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  • 8/21/2019 Ostermann Bob Hollar

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    Bob Hollar: Hello!

    Dr. Ostermann: Hello, it’s Dr. Molly Ostermann.

    Bob Hollar: Good afternoon Dr. Ostermann! Am I pronouncing your

    name correctly?

    Dr. Ostermann: Yeah, very good.

    Bob Hollar: Tan you! Tan you so muc for "oining me tis

    afternoon and let#s $or to our con%ersation. &at I

    $ould lie to start it out $it Dr. Ostermann' if it is all

    rigt' is to go o%er some of our inda ground rules to

    mae sure you understand e%eryting and e%eryting is

    agreeable to so...

    Dr. Ostermann: Sure.

    Bob Hollar: If you $ill' I $ill as you a moment. I $ill e(plain tat )rst

    of all introduce myself. I am Bob Hollar and I am $it te

    company Giles * Associates and $e are a consulting )rm

    so $oring $it te client currently in te ealtcare

    industry $o is in%estigating a %accine for +,- and...

    Dr. Ostermann: Very good.

    Bob Hollar: or tat' under tat general area $e are interested to

    understand more about your medical practise and te

    patients tat you managed tat migt be at ris for +,-'and also to tell you a little bit about tis proposed product

    and get your reaction to it. I am going to be recording our

    inter%ie$ today if tat#s all rigt $it you.

    Dr. Ostermann: Sure.

    Bob Hollar: At least for te purpose of being able to $rite up a report

    from our con%ersation. I am $e#ll a $orld $orst taer of 

    note' and to try to do so' I $ould become

    incompreensible on te pone and so rater tan a%e

    tat appen' $at I am going to do is record our

    con%ersation today and go bac later to inda rebuild my

    report. But in tat report' none of te information or none

    of te speci)c tings tat you tal about today $ill be

    reported bac to our client $it your name. /o' all te

    comments and te tining about a reaction to te

    product $ill all be reported in aggregate. /o' you are

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    assured tere is con)dentiality in tat regard. /o' does

    tat all sound all rigt too?

    Dr. Ostermann: Sounds good.

    Bob Hollar: Oay' great! /o' I a%e a lot of speci)c 0uestions tat I

    lie to go troug and I apologi1e if some of tese tings

    become repetiti%e. It is de)nitely not my intent to do

    tat' but sometimes I don#t manage te con%ersation $ell

    and I reali1e tat you may occasionally mention tings

    tat I end up asing about later and I apologi1e in

    ad%ance for tat only because I a%e ind of a list of 

    tings tat I need to get to you and I $ant to mae sure I

    do tem all. But to$ards tat end' I tin it $ould be

    really elpful for me if I $ould "ust sort of gi%e you te

    freedom to actually describe your practice and $at inds

    of patients you see and $at your specialty is and a littlebit about o$ +,- enters into your practice and patients.

    Dr. Ostermann: Sure. So, I am a consultant in a large teaching

    hospital in central ondon and the hospital has a

    very large critical care department, !ut also has a

    very large renal unit and it is a tertiary cancer

    center and I "or# in the intensive care unit and I

    also "or# in the renal unit. So, I routinely loo# 

    a$ter patients "ho are immunosuppressed and they

    are either immunosuppressed in spite o$ their renal

    illness or they immunosuppressed $ollo"ing a renaltransplant or a #idney%pancreas transplant, or they

    are immunsuppressed as the result o$ a

    chemotherapy $or cancer, and I come across &MV in

    the renal unit either in patients "ho are inpatients

    admitted to the "ard or in the outpatient setting.

    So, these are transplant patients "ho have &MV

    disease !ut are not sic# enough to !e admitted and

    they are !eing $ollo"ed up in the outpatient clinic

    and I come across &MV disease in the intensive

    care unit and again these are patients "ho have&MV disease either as a result o$ their renal

    disease or $ollo"ing chemotherapy to cancer. So, a

    numerous di'erent types o$ patients "ho develop

    an in$ection or &MV reactivation in my clinical

    practise.

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    Bob Hollar: Oay' terri)c! I am going to occasionally try to pare it

    bac $at I tin I eard you said and sometimes a %ery

    good "ob of tat' but in part because I "ust $ant to mae

    sure tat I understand. /o' it sounds lie te cief 

    contributors of patients $it a signi)cant +,- ris are

    eiter te cancer patients $ere tat additional ris iscoming from te immunosuppression generated by

    cemoterapy regimen or in renal patients $ere tey are

    acti%ely being immunosuppressed because of a

    transplant' is tat rigt?

    Dr. Ostermann: (ransplant or a renal disease, so lupus patients $or

    instance.

    Bob Hollar: Oay.

    Dr. Ostermann: )ut there are patients "ith &MV disease posttransplant as opposed to &MV disease post lupus.

    Bob Hollar: Oay. /o' do you manage as part of your practice people

    tat are on dialysis and end2stage renal disease as $ell?

    Dr. Ostermann: Yes, yes.

    Bob Hollar: Oay. &e#ll )rst of all could you gi%e me an idea $at

    tat number is' o$ many patients $ould you manage at

    any gi%en timeframe?

    Dr. Ostermann: I have *+ dialysis patients under my care.

    Bob Hollar: Oay. Are tey at any inerently increased ris for +,-

     "ust by te nature of teir emodialysis and te ad%anced

    idney disease?

    Dr. Ostermann: Yes, they are.

    Bob Hollar: Oay. +ould you 0uantify or least or gi%e me an idea $at

    le%el of ris' is it %ery lo$? Ho$ $ould you compare it to

    te pre%ious ris groups tat $e "ust identi)ed' te

    immunosuppressed cancer patients or te transplant

    patient?

