOGYS, IS SOMEBODY REALLY
CURED?
DOES SOMEONE HAVE SYPHILIS?
ALL OF THESE ARE THE SAME
PROBLEMS BECAUSE WE'RE DEALING
WITH THE SAME SEROLOGIC TEST
WHEN I WAS A FELLOW.
YTION, THERE ARE BETTER WAYS TO
DO IT, YOU YOU HAVE THE ENZYME
IMOWN O ASSAY, BUT REALLY YOU'RE
STILL DEALING WITH LOOKING AT
THE SAME ANTIIENS AND SAME
CHALLENGES, SO HOPEFULLY WE WILL
BE ABLE TO GET SOME NEW
THOUGHTS, NEW IDEAS AND GET
THINGS OUT THERE, AND IF YOU TRY
TO DIAGNOSE CONGENITAL SYPHILIS,
THAT'S A REAL CHALLENGE, IF YOU
LOOK AT THE FLOW CHART TO DO IT,
YOU DON'T WANT TO GO NEAR IT,
IT'S VERY CONFUSING.
SO CIVILIS IS A BIG PROBLEM,
GONORRHEA IS A VERY BIG PROBLEM,
40% INCREASE IN THE EU, NATIONS
OVER IN 2021 FROM 2022, AND THE
RESISTANCE PROFILES CONTINUE TO
BE VERY ALARMING.
SWRIGHT ROUGH ATOM MICEIN YOU
MAY RECALL AS 2012 WAS ADDED AS
AN ADDITIONAL THERAPY FOR
GONORRHEA, IT WAS ADDED TO
SIEVEULOUS FOREIGN, THE THINKING
THERE WAS THAT IT WOULD
FORESTALL SOME ANTIMICROBIAL
RESISTANCE AND AT THE TIME WE
THOUGHT IT WAS MAGICAL THINKING
AND IT WAS BECAUSE WHAT HAPPENED
OF COURSE WAS THAT YOU ENDED UP
DEVELOPING MORE SWRIGHT ROUGH
ATOM MICEIN RESISTANCE AND IN
PARTICULAR, IN PHARYNGIAL
ISOLATES WHICH KIND OF MAKES
SENSE.
SO WE NOW ARE LOOKING AT ABOUT A
QUARTER OF ISOLATES BEING FULLY
RESISTANT TO 2 SWRIGHT ROUGH
ATOM MICEIN, CIPROFLOCKS SIN CAN
NOT BE USED THERE ARE NO QUINA
LONES, IT'S A HIGH RATE OF
RESISTANCE AND NOTABLY
RESISTANCE IS MUCH HIGHER IN MEN
WHO HAVE SEX WITH MEN.
WE CAN TALK ABOUT THAT IF WE
HAVE TIME, IT'S NOT REALLY CLEAR
WHY THAT IS, THERE'S SOME
THINKING THAT THERE MAY BE A
HIGHER PREVALENCE OF PHARYNGIAL
GONORRHEA IN THAT GROUP AND THAT
THE ABILITY FOR PLASMA
EXCHAIRVELG TO OCCUR WITH
COMMENSAL GONORRHEA -- SORRY
COMMENSAL NISERIES POINTSIOUS
SPECIES MAY BE EXPOSED TO THAT.
FORTUNATELY RESISTANCE TO
CFIXIME REMAINS LOW, WE HAVE 1
POPULATION WE CAN USE AT .3% BUT
WELL IS CONTINUED DETECTION OF
OCCASION CEFTRIAXONE RESISTANCE
AND I WILL SHOW YOU THAT IN A
COUPLE SLIDES IN A SECOND EMPLOY
SO LET'S SHIFT TO THINKING ABOUT
HOW YOU MIGHT USE DOXY-PEP
PSYCHE LYNN FOR SOMETHING LIKE
SYPHILIS, GONORRHEA AND
CHLAMYDIA, WHEN WE TARTED
TALKING ABOUT DOXY-PEP PSYCHE
LYNN, THE BIG SPRRN WAS THAT WE
WERE GOING TO DRIVE THE INCREASE
IN EABT BI ATTIC RESISTANCE IN
GONORRHEA SIMPLY BY GETTING THIS
OUT THERE A BIT MORE.
PEOPLE HAD BEEN VERY INTERESTED
IN TRYING TO FIGURE OUT IF
THAT'S WHAT'S GOING ON.
THIS IS SOME UNPUBLISHED WORK BY
[INDISCERNIBLE] IN SEATTLE, HE
RUNS THE GONORRHEA LAB THERE AND
WHAT HE HAS SHOWN IS THAT IN MEN
WHO HAVE SEX WITH MEN AT LEAST
BEING SEEN IN SEATTLE COUNTY
CLINICS WHERE DOXY-PEP HAS BEEN
INTRODUCED, THERE HAS BEENA AN
INCREASE IN HIGH LEVELS OF
TETRAPSYCHE LYNN RESISTANCE AND
INDEED THAT THIS RESISTANCE WAS
HIGHER AMONG PEOPLE WHO WERE
USING DOXY-PEP.
THESE ARE NOT REALLY NATIONALLY
VALIDATED YET, BUT I THINK THIS
IS AN EARLY SIGNAL, THAT WE'RE
JUST GOING TO HAVE TO BE VERY,
VERY CAREFUL AS THIS ROLLS OUT.
AND ALSO, WE NEED TO,A SUM THAT
DOXY-PEP WILL NOT WORK FOR
GONORRHEA AND THAT WILL CONTINUE
TO BE A BIG PROBLEM WHICH IS WHY
WE NEED TO CONTINUE THAT WORK ON
NEW ANTIBIOTICS, JUST A COUPLE
COMMENTS ABOUT THIS, IT'S
SOMETHING YOU MAY HAVE HEARD
ABOUT, THIS WAS A NEW IN CLASS
GIVING--YOU RACE INHIBITOR THAT
NIAID ESSENTIALLY BANK ROLLED
THE FIRST DEVELOPMENT PHASES OF,
SO PRECLINICAL WORK, PHASE 1,
PHASE 2, AND MOVE TO PHASE 3
TRIAL INTO U.S. AND
INTERNATIONAL SITES IN
PARTNERSHIP WITH GUARD P.
SO A REALLY GREAT WAY TO GET A
DRUG OUT THERE THAT REALLY HAS
NO COMMERCIAL MARKET.
YOU KNOW YOU ARE NOT GOING TO BE
RETIRING OFF THE PORTFOLIO
SHARES OF YOUR GONORRHEA DRUG,
SO IT'S REALLY IMPORTANT TO FIND
WAYS TO GET THESE DRUGS STUDIED
AS IS THE CASE FOR MANY OF THE
DRUGS WE NEED TO DEVELOP FOR
NEGLECTED DISEASES.
WHY ARE WE REALLY CONCERNED THAT
WE FIND THESE DRUGS, WELL, AS I
JUST MENTIONED LAST SEPTEMBER,
SO LAST MONTH, IN FRANCE, THERE
WERE 4 CASES OF EXTENSIVELY DRUG
RESISTANT GONORRHEA, THIS IS THE
FIRST TIME THAT FRANCE HAS
REPORTED ISOLATES THAT WERE
HIGHLY RESISTANT TO SWREGHT
ROUGH ATOM MICEIN AND CLEARLY
RESISTANT TO SIEVE LAXON, THESE
WERE TREATED WITH ANTIBIOTICS
AND DID OKAY, BUT THESE
INDIVIDUALS ACTUALLY HAD NOT
TRAVELED WHICH IS NOT TERRIBLY
SURPRISING GIVEN SORT OF SEXUAL
PARTNERSHIPS, SEXUAL COMMERCE,
SO WE NEED TO HAVE THESE DRUGs
AS A BACK UP ESPECIALLY BECAUSE
WE WILL RELY ON DOXY-PEP.
OF COURSE THE ULTIMATE SOLUTION,
I THINK WILL BE TO HAVE A
VACCINE.
THE QUESTION IS, WHAT IS THAT
VACCINE GOING TO LOOK LIKE IN
GONZALEZRY ISA A VERY TRICKY
PATHOGEN BECAUSE IT DOESN'T
INDUCE -- PROTECTIVE HUMAN
IMMUNITY.
