Transcript s - Indiana Pharmacists Alliance

Pharmacist on the Front Lines:
Responding to HIV
Eric K Farmer, PharmD, BCPS, AAHIVP
Indiana University Health, LifeCare Program
April 20, 2016
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Disclosures
I have no actual or potential conflicts of interest
to disclose.
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Objectives
• Discuss the 2015 HIV epidemic in Indiana
• Outline opportunities for pharmacists to
support patients including education, testing,
and syringe exchange
• List current treatment guidelines and key
therapy recommendations
• Discuss strategies to improve medication
access and adherence
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HIV Transmission
• Transmission modalities
1. Bodily fluids: blood, semen, vaginal fluid,
breast milk
2. Mother to child (Vertical Transmission)
3. Intravenous drug use
4. Transfusions
Blood transfusion
• Transmission risk:
MMWR 54, Jan 2005
90%
Perinatal – no ART
25%
IVDA Needle sharing
0.67%
Receptive anal intercourse
0.5%
Percutaneous needle stick
0.3%
Receptive vaginal intercourse
0.1%
Receptive oral intercourse
0.01%
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https://aidsinfo.nih.gov
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DHHS Criteria to Start ART
CD4 count
1996
2001
2006
2008
2009
2012 present
> 500
Offer if
VL > 20k
Offer if
VL > 20k
Consider if
VL ≥ 100k
Consider in
certain
groups*
Consider
Treat
350-500
Offer if
VL > 20k
Consider if
VL > 55k
Consider if
VL ≥ 100k
Consider in
certain
groups*
Treat
Treat
200-350
Offer if
VL > 20k
Offer, but
controversy
exists
Consider
Treat
Treat
Treat
< 200 or
symptoms
Treat
Treat
Treat
Treat
Treat
Treat
*Pregnant women, HBV co-infection, HIVAN, compelling indication
www.clinicalcareoptions.com/HIV
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DHHS Recommendation to Start ART
ART is recommended for all HIV-infected
individuals to:
– Reduce the risk of disease progression (AI)
– Reduce morbidity and mortality associated with
HIV infection (AI)
– Prevent the transmission of HIV (AI)
Indications for “increased urgency” to start ART
CD4<350 or high VL (>100k)
Pregnancy
HBV/HCV co-infection
HIV-associated malignancy
Opportunistic infection
Acute/Early HIV-infection
HIVAN
AIDS-defining condition (HAD, etc)
Serodiscordance
Other compelling indication
DHHS guidelines 2016
http://aidsinfo.nih.gov
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Balancing When to Start ART
 Drug toxicity
 Preservation of limited
Rx options
 Risk of resistance (and
transmission of
resistant virus)
 ↑ potency, durability, simplicity,
safety of current regimens
 ↓ emergence of resistance
 ↓ toxicity with earlier therapy
 ↑ subsequent treatment
options
 Risk of uncontrolled viremia at
all
CD4+ cell count levels
 ↓ transmission
Delayed ART
Early ART
www.clincalcareoptions.com/HIV
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START Study
HIV-positive, ART-naive
adults with CD4+ cell
count > 500 cells/mm3
(N = 4685)
Immediate ART
ART initiated immediately
following randomization
(n = 2326)
Deferred ART
Deferred until CD4+ cell count ≤ 350 cells/mm3
AIDS, or event requiring ART
(n = 2359)
Primary Composite Endpoint (target = 213)
Serious AIDS or death from AIDS
Serious non-AIDS events and death not attributable to
AIDS
57% reduced risk of serious events or death with immediate ART
INSIGHT START Study Group. NEJM. 2015.
Lundgren J, et al. IAS 2015. Abstract MOSY0302
www.clinicalcareoptions.com
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HIV Care Continuum
Mugavero MJ et al. CID 2013
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http://crine.org/
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Antiretroviral Timeline
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Rilpivirine Patient Counseling
• Take with food
– “Full meal” with more than just protein
– Ideally at least 500 calories
• Take at same time each day
• Avoid any acid suppressing medications,
including OTC
• Inform doctor of a
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Considerations for Initial ART
Presence of Comorbidities/conditions
Cardiovascular disease, psychiatric illness, renal disease, drug abuse, etc.