    Dr. Ostermann: It is lo"er.

    Bob Hollar: Oay.

    Dr. Ostermann: It is lo"er and until the point that they get a

    transplant and then it is high.

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    Bob Hollar: Oay' perfect. 3ou mentioned speci)cally lupus' is it

    lupus nepritis ten tat typically puts tem into tat?

    Do tey enter into tat sort of renal 4o$ or tey sort of a

    separate patient group unto temsel%es tat you

    addressed separately?

    Dr. Ostermann: I only loo# a$ter patients "ith lupus nephritis.

    Bob Hollar: Oay.

    Dr. Ostermann: I$ it has got lupus "ithout #idney involvement, I

    don’t get involved. s a nephrologist, I "ould only

    loo# a$ter and come across patients "ith lupus

    nephritis on immunosuppression so the num!er o$ 

    patients "ith &MV disease post treatment $or lupus

    nephritis are all restricted to renal lupus.

    Bob Hollar: Oay' and about o$ many patients $ould tat represent

    doctor in your recurrent practise?

    Dr. Ostermann: -ith &MV disease or the lupus nephritis

    Bob Hollar: Te lupus nepritis group.

    Dr. Ostermann: I have got a!out at the moment /ust under 01 so

    23, I thin#.

    Bob Hollar: Oay' and o$ $ould you compare teir ris to lie te

    baseline dialysis patients? Are te posttreatment lupuspatients greater or e0ui%alent ris or lo$?

    Dr. Ostermann: Higher, yeah higher.

    Bob Hollar: Higer. T$ice as muc' 56 times as muc?

    Dr. Ostermann: ("o to 0 times higher.

    Bob Hollar: Tan you' and tell me a bit about te practise at your

    institution as far as people on dialysis are getting put on

    te idney transplant $aiting list. &at percentage of 

    your total dialysis patients $ould be on te transplant$aiting list? &ould it be all of tem or a portion?

    Dr. Ostermann: 4o, at the moment 5+6 o$ our dialysis patients are

    necessarily up to 51. 7orty are on the transplant

    "aiting list.

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    Bob Hollar: Oay. &ould you classify tat group as any di7erence in

    terms of teir relati%e ris as far as +,- goes? Are tey

    te same as all te emodialysis patients?

    Dr. Ostermann: (he ris# o$ &MV disease is the same as the total

    group.

    Bob Hollar: Oay.

    Dr. Ostermann: (hey are other"ise a little !it. So, in particular,

    cardiovascularly they are a little !it s"eeter and

    stronger.

    Bob Hollar: I see.

    Dr. Ostermann: )ut their ris# o$ &MV disease is the same as the

    total population on dialysis.

    Bob Hollar: Oay' and ten tell me a little bit about te patients tat

    you migt be treating $it tat migt be enanced teir

    ele%ated +,- ris because of teir immunosuppression

    from a cancer treatment. I assume tat te once tat you

    see $ould a%e eiter some you $ould be consulting on

    te basis of te renal aspect. &ould teir disease a%e to

    in%ol%e teir idney or $ould you "ust be in%ol%ed in a lot

    of tose cases "ust to ind of consult $it regards to

    idney function? 8(plained o$ $or te patient.

    Dr. Ostermann: 4o, on this case I "ould loo# a$ter them simply!ecause I am also a physician in the critical care

    unit, so I loo# a$ter patients in the intensive care

    unit, and so the cancer patients "ith &MV disease

    "hy I loo# a$ter are the ones "ho have severe &MV

    disease need to !e admitted to the intensive care

    unit and then I "ould loo# a$ter them independent

    o$ "hether they #idneys are e'ected or not.

    Bob Hollar: I see.

    Dr. Ostermann: Or the other group are the people "ho have cancerincluding hematological malignancy, so leu#emia

    also, "ho are in the intensive care unit $or a

    di'erent reason, "ho then get chemotherapy in the

    I&8 and then as a result develop &MV disease or

    reactivation. So, there is 9 group o$ cancer

    patients "ho need to come to the I&8 primarily

    !ecause they have gotten &MV disease and that is

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    their admitting diagnosis and then there is a

    di'erent group "ho come in "ith something else,

    say an in$ection or pneumonia or something, and

    then "e do something to them and then they

    develop &MV disease as a complication "hilst in

    the intensive care unit.

    Bob Hollar: I see. Any idea $at te proportion bet$een tose 9

    groups is? Is it mostly te +,- people tat ind of come

    in $it it or it is a?

    Dr. Ostermann: 4o, "e course more so it is pro!a!ly 2:9. So, more

    patients develop &MV reactivation or in$ection

    "hilst still "ith us as opposed to having such !ad

    &VM in$ection that they need to come to the

    intensive care unit.

    Bob Hollar: /o' are tere potential indications or te feeling lie tere

    migt be a eigtened ris for +,- tat migt be in te

    intensi%e care unit $ould also include potentially burns

    patients? Do you see any?

    Dr. Ostermann: 4o, "e do not loo# a$ter !urns patients.

    Bob Hollar: Oay.

    Dr. Ostermann: So, they go a specialist !urns unit.

    Bob Hollar: &at about patients tat are in a long2term use of temecanical %entilator' a%e you obser%ed te eigtened

    ris or potential for +,- infection as a result of tat

    treatment?

    Dr. Ostermann: Sadly, yes "e have seen uite a $e". (hey are

    uite tric#y !ecause "e don’t uite #no" "hat to

    do "ith them, !ut yes, yes "e have.

    Bob Hollar: /ince tere are so many potential contributors ere or

    patient groups tat migt be at +,- ris' I am gonna sort

    of try to see if $e can inda narro$ tis do$n to $at youtin te patients at igest ris are. /o' if you don#t

    mind I am gonna inda eco bac some of $at you told

    me...