IT DOESN'T INDUCE A MUCOSAL
IMMUNE RESPONSE TO, SOME EXTENT
IT INUSE DUCES A SYSTEMIC
RESPONSE BUT IT'S BEEN HARD TO
CHARACTERIZE THIS,
[INDISCERNIBLE] HAS HAD A HUMAN
GONORRHEA MODEL FOR MANY YEARS
AT THE UNIVERSITY OF NORTH
CAROLINA, MARSHAL HOPS IS,
WOOING ON THAT NOW AND THAT
LEDITOUS A LOT OF INSIGHTS ABOUT
WHAT HAPPENS WHEN YOU INFECT THE
MALE URETHRA WITH THIS BUG BUT
IT'S BEEN VERY HARD TO FIGURE
OUT HOW YOU CAN DO THAT IN A WAY
THAT ILLICITS LONG STANDING
IMMUNITY.
WHAT GOT US A LITTLE EXCITED
ABOUT THE POSSIBILITIES HERE,
WAS THE EMERGENCE OF THE GROUP B
MENING COCKAL VACCINE THAT CAME
OUT IN THE MIDEARLY 2010S, AND
SOME OF YOU MAY KNOW WHO WORKED
ON THIS WHEN HE WAS AT GSK, AND
HE USE THE WHOLE CONCEPT OF
RIVERS VACNOLOGY WHICH WE KNOW
NOW ARE VERY INTENTLY USING TO
INTERROGATE THE RESPONSE TO
PATHOGENS TO LOOK AT WHAT WOULD
CONFER PROTECTION TO GROUP B
MENING CAUCUS AND MOW YOU COULD
MAKE A VACCINE THAT WOULD DO
THIS BECAUSE OF CORS WE DIDN'T
HAVE 1, WE HAD ACY, ET CETERA,
AND THIS VACCINE HAS PROVEN TO
BE EFFECTIVE IN AT LEAST IN THE
MENING COCKAL WORLD.
IT TURNS OUT THAT THE MAIN
CONCOMPONENTS OF THIS VACCINE
HAVE PROFOUND SEQUENCE
SIMILARITY TO GONOCOCCALL
MONOLOGUES, AND IF YOU DO THESE
SPRMS CAN YOU MODEL AN IMMUNE
RESPONSE IN PEOPLE AGAINST
GONORRHEA.
THIS WAS FIRST SIGNAL INDEED
EPIDEMIOLOGIC STUDIES WHERE
PEOPLE LOOKED BACK AT
POPULATIONS THAT HAD GOTTEN
TREATED WITH PROTECTIVE MENING
COCCALL VACCINE AND SHOWED THAT
SUBSEQUENTLY THEY HAD LOWER
LIKELIHOOD OF GONORRHEA.
SO WE'RE JUST POINTING OUT THIS
STUDY THAT'S BEING DONE BY DMID,
TO BE CLEAR I WAS INVOLVED WITH
THE STUDY BEFORE I CAME TO NIH,
THIS IS A TODAY THAT IS GOING TO
BE LOOKINGA THE EFFICACY OF THIS
VACCINE FOR PREVENTION OF
GONORRHEA, AND THE ENROLLMENT
NOW STANDS AT OVER 23,000
PARTICIPANTS AND VERY HOPEFUL
THAT WE WILL SEE A SIGNAL HERE.
THE POINT OF THE EDITORIAL THAT
MIKE COHEN AND I WROTE WAS THAT
WE PROBABLY DON'T NEED A PERFECT
VACCINE TO HELP US OUT HERE.
IF YOU MODEL THE EFFICACY OF A
VACCINE AND IT'S EFFECT ON
SPREAD OF GONORRHEA, YOU
PROBABLY ONLY NEED SOMETHING IN
THE RAINCHL OF 30-50% IF YOU CAN
WIELD IT IN PEOPLE WHO ARE THE
MOST EFFICIENT TRANSMITTERS AND
THAT'S THE MOST INTERESTING
THING ABOUT STD VACCINES, IT'S
NOT A TYPICAL VACCINE, NOT A
TYPICAL ADULT VACCINE, YOU HAVE
TO THINK ABOUT WHO YOU ARE
TRYING TO ATTRACT AND WHO'S
LIKELY TO TRANSMIT AND THAT
REQUIRES SOPHISTICATED MODELING.
SO IT BRINGS TOGETHER A LOT OF
PEOPLE.
SO THE NICE CONCLUSION OF THIS,
THE EDITORICAL WHICH COMMENTED
ON THE PAPER THAT LOOKEDDA THE
THIS MODEL WAS AGAIN, EVEN IF WE
HAD SOMETHING WITH EFFICACY, WE
COULD BUY SOMETIME AND AT THIS
POINT, I THINK WHAT WE REALLY
WANT TO DO IS BUY SOME TIME
UNTIL WE GET MORE APPROPRIATE
CANDIDATES FOR VACCINE.
AND JUST TRANSITIONING TO
DOXY-PEP, THAT'S HOW I SEE
DOXY-PEP PEP.
I SEE DOXY-PEP AS A BUYER OF
TIME UNTIL WE CAN GET -- WE CAN
GET A GOOD VACCINE FOR SOME MUCH
THESE THINGS THAT REALLY AFFECT
OUR COMMUNITIES.
COMMENT ABOUT WOMEN BECAUSE I'M
GOING TO TALK ABOUT DOXY-PEP
LARGELY IN THE CONTEXT OF MEN
AND I WILL REMIND YOU THAT THE
CDC, IN -- FOR THOSE WHO DON'T
KNOW, IT'S STUDY SAYS OF MEN WHO
HAVE SEX WITH MEN AND STUDIES
SHOW THAT WILL REDUCE THE
INCIDENCE OF GONORRHEA, SORRY
CHLAMYDIA AND GONORRHEA BY
SEIVET%, SO PEOPLE WERE EXCITED
TO LOOK AT THIS IN WOMEN.
WOMEN HAVE A HIGH INCIDENCE OF
CURABLE STIs, THESE ARE DATA
AGAIN FROM THE W. H. O. REPORT
IN 2024.
THERE WAS A FAIR AMOUNT OF
EXCITEMENT THAT THIS MAY BE A
POPULATION THAT COULD BENEFIT
FROM DOXY-PEP.
UNFORTUNATELY, THERE WAS A STUDY
IN THE NEW ENGLAND JOURNAL THAT
I WROTE ABOUT IT LAST DECEMBER
SHOWING THAT IN A RANDOMIZED
CONTROL TRIAL OF WOMEN IN KENYA,
DOXY-PEP RELATIVE TO PLACEBO
GIVEN IN THAT DOSAGE I MENTIONED
HAD NO EFFECT ON THE INCIDENCE
OF CHLAMYDIA, SYPHILIS OR
GONORRHEA.
I FOUND THAT TRIAL TO BE -- I
DON'T WANT TO BE TOO, TOO
NEGATIVE BUT I FOUND THE TRIAL
TO BE INSUFFICIENTLY THOUGHTFUL
ABOUT ITS DESIGN, I WOULD SAY.
NO SOT MUCH ITS EXECUTION, IT'S
WELL DONE, BUT WHAT THE TRIAL
DID ESSENTIALLY WAS TO TAKE AN
INTERVENTION THAT WAS
ESSENTIALLY DESIGNED TO PREVENT
STIs IN A POPULATION WHO HAD
VERY FREQUENT SEX AND REALLY
WANTED TO HAVE SAFE SEX IN THE
CONTEXT OF HIV PREEXPOSURE
PROPHYLAXIS, I. E. WITHOUT
CONDOMS AND NOT GET STIs, AND
THEN TRANSFER THAT TO A
POPULATION OF WOMEN IF KENYA,
CISGENDER WOMEN AND USE THE SAME
PRODUCT FOR ESSENTIALLY WHAT WAS
ASSUMED TO BE THE SAME BENEFIT.
SO I'LL LET YOU THINK ABOUT THAT
A LITTLE BIT.
I THINK THAT WHEN THINK ABOUT
DOXY-PEP, REALLY AGAIN, IT WAS
THOUGHT ABOUT IN THE CONTEXT OF
HIV PEP WORKS SO WELL,
PREEXPOSURE PROPHYLAXIS AND OF
COURSE IT'S PERRY EXPOSURE
PROPHYLAXIS YET WE WERE SEEING
SUCH INCREDIBLY HIGH RATES OF
STIs, WHAT WERE WE GOING TO DO
ABOUT THAT, RIGHT?