Pregnancy, pregnancy potential, or desire for pregnancy
Coinfections: Tuberculosis, HBV, HCV
Patient characteristics
Pre-treatment CD4 and VL
Presence of drug resistance
Regimen-specific characteristics
Potential side effects
Inherent genetic barrier to resistance
Patient preferences
Anticipated adherence
Potential drug interactions
Convenience
Pill burden
Cost
DHHS guidelines 2015
http://aidsinfo.nih.gov
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Recommended Initial ART Regimens
Integrase Inhibitor-based regimens
• Abacavir/dolutegravir/lamivudine 600/50/300mg daily
• Dolutegravir 50mg daily +
emtricitabine/tenofovir DF 200/300mg daily
• Elvitegravir/cobicistat/emtricitabine/tenofovir DF
150/150/200/300mg daily
• Elvitegravir/cobicistat/emtricitabine/tenofovir AF
150/150/200/10mg daily
• Raltegravir 400mg BID +
emtricitabine/tenofovir DF 200/300mg daily
Protease Inhibitor-based regimen
• Darunavir 800mg daily + ritonavir 100mg daily +
emtricitabine/tenofovir DF 200/300mg daily
DHHS guidelines 2016
http://aidsinfo.nih.gov
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Alternative ART Regimens
NNRTI-Based Regimens
Tolerability;
association with exacerbation
of psych issues200/300/600mg
• Emtricitabine/tenofovir
DF/Efavirenz
daily
• Emtricitabine/tenofovir
DF/rilpivirine
200/300/25mg
Pre-treatment
HIV viral loaddaily
< 100,000
400 calorie
requirement; Drug
and CD4 >200
interaction with PPIs
PI-Based Regimens
• Atazanavir/cobicistat
Hyperbilirubinemia
300/150mg daily + Pre-treatment Crcl ≥
70 mL/min
emtricitabine/tenofovir DF 200/300mg daily
• Atazanavir 300mg daily + ritonavir 100mg daily +
Hyperbilirubinemia
emtricitabine/tenofovir DF 200/300mg daily
• [Darunavir/cobicistat 800/150mg or Darunavir
800mg
HSR; Possible association with ↑ CV
HLA-B*5701 negative
daily + ritonavir 100mg daily] + abacavir/lamivudine
disease (ABC)
600/300mg daily
• Darunavir/cobicistat 800/150mg daily + Pre-treatment Crcl ≥
emtricitabine/tenofovir 200/300mg daily 70 mL/min
DHHS guidelines 2016
http://aidsinfo.nih.gov
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Single Tablet Regimens
Advantages
Disadvantages
Simplicity
Inability to adjust dosages of
components if needed due to
drug interaction or renal
insufficiency
Convenience
Not available for all ART
regimens
Fewer copays
May facilitate resistance of
certain antiretroviral agents
Reduces selective adherence to
components of regimen
Travel convenience
www.clinicalcareoptions.com
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Recommended Laboratory Monitoring
CD4 count
Viral load
Resistance testing
Hepatitis serology
BMP
LFTs
CBC with differential
FLP
Fasting BG or A1C
Urinalysis
Other specialty tests as clinically appropriate
DHHS guidelines 2016
http://aidsinfo.nih.gov
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Assessing Regimen Failure
DHHS guidelines 2016
Adherence
Resistance
PK Issues
Intolerance
http://aidsinfo.nih.gov
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HIV & ART Resources
• www.aidsinfo.nih.gov
• www.cdc.gov
• www.hiv-druginteractions.org
• www.hivinsite.com
• www.nccc.ucsf.edu
• www.clinicaloptions.com/HIV
• www.iasusa.org
• www.matec.info
• www.aidsetc.org
• www.thebody.com
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Antiretroviral Pearls
• In ANY setting, a quality and accurate medication
reconciliation involving ART is well worth the extra
time and effort
• Remember lesson 1 from pharmacy school: When
in doubt, look it up
• When ART is involved, always consider a potential
drug interaction as significant until proven
otherwise
• Use your resources
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Celebration of Learning Question #1
Which of the following single-tablet regimens is
recommended by the DHHS as an initial ART
regimen?
A. Elvitegravir/cobicistat/emtricitabine/tenofovir
B. Abacavir/zidovudine/lamivudine
C. Emtricitabine/tenofovir/efavirenz
D. Emtricitabine/tenofovir/rilpivirine
E. Emtricitabine/tenofovir
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Practical Strategies to
Improve Medication
Adherence
Adherence is a Journey, Not a
Destination
-E Farmer
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Dr. Seuss’s Pill Drill
For your Pill Drill you’ll go to Room Six
Sixty-three,
“I take three BLUES at half past eight
where a voice will instruct you, “Repeat
after me…
On alternative nights at nine p.m.
This small WHITE pill is what I munch
to slow my exhalation rate.
I swallow PINKIES. Four of them.
I take the pill that’s kelly green
The reds, which make my eyebrows
strong,
before each meal and in between.
