Episode Transcript
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(00:08):
This transcript is automatically generated.
Caitlin Prather (00:00):
Honestly,
anybody who's HIV negative and
they're coming in and, you know,someone's requesting PrEP, it's
usually fair.
There may be something thatthey don't want to disclose to
you, you know, something thatthey consider private or
uncomfortable discussing.
So as long as they're HIVnegative and don't have any
(00:23):
contraindications to therapy,then PrEP can be used in quite a
Michael A. Deaney (00:28):
Both PrEP and
PEP regimens are extremely
effective against HIV.
Specifically with PrEP, they'revery effective if you're using
daily oral PrEP or injectable.
About 99% for sexual exposuresand 74% effective for those who
inject drugs and have thatexposure risk factor.
Narrator (00:48):
Welcome to Medication
Talk, an official podcast of TRC
Healthcare.
Home of pharmacist's letter,prescriber insights, and the
most trusted clinical resources.
Proud to be celebrating 40years of unbiased evidence and
recommendations.
On today's episode, we explorethe latest pharmacologic
strategies for HIV prevention,before and after exposure.
(01:09):
Our expert panel breaks downkey considerations for PrEP and
PEP, including indications, drugselection, dosing, and
monitoring.
Our guests today include twopharmacists accredited by the
American Academy of HIVMedicine.
Dr.
Caitlin Prather from the InnovaHealth System, and Dr.
Michael A.
Deeney from Children's HospitalColorado.
You'll also hear practicaladvice from TRC's Editorial
(01:32):
Advisory Board member, Dr.
Andrea Darby-Stewart from theUniversity of Arizona College of
Medicine, Phoenix.
This podcast is an excerpt fromone of TRC's monthly live CE
webinars.
Each month, experts andfrontline providers discuss and
debate challenges in practice,evidence-based practice
recommendations, and othertopics relevant to our
subscribers.
CE Narrator (01:52):
And now, the CE
information.
Narrator (01:58):
This podcast offers
continuing education credit for
pharmacists, pharmacytechnicians, physicians, and
nurses.
Please log in to yourpharmacist's letter, pharmacy
technician's letter, orprescriber insights account and
look for the title of thispodcast in the list of available
CE courses.
For the purposes of disclosure,Dr.
Prather reports a relevantfinancial relationship by
(02:18):
serving on Speaker's Bureau forHIV Prep with Veve Healthcare.
The other speakers you'll hearhave nothing to disclose.
All relevant financialrelationships have been
mitigated.
Now, let's join TRC editor, Dr.
Stephen Small, and start ourdiscussion.
Stephen Small (02:35):
This is a great
topic for this month since it
connects to our 40thanniversary.
Our first pharmacist letterissue was released in June 1985
when the HIV epidemic wasbecoming a major concern for
patients and healthcareproviders in the U.S.
and abroad.
In that issue, we noted thatthere is no cure for AIDS on the
(02:56):
immediate horizon despite allthe news coverage.
And we also pointed out that ateam of researchers at the
University of Colorado warnedthat switching needles by using
the same syringe invitestransmission of AIDS viruses.
Now, although we still don'thave a cure for HIV, we do now
have meds that can prevent HIV,including exposure from things
(03:16):
like injection drugs or needlesticks, which we'll talk about
today.
Before we dive into questionsfor our panelists, let's briefly
define PrEP and PEP.
PrEP, or pre-exposureprophylaxis, is intended to
prevent infection before HIVexposure from things like sexual
activity or injection drug use,and we've had med options for
(03:36):
this since 2015.
On the other hand, PEP, orpost-exposure prophylaxis, is
intended to prevent infectionafter exposure.
This includes exposures fromsexual activity, including cases
involving assault, injectiondrug use, and also occupational
exposures for healthcareworkers, things like needle
stick injuries.
So keep in mind, PEP has beenaround longer than PrEP.
(04:00):
It was introduced back in 1990.
Now with that context, let'sget into our questions.
Caitlin, which medications canbe used for PrEP and PEP?
What are sort of thedifferences maybe there we can
highlight?
Caitlin Prather (04:16):
So there are
three medications that are
currently FDA approved for usein PrEP or pre-exposure
prophylaxis.
The two oral options bothcontain emtricitabine as well as
a version of tenofovir.
So emtricitabine with tenofovirdisaproxyl fumarate.