SO WE FIGURED OUT HOW TO REDUCE
HIV INFECTIONS IN MEN WHO HAVE
SEX WITH MEN, AND NOW, WHAT ARE
WE GOING TO DO ABOUT THE VERY,
VERY HIGH RATES OF STIs THAT
WE'RE SEEING.
SO THAT WAS WHERE DOXY-PEP CAME
IN.
SO WHAT I ARGUED IN THIS
EDITORIAL WAS THAT IT'S REALLY
TIME TO STOP THINKING ABOUT
WOMEN AS KIND OF A ME TOO
POPULATION AND THAT'S EXACTLY
WHAT I THINK THAT STUDY DID.
THEY REALLY DIDN'T ACCOUNT FOR
WHY WOMEN MIGHT WANT TO PREVENT
STIs, DID WOMEN KNOW WHAT
STIs THEY WERE GETTING.
NINETY% OF THE CHLAMYDIA IN
WOMEN IS ASYMPTOMATIC, SO WHEN
YOU LOOK AT KNOWLEDGE OF
CHLAMYDIA AND KNOWLEDGE OF THE
CONSEQUENCES PARTICULARLY IN
NEEZ POPULATIONS, IT CAN BE
VERY, VERY LOW.
SO LOTS OF THINGS THAT THINK
ABOUT.
THAT SAID, DESPITE ALL MY
SKEPTICISM, DESPITE ALL MY NOT
NECESSARILY NEGATIVITY, BUT
CAUTIOUS, I THINK IT'S PRETTY
CLEAR THAT DOXY-PEP IS HAVING AN
EFFECT.
THESE ARE DATA THAT WERE SHOWN
AT [INDISCERNIBLE] LAST YEAR AND
OUR -- ABOUT TO COME OUT VERY
SOON IN A MAJOR JOURNAL AGAIN
WITH AN EDITORIAL THAT YOU MIGHT
FIND OF INTEREST.
AND WHAT THIS IS SHOWING IS THAT
IN SAN FRANCISCO WHICH EMBRACED
DOXY-PEP GUIDELINES VERY EARLY
MUCH TO THE DISMAY I WOULD SAY
OF OTHER COUNTIES INCLUDING
SEALT WHICH DID NOT GO THIS
ROUTE BECAUSE THEY WERE
CONCERNED ABOUT A LACK OF
EVIDENCE AND ALSO INCREASING
TETRAPSYCHE LINE RESISTANCE IN
GONORRHEA, WHAT THE INVESTIGATOR
SHOWED AT CROI THIS YEAR WAS
THAT OVER THE COURSE OF ABOUT A
YEAR OF MAKING DOXY-PEP
AVAILABLE IN THE SAN FRANCISCO
STD CLINICS THAT THERE WAS A 51%
DECREASE IN EARLY SYPHILIS, A
50% DECREASE IN CHLAMYDIA AND
SURPRISE, NO DECREASE IN
GONORRHEA.
SO THIS IS REALLY THE FIRST REAL
WORLD EVIDENT THAT WE HAVE IN A
COMMUNITY BASED SETTING AND IT'S
REALLY A TESTAMENT TO I THINK
THE ROBUST NATURE OF PUBLIC
HEALTH PROGRAM IN SAN FRANCISCO,
TO SHOW THAT YOU CAN ACTUALLY
IMPACT POPULATION BASED
INCIDENCE OF DISEASE.
INTERESTINGLY ENOUGH, THE
MAGNITUDE OF THE DECLINES IN
BOTH OF THESE INFECTIONS IS VERY
SIMILAR TO WHAT WAS SHOWN IN THE
RANDOMIZED CONTROL TRIALS IN
FRANCE AND IN THE U.S. WHICH WAS
AROUND 50-70%.
SO I THINK THIS WAS VERY
ENCOURAGING.
I THINK THE QUESTION IS REALLY
GOING TO BE WHAT ARE WE GOING TO
DO FOR WOMEN?
IS IT GOING TO WORK FOR WOMEN?
WOMEN ONCE AGAIN ARE COMPLETELY
LEFT OUT OF THE GUIDELINES, I
THINK THERE'S AN APPETITE TO
STUDY IN WOMEN, RIGHT NOW
PROVIDERS ARE REALLY LEFT WITH
THIS SORT OF JUST TALK TO YOUR
PATIENT AND FIGURE OUT IF IT IS
FOR THEM.
BUT AGAIN, NO CLEAR GUIDANCE FOR
CISGENDER WOMEN, TRANSGENDER
WOMEN WERE INCLUDED IN THIS
GROUP AND ACTUALLY DID QUITE
WELL.
SO OVERALL I WOULD SAY EXCITING
AND INTERESTING TIMES.
THERE ARE GOING TO BE A LOT OF
QUESTIONS, I THINK ABOUT HOW
THIS IS GOING TO ROLL OUT IN
POPULATIONS WHO MIGHT NOT BE
USING IT AS FREQUENTLY.
I SHOULD MENTION THAT IN THE
RANDOMIZED CONTROL TRIALS OF
DOXY-PEP, THERE WERE NO DATA FOR
THIS GROUP BUT ON AVERAGE THE
PARTICIPANTS WHO WERE USING IT,
WERE USING IT 4 TIMES A WEEK.
SO, 4 TIMES A WEEK OF POST
EXPOSURE PROPHYLAXIS IS A LOT.
AND IT'S PRETTY MUCH EQUIVALENT
TO THE MINIMUM DOSE THAT YOU
PROBABLY NEED TO GET SORT OF
PREEXPOSURE TO PROPHYLAXIS FOR
IF YOU THINK ABOUT IT FOR
TENOFOFAVIR, IT WILL MAKE SENSE
SO WILL THAT TRANSLATE TO PEOPLE
WHO ARE WILL NOT BE AS SEXUALLY
ACTIVE OR FREQUENTLY SEXUALLY
ACTIVE.
WE DON'T KNOW.
SHOULD WE LOOK AT A PREAND POST
DOSE FOR PEOPLE WHO MIGHT WANT
TO BE COVERED FOR A WEEKEND AND
WEEK.
I THINK THOSE ARE INTERESTING
QUESTIONS THAT THE
PHARMACOKINETICS AND ADDRESS AND
REAL WORLD STUDIES CAN ADDRESS.
AGAIN, I JUST WANT TO POINT OUT
THAT WE ARE PROBABLY UP AGAINST
A BURGEONING INCREASE IN
TETRAPSYCHE LINE RESISTANCE THAT
PREDATED THE DOXY-PEP TIMELINE
SO THE GONORRHEA PROBLEM IS NOT
GOING TO GO,A AWAY AND I THINKI
MADE THAT POINT.
SO IF YOU LOOK AT WHAT'S
HAPPENING IN THE U.S. RIGHT NOW,
THERE'S SEVERAL UPTAKE OF
ADOPTER CITIES, PHILADELPHIA,
BALTIMORE, THEY HAVE BEEN USING
IT QUITE FREQUENTLY AND
OBVIOUSLY SAN FRANCISCO, AND I
THINK WE CAN SAY RIGHT NOW,
BASED ON THE RANDOMIZED CONTROL
TRIAL DATA, AND THE POPULATION
LEVEL DATA COMING OUT OF
SAN FRANCISCO, THAT IT IS
EFFECTIVE IN PREVENTING SYPHILIS
AND CHLAMYDIA.
ONE THING I WOULD MENTION IS
THAT THERE AREN'T A LOT OF DATA
ON WHETHER IT PREVENTS ANATOMIC
SITE SPECIFIC INFECTION FOR
CHLAMYDIA IN PARTICULAR, SO IS
IT BETTER AT PREVENTING RECTAL
VERSUS URETHRAL VERSUS
PHARYNGIAL INFECTION, WE REALLY
DON'T KNOW.
SOME OF THOSE THINGS MAY BE
IMPORTANT.
I WOULD SAY THE BIGGEST NAY
SAYERS ARE ASKING, SO, WHAT'S
THE BIG DEAL, WHY WORK SO HARD
TO PREVENT CHLAMYDIA INFECTION
IN MEN WHO HAVE SEX WITH MEN.
IT'S NOT REALLY CAUSING ANY
PROBLEMS.
SO PUT THAT OUT THERE AGAIN, I
WOULD LOVE TO HEAR YOUR THOUGHTS
ABOUT THAT BUT [INDISCERNIBLE]
AND THE GROUP IN MELBOURNE,
AUSTRALIA HAVE BEEN PRETTY
PROVOCATIVE IN THIS REGARD.