    Dr. Ostermann: Sure.

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    Bob Hollar: And maybe you inda clarify if I a%e it correct and if I do

    peraps $at te biggest current ris groups I sould say.

    /o' $e a%e te ind of baseline I $ill call it te dialysis

    patients tat you are currently treating and ten abo%e

    and beyond tat $e a%e also te posttreatment lupus

    nepritis patients tat' as I recall' you mentioned' are atsome$at iger ris tan te base patients. &e also

    a%e te transplant list tat tose really aren#t

    di7erentiated from te sort of larger group of 

    emodialysis patients rigt?

    Dr. Ostermann: (he transplant patients have the higher ris#.

    Bob Hollar: Oay.

    Dr. Ostermann: )ut only "hen they have received the transplant,

    not "hen they go on the transplant "aiting list.

    Bob Hollar: 3es' tey are.

    Dr. Ostermann: -hen they are on the "aiting list, the ris# is the

    same !ut as soon as the moment they get a

    transplant, then they are at the increased ris#.

    Bob Hollar: Oay.

    Dr. Ostermann: -hilst "aiting on the "aiting list and receiving

    dialysis, the ris# is the same as the normal dialysis

    population.

    Bob Hollar: And ten you also mentioned tat te cancer patients

    $o are recei%ing because of te nature of teir cancer

    treatment are actually at an increased ris for +,- and

    ten $e also a%e te posttransplant patients $o are at

    muc iger ris for +,-' I assume.

    Dr. Ostermann: (hat’s right.

    Bob Hollar: And ten $e also taled about te %entilator patients

    $ic seem to be te contributor and you also mentioned

    te ematological cancer. /o' I don#t $ant us to get too

    bogged do$n because I $ant to go into a little bit of detail

    about te indi%idual' te caracteristics of eac one of 

    tose indi%idual patients. /o' I $ant to inda narro$ it

    do$n to te tings tat you tin are sort of te igest2

    ris groups out of tose. /o could you elp me out $it

    tat?

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    Dr. Ostermann: (he highest%ris# group

    Bob Hollar: &e#ll' groups you no$. ,y guess is tat te solid organ

    transplant' te idney transplant are amongst te igest'

    but could you elp me out from tat point on do$n?

    Dr. Ostermann: Yeah, so you’re right they are the highest group. In

    particular, since "e increasingly do comple; and

    higher ris# transplant procedures. So these are

    patients "ho are immunologically at high ris# and

    as a result need e;tra immunosuppression and

    more heavy immunosuppression, they are at very

    high ris#, and then $ollo"ing on $rom that I "ould

    say the cancer patients, people "ho have received

    chemotherapy $or active malignancies, in

    particular, the hematological cancers, and that is

    !ecause the hematological cancers are leu#emiaand so they get treated uite aggressively during

    the acute phase. So, the ris# o$ &MV disease is

    directly proportional to the !urden o$ 

    immunosuppression.

    Bob Hollar: And beyond te sort of $e a%e te comple( ig2ris

    transplant and ten I $ould assume $e a%e te more

    uncomplicated less ig2ris solid organ transplant' and

    ten belo$ tat' $e a%e te immunosuppresed cancer

    patients and ten ematological cancers or

    Dr. Ostermann: Yeah, yeah that ma#e sense and then "e "ould

    have the renal patients "ho receive

    immunosuppression $or renal disease, so lupus $or

    instance, lupus nephritis patients.

    Bob Hollar: /o' for no$' $at I am gonna do is sort of e(clude te

    standard transplants because I tin $e probably a%e

    looed at tat' but I am in particular interested in te

    oter cases tat you mentioned. /o' can I as you about

    eac one of tose brie4y?

    Dr. Ostermann: O#ay.

    Bob Hollar: irst of all' could you gi%e me an idea $at your typical

    1ero pre%alence of +,- is? &at percentage of your

    patients in general is +,- positi%e?

    Dr. Ostermann: !out

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    Bob Hollar: And so for eac one of tese groups' could you gi%e me

    an idea tat' $e#ll let#s start out $it te igest ris

    group and te %ery ig2ris transplants; $ould tis be

    because of te immunological complications $ere tey

    $ould necessitate lie an induction terapy ind of 

    regimen or is tere someting beyond tat?

    Dr. Ostermann: It is the !urden or this intensity o$  

    immunosuppression right in the !eginning.

    Bob Hollar: /o' tey are on aggressi%e regimen or dosage tan your

    standard patients under te conse0uence or more tan

    tose?

    Dr. Ostermann: Yes, correct.

    Bob Hollar: Oay' and so o$ often' $e#ll tell me o$ you manage

    +,- for tose patients. Do you monitor tem or do you

    propyla( tem? &at $ould typically be done?

    Dr. Ostermann: So, "e prophyla; patients "ho are &MV negative

    !ut receive a &MV%positive #idney.

    Bob Hollar: Oay.

    Dr. Ostermann: (his group gets receives prophyla;is $or 0 months.

    Bob Hollar: Oay.

    Dr. Ostermann: ll the others get monitored once a "ee#. So, the

    &MV positive receiving a positive #idney or the

    &MV negative "as receiving a negative #idney get

    monitored every "ee#.

    Bob Hollar: /o' I am sorry did I ear tat you e%en monitor te minus2

    minus patients?

    Dr. Ostermann: -e do, yeah "e do.

    Bob Hollar: And you could you brea do$n o$ often you migt

    e(pect to see? Do you see any signi)cant incidence of disease in any of tose groups?