This is the older version oftenofovir.
It's often abbreviated as TDF.
This is the generic of Truvada.
(04:37):
And then emtricitabine withtenofovir alafenamide or TAF is
Descovy.
These are both taken as onetablet by mouth daily.
And then our third option forPrEP is a long-acting injectable
of cabotegravir.
The brand name of this one isApertude.
And this one is administeredintramuscularly as a lead-in
phase of two doses given onemonth apart.
And then after that, it isevery two months.
(04:58):
For PEP, we have a fewdifferent options for
combinations.
Essentially, in the preferredregimen, it's either a version
of tenofovir and PrEP.
either emtricitabine orlamivudine plus an insti, so
either bictagravir ordolutagravir.
So this regimen can be achievedby using either combining
(05:19):
multiple combo products or as asingle tablet regimen of
something like bictarbi.
So that's bictagravir,emtricitabine, and TAF.
For our alternative agents, youcan use the same NRTI backbone
with the protease inhibitordarunavir boosted with either
cobicista or ritonavir.
And again, this can be achievedby either combining a few
different tablets or it can bedone as a single tablet regimen
(05:41):
with Symptusa, which isdronviricobisustat,
emtricitabine, and tenofoviralafenamide.
Stephen Small (05:49):
Excellent.
So we do have a couple optionsthere.
And this leads us to a goodquestion here.
We have a lot of differentmedication classes we just
pointed out.
Michael, how do these differentmedication classes work?
Michael A. Deaney (06:02):
Sure.
So the way that these differentmedications work is that
patients will take thesemedications preemptively to
protect themselves from HIVinfection.
The actual mechanisms of howthey work, basically in early
HIV infection, your lymphocytes,gut, vaginal, cervical tissue,
and rectal tissue all act asreservoirs of HIV.
(06:23):
So PrEP agents work by beingactive against different stages
of HIV replication, basicallystamping it down before it
starts replicating out ofcontrol.
So Truvada and Descovy, asCaitlin said, both contain
tenofovir and emtricitabine.
They're called nucleosidereverse transcriptase
inhibitors, more commonlyreferred to as NUCs, since
(06:43):
that's quite a mouthful.
They were blocked reversetranscriptase, an enzyme that
converts HIV RNA to DNA.
The first one that came out wasTruvada, and it's now one of
the only generic ones as well.
And it specifically containsTDF, so tenofovir-gestaproxyl
fumarate, which is a prodrug ofthe active tenofovir.
It achieves the goodconcentrations in all of the HIV
(07:07):
reservoirs and, like I said, isavailable as an oral tablet.
As far as Descovy goes, it alsocontains two nukes, just like
Truvada.
The difference highlighted hereis going to be that the
tenofovir prodrug is a littlebit different.
So it's tenofovir alafenamide,CAF, instead of TDF.
Basically, its structure ismodified to have a bit of a
(07:28):
longer half-life in the plasma,allowing it to have higher
concentrations in thelymphocytes and lower off-target
concentrations like in therenal tubules, which is
potentially why we see reducedrates of renal toxicity with
this drug.
But it's otherwise non-inferiorto Truvada in terms of efficacy
and just maybe a little lessharsh on the kidneys.
And then the last one iscabotegravir, which is an
(07:49):
integrase inhibitor.
It blocks the integrase enzymeto stop HIV DNA from entering
the host cell DNA.
It is the newest agent on themarket, and it is formulated as
a depot formulation that allowsit to be released slowly when
given as an intramuscularinjection, allowing for much
less frequent dosing intervals.
Stephen Small (08:09):
Great review of
how PrEP meds work.
And how about PEP, though?
We have lamivudine, that isalso a nuke, and bactegravir and
dolutegravir that are integraseinhibitors, like you said
before.
But what about proteaseinhibitors that are an
alternative for PEP?
Michael A. Deaney (08:27):
Yeah, so
protease inhibitors will stop
the new HIV viruses from makingimportant proteins for
replication, drugs likedurinavir or ritonavir.
Stephen Small (08:39):
Right.
And I believe cobicistat isalso there as sort of a booster
like ritonavir to boost thelevels of darunavir is my
understanding.
Excellent.
And then one question we get alot from our listeners is how do
these PrEP and PEP regimensdiffer from actual HIV
treatment?