I THINK THERE'S A LOT OF DEBATE
TO BE HAD ON OTHER SIDE, NOT THE
LEAST OF WHICH TO DO IS WITH
JUST SORT OF THE WHOLE CONCEPT
OF SEXUAL HEALTH.
HOW DO YOU HAVE SORT OF SEXUAL
HEALTH WITH THE ASSURANCE THAT
YOU'RE NOT GOING TO BE ABLE TO
TRANSMIT OR ACQUIRE THESE
INFECTIONS SO IT'S A VERY, VERY
RICH AREA, I WOULD SAY OF
DEPARTICIPATE --
DEBATE.
I ALREADY MENTIONED THE DECLINE
IN SYPHILIS AND TO DATE NO
IMPACT ON GONORRHEA THAT WE
REALLY CAN TELL AND THE CONCERN
WITH RESISTANCE.
THERE ARE A COUPLE OF OTHER
CONCERNS, I WOULD JUST MENTION
REMEMBER THAT WE USE DOX
YCYCLINE, TO TREAT BAF, SO THERE
ARE PEOPLE WHO ARE INTERESTED IN
TRACKING COMMUNITY BASED STAFF
AURIOUS ANTIMICROBIAL
SUSCEPTIBILITY, THERE IS A
SUGGESTION THAT THERE MAY BE A
GROUP CASE FOR STREP, I THINK
IT'S THEORETICAL AND I DON'T
KNOW WHAT THE OUTCOME OF THAT
REALLY IS, AND SO, I WOULD SAY,
THAT IT'S JUST GOING TO BE
REALLY IMPORTANT TO MONITOR THE
IMPACT.
I HAVE PERSONALLY, WHEN I WAS
PRACTICE RESEARCH IT-SHERLOCKING
IS SEEING PATIENTS BEEN PRETTY
LIBERAL WITH THE DISPENSATION OF
DOXY-PEPY PEP, IT WAS GOOD, BUT
PEOPLE NEED TO UNDERSTAND THAT
IT IS NOT GOING TO BE PANACEA
FOR PREVENTING EVERYTHING AND
YOU STILL GOT TO WORRY ABOUT
GONORRHEA, PEOPLE ARE ALSO VERY
INTERESTED IN FOLLOWING THE
EFFECT ON THE GUT MICROBIOME.
YOU KNOW WE USE DOXYCYCLINE FOR
MANY THINGS, FOR LIME
PROPHYLAXIS AND ALL KINDS OF
OTHER THINGS SO I DON'T THINK WE
WILL SEE A BIG PROBLEM WITH THE
GI MICROBIOME, BUT I REALLY
DON'T THINK WE KNOW AND I THINK
WE WILL HAVE TO LOOK CAREFULLY
AT IT.
SO THAT IS MY SUMMARY OF WHERE
WE'RE AT IN DOXY-PEP.
INTERESTED IN HEARING ANY
COMMENTS OR QUESTIONS BEFORE I
SHIFT TO HIV.
I THINK THERE'S NOTHING COMING
UP FOR WOMEN ANYTIME SOON,
IMEAN, IF YOU ARE TAKING CARE OF
WOMEN WHO ARE INTERESTED IN
THIS, I THINK THIS HAS TO BE A
ONE-ON-ONE CONVERSATION AND I
THINK WE HAVE TO SAY WE DON'T
KNOW THE PHARMACOKINETICS, IT
SUGGESTS THEY'RE GOOD AS
RECOMMENDED BUT THAT'S WHERE
WE'RE AT.
ALL RIGHT.
I'M GOING ON.
WE WILL SAVE QUESTIONS FOR THE
END.
SO LET'S TALK A LITTLE BIT
ABOUT, I THINK THE -- I DON'T
KNOW IF I WANT TO SAY IT'S MORE
EXCITING BUT IT'S CERTAINLY MORE
QUICK MOVING AS THE FIELD OF HIV
ALWAYS IS, RELATIVE TO STIs,
AND I DON'T NEED TO BELABOR SOME
OF THESE STATISTICS WITH YOU.
YOU KNOW I THINK THAT THE HIV
PANDEMIC IS NOT SLOWING DOWN AND
IT CONTINUES TO AFFECT GROWING
EPIDEMICS OUTSIDE OF SUB-SAHARAN
AFRICA, IN FACT, AT MIEWN ITCH
INTERNATIONAL AIDS SOCIETY
MEETING THIS YEAR, IT WAS
REPORTED THAT FOR THE FIRST
TIME, THE INCIDENCE OUTSIDE OF
SUB-SAHARAN AFRICA IN SEVERAL
COUNTRIES EXCEEDED THAT OF
SUB-SAHARAN AFRICA WHICH SHOWS
THAT WHEN YOU PUT RESOURCES TO
SOMETHING, LIKE WE HAVE FOR HIV
PREVENTION AND SUB-SAHARAN
AFRICA, IT MIGHT TAKE SOME TIME
BUT YOU WILL HAVE AN IMPACT AND
WE CLEARLY HAVE HAD IN THOSE
COUNTRIES.
ON TOP OF THIS, THE RESOURCES
FOR HIV, AS I THINK THOSE OF YOU
NATHE FIELD KNOW HAVE DROPPED,
RIGHT?
WE'RE NOT GETTING MORE
INVESTMENT IN HIV PREVENTION AND
IN HIV TREATMENT.
IF ANYTHING WE'RE BEING
QUESTIONED MORE ABOUT WHAT THOSE
DOLLARS ARE BEING USED FOR AND
WHY WE NEED THEM.
AND THEN OF COURSE, JUST A
REMINDER THAT WHEN YOU LOOK AT
WHO IS MORE LIKELY TO GET
INFECTED WITH HIV, PARTICULARLY
IN EASTERN AND SOUTHERN AFRICA,
ADOLESCENT GIRLS ARE REALLY THE
MAIN FOCUS FOR MANY, MANY
INTERVENTIONS.
SIX TIMES AS LIKELY TO ACQUIRE
HIV, BOYS SENT TO GET IT LATER,
LATER IN LIFE, GIRLS TEND TO GET
IT EARLIER AND OFTEN SIN DEMIC
WITH RATES OF EARLY PREGNANCY
AND UNINTENDED PREGNANCY AND
GENDER BASED I HAVEERENCE.
SO I
-- GENDER BASED VIOLENCE.
SO I WILL TAKE A QUICK DETOUR TO
TALK ABOUT PREVENTION, BUT TO
THINK ABOUT WHOLISTICALLY WITH
WE THINK ABOUT PREVENTING
INFECTIONS, IT'S IMPORTANT TO
THINK ABOUT NOT JUST THE MAGIC
PILLS AND SHOTS BUT WE HAVE TO
THINK ABOUT WHAT PEOPLE WANT,
WHY PEOPLE COME TO THE DOCTORS,
WHY PEOPLE COME TO THE CLINICS,
WHAT ARE THEY COMPLAIPING ABOUT
AND WHAT DO THEY NEED AND I WILL
COME BACK TO THAT BECAUSE I WANT
TO TALK ABOUT CHOICE AND WHY
IT'S IMPORTANT EVEN WHEN YOU
THINK YOU'VE FIGURED OUT WHAT
THE MAGIC SHOT IS, YOU STILL
NEED TO MEET PEOPLE WHERE
THEY'RE AT AND I FEEL QUITE
STRONGLY ABOUT THAT.
AND WE'LL BE INTERESTED TO HEAR
YOUR THOUGHTS ABOUT THAT AS
WELL.
I WANT TO SHOW THIS BECAUSE WE
FINALLY PUBLISHED DATA RELATIVE
TO THIS, SINCE THE LAST TIME I
SPOKE TO ABOUT THIS.
IT'S JUST A REMINDER THAT IF YOU
LOOK AT THE VAGINAL MICROBIOME
HAVING A HEALTHY LACTIC
ACIDOSEIS ON BACILLUS
[INDISCERNIBLE] DOMINATED MIKE
ARE -- MICROBIOME FOR GREAT
PROTECTION AGAINST ACQUISITION
OF HIV AND OTHER SUCCESSESSUALLY
TRANSMITTED INFECTIONS.