    Dr. Ostermann: So, "e see a disease in the &MV positive ones

    receiving a negative #idney and it is usually a

    reactivation. Yeah, "e see uite o$=

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    Bob Hollar:

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    Dr. Ostermann: (hat is signi>cantly. So, the &MV%positive lupus

    patients, the ris# o$ &MV is, it depends a little !it

    on the degree and intensity o$ immunosuppression

    they have received !ut the standard patient only

    has a ris# o$ +%916.

    Bob Hollar: Oay. Tat is %ery elpful. Tey ind of sort of establis

    $at te riss ere are. =o$' o$ many of tese patient

    groups $ould be? I no$ you already clari)ed te

    situation $it regards to te organ transplant' but

    amongst te rest' bet$een te cancer patients and te'

    peraps' e%en te lupus patients' o$ often do you test or

    do you at any time acti%ely ind of monitor tese patients

    for +,- status?

    Dr. Ostermann: Ho" do "e monitor

    Bob Hollar: 3ea' monitor tem at all. Do you "ust monitor tem

    symptomatically or do you sort of regularly cec teir

    %iral load as you $ould $it te transplant?

    Dr. Ostermann: 4o, "e don’t monitor them, "e "ait $or symptoms.

    So, i$ they have a $ever or an une;plained $ever or

    some ne" changes on ;%ray so then "e "ould

    chec# !ut "e "ould not routinely monitor, no.

    Bob Hollar: Oay' and $en tese symptoms did so$ up' $ould tat

    be te ne(t step as to do a blood test?

    Dr. Ostermann: Yes, that’s right.

    Bob Hollar: And $ould tat be %eri)ed troug ? Is tat te

    metodology is?

    Dr. Ostermann: ?&@, yes.

    Bob Hollar: Oay' and $at $ould you loo for in tat test result to

    base your decision upon furter action? &at ind of

    result $ould trigger a response?

    Dr. Ostermann: So, "e measure ?&@ then "e measure the viral

    load, and as soon as it is positive, it certainly

    triggers a response. (he response may not

    necessarily !e treatment !ut, it "ould !e, the

    response is alertness. I$ the level is lo", "e "ould

    repeat it again and i$ the level "as high and the

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    symptoms >tted in the right patient, "e "ould

    initiate treatment.

    Bob Hollar: Oay.

    Dr. Ostermann: So, i$ it is positive "ith a lo" viral load, "e may /ust

    repeat it again and "ait a !it longer and also

    consider or e;plore "hether the

    immunosuppression can !e reduced a !it.

    Bob Hollar: I see. Is tere a guideline as far as an e(act tresold of 

    number of copies or someting along tose lines tat you

    migt say' $e#ll somebody o%er 666 is going to get

    treatment' or is it all indi%iduali1ed by te o%erall patient?

    Dr. Ostermann: (here is a guideline $or the management o$ &MV

    post transplant, and yeah "e o$ten use this

    guideline also $or the management o$ patients "ith

    &MV post lupus !ut "e don’t have a guideline $or

    the management o$ patients in the intensive care

    unit, so patient "ith &MV disease post

    chemotherapyA that is a !it more individualiBed,

    patient%!y%patient decisions.

    Bob Hollar: Oay. Tell me $ould tere be any circumstances in $ic

    you try to sort of pre2assess or use patient ris factors to

    ind of cange te $ay tat you manage particular

    patients for +,-? Are tere patients tat migt be at

    suc ig ris tat you $ould in some $ay treat tem

    di7erently so as to tae greater care to a%oid infection or

    someting lie tat? Te ting tat I $as tining about

    $as te immunosuppression you mentioned tat tere are

    some patients tat are %ery aggressi%ely

    immunosuppressed. Are tere oter inds of eiter

    terapy or comorbidities tat $ould in you mind really

    ele%ate a patient#s +,- ris?

    Dr. Ostermann: 4ot really. -e don’t do any other ris# assessment

    apart $rom chec#ing their &MV status in transplantpatient. I$ it is negative and they have received a

    positive #idney, "e "ill initiate prophyla;is !ut that

    is the only type o$ ris# assessment "e do.

    Bob Hollar: Oay.

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    Dr. Ostermann: So, "e identi$y the high%ris# patient and "e thin# 

    the person "ho is negative receiving a positive

    #idney has the highest ris#, !ut "e don’t do any

    other ris# assessment.

    Bob Hollar: or instance' in your I+@ e(perience' $en you treatcancer patients' is teir +,- status automatically no$n?

    Is tat someting tat is tested?

    Dr. Ostermann: 4o, not necessarily, no.

    Bob Hollar: Oay.

    Dr. Ostermann: It may !e #no"n, it may!e availa!le !ut it is rarely

    availa!le so not routinely.

    Bob Hollar: /o' if I understand correctly ten most of tose cases tey

    are not acti%ely managed tat if a patient presents $itsymptoms tat cause you to be suspicious tat tey may

    a%e a +,- infection' ten at tat point' you $ould do

    testing and oter follo$up terapy as $arranted' is

    tat rigt?

    Dr. Ostermann: &orrect.

    Bob Hollar: &at about te %entilator use' is tat someting $ere

    te patient is' is tere e(posure or potential ris to +,-

    proportional to basically teir e(posure to te %entilator

    by te time tat tey are out of tis? I am looing for anyoter factors tat migt sort of elp stratify $at tese

    patient ris populations are. /o' $ould time on te

    %entilator be a possibility?