Does anybody want to kind ofspell out those differences
there to put that inperspective?
(09:00):
Michael, how about you help usout here?
Michael A. Deaney (09:05):
Sure.
So PrEP and PEP regimens aredifferent from HIV treatment,
mostly in terms of treatmentgoals.
With PrEP regimens, we usuallyuse more active agents than
just, say, two nukes or oneintegrase inhibitor.
Oftentimes, we'll use multipleagents from different classes of
drugs that are active againstHIV in order to target different
(09:26):
stages of its replicationlifecycle to keep it at bay.
Stephen Small (09:31):
And another
important point here, too, is
sort of the duration we'retalking about, right?
Where treatment is going to bea different duration than maybe
PrEP or PEP.
What are the differences there?
Michael A. Deaney (09:42):
Yes, exactly.
So with PrEP regimens, most ofthe time they're only taken for
the duration where HIV exposurefactors are going to be present.
And then PEP is a fairlylimited duration of 28 days
after the exposure.
However, treatment, at least asof right now in our treatment
landscape for HIV, is going tobe indefinite.
So that's the other majordifference is treatment goals
(10:05):
and duration.
Yeah,
Stephen Small (10:07):
that's a great
way to put that in context.
Excellent.
And then, Michael, while I haveyou here, how effective are
these PrEP and PEP regimensagainst HIV?
We actually get that question alot from our listeners.
Since many patients are nowtaking these, how effective
would you say these are?
Michael A. Deaney (10:23):
Both PrEP and
PEP regimens are extremely
effective against HIV.
Specifically with PrEP, they'revery effective if you're using
daily oral PrEP or injectable.
About 99% for sexual exposuresand 74% effective for those who
inject drugs and have thatexposure risk factor.
Typically when we counselpatients, and we try to counsel
them to take it every singleday, in order to keep this down,
(10:45):
but there's somepharmacokinetic data that
suggests two to four doses perweek for rectal tissue and six
to seven doses per week forvaginal tissue may be
sufficient.
Clinical data seem to supportthat at least four to six doses
confer protection and low levelsof HIV acquisition, no matter
which group, though.
It usually takes about sevendays to max protection with oral
(11:06):
therapy for receptive anal sexand 21 days for receptive
vaginal or for people who injectdrugs.
Stephen Small (11:14):
Great.
And then, Caitlin, who would beeligible for these PrEP
therapies?
Are there certain risk factorsyou'd be looking for for a
patient to make them eligible toeven get these?
Caitlin Prather (11:28):
Yeah, so
honestly, anybody who is HIV
negative and is sexually activeand they're not in a monogamous
relationship with another HIVnegative individual can probably
benefit from PrEP.
But specifically, somecategories of folks that you may
want to kind of take a closerlook at in terms of determining
who could benefit the most fromit could be those who are having
(11:50):
anal or vaginal sex recentlyand they either have a partner
who is HIV positive or they'renot consistently using condoms
or they've also been diagnosedwith an STI recently.
We can also use PrEP inindividuals who inject drugs
with either an injection partnerliving with HIV or someone who
shares their supplies orequipment like needles and
(12:11):
syringes.
And then the third group wouldbe those who have been
prescribed PEP in the past, soour post-exposure prophylaxis.
So if we see that someone hasbeen using PEP historically,
that might show that they havesome type of potential
condition.
risk or some type of potentialexposure to HIV.
So that could be another goodcategory to look at for
(12:32):
potential patients.
But like I said, honestly,anybody who's HIV negative and
they're coming in and, you know,someone's requesting PrEP, it's
usually fair.
There may be something thatthey don't want to disclose to
you, you know, something thatthey consider private or
uncomfortable discussing.
So as long as they're HIVnegative and don't have any
contraindications to therapy,then PrEP can be used in quite a
(12:53):
few different individuals.
Stephen Small (12:57):
And then that
leads to our next question, who
is eligible for PEP?
PEP is indicated within 72hours of a possible HIV
exposure, whether that sourcehas HIV or their status is
unknown.
And this exposure generallyneeds to involve blood or
mucosal exposure, such as themouth or eyes, to high-risk
secretions that could carrylarge amounts of the virus.
(13:19):
These secretions can includeblood, breast milk, semen, and
vaginal or rectal secretions.