SOME PEOPLE CALL TAKEN--THEY A
COMMUNITY TYPE 1 BUT IT'S JUST A
VERY GOOD PLACE TO BE AS OSHES
POSE TO HAVING A DIVERSITY OF
PREDOMINANTLY ANAROBES ON THE
OTHER END OF THE SPECTRUM AND
THIS WAS SWRUOF THE SOME DATA
FROM A VERY EARLY STUDY, DONE BY
DOUG QUAN AND THE FRESH COHORT
AT HARVARD, LOOKING THE RATES OF
HIV ACQUISITION IN YOUNG WOMEN
AND SOUTH AFRICA, THIS WAS PRIOR
TO PREP BECOMING AVAILABLE AND
SO THE INCIDENCE AS YOU CAN SEE
THERE, WAS QUITE HIGH IN THE
WOMEN WHO HAD THE MOST DISRUPTED
VAGINAL FLORA, THE CT4 GROUP,
ACTUALLY, YOU CAN SEE THAT ABOUT
12% OF THOSE PEOPLE ACQUIRED
HIV.
IF THEY HAD A COMPLETELY NORMAL
VAGINAL MICROBIOME, THEY SAW NO
HIV ACQUISITIONS, INTERESTINGLY
ENOUGH, SO NOT A CONTROLLED
STUDY BUT A NICE OBSERVATIONAL
STUDY.
WHAT'S NEW AND I SHOULD SAY IT'S
JUST BEEN PUBLISHED IN JID IS
THAT WE HAVE HAD THE OPPORTUNITY
TO LACK MORE DEEPLY AT WHAT IS
GOING ON IN THOSE VAGINAL MICAH
ROUGH ATOM BIOME SAMPLES AND
THIS IS A STUDY WE WERE INVOLVED
IN CALL THE VOICE TRIAL WHERE WE
LOOKED AT THE LIKELIHOOD OF
WOMEN ACQUIRING HIV BY WHAT
THEIR VAGINAL BACTERIA LOOKED
LIKE.
IT'S A VERY COMPLICATED ANALYSIS
BECAUSE OF COURSE, HAVE YOU MANY
COMPARISONS, GOING ON HERE, BUT
THE BOTTOM LINE IS THAT YOU CAN
SHOW, EVEN WHEN YOU'VE GOT
MULTIPLE COMPARISONS, THAT
HAVING A LACTOBACILLUS DOMINANT
AT THE HIGH AT THE TOP IS
MARKEDLY PROTECTIVE AGAINST
GETTING HIV AND THERE WERE
SEVERAL BACTERIA THAT WERE
STRONGLY ASSOCIATED WITH
INCREASED LIKELIHOOD ESPECIALLY
AT HIGH LEVELS OF GETTING HIV,
PARTICULARLY MICROPLASMA
HOMINIDS, SOMETHING CALLED
SPHERE O TYPE 2, LEPTOTRICKIA
AND [INDISCERNIBLE].
WHICH IS AN INTERESTING BUG
BECAUSE IT'S BEEN LINKED TO SOME
OTHER ADVERSE EFFECTS IN THE
FEMALE REPRODUCTIVE TRACT AND
OTHER PLAYERS HERE THAT YOU
PROBABLY HAVE NEVER HEARD OF.
EXCUSE ME.
AGAIN, PROBABLY A MARKER FOR A
REALLY SUBOPTIMAL VAGINAL
MICROENVIRONMENT.
SO THAT BEGS THE QUESTION OF
WHETHER YOU CAN CHANGE THAT
ENVIRONMENT AND AGAIN, I WILL
BRING THIS TOGETHER, I PROMISE
IT'S NOT A TOTAL DIVERSE, EXCUSE
ME, SO REMEMBER THAT VAGINAL
COMPLAINTS ARE PROBABLY THE
BIGGEST REASON WOMEN COME TO
SEEK CARE IN CLINICS IN THE
U.S., CERTAINLY, AND SO, WE
ASKED THE QUESTION ABOUT WHETHER
YOU COULD MODIFY THE VAGINAL
MICROBIOME TO MAKE IT MORE
LACTOBACILLUS PREDOMINANT, AND
ACTUALLY RANDOMIZE WOMEN TO
SOMETHING CALLED THE NUVU RING,
WHICH HAS ESTRO GENERATED AND
PROGUEST ROAN, WE KNOW ESTROGEN
IS A PROMOTER OF LACTOBACILLUS,
THEY LOVE AN ESTROGEN RICH
ENVIRONMENT AND WE LOOKED AT
CONTINUOUS USE WHICH YOU CAN DO
IN ORDER TO SUPPRESS MENESES OR
CYCLIC USE WHICH IS HOW THE RING
IS ACTUALLY SUPPOSED TO BE
PRESCRIBED BECAUSE TECHNICALLY
YOU TAKE THE RING OUT AND MEN
STRAIGHT, MOST WOMEN LEAVE IT IN
AND NOT MEN STRAIGHT BECAUSE
THEY WOULD RATHER FOCUS ON THE
MEN STRAIGHT.
THE BOTTOM LINE IS WHAT WE
SHOWED AND THIS IS I THINK
FASCINATING WHEN YOU THINK AGAIN
ABOUT OFFERING WOMEN CHOICE.
WE HAVE A RING FOR PREVENTION OF
HIV.
IT'S CALLED THE [INDISCERNIBLE].
ARE WOMEN GOING TO USE A RING
JUST TO PREVENT HIV OR MAYBE
WOULD THEY LIKE A RING THAT
PREVENTS HIV AND ALSO PREVENT
THEM FROM HAVING THEIR PERIODS
AND ALSO MAYBE PREVENT THEM FROM
HAVING BACTERIAL VAJINOSEIS
WHICH 60% OF THE WOMEN WHO CAME
TO OUR STUDY IN KENYA HAD ON
EVALUATION AND MOST WERE
SYMPTOMATIC, SO THE BOTTOM LINE
HERE IS THAT IF YOU USED RING
CONTINUOUSLY, YOU MARKEDLY
REDUCED AND ANAROBES WHERE I
JUST SHOWED YOU WERE ASSOCIATE
WIDE AN INCREASED RISK OF EBV
OVER THE COURSE OF 6 MONTHS.
WE DID NOT HAVE ENOUGH WOMEN
THANKFULLY WHO HAD HIV INFECTED,
WE HAD NO WOMEN HIV INFEC INDEED
THIS STUDY SO WE COULDN'T LOOK
AT A PROTECTIVE EFFECT AND IT
WAS BT DESIGNED TO DO THAT BUT
IT'S A SIGNAL WITH PERHAPS THE
RIGHT SORT OF COMBINATION OF
HORMONAL MANIPULATIONS COMBINED
WITH AN ANTIRETROVIRAL YOU MAY
BE ABLE TO DELIVER INTERVENTIONS
AT SEVERAL LEVELS IN THEIR
QUALITY OF LIFE THAT WOULD
PREVENT HIV, IDEALLY ENHANCE
THEIR QUALITY OF LIFE, AND MAYBE
EVEN SOLVE SOME OF THE PROBLEMS
OF VAGINAL INFECTIONS WHICH ARE
QUITE SUBSTANTIAL IN SUB-SAHARAN
AFRICA.
THERE ARE DATA TO SAY THAT
BACTERIAL VAJINOSEIS OR
ANAEROBIC PREDOMINANCE OF THE
VARMIS BEGINNA IS RESPONSIBLE
FOR ABOUT 22% OF THE POPULATION
ATTRIBUTE AUTOMOBILE RISK FOR
HIV INFECTION JUST BECAUSE IT'S
SO PREVALENT AND WHEN YOU TAKE
ARK WAY ALL THE OTHER STIs,
THAT'S REALLY THE ONLY OTHER
THING THAT REMAINS, SO THOSE
DATA REALLY SUPPORT THAT, SO IT
SHOWS THERE'S SOMETHING IN THE
ENVIRONMENT THAT IS REALLY
SUPPORTIVE.
SO LET'S GET BACK TO HIV
PREEXPOSURE PROPHYLAXIS WITH
THAT BACKGROUND.
I REALLY LIKED THIS ARTICLE IN
THE LANCET HIV, AND AGAIN, IT
GETS TO THIS ISSUE OF HOW WE
CONTINUE TO TALK ABOUT PEOPLE AT
RISK AND HOW PEOPLE
QUOTE-UNQUOTE AT RISK ARE
DEFINED.
