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8/21/2019 Ostermann Bob Hollar
1/26
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
8/21/2019 Ostermann Bob Hollar
2/26
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.
8/21/2019 Ostermann Bob Hollar
3/26
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 $e "ust identi)ed' te
immunosuppressed cancer patients or te transplant
patient?
Dr. Ostermann: It is lo"er.
Bob Hollar: Oay.
Dr. Ostermann: It is lo"er and until the point that they get a
transplant and then it is high.
8/21/2019 Ostermann Bob Hollar
4/26
Bob Hollar: Oay' perfect. 3ou mentioned speci)cally lupus' is it
lupus nepritis ten tat typically puts tem into tat?
Do tey enter into tat sort of renal 4o$ 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.
8/21/2019 Ostermann Bob Hollar
5/26
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
8/21/2019 Ostermann Bob Hollar
6/26
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.
8/21/2019 Ostermann Bob Hollar
7/26
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 $it
tat?
8/21/2019 Ostermann Bob Hollar
8/26
Dr. Ostermann: (he highest%ris# group
Bob Hollar: &e#ll' groups you no$. ,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
8/21/2019 Ostermann Bob Hollar
9/26
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$=
8/21/2019 Ostermann Bob Hollar
10/26
Bob Hollar:
8/21/2019 Ostermann Bob Hollar
11/26
Dr. Ostermann: (hat is signi>cantly. So, the &MV%positive lupus
patients, the ris# o$ &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
8/21/2019 Ostermann Bob Hollar
12/26
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.
8/21/2019 Ostermann Bob Hollar
13/26
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 $act that this time on the
8/21/2019 Ostermann Bob Hollar
14/26
ventilator may have !een associated "ith
immunosuppression.
Bob Hollar: 3ou "ust sort of triggered anoter possibility. Is it "ust te
amount of time tat tey spend in te I+@' is tat anoter
potential?
Dr. Ostermann: Yes, it is also. Yes, de>nitely so. longer stay in
the I&8 usually means that patients "ere sic#er so
it correlates "ith severity o$ 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 $en during teir stay in te I+@ so you see
some infections or disease immediately or does it
basically "ust increase gradually o%er time?
I=GI=G
Dr. Ostermann: &an I /ust interrupt you. &an I /ust ans"er this
phone a second
Bob Hollar: /ure.
8/21/2019 Ostermann Bob Hollar
15/26
A=/&8>I=G cant increase in their ris# o$
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.
8/21/2019 Ostermann Bob Hollar
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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 +,
8/21/2019 Ostermann Bob Hollar
17/26
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.
8/21/2019 Ostermann Bob Hollar
18/26
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 $e" years !ut a!out 91 years ago "e
changed the prophyla;is to valaciclovir.
Bob Hollar: To %alaciclo%ir?
Dr. Ostermann: Sorry, valganciclovir.
8/21/2019 Ostermann Bob Hollar
19/26
Bob Hollar: Oay' %ery good. /o' again sort of focusing in an I+@
aspect of your e(perience rigt no$' 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
8/21/2019 Ostermann Bob Hollar
20/26
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
8/21/2019 Ostermann Bob Hollar
21/26
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.
8/21/2019 Ostermann Bob Hollar
22/26
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 $ic migt con)rm
more immediate immune bene)t to be used as sort of a
sort2term strategy and te %accine being more of a long2
8/21/2019 Ostermann Bob Hollar
23/26
term strategy to$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.
8/21/2019 Ostermann Bob Hollar
24/26
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
8/21/2019 Ostermann Bob Hollar
25/26
"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
8/21/2019 Ostermann Bob Hollar
26/26
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