And CDC's 2025 PEP guidelineshave several visual algorithms
that help to really determine ifa patient needs PEP based on
the exposure, since these casescan be pretty complex.
And I recommend it as a helpfulresource if there are any
questions.
(13:39):
A key point to really rememberfrom all this is that the
72-hour mark after exposure iskey.
If we pass this time frame,it's generally too late to start
PEP, and patients may needdifferent care and monitoring.
That actually leads us to ournext question.
What lab tests are requiredwhen we're starting a patient or
(13:59):
maintaining a patient on PrEPand PEP?
What are some things maybepharmacists should be looking
out for for results?
Michael A. Deaney (14:09):
Sure, so I
can take this one.
So I think one of the very mostimportant lab tests that were
required for PrEP initiation isgoing to be an HIV test.
So this should be obtained atbaseline and then periodically
as well throughout treatment.
Because if you are positive forHIV and started on PrEP, you
are potentially being started onan inadequate regimen.
(14:31):
And this could lead topotential formation of
resistance for when you need toform a complete regimen for HIV
treatment later.
Other important things includeserum creatinine.
This is especially importantfor TDF-based regimens because
there are serum creatininecutoffs for using either TDF or
TAF-based regimens.
(14:52):
And that's also monitoredperiodically throughout.
You can see here every 6 and 12months.
And also other STIs.
Patients who are on PrEP are ata higher risk for additional
STIs outside of just HIV.
And having other STIs that areactive infections while being
exposed to HIV also heightensyour risk for acquiring HIV.
(15:13):
So at baseline, all patientsshould be tested for syphilis as
well as gonorrhea andchlamydia.
and the men, again,periodically thereafter.
It's recommended every threemonths for additional STI
testing for transgender womenand men who have sex with men,
just due to higher risk ofacquisition, and then every six
months for other populations.
Other important things includea lipid panel at baseline, and
(15:35):
then every 12 months thereafterfor patients on tenofovir
alafenamide, due to a slightlyhigher risk of lipid
abnormalities, and then baselinetesting for hepatitis B and
hepatitis C as well.
These are also transmissibleviruses that should be caught if
they're there, and this is agreat opportunity to get those
patients into care.
Andrea Darby-Stewart (15:54):
The one
comment that I had on this was
that I think that underhepatitis C at baseline, we need
to have a reminder to everyonethat all of our patients who are
18 and older should be screenedfor hepatitis C if they have
not been screened in the past.
And this implies that there areonly a subset of people who
(16:16):
might take oral PrEP that wouldneed to be screened for
hepatitis C.
Stephen Small (16:21):
That's excellent.
Thank you for that call outthere.
And I think it's also worthnoting that injectable PrEP
using cabotegravir has aslightly different monitoring
approach that you may see.
Since it doesn't have tenofovirin the formulation, it's not
necessarily required to checkrenal function labs, but
monitoring for HIV and othersexually transmitted infections
is still generally the same,usually timed up with the every
(16:44):
two-month visits to actuallyadminister the med.
And then how might thatcontrast with PEP if we're sort
of looking at post-exposureprophylaxis.
Is that lab testing similar?
Michael A. Deaney (16:54):
The lab
testing is extremely similar.
So as you can see here, we arealso testing at baseline and
then periodically thereafter forHIV antigen antibody, hepatitis
B, hepatitis C, other STIsincluding syphilis, gonorrhea,
and chlamydia, pregnancy aswell, and then serine creatinine
as well as liver enzymes.
Stephen Small (17:18):
And then this is
actually a good segue into our
next question from both aprescriber and pharmacist
perspective.
Andrea, how do you choose aPrEP regimen for a patient?
We actually have a patientexample here that can maybe help
us out, Lenny.
He's a 24-year-old cisgenderman who has sex with men, wants
to start PrEP since he prefersto not really use condoms during
(17:39):
intercourse.
And I'm curious, what questionswould you ask a patient first?
And what prep option might youeven advise for Lenny here?
Andrew, maybe you can startfrom the prescriber perspective.
Andrea Darby-Stewart (17:52):
Yeah,
absolutely.
Well, you know, as a primarycare physician, I need a little
bit more information about Lennythan what we provided here,
which is obviously the point ofthis discussion.