WE HAD THIS SORT OF THEY--THE
RETINAL LOCATIONERAL IDEA THAT
BY 2030 WE MIGHT BE ABLE TO
CONTROL HIV.
I DON'T THINK THAT'S REALISTIC
BASED ON WHAT WE HAVE BEEN
TALKING ABOUT TODAY.
AND I DON'T THINK IT'S REALISTIC
BECAUSE AS THIS ARTICLE POINTS
OUT MANY NEW INFECTIONS ARE IN
PEOPLE WHO DON'T CLASSIFY
THEMSELVES AS QUOTE-UNQUOTE HIGH
RISK AND YOU REALLY HAVE TO
THINK ABOUT WHAT YOU MEAN WHEN
YOU TALK ABOUT THAT.
I THINK ABOUT IT AS THOSE PEOPLE
WHO ARE NOT PRIORITIZED FOR
PREVENTION INTERVENTIONS.
SO THERE ARE PEOPLE WHO MAY BE
HAVE 1 PARTNER AND THEIR PARTNER
IS THE SOURCE OF THEIR HIV
INFECTION OF COURSE BECAUSE THEY
HAVE MORE PARTNERS.
SO THIS IDEA OF HAVING SOME
CONCEPT OF POPULATION LEVEL
BASED CONTROL AGAIN THINK BEING
DEVELOPING INTERVENTIONS THAT
ARE DESIGNED TO MEET PEOPLE
WHERE THEY'RE AT.
WHETHER THEY THINK THEY'RE HIGH
RISK OR NOT, WHETHER THEY WILL
GO IN FOR AN EVERY 6 MONTH
INJECTION OR NOT, I THINK IS
VERY IMPORTANT.
SO I KNOW THAT WE STILL NEED TO
FOCUS ON THE HIGH INCIDENCE
COUNTIES RIGHT, WE STILL HAVE A
BIG NEED IN THE HIV EPIDEMIC,
THAT'S NO QUESTION, BUT, I THINK
THAT HAVING THIS MORE GLOBAL
CONCEPT OF PEOPLE AT
QUOTE-UNQUOTE INCREASED RISK IS
GOING TO REALLY BE IMPORTANT.
SO LET'S TALK A FEW THINGS, I
WILL NOT TALK ABOUT VACCINES OR
BROADLY NEUTRALIZING ANTIBODIES
I REALLY WANT TO TALK ABOUT AS
MY TITLE MENTIONED PROPHYLAXIS
AND I HOPEFULLY YOU SAW THAT
ARTICLE IN THE NEW ENGLAND
JOURNAL OF MEDICINE AND
PRESENTED MUNICH FOR PRESENTATS
SHOWING THAT TWICE YEARLY
INJECTIONS OF LANACAPPA VIR,
WITH A SAP SID ASSEMBLY
INHIBITOR, TOTALLY NEW CLASS
WHICH IS AVAILABLE FOR TREATMENT
IN THE UNITED STATES AT A COST
OF, ANYBODY KNOW WHAT IT COSTS
TO GET LENACOP A VIR, ANYONE
KNOW HOW MUCH CONTREATMENT
COSTS?
$42,000.
THIS WAS STUDIED IN CISGENDER
WOMEN IN KENYA, UGANDA AND SOUTH
AFRICA AND THE STUDY WAS STOPPED
EARLY BECAUSE THE DSMB NOTE THAD
THERE WERE 0 INFECTIONS IN THE
GROUP THAT WAS RANDOMIZED TO
LENACAPP A VIR, THE BACKGROUND
GROUPS ARE CONFUSING WOMEN WERE
EITHER GIVEN -- IT WAS BLINDED
SO THEY WERE GIVEN EITHER ACTIVE
ORAL TAF BASED PREVENTION OR
ORAL LENACAPP A VIR INJECTIONS
AND IN THE GROUP THAT USED ORAL
LENACAPP A VIR, ONLY 1-2%
ACQUIRED HIV.
I THINK THIS STUDY IS
FASCINATING BECAUSE WE'RE NOW
LOOKING AT A STUDY WHERE YOU
ESTABLISHED 0 BASE LINE FOR WHAT
YOU THINK SHOULD BE HAPPENING IN
PREVENTION WHICH IS GOING TO
MAKE IT VERY HARD TO STUDY
ANYTHING IF YOU'RE NOT GOING TO
USE A DESIGN LIKE THIS.
IT'S A COMPLICATED DESIGN.
WHAT THEY DID TO DO THIS AND IF
THERE ARE STATISTICIANS IN THE
ROOM, THEY CAN EXPLAIN THIS
BETTER THAN I CAN, THEY
ESTABLISHED THE BASE LINE
PREVALENCE OR WHAT YOU WOULD
HAVE EXPECTED IN THE CONTEXT OF
A PLACEBO, BY TAKING ALL THE
PEOPLE WHO TESTED POSITIVE WHEN
THEY COME IN TO BE SCREENED FOR
THE STUDY AND DOING A RECENTSY
ASSAY AND LOOKING AT THE LIKELY
INCIDENCE OVER THE LAST 6 MONTHS
IN PEOPLE WHO WERE MOST LIKELY
RECENTLY INFECTED.
AND THAT'S WHERE THEY GOT THE
BASE LINE THAT THEY USE FOR
COMPARISON.
I THINK THAT'S THE ONLY WAY WE
WILL BE ABLE TO DO STUDIES IN
THE FUTURE SO IF YOU DON'T
UNDERSTAND IT, IT'S WORTH TAKING
A QUICK LOOK AND READING UP
ABOUT IT.
IT'S QUITE FASCINATING.
SO BOTTOM LINE, 0 INFECTIONS IN
THE WOMEN IN THIS STUDY.
SO THE UNAIDS EXECUTIVE DIRECTOR
CALLED IT A MIRACLE PREVENTION
TOOL.
THERE WERE PEOPLE DEMONSTRATING
AS THEY DO AT THE INTERNATIONAL
AIDS SOCIETY MEETING FOR GILLIAD
TO GET THIS OUT THERE YESTERDAY
DESPITE THE FACT THAT THE STUDY
WAS BEING PRESENTED AT THE
MUNICH MEETING AND JUST BEFORE
THE LIMA, PERU MEETING, THE
PURPOSE 2 TRIAL CAME OUT AND
THIS WAS A STUDY AMONG GAY MEN,
TRANSAND NONBINARY PEOPLE.
THIS HAS NOT BEEN PUBLISHED YET,
BUT THIS WAS AGAIN IN A
DIFFERENT POPULATION, ABOUT 3200
PEOPLE AND AMONG MORE THAN 2000
PEOPLE WHO RECEIVED LENACAPP A
VIR, THERE WERE ONLY 2 HIV
INFECTIONS AND IN THOSE PEOPLE
THERE WAS A SUGGESTION THAT THAT
WAS NOT TOTALLY SURPRISING.
WE DON'T KNOW THE DETAILS YET.
THIS IS NOT BEEN PUBLISHED TO MY
KNOWLEDGE YET.
SO, AGAIN, 99.9% OF PEOPLE DID
NOT ACQUIRE HIV INFECTION.
AND IN THE TENAFAVIR GROUP, IT
WAS SIMILAR, AGAIN THIS IS A
PRESS RELEASE TO WHAT I SHOWED
TO THE PURPOSE 1 TRIAL EMPLOY SO
THIS WAS STOPPED BY THE DSMB,
AND IF YOU LOOK AT WHAT THE
LANDSCAPE OF THE FUTURE STUDIES
FOR LENACAPP A VIR HERE, WHAT WE
TALKED ABOUT PURPOSE 1, 2, 3,
WAS TO BE IN CISGENDER WOMEN IN
THE UNITED STATES, PURPOSE 4 WAS
TO BE IN PEOPLE WHO INJECT DRUGS
AND PURPOSE 5 WAS GOING TO BE
LARGER STUDY IN CISGENDER MEN
WHO HAVE SEX WITH MEN
TRANSGENDER MEN AND WOMEN AND
BINARY.
IT'S NOT CLEAR WHAT THESE
STUDIES WILL LOOK LIKE NOW GIVEN
THE ROBUST FINDING OF THE 2
TRIALS AND GILLIAD ALREADY
SUBMITTED OR IS READ READY TO
SUBMIT FOR REGULATORY APPROVAL
SO THE QUESTION SOPHISTICATED
EVERYBODY'S MIND IS IS IT TIME
TO DECLARE VICTORY.