    Dr. Ostermann: Yes it is, time on the ventilator, mainly !ecause it

    correlates "ith underlying illness and o$ten "ith !it

    o$ immunosuppression during their stay in I&8. So,

    "e give hydrocortisone to people "ith severe

    sepsis and these are e;actly the patients "ho may

    need to stay in the I&8 $or longer recovering $rom

    their illness. (his other group is the people "ithDS. gain, they occasionally get treated "ith

    steroids $or their DS, and these are e;actly the

    people "ho also spend a longer time on the

    ventilator and there$ore it is the time on the

    ventilator plus the $act that this time on the

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    ventilator may have !een associated "ith

    immunosuppression.

    Bob Hollar: 3ou "ust sort of triggered anoter possibility. Is it "ust te

    amount of time tat tey spend in te I+@' is tat anoter

    potential?

    Dr. Ostermann: Yes, it is also. Yes, de>nitely so. longer stay in

    the I&8 usually means that patients "ere sic#er so

    it correlates "ith severity o$ illness. It also

    correlates "ith a reduced immunity, so people "ho

    spend a long time in the I&8 entirely !ecome more

    immunosuppressed as a result o$ "ea#ness, critical

    illness.

    Bob Hollar: I see. /o' is it fair to say ten tat te amount of  

    e(posure tat tey a%e basically to "ust te I+@ is

    proportional' I mean as soon patients arri%e in te I+@ do

    tey basically become at certain le%el of ris and tat sort

    of proportionally increases as teir stay e(tends or is

    tis..? I probably not asing tat 0uestion.

    Dr. Ostermann: Yeah. I mean the ris# is high in the !eginning "hen

    they are very sic#.

    Bob Hollar: I see.

    Dr. Ostermann: It is "e then add immunosuppression or

    chemotherapy, then the ris# increases $urther, andthen as patients get !etter, their ris# reduces a !it

    !ecause it is not uite as high as during the acute

    phase, !ut as patients stay in the I&8 $or a long

    time, then gradually it goes up again.

    Bob Hollar: Is it possible tat you can sort of' are tere any trends

    $it regards to $en you migt see +,- incidence in

    terms of $en during teir stay in te I+@ so you see

    some infections or disease immediately or does it

    basically "ust increase gradually o%er time?

    I=GI=G

    Dr. Ostermann: &an I /ust interrupt you. &an I /ust ans"er this

    phone a second

    Bob Hollar: /ure.

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    A=/&8>I=G cant increase in their ris# o$ 

    dying. So, i$ &MV disease occurs in some!ody "ho

    is very ill in the intensive care unit to start "ith,

    then sadly it increases the ris# o$ needing more

    organ support so they may need more help $rom

    the ventilator, they may need drugs to support the

    heart, and they also needs medication and the

    medication o$ ganciclovir is e'ective !ut has

    serious side e'ects especially side e'ects on the!one marro", and so &MV disease has serious

    conseuences and could #ill people.

    Bob Hollar: Oay.

    Dr. Ostermann: Cspecially, these are o!viously people vulnera!le to

    start "ith.

    Bob Hollar: /ure. Tere are fe$ oter metrics I "ust $ant to sort of 

    read tem o7 ere to see if it triggers anyting in terms of 

    your e(perience. In)rm' 0uantitate if you can. &atabout te occurrence of oter complications ?

    Dr. Ostermann: Yeah, de>nitely. So, &MV disease can e'ect the

    lungs and can e'ect the gut or the lining o$ the

    stomach. It can cause serious !leeding $rom the

    stomach or $rom the gut. Yeah, de>nitely.

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    Bob Hollar: &at about impact on days of stay' does tat a%e a..?

    Dr. Ostermann: Oh yeah, yeah, people "ho get &MV disease sits

    some !ac# and they spend e;tra days in the

    intensive care unit.

    Bob Hollar: Any guesses on $at te order of magnitude of tat?

    Dr. Ostermann: 4o, that is dicult to stay.

    Bob Hollar: Oay.

    Dr. Ostermann: lthough you are tal#ing days, several days, not

     /ust 9 day, several days.

    Bob Hollar: And you mentioned te added medication burden tat

    typically $ould be' te anti%iral for treatment in te I+@

    setting $ould be ganciclo%ir' did I understand tat rigt?

    Dr. Ostermann: &orrect, yeah, yes.

    Bob Hollar: Oay.

    Dr. Ostermann: nd ganciclovir reuires a central line so they need

    an e;tra catheter in one o$ the !igger veins to put

    this catheter in their "rists so it may have

    complications, and then the treatment is at least

    91%day course o$ ganciclovir and ganciclovir is

    e'ective !ut can suppress the !one marro".

    Bob Hollar: I reali1ed tat doctors are typically abo%e te cost aspects

    of disease but te reality is in many cases I tin you are

    still ased to ind of at least consider tat. As a result of 

    tat' is tere any $ay tat you could mae an assessment

    of $at te cost of te +,- complication migt be if you

    diagnosed te patient as a%ing +,- disease during teir

    stay in te I+@? &ould you assle to guess as to $at te

    incremental cost if tat patient ends up re0uiring as te

    result of tat infection?

    Dr. Ostermann: You mean >nancial cost presuma!ly

    Bob Hollar: 3es.

    Dr. Ostermann: So, a day in the intensive care unit in the 8E costs

    9nitely increases the

    length o$ stay !y several days, say +,

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    91,111 pounds and in !et"een i$ they have a

    complication they may need e;tra intervention so

    the person "ho gets a GI !leed $rom &MV colitis,

    may need an endoscopy !ut may also need

    interventional radiology and all this increases the

    cost $urther.