So, you know, for a Me, I wantto know, I want to clarify that
he's having sex with cisgendermen rather than trans men and
(18:13):
want to know what his partner'sstatus is in terms of HIV for
future reference, if he doesknow, if he does have a partner
who happens to be positive andthen has sex or sexual contact
with other partners as well.
How many partners does he have?
What is his sexual activitylike?
Where do body partners connect,basically, for him, because
(18:37):
that will have an implication aswell.
And then how good does he thinkhe's going to be at taking his
medications?
Taking a medication on a dailybasis versus using an as-needed
PrEP might be beneficial forhim, depending on how frequently
he does have sex.
And then also, we have to getdown to the brass tacks of how
(19:00):
much these medications cost andwhether or not he has an
insurance that will cover one oranother of the medications
that's available currently.
Stephen Small (19:11):
And Caitlin, is
there anything added from a
pharmacist perspective you mightbe wanting to ask or look for
in terms of info?
Caitlin Prather (19:20):
Sure.
So with regard to choosing aPrEP regimen, it's definitely
very patient-specific.
There are going to be manypatients who are eligible for
any of the products, and then itreally comes down to patient
preference and what's going towork best for them.
When that happens where thepatient doesn't have any
contraindications to any ofthem, I like to have that
(19:40):
conversation with them and say,whatever PrEP agent you can
adhere to is the best one foryou.
If you're able to be 100%adherent to a tablet and it
would be inconvenient for you tocome into the office to get
injections, then great, go withan oral PrEP agent.
If cost is your number oneconcern and maybe you don't have
insurance or you don't haveinsurance that covers PrEP very
(20:00):
well, then sure, do the generic.
But for some patients, it'sreally tough to take a pill
every single day.
And so they would prefer to dothe injection.
So really, it's just kind ofwhatever the patient prefers and
they're going to be able toadhere to.
Otherwise, it does come down tojust some of those key
differences.
So, you know, for example, ifthe patient has renal
dysfunction, then maybe ourinjectable would be best, or
(20:23):
there might be certain druginteractions that are only with
some of them.
So then you just have to kindof consider those individual
factors.
But there are going to be manypatients who who really qualify
for any of the three agents.
Stephen Small (20:37):
And Andrea, you
mentioned a moment ago kind of
as-needed dosing.
I think you're referring to the2-1-1 dosing for PrEP.
What is that, and how often doyou actually see this used in
your practice?
Andrea Darby-Stewar (20:50):
Absolutely.
It's a great question.
So 2-in-1 dosing is used forpeople who have planned
high-risk sexual activity, andit can be referred to basically
as on-demand dosing.
So if patients have infrequentintercourse and they can time
when that might happen, we wouldhave them take two tablets
anywhere between 2 and 24 hoursprior to having sexual
(21:13):
activities, and then they take asecond dose at 24 hours after
intercourse and a third dose 24hours later.
It's not FDA approved, butpatients find this helpful,
particularly if they are nothaving intercourse regularly and
still want to protectthemselves with a pharmacologic
method.
Stephen Small (21:35):
And then,
Michael, we talked earlier about
cabotegravir being a neweroption and that it's an
intramuscular injection.
How is that exactlyadministered for PrEP?
I know a lot of our listenershave questions about the steps
to that.
Is it just like any typicalinjection or are there maybe
some other things to think abouthere?
Michael A. Deaney (21:54):
Sure.
So I guess some basic steps toadministration.
Usually the way it's done isyou obtain the vial of the
cabotegravir.
It's about three milliliters ofdrug, so a pretty substantial
volume.
Allow it to reach roomtemperature before
administration since it istypically refrigerated
beforehand.
We de-shake the vial for about10 seconds to get a uniform
(22:16):
suspension before swabbing it,attaching the included adapter
in the kit, and then screwing ona syringe.
The kit does contain twodifferent sizes of syringes
depending on patient weight.
So there's a longer syringeattached for patients with a BMI
of greater than 30.
And then you draw up abouttheir three milliliter dose into
the syringe and administer itwithin two hours of preparation,
(22:39):
noting not to store the dose inthe refrigerator as it can
increase patient discomfort.
So other things to know aboutadministration of cabotegravir.
For first dose, sometimespatients will use an oral
lead-in, so the 28 days of oralcavitagravir, which is supplied
by the manufacturer, versus thatthey'll go straight to the
(22:59):
injections.