DO WE HAVE A PRODUCT YOU CAN
JUST GIVE PEOPLE EVERY 6 MONTHS
AND SAY WHY DO WE EVEN NEED TO
WORK ON AN HIV VACCINE, AND
THAT'S REALLY THE BIG QUESTION.
SO MY JOB HERE IS TO CAST SOME
DOUBT ON THIS ROSIE SCENARIO.
I THINK THAT YOU MAY BE FAMILIAR
WITH EYOR, THE CHARACTER WHO'S
ALWAYS COMING UP WITH REASONS TO
BE NOT OPTIMISTIC, SO I LISTED
SOME OF THE REASONS THAT I JUST
THINK WE NEED TO PAY ATTENTION
TO.
FIRST OF ALL RESISTANCE
MUTATIONS, TIME TO MARKET,
ACCESS, COST, DEMAND AND
DELIVERY STRUCTURE.
SO LET ME TALK ABOUT THOSE
REALLY QUICKLY.
WE DO HAVE A LONG ACTING
INJECTABLE FOR HIV, LONG ACTING
CAPP A TEGAVIR, IT'S OUT THERE,
AVAILABLE, AND TOUGH FOR PEOPLE
TO GET IT AND GET IT PAID FOR.
IT DOES WORK VERY WELL, THE
EFFICACY FOR LONG ACTING CAB, IT
WAS ABOUT 93%.
, SO NOT QUITE AS HIGH AS
LENACAPP A VIR, BUT REALLY, VERY
GOOD.
THE PROBLEM IS WE HAVE ALREADY
SEEN A CASE OF CABOTEGRAVIR, IN
A PERSON WHO CLEARLY GOT THE
RESISTANCE WHILE THEY WERE ON
THE DRUG AND THAT'S THE KEY
THING, THIS WAS NOT JUST A
MATTER OF DELAYED DETECTION
BECAUSE DETECTING INCIDENT HIV
INFECTION IN LONG ACTING CAB, IS
INCREDIBLY COMPLICATED.
THE TEST RESULTINGS ARE WONKY,
YOU CAN'T USE RAPID HIV TESTS,
YOU HAVE TO DO MORE
SOPHISTICATED TESTING.
BUT THIS PERSON I LIKE TO USE,
AND THIS WAS JUST PUBLISHED A
COUPLE WEEKS AGO BECAUSE IT WAS
A PERSON WHO I THINK EMBODIES
THE CHALLENGES TO HIV PREVENTION
IN OUR MOST VULNERABLE PATIENTS.
THIS WAS A PERSON WHO WAS ABLE
TO GET THEIR CAB LA PREP
INJECTIONS BUT THEN HAD A 6
MONTH GAP IN CARE.
WHY?
BECAUSE THEY CHANGED INSURANCE
AND THE INSURANCE WOULDN'T COVER
IT SO FELL OUT OF CARE, CAME
BACK IN, HAD SOME OTHER
CHALLENGES WITH GETTING CAB LA,
THE INSURANCE PAPERWORK WAS BT
DONE, ALL THE THINGS THAT WE'RE
SO FAMILIAR WITH WHEN WE'RE
TRYING TO GET THINGS DONE FOR
OUR PATIENTS, ANYWAY, BOTTOM
LINE IS THIS ENDED UP IN A VERY
CLEAR INFECTION WITH A
CABOTEGRAVIR MARKER WITH THAT
WAS ASSOCIATE WIDE THE
INTERRUPTED EXPOSURE TO
CABOTEGRAVIR, SO AGAIN, THIS IS
AN IMPERFECT SITUATION BUT YOU
KNOW MOST LIFE SITUATIONS ARE
IMPERFECT.
LIFE IS NOT PERFEJT.
MOST PATIENT'S LIVES HAVE SOME
ELEMENT OF CHAOS.
SO, AGAIN, THE DRUGS ARE ONLY
PERFECT WHEN YOU CAN ADMINISTER
THEM PERFECTLY AND MONITOR THEM
PERFECTLY AND I DON'T KNOW
THAT'S POSSIBLE.
THE TIME TO MARKET AND
DISTRIBUTION OF THESE DRUG IS A
REALLY BIG CHALLENGE AND IF YOU
ARE LOOKING AT THIS, TAKE A LOOK
AT THE AVERY CLOSE AK CO-WORKERS
SITE, THEY POINT OUT HOW LONG IT
TAKES FOR THIS TO GET TO MARKET.
CAB-A, THE COMPANY THAT STOOD IT
UP IN THE BEGINNING WAS
UNPREPARED TO GET IT OUT THERE
AFTER THE POSITIVE RESULTS SO
THERE'S BEEN A BIG LAG GETTING
CAB-LA OUT THERE TO PLACES THAT
REALLY NEED IT.
THE OTHER THING I WANT TO POINT
OUT IS THAT, YOU KNOW THESE
DRUGS ARE NOT GIVEN IN A VACUUM,
AND I AGAIN THINK ABOUT
SITUATIONS WHERE PEOPLE HAVE
ESTABLISHED EXCELLENT
INFRASTRUCTURES FOR CARE AND
REALLY HOW FRAGILE THOSE
INFRASTRUCTURES ARE, RIGHT?
SO PEOPLE ARE LIVING IN
SITUATIONS AND ALL YOU HAVE TO
DO IS LOOK AT THE NEWS TO SEE
WHETHER HEALTHCARE CLINICS THAT
HAVE BEEN BUILT UP OVER MANY
YEARS ARE DESTROYED AND IT'S A
REMIND THEY'RE TO DELIVER ANY
PRODUCT REQUIRES A STABLE
ACCESSIBLE INFRASTRUCTURE WHERE
THE PRODUCT CAN BE STORED SAFELY
AND ADMINISTERED BY TRAINED
WORKERS.
LENACAPP A VIR, HAS TO BE GIIVE
BY 2 SUBCUTANEOUS INJECTIONS
INTO THE ABDOMEN, IT'S NOT JUST
SOMETHING YOU JAM INTO
SOMEBODY'S ARM.
IN FACT THIS WAS 1 CASE OF A
PARTICIPANT IN SOUTH AFRICA IN
THE LENACAP A VIR STUDY, AND HAD
AN TUMOR NECROSIS BECAUSE THE
HEALTHCARE WORKER HAD NOT BEEN
TRAINED ENOUGH IN ADMINISTRATION
SO THIS IS NOT SOMETHING YOU'RE
JUST GOING TO BE ABLE TO ROLL
OFF THE SHELF.
AND I THINK IT'S NOT -- IT'S
IMPORTANT TO NOTE THAT PEOPLE
ARE LIVING IN PLACES WHERE THESE
INFECTIONS ARE HAPPENING WHERE
THESE INFRASTRUCTURES ARE REALLY
THREATENED EVERY SINGLE DAY.
AND BETWEEN POLITICAL VIOLENCE,
BETWEEN MILITARY VIOLENCE,
BETWEEN EVEN CLIMATE CHANGE AND
CLIMATE DISASTERS TAKING OUT
THESE INFRASTRUCTURES, THERE'S A
LOT THAT CAN HAPPEN.
AND OF COURSE WHEN YOU HAVE
CONFLICT WHO SUFFERS THE MOST,
THE MOST VULNERABLE, RIGHT IN SO
WOMEN IN PARTICULAR, IN CONFLICT
AFFECTED COUNTRIES ARE
EXPERIENCING SOME OF THE WORST
CONDITIONS.
SO MY POINT HERE IS AGAIN, NOT
TO BE LIKE GLOOMY, BUT TO SAY,
THAT WE REALLY NEED TO HAVE 2
THINGS, 1 MORE CHOICES AND 2, WE
CAN'T STOP PURSUING DURABLE
INDIVIDUAL IMMUNITY.
WE NEED AN HIV VACCINE, WE NEED
STI VACCINES BECAUSE ALL OF
THESE OTHER MEASURES AS
FANTASTIC AS THEY MAY BE AND AS
GREAT AS THEY MAY BE IN A SINGLE
COMMUNITY OR SINGLE
INFRASTRUCTURE OR SINGLE CLINIC,
ARE NOT GOING TO GET US WHERE WE
NEED TO BE IN THE PLACES WHERE
THINGS ARE NOT GETTING BETTER
AND IN FACT, MAY BE GETTING
WORSE.