    Bob Hollar: /ure. Tat#s terri)c. Tan you doctor' tat is really

    elpful. /o' to clarify $en' I am going to focus' I really

    tin tat te information about te I+@ patients because

    you do see 0uite a cross section of tem and your

    e(perience teir sounds lie' so I am going to ind of 

    focus on tat for some of te subse0uent 0uestion' and

    did mention tat typically you don#t no$ te +,- 1ero2

    status of tose patients in te I+@. 3ou migt but it is not

    routinely a%ailable and so you $ould not necessarily

    stratify' you $ouldn#t cange anyting in teir treatment

    based upon teir serological +,- status because you

    typically $ould not be a$are of tat rigt?

    Dr. Ostermann: &orect, yeah correct.

    Bob Hollar: Oay. Once tey become infected and a%e been

    diagnosed' do you ten monitor teir +,- load

    subse0uently during treatment? Ho$ is tat?

    Dr. Ostermann: Yeah.

    Bob Hollar: And o$ often or for o$ long $ould you typically do

    tat?

    Dr. Ostermann: So, "e monitor them "ee#ly. So, i$ they have had a

    positive result and a positive viral count, so the

    person "ith the positive count and "ho "ill start

    treatment, a 91%day course o$ ganciclovir, "ill !e

    monitored "ee#ly.

    Bob Hollar: Oay.

    Dr. Ostermann: )ut the person "ho has a positive count and it isstill lo" !ut positive and the decision is made not

    to start treatment, then they "ill have a repeat

    test 2%0 days later.

    Bob Hollar: Oay.

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    Dr. Ostermann: So, "hilst "ee#ly is not treatment !ut positive,

    then every 2%0 days.

    Bob Hollar: Oay. Cet me "ust get do$n ere. /o' you typically $ould

    not be a$are necessarily of any subclinical infection of 

    +,- tat migt be sort of testing prior to producing anysort of clinical symptoms' rigt so..?

    Dr. Ostermann: 4ot really, no.

    Bob Hollar: Is tat a concern to you or do you $orry about tose ind

    of subclinical infections in te setting tat you are up

    running?

    Dr. Ostermann: Yeah, I do !ecause occasionally "e have patients

    "ho deteriorate a !it and "ho in a nonspeci>c "ay

    and their ;%ray gets a !it "orse and then "e screen

    $or lots o$ things including &MV and then "e >nd

    they have got pneumonia $rom an ordinary !ug, !ut

    at the same time they are also &MV positive, so you

    are not sure "hether the deterioration is due to

    &MV or "hether it is due to another in$ection.

    Bob Hollar: I see.

    Dr. Ostermann: nd you, in this case it is dicult to interpret the

    &MV result !ecause it may /ust !e a !it o$ 

    reactivation in the conte;t in some!ody "ho has

    !ecome ill.

    Bob Hollar: I see.

    Dr. Ostermann: Or it may !e the !eginning o$ serious &MV in$ection

    and reuiring the treatment !ut only "ant to give

    the treatment o$ the say the ganciclovir to people

    "ho really need it and not the people "ho have /ust

    reactivated !ut it is not causing any pro!lems yet.

    Bob Hollar: /ure' oay I understand. Ha%e you or your institution

    canged anyting in te last fe$ years $it regards too$ you manage +,- or te ris for +,-?

    Dr. Ostermann: 4ot in the last $e" years !ut a!out 91 years ago "e

    changed the prophyla;is to valaciclovir.

    Bob Hollar: To %alaciclo%ir?

    Dr. Ostermann: Sorry, valganciclovir.

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    Bob Hollar: Oay' %ery good. /o' again sort of focusing in an I+@

    aspect of your e(perience rigt no$' o$ satis)ed are you

    $it te tools tat you currently a%e at your disposal to

    manage and treat +,-?

    Dr. Ostermann: 4ot very satis>ed !ecause "hat "e don’t #no" is"hether "e don’t #no" the meaning o$ a slightly

    positive result. -hat "e don’t #no" is "hether it

    is /ust a mar#er o$ illness so that the patients have

    reactivated and it is !ecause i$ they are very sic# or

    "hether it is a serious disease contri!uting their

    illness and needs treatment, so "e don’t #no" "ho

    to treat and "ho not to treat.

    Bob Hollar: /o' I am trying to tin about in you mind $at could be

    done to impro%e tat' does it need a better screening

    tecnologies or I mean $ould a %accine or some oterinds of pre%entati%e measure o7er an impro%ement tat

    $ould address some of te concerns tat you a%e?

    Dr. Ostermann: I don’t thin# a vaccine "ould help here !ecause "e

    are tal#ing a!out the patient "ho has returned

    positive, and that is "hen "e $ace its dilemma.

    -hat "ould either !etter test to di'erentiate

    active in$ection $rom reactivation, so !etter

    diagnostic tools, or more clinical trials sho"ing that

    active treatment "ith "hatever drug, ganciclovir or

    valganciclovir to people "ho are even i$ their viralcount is lo" is help$ul.

    Bob Hollar: Oay. Do $ant to as you no$ about te sort of te

    concept of pre%ention strategies or proacti%e +,-

    management strategy. /o' you mentioned tat you did

    not tin a %accine $ould be elpful.

    Dr. Ostermann: 4ot in the intensive care setting !y the time

    some!ody is positive, no.

    Bob Hollar: Oay.

    Dr. Ostermann: &learly, !e$ore yes. I$ you "ant to reduce the

    num!er "ho may turn positive, clearly a vaccine

    may help, yes.

    Bob Hollar: &at if te %accine $ould elp people tat $ere +,-

    positi%e as $ell toug' $at if tere $as demonstrated

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    ecacy $it regards to te ability to eiter enance or

    produce a better immune response to tat' te late

    infections' so as to suppress any reacti%ation' $ould tat

    cange your opinion of te utility of tat tool to manage

    +,- proacti%ely?