There's no strong preferencebetween these two in terms of
efficacy or anything like that,but you might consider an oral
lead-in for patients that are abit more nervous about having a
long-acting injectable orpotentially having have a
history of hypersensitivityreactions where you might want
to see how the drug does on ashort-acting basis before
(23:20):
something long-acting.
Caitlin Prather (23:24):
I probably have
about maybe 100 to 150 patients
who are on Apertude.
We've had very, very few whohave chosen to use the oral
lead-in.
It's mostly those patients whoeither have a long history of
drug allergies, so they're a Orthey've also just had some maybe
some bad experiences in termsof drug side effects in the
past.
(23:44):
So they want to, you know, kindof try it out.
I always have to give them thatwarning, though, of let's say
if you have a side effect andit's more of a GI type side
effect with the oral edin, thatdoesn't necessarily mean that
that's going to translate overto the injection.
So we have to kind of takethose, you know, whatever side
effects that they might get fromthe oral weed in with a grain
of salt because it's not theexact same product.
(24:06):
But yeah, we don't have verymany patients opt to do it.
We've probably had maybe two orthree total.
Michael A. Deaney (24:12):
Another
thing, too, about the
intragluteal injections, theycan definitely hurt.
That's the most common sideeffect with these meds.
And I'd say pretty much everypatient that we've administered
cabotegravir to in any form hascomplained of this, but it
doesn't normally stop them fromusing the drug, I'd say.
For patients where it feelssevere enough, we'll tell them
(24:34):
to use acetaminophen oribuprofen as well.
Oh, and one other thing aboutadministration that I think is a
good pearl is that fillers andimplants are typically excluded
from the trials.
So it's unclear about, and itcan certainly vary depending on
the filler implant as well inthe gluteal muscle.
(24:56):
So it's something to considerand something to ask patients if
we're considering them forcabotegravir injections, just to
make sure that we don'tpotentially administer something
that isn't actually going toget into the muscle because
there's an implant in the way.
Stephen Small (25:09):
That's really
unique.
I didn't think about that.
Thank you for pointing thatout.
And how long does maybe thatpain last after injection?
I'm sure it's variable, but isit like a week, maybe a day?
What have you seen in yourexperience, Michael?
Michael A. Deaney (25:26):
I'd say it's
relatively variable.
I've talked to patients andthey've said that they feel fine
by the end of day.
Sometimes it lasts for a coupleof days extra.
Yeah, it's not normally tooterribly long.
Definitely gone within a week,I'd say.
Stephen Small (25:37):
That's great.
Thank you for that insight.
That's super helpful.
And now that we've kind ofcovered PrEP, The next question
becomes, how do you choose apost-exposure prophylaxis
regimen?
Andrea, what's your take onthat from a prescriber
perspective?
And then I can move to Kaylaand Michael from the pharmacist
side of things.
Andrea Darby-Stewart (25:59):
So again,
for me, a lot of it is going to
be related to coverage andwhether or not, you know, what
my organization is covered, ifthis is a healthcare worker
exposure for my patients,insurance coverage as well.
Those are the two big areasthat tend to be the focus for my
team.
Stephen Small (26:19):
Great.
And Caitlin, anything from yourperspective for PET, if that's
prescribed, that you're lookingat from a pharmacist's point of
view?
Caitlin Prather (26:27):
Yeah, really,
it's primarily, like Andrew
said, the cost is definitely abig component of it.
And then with the updatedguidelines, We now have some
options for single tabletregimens.
So that also can play a role interms of, you know, finding
what's going to be the bestoption for the patient in order
for them to maintain goodadherence to that regimen.
Stephen Small (26:46):
Excellent.
And when we're writing theseprescriptions, what are common
errors to watch for with thesemeds?
It's a very unique class andthere's a lot of meds, a lot of
different names.
What are some things you watchout for?
Maybe how you mitigate thoserisks?
Andrea Darby-Stewart (27:04):
Oh boy.
Yeah.
This is all about names, namingconventions, right?
Like my head sometimes spinswhen I look at all of these
names.
And so I have an electronichealthcare record.
I'm able to set up a preferencelist, which help reduce the
risk for medication errors, butI try not to use abbreviations
for these medications.
And then one of the things thatwe want to do is make sure that
(27:26):
Tenofovir actually has theentire form written out as
opposed to just writing TNF,making sure you're including the
alafenamide versus thedisaproxyl fumarate.