I ALSO FIND IT SOMETIMES,A
MAZING THAT I HAVE TO REMIND
PEOPLE THAT SEXUAL COUNTERS MAY
BE NOT PLANNED, OR FREQUENT LEER
CONSENTUAL, IN THAT CASE MAYBE
YOU DON'T HAVE THE FORETHOUGHT
OR OPPORTUNITY TO GET TO A
CLINIC AND LOAD UP ON WHATEVER
HEMOPROPHYLACTIC WE'RE TALKING
ABOUT HERE.
SO I DO THINK THAT ON DEMAND
PRODUCTS WILL WORK, I JUST HEARD
TODAY, THAT AND ENROLLED FIST
FIRST PARTICIPATE, SO THAT'S
EXCITING PARTICULARLY WHEN YOU
TALK TO SOME PEOPLE WHO REALLY
ARE SO STIGMATIZED THAT CAN'T
GET ORAL PREP AND WE CAN COME
BACK TO THAT EMPLOY ALSO A NICE
STUDY RECENTLY BY SHARON RIDDLER
AND COLLEAGUES LOOKING AT A
RECTAL INSERT THAT HAS
TENAFAVIR, AND ADMINISTERED
RECTIFIEDALLY FOR HIV PREVENTION
AND THEN THE LAST THINK THIS I
WILL POINT OUT IS THAT, YOU KNOW
WE'RE NOT DOING GREAT WITH
PREVENTION OF VIRTUAL MACHINE
KRAL TRANSMISSION.
WE STILL HAVE 160,000 NEW
PERINATAL INFECTIONS OF HIV IN
THE WORLD.
MOST OF THESE ARE IN COUNTRIES
THAT THERE'S NO PEP FOR, AGAIN
GETTING BACK TO THE
INFRASTRUCTURE AND THE
COMMITMENT TO HAVE A SUSTAINED
PRESENCE AND DELIVER THESE
PRODUCTS.
SO, IT'S -- IT'S -- I LOVE TO
THINK ABOUT THE MAGIC OF CHEMO
PROPHYLAXIS, I LOVE TO THINK
ABOUT THE POTENTIAL, BUT I JUST
DON'T WANT PEOPLE TO GET SO
CAUGHT UP IN THIS CONCEPT THAT
ALL WE HAVE TO DO, IS GET IT
APPROVED TO GET IT TO PEOPLE.
THE OTHER THING IS NOT EVERYBODY
WANTS A SHOT AND NOT EVERYBODY
WANTS A PILL, NOT EVERYBODY
WANTS A GEL, RIGHT?
PEOPLE REALLY DO NEED CHOICE AND
I JUST AGAIN, ANOTHER PLEA, THIS
IS SOMETHING I ALSO WANT TO
POINT OUT IS THAT IF WE DON'T
INCLUDE PREGNANT AND BREAST
FEEDING WOMEN IN PARTICULAR IN
THESE STUDIES, THEN WE'RE NOT
REALLY GOING TO MAKE A DENT
PARTICULARLY IN PREVENTING
VERTICAL TRANSMISSION AND THIS
IS JUST A NICE SLIDE THAT I GOT
FROM LISA [INDISCERNIBLE], WHO
IS THE DIRECTOR OF THE JOHNS
HOPKINS INTERNATIONAL PREGNANCY
NG O, LOOKING AT AND POINTING
OUT THAT WE HAVE REASSURING DATA
FOR TEGAVIR, AND LENACAPP A VIR,
AND 1 THING ABOUT THESE STUDIES
THEY DIDN'T EXCLUDE THEM FROM
BEING ON A HORMONAL
CONTRACEPTIVE WHICH IS A REMNANT
MATERIAL IN STUDIES WE HAVE DONE
IN THE PAST.
SO THEY HAVE A NUMBER OF WOMEN
PREGNANT ON THESE STUDIES AND
THEY WILL BE A GOLD MINE FOR
INSURING THAT THESE WILL BE
GIVEN SAFELY IN PREGNANCY.
SO I THINK IT'S JUST GOING TO BE
IMPORTANT TO CONTINUE TO
PRIORITIZE THEM, NOT JUST IN
STUDIES OF [INDISCERNIBLE] BUT
IN ALL THESE STUDIES.
SO I SHOULD SAY THAT THIS SLIDE
IS TRUE FOR STI VACCINES AS
WELL.
THIS WHOLE CONCEPT OF DURABLE
INDIVIDUAL IMMUNITY IS A PLACE
WE HAVE TO GET TO.
WE NEED TO THINK ABOUT HIGHLY
EFFECTIVE VACCINES BUT EVEN IF
WE DON'T HAVE HIGHLY EFFECTIVE
VACCINES, WE MAY GET VACCINES
THAT ARE LOOKING AT THESE
MODELS, MIGHT BE ENOUGH TO BUY
US SOME TIME.
AND WE DO HAVE NEW MANUFACTURING
PLATFORMS, LIKE MRNA PLATFORMS
THAT COULD GIVE US WAYS THAT WE
COULD GET THIS OUT THERE FASTER
AND STUDY IT FASTER WITH IDEALLY
SURROGATE MARKER PROTECTION, SO
AND THEN I THINK THE INNOVATIONS
AND TRIAL DESIGNS FOR THOSE WHO
DESIGN TRIALS, AND STUDIES, THE
BIOSTATISTICIANS GIVEN THE
LENACAPP A VIR RESULTS, THIS IS
GETTING INTERESTING EMPLOY HOW
WILL WE STUDY AN HIV VACCINE,
HOW WILL WE STUDY AN HIV VACCINE
WHEN YOU HAVE TO OFFER PEOPLE
THE STANDARD OF CARE WHICH IS
NOW IS PREP AND IN THE BEST CASE
SCENARIO PREVENTS HIV INFECTION,
SO I'LL LIVE YOU WITH THAT.
BECAUSE I CAN'T ANSWER THAT.
JUST SAY THANK IF YOU ARE YOUR
ATTENTION AND WOULD LOVE TO HEAR
YOUR THOUGHTS.
[ APPLAUSE ]
NTHANK YOU FOR A VERY THOUGHTFUL
AND THOROUGH PRESENTATION.
I THINK WE HAVE TIME FOR 1 OR 2
QUESTIONS HERE BEFORE WE CLOSE.
>> DOCTOR, I WOULD LIKE TO ADD A
CAVEAT ABOUT THE DOXY-PEP STORY
IS THAT IS WE HAVE ENCOURAGING
DATA FROM YEAR 1 BUT MY CONCERN
IS YEARS 2, 3, 4, 5.
THESE PEOPLE NEED PROTECTION
EVERY YEAR.
>> YEAH NAND WHAT WE LEARNED
FROM THE TENOFAVIR STORY IS THAT
COMPLIANCE WITH PREEXPOSURE FOR
TENOFAVIV, AND IT GOES DOWN WITH
TIME AND OVER TIME AND GOES DOWN
WITH DOXY-PEP THAT WE MAY SEE A
DIFFERENT RESULT IN SUBSEQUENT
YEARS.
>> I COULD NOT AGREE MORE WHICH
IS WHY I KEEP BRINGING UP THAT
WORD DURABLE, I DON'T THINK PREP
IS A DURABLE STRATEGY, I'M
PROBABLY OUT THERE IN SAYING
THAT IT'S NOT A DURABLE STRATEGY
AT A COMMUNITY LEVEL BECAUSE OF
THE CONCERNS I RAISED AROUND
ANTIBIOTIC RESISTANCE.
YOU KNOW WE'RE NOT SEEING
CHLAMYDIA RESISTANT DOXY-PEP
RESISTANCE, IT'S A CELLULAR
ORGANISM, IT'S AN ORGANISM
THAT'S NOT KNOWN TO EVOLVE
RESISTANCE, WE'RE NOT SEEING
RESISTANT SYPHILIS, BUT YOU
NEVER KNOW WITH SYPHILIS, I
WOULD NEVER COULD YOU WANT IT
OUT.
IT'S A NERVE WRACKING PATHOGEN.
ANY OTHER QUESTIONS, ANY
QUESTIONS ONLINE YOU WANTED TO
MENTION?
>> WE DON'T HAVE ANY QUESTIONS
COMING IN.
>> OKAY, WELL, THANK YOU FOR
YOUR ATTENTION, I REALLY
APPRECIATE IT AND THANKS.
[ APPLAUSE ]