    Dr. Ostermann: Yes, that "ould !e very good yeah. I$ a vaccine to

    !oost as you descri!ed the reactivity to &MV virus

    could help, that "ould !e very good.

    Bob Hollar: Oay. &e#ll let us tal about tis

    Dr. Ostermann: I mean the vaccine "ould !e o$ highest use to

    people "ho are &MV negative as to that aspect.

    Bob Hollar: Oay' sure.

    Dr. Ostermann: nd they "ould have to !e vaccinated !e$ore theyare e;posed to horri!le immunosuppression, so

    !e$ore they receive the transplant, !e$ore they

    receive chemotherapy. )ut i$ the vaccine also

    helped to !oost immunity in people "ho are

    positive, then yes that "ould !e very use$ul.

    Bob Hollar: &e#ll' let me as you about tat te necessity to

    %accinate prior to immunosuppression' is tat based on

    your presumption tat no %accine could mount or tat a

    %accine simply $ould not $or if someone $o is se%erely

    immunosuppressed' does tat..?

    Dr. Ostermann: 4o, it is !ased on the assumption that any patient

    receiving a transplant "ill heavy

    immunosuppression and it "ould !e during this

    time o$ heavy immunosuppression that is "hen

    they are most vulnera!le. So, it "ould !e use$ul to

    have adeuate anti!ody load on!oard at that time.

    Bob Hollar: Oay.

    Dr. Ostermann: In order to have produced the anti!odies you "ouldhave to I assume you have to give the vaccine

    !e$ore.

    Bob Hollar: Oay' you no$ I $ant to tal to you about tat after $e

    ind of go troug a little bit of te particular %accine tat

    tey are de%eloping' but I $ant to as you about as an

    optimum strategy you $ould $ant to a%e people

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    basically %accinated $ell in ad%ance in order for tem to

    be $ell immuni1ed by te time tat you migt see tem

    in te I+@' is tat daily?

    Dr. Ostermann: Yeah, some time.

    Bob Hollar: +orrectly?

    Dr. Ostermann: &orrect.

    Bob Hollar: /o' doctor did you recei%e te discussion guide and te

    materials tat $ere sent in ad%ance by email by any

    cance?

    Dr. Ostermann: Yes, I did.

    Bob Hollar: In te middle tere is a sort description' a %accine

    description' "ust after =e$ Team and I $onder if you migtloo it o%er and $e could go o%er tat brie4y and ans$er

    any 0uestions and I $ould "ust lie to as you about your

    reaction to a product lie tat.

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    applications migt e(ist and so ob%iously te reason I am

    asing you a lot of tat 0uestions about te I+@ is

    because I tin lie tat is $ere a lot of te patients tat

    de%elop +,- complications end up getting collecti%ely

    identical. I am trying to )nd out beyond te clearer

    bene)ts of someting lie tis migt a%e at found inorgan transplant en%ironment. &at about some of te

    cancer patient' oter renal patients tat also migt be

    immunosuppressed or ob%iously %ery ill in te I+@' $ould

    any of tem bene)t from a product lie tis? Is tere a

    $ay tat tis could be administered to $ere it $ould

    o7er tem some protection?

    Dr. Ostermann: I$ the vaccine "or#s in patients "ho are

    immunosuppressed receiving chemotherapy, then it

    may have a role !ut clearly to "ait $or < months to

    reuire + in/ections over < month means youpresuma!ly it ta#es a couple o$ some time !e$ore

    the anti!odies are produced, no" that is unrealistic

    $or people "ith ne"ly diagnosed cancer. So, i$ I

    have cancer no" diagnosed today and needed

    chemotherapy no", then I "ould not "ant to "ait

    $or < month, I "ould "ant my chemotherapy to

    start as soon as possi!le. )ut clearly i$ I could

    have my chemotherapy and I could have the

    vaccine and the vaccine "as still "or#ing despite

    chemotherapy on !oard, then I "ould have it!ecause although it ma not protect me

    immediately, hope$ully, it "ill protect me $or my

    second or third course o$ chemotherapy.

    Bob Hollar: I ate to op around on you doctor' I am sorry. I am

    running "ust a little bit long. +ould you indulge me for a

    fe$ more minutes "ust to $rap a fe$ more tings?

    Dr. Ostermann: Sure.

    Bob Hollar: A couple of pages past $ere $e $ere' tere is a sort

    description of anoter product $ic tey are considering'

    and tis is a monoclonal antibody against +,-' sort of 

    same line of tat side again and $as $ondering if o$

    you migt see a product lie tat $ic migt con)rm

    more immediate immune bene)t to be used as sort of a

    sort2term strategy and te %accine being more of a long2

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    term strategy to$ards conferring immediately' $ould you

    see any %alue to tat approac?

    Dr. Ostermann: De>nitely. So, a medication "hich is $or the acute

    setting so enhancing the antiviral activity o$ 

    ganciclovir so !oosting the therapy "ould !e verygood, !ecause not every!ody responds to

    ganciclovir and sometimes people get

    complications $rom &MV disease !e$ore the

    ganciclovir has an e'ect. So, i$ you could prevent

    that, that "ill !e very good.

    Bob Hollar: &e#ll let us tal toug for a moment about te situation

    tat you mentioned $ere some ne$ly diagnosed $it

    cancer and based $it you no$ %ery aggressi%e and

    debilitating potentially cemoterapy regimen' is tat a

    patient tat you migt immediately treat $it tis ind of immunoglobin to minimi1e te sort of upfront ris and

    ten also start on te +,- %accine to sort of confer a

    longer term protection' I mean $ould tere be a net

    bene)t to patients? &ould you consider doing tat gi%en

    $at te le%el of ris is to patients at tat point?