Stephen Small (27:42):
I really like
those points, Andrea.
And it's a good time to specifythat tenofovir alafenamide and
tenofovir disaproxyl fumarateare not interchangeable
one-to-one.
Even though both can be usedfor PrEP and PEP, each salt form
has different dosing.
And also, watch cabotegravirproducts carefully.
We know from this discussion,IM cabotegravir alone is
(28:02):
approved for PrEP, but thesimilar cabotegravir plus
rilpivirine injection product onthe market is only intended for
HIV treatment, not PrEP.
So keep that in mind to avoidmix-ups.
And from the pharmacist'sperspective, what do you insure
is on these prescriptions whenyou receive them?
Michael A. Deaney (28:25):
Yeah, I
think...
Specifying the indication inthe SIG is important while
noting also the privacy of thepatient.
So wording it discreetly whatit's for and then specifically
the duration for sure.
So if it's daily oral prep,strict daily adherence,
preferred if the 201 method isgoing to be utilized, listing
(28:45):
that on the SIG as well.
And then write the duration andthe importance of adherence for
PEP for 28 days.
Caitlin Prather (28:56):
Really, I mean,
they're relatively
straightforward.
I think the biggest thing is tolook out for those errors with
the nomenclature like Andrea wasdiscussing.
The biggest thing I would sayis to really continue that full
regimen for PEP to make surethat, you know, they do continue
that for the full 28 days.
They don't discontinue justbecause they are not worried
about it anymore or whatever.
(29:17):
You know, make sure thatthey're completing that therapy
and having that follow-up withtheir provider at the end in
order to get those labs.
And for PEP, Same thing, justto ensure that there are no
lapses in adherence, so ensuringthat there are enough refills
and that it's very clear thatthis should be taken daily and
not on an as-needed basis.
Stephen Small (29:39):
And then we're
getting questions from our
technicians in the audience.
Are there any specificdispensing considerations for
technicians with thesemedications they should be
looking for?
Michael A. Deaney (29:50):
Yes.
I think when handing over thesemedications, I think it's very
important to to keep the meds inthe original containers due to
high costs, watch the quantitiesand durations on the
prescriptions to make sure thatthey match the appropriate
indication, utilizing thosecombo tablet options to improve
adherence where possible, andthen having the med supply on
hand to start therapy ASAP.
(30:10):
We definitely want to make surethat if a pharmacy is able to
dispense Pref or Cup, it's goingto be available at the ready.
I think another important thingtoo, especially when handing
the medication over to thepatient, is just to be discreet,
both about what the name of themedication is as well as the
indication for it, just in casethe patient isn't comfortable
with that kind of thing beingsaid out loud, especially in a
(30:32):
more busy pharmacy.
And then I think technicians aswell as pharmacists can kind of
watch out for some errors asfar as the medications go.
I know that Andrea pointed outa number of really, really good
observations.
The only ones that I'll add arethat pediatric dyscovy does
exist and is at a lower dosethan adult dyscovy.
(30:54):
It's not often kept in stocknecessarily in many retail
pharmacies, but it's definitelysomething to be aware of just
because it says dyscovy or justbecause it says FTAF, making
sure that dose does align sincethere are multiple doses.
Caitlin Prather (31:10):
Yeah, I agree
with everything that Michael
said.
Just a few additional things.
considerations would be to keepin mind that there are some
products that have both thegeneric and the brand name
products still available.
So Truvada is kind of the goodexample of that right now, where
the brand product is stillavailable.
So some patients may be gettingthat through like a patient
assistance program or a couponcard or something like that, but
(31:33):
we can't use those coupon cardsfrom the manufacturer when
we're talking about thegenerics.
And then another is just if youdo see a PrEP prescription, so
again, for Truvada or Descovy,or even Apertude, and it's being
filled less frequently than itshould, so it's not really
meeting that appropriate daysupply, that could imply that
that patient is having less thanideal adherence.
(31:53):
And that could be something tojust bring up with your
pharmacist so that they can havethat conversation with that
patient as well.
Stephen Small (32:01):
So Andrea, what
are some key counseling points
about these meds you might wantto share with patients that you
sort of focus on in yourpractice?
Andrea Darby-Stewart (32:09):
That's a
great question.
You know, I really emphasizethe need to take the medications
on a daily basis to optimizethe protective benefits of the
medications.
I try and emphasize 100%barrier method use for patients,
whether or not that's aninternal condom for people with
vaginas or an external condomfor those with penises, and want
(32:34):
to make sure that theyunderstand the need for regular
follow-up to ensure that theirHIV- status doesn't change while
they're taking this medicationbecause that can impact future
choices for their HIV treatmentmethodology.
If somebody is using PrEPintermittently, that's kind of
an important thing to keep inyour, in the case of my patient,
(32:55):
their travel go-to bag so thatthey actually have the
medication on hand when theyneed it.
And just emphasize that we arereally here to provide them with
great care and appreciate theirwillingness to have this
conversation with us.
Stephen Small (33:10):
And any adverse
effects you maybe warn patients
about ahead of time that you seecommonly?
Andrea Darby-Stewart (33:17):
You know,
we talk about things that seem
to pop up on almost every singlemedication's list of problems.
So nausea, diarrhea, headaches,fatigue, uncommon for patients
to develop the things that wecontinue to screen for, things
like kidney injury orhyperlipidemia.
But that's why emphasizingthose follow-ups and appropriate
(33:37):
laboratory follow-up forpatients on these medications is
done in our office.
Stephen Small (33:45):
That brings up
common questions we get around
billing considerations for thesePrEP and PEP meds.
What are some important thingsto consider here?
Caitlin Prather (33:54):
Sure, billing
considerations.
Definitely a great andimportant question.
I'll start with post-exposureprophylaxis.
So if it was an occupationalexposure, that's usually covered
under the patient's workplaceinjury compensation.
For other general exposuresoutside of the workplace, so for
NPEP, insurance will oftencover it, and there are some
(34:14):
state governments that provideadditional financial assistance,
likewise for sexual assaultexposures.
PrEP can be a little bit moretricky.
In general, most private andMedicaid plans do cover PrEP,
but that sometimes means thatthey cover all PrEP agents, and
sometimes it means that theyonly cover one, which they would
usually pick the leastexpensive product, which would
be the generic of Truvada, whichis emtricitabine with TDF.
(34:37):
Also, Medicare Part B doescover PrEP and related services
like labs without any costsharing.
And then there are, again, somestates with additional
assistance programs.
The drug companies also havesome really nice patient
assistance programs to help outwith patients who are uninsured.
For injectable aptitude,there's a lot that we could go
into that we just don't havetime to today.
(34:59):
But some key considerations arethat the injection may be
covered under the patient'spharmacy benefit or their
medical benefit throughspecialty pharmacy dispensing.
And then some insurance plansare only going to allow it to be
billed under the medicalbenefit of the insurance, and
clinics would then have toacquire that medication through
buy-and-bill practices.
So it's very...
(35:19):
dependent on each individualplan.
I really haven't found anyspecific trends.
So some places will fill itvery easily through the
specialty pharmacy and othersare kind of forcing it to go
through buy and build.
So that does vary a lot when itcomes to injectables because
then we're looking at specialtypharmacies rather than your kind
of more typical retailcommunity pharmacies.
Stephen Small (35:43):
And some audience
members are asking right now,
what are upcoming changes ordevelopments with PrEP and PEP
to keep in mind?
And in fact, FDA approvedlenacapivir or Yeztugo in June
2025 as another option for PrEP.
It's a unique antiretroviral,being the first-in-its-class
capsid inhibitor, and it stopsthe virus from assembly.
And its tablet and injectableformulations have already been
(36:06):
approved for HIV treatment.
Now, for PrEP, lenacapivir is along-acting subcutaneous
injection that can be used asmonotherapy.
And patients first start with atwo-day lead-in phase using an
injection along with oraltablets.
And then for maintenanceinjections, these are given as
two separate 1.5 ml doses intothe abdomen every six months.
(36:27):
Now, it's been approved foradults and adolescents down to
35 kilos.
And it's been shown to decreasesexually transmitted HIV
infection in cisgender men andwomen.
transgender men and women andnon-binary people as well.
However, it may take time forthis med to become available on
the market for purchasing andthe estimated costs are high,
(36:47):
possibly over $20,000 per year.
But the manufacturer alreadyhas a cost savings program in
place and we'll see how thatgoes.
And stay tuned for developmentsas we learn more.
Narrator (37:02):
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