    Dr. Ostermann: I "ould not do that, no, not !ased on "hat I am

    reading here. So, !ased on "hat I am reading

    here, here is an anti!ody "hich is given as an

    ad/unct to ganciclovir in order to "hilst treating

    active &MV in$ection so I "ould only give thisanti!ody in the setting o$ con>rmed &MV in$ection

    treated "ith ganciclovir.

    Bob Hollar: 3ou $ould not under any circumstances use tis as a

    propylactic agent?

    Dr. Ostermann: 4ot !ased on "hat is in this paragraph. 8nless

    there is di'erent in$o and then I "ould not.

    Bob Hollar: Oay. Going bac to te %accine doctor' te in"ection

    scedules o%er monts' you ad mentioned tat' doestat seem onerous. &ould tis be a dra$bac to you?

    Dr. Ostermann: 4ot really #no", no, it is + in/ections !ut renal

    patients, in nephrology most patients are

    vaccinated against hepatitis ) and that is at least 0

    in/ections so 2 more in/ections $or high%ris# group

    is not unusual and it is not too dicult.

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    Bob Hollar: Oay. Is tere anyting tat $ould pre%ent you or

    dissuade you from using a %accine lie tis? &at $ould

    be te tings tat you $ould need to satisfy yourself of 

    prior to use?

    Dr. Ostermann: (he sa$ety pro>le and I "ould "ant to see theclinical data so the num!er o$ patients enrolled.

    So, you said it "as prevented in 51, so it says 516

    reduction, I don’t #no" "hat reduction means,

    does it mean complete prevention or does it mean

    reduction in severity I "ould "ant to see the

    e;act clinical data !e$ore using it.

    Bob Hollar: 3es of course. ust for te record' I tin it $as a

    reduction in incidence so tere is E6F patients actually

    contracted disease.

    Dr. Ostermann: O#ay, that is good.

    Bob Hollar: /o' tell me o$ tis migt impact your practice? Ho$

    migt assuming tese reser%ations or tings tat are

    uncertainties rigt no$ resol%e' o$ migt you use some

    product lie tis? &ere $ould you see at setting?

    Dr. Ostermann: re "e tal#ing a!out renal practice or critical care

    practice

    Bob Hollar: 3ou no$ $at' $ere you see if tere is a )t in bot

    place' $ould tat appreciate you ind of tin eac?

    Dr. Ostermann: O#ay, so thin# the most suita!le role is dialysis

    patients "ho are going on the transplant "aiting

    list and "ho have an increased ris# o$ &MV, so high%

    ris# dialysis patients pre%transplantation. I thin# 

    they "ould !e suita!le $or a vaccine and ta#es the

    "aiting list in the 8E $or transplant is longer than a

    year so < months o$ regular in/ections "ould !e

    >ne.

    Bob Hollar: Do you see any applicability beyond tat particularapplication?

    Dr. Ostermann: I$ you said the vaccine also "or#s in people actively

    receiving immunosuppreesion, then I could also see

    a role in patients "ho are receiving

    immunosuppresion $or other condition >rstA $or

    instanceA lupus and I could see a role $or people

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    "ho $or some 9 reason or another receive a

    transplant "ithout having had the vaccine !e$ore.

    So, i$ a high%ris# patient received the transplant

    !ut has not had the vaccine !e$ore and you pay to

    con>rm that the vaccine Is compati!le "ith

    immunosuppresion then I could see it !eing used attime o$ transplantation.

    Bob Hollar: Oay' %ery good. Doctor is tere anyting and I

    appreciate you being so indulge about te time but I am

    going to $rap it up rigt no$ and "ust as you if tere is

    any ting tat comes to mind tat $e did not discuss and

    I did not as you about at least tat you tin is rele%ant

    to te topics $e it on today?

    Dr. Ostermann: 4o not really, I thin# you have as#ed those

    uestions.

    Bob Hollar: Is tere migt you suggest' anyone tat $ould be really

    good for us to tal to tat as a broad' sort of base and a

    lot of disease indications to a potential +,- ris' are

    tere?

    Dr. Ostermann: (he HIV doctors, so doctors specialiBed in HIV

    disease.

    Bob Hollar: I s tere somebody tat you tin of tat $ould be

    somebody in particular tat $e sould tal to?

    Dr. Ostermann: I can’t thin# o$ any!ody !ut I thin# any doctor "ho

    specialiBes in loo#ing a$ter patients "ith retroviral

    disease is $ear$ul o$ &MV disease, especially i$ it

    e'ects the eyes and people get !lind.

    Bob Hollar: Oay. Doctor you a%e been %ery pleasant to tal to and

    %ery informati%e so I appreciate tat %ery muc. I am

    going to a%e my colleague for$ard on an email to you

    tat ind of con)rms our tal today and also introduce

    some furter details about your onorarium. Tere is also

    going to be a lin in tat email. I $onder if I could impose

    upon you enoug to "ust clic on tat and tere a sort'

    maybe 2 or 2minute online sur%ey tat is going to as

    you to "ust 0uantitati%ely rate a fe$ items and if tis goes

    so muc after ind of clicing on tings online' ten it

    $ould for me to %erbally poll you on tat. /o' if you $ill

    be ind enoug to do tat' $e $ill get your onoraria on

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    its $ay to you as soon as $e get a feedbac from tat and

    you sould be good to go. I really en"oyed our tal today

    and I tin $e got some %aluable information and I $ant

    to $is you a good rest of your day and tan you for

    your participation.

    Dr. Ostermann: O#ay, it "as my pleasure.

    Bob Hollar: All rigt' tan you doctor?

    Dr. Ostermann: O#ay, than# you !a%!ye

    (: )&M

    D: 109