I eat like popcorn all day long.
These loganberry-colored pills
The SPECKLED BROWNS are what I keep
I take for early morning chills.
beside my bed to help me sleep.
I take the pill with ZEBRA STRIPES
This long flat one is what I take
to cure my early evening gripes.
if I should die before I wake.”
at breakfast and right after lunch.
These orange-tinted ones, of course,
I take to cure my charley horse.“
You’re Only Old Once -Dr. Suess
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Adherence in Your Practice
• How many have recommended a medication to
a patient and the patient did not take it?
• How many have prescribed a lifestyle
modification to a patient and the patient did not
take it?
• How many have been nonadherent to YOUR
doctor’s recommendations
• How many have made recommendations to
patients to which you have not or would not be
adherent?
• $290 Billion Dollar Question: WHY?
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Financial Implications of Adherence
http://pharmacy.ucsd.edu/pmt/mtm/benefits.shtml
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Relative Adherence
Briesacher Pharmacotherapy 2008
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CHD & Adherence
*p<0.0001
*p<0.0001
R Kazerooni Pharmacotherapy 2013
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Dose Frequency & Effect on Adherence
Parienti, Clin Infect Dis 2009;48:484
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Dosing Frequency & Effect on VL
Parienti, Clin Infect Dis 2009;48:484-488
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Gender Differences in Adherence?
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Medication Goals
• Start patients on medications that are likely to
fit well into their current lifestyle.
• Maintain patients on medications that:
– Are effective for their given disease state
– Patients are able to tolerate with no significant
complaints or lab abnormalities
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Adherence at Every Visit
Readiness
Health
literacy
Adherence
barriers
Self-report
Assessment
Measurement
Pill count
Refill data
Provider
estimate
Education
Interventions
Hardy H, J Pharmacy Practice 2005;18(4):247
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Readiness to Commit to Adherence
I am ready
to start
It’s too stressful
I don’t want to
I am OK with it
I guess I’ll give it
a try
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Adherence Barriers
Patient
Medication
Environment
Provider
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Patient-related Barriers
• Forgetfulness
• Active substance abuse
• Mental illness
• Low health literacy
– Reading skills deficient in 51% US adults
• Negative belief about efficacy
• Confidentiality
Kalichman SC J Gen Intern Med 1999;14:267-273. Stone VE JAIDS 2001;28:124-131
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Medication-related Barriers
• Pill burden / Pill fatigue
• Side effects
• Dosing frequency
• Regimen complexity
• Dietary and water requirements
• Pharmacy barriers
– Insurance co-payments or other issues
– Refill method
– Confidentiality
Kalichman SC J Gen Intern Med 1999;14:267-273. Stone VE JAIDS 2001;28:124-131
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Social/Environmental-related Barriers
• Poor family or social support
• Cultural / religious beliefs
• Confidentiality
• Work / School / Family responsibilities
• Number of follow up appointments
• Access to adequate nutrition
• Access to reliable transportation
Kalichman SC J Gen Intern Med 1999;14:267-273. Stone VE JAIDS 2001;28:124-131
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Provider-related Barriers
• Lack of sensitivity
• Body language
• Prejudices
• Time constraints
• Language and/or cultural barriers
• Patient vs. Provider competing
priorities
Kalichman SC J Gen Intern Med 1999;14:267-273. Stone VE JAIDS 2001;28:124-131
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Approaches to Enhance Adherence
• Identify nonadherence
• Involve patient and family/partner in care
• Tailor treatment or schedule to patient’s lifestyle
• Anticipate and coordinate pharmacy-related issues
• Make appropriate medical or social referrals
• Resist adherence attrition
• Disease education
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“Easy” Adherence Interventions
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Making the Right Choice
Put a CHOICE in healthcare
Power
Choice
Options
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Motivational Interviewing
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Health Literacy
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Swallowing Medications: Tip #1
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Swallowing Medications: Tip #2
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Swallowing Medications: Tip #3
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Swallowing Medications: Tip #4
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Medication Access
• Patient Assistance Programs (PAP)
• Copay Assistance
• $4 dollar lists
• Social workers
• Pharmacists
• Refill reminder programs
• Auto-refill programs
• Rx delivery programs
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MedCoach for iPhone & Android
https://itunes.apple.com/us/app/medcoach-medication-reminder/id443065594?mt=8
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MyMedSchedule for iPhone & Android
J Am Pharm Assoc. 2013;53(2):172-181 http://www.mymedschedule.com/
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Care4Today App
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“Wearables”
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Medication Adherence Pearls
1. Medications will work if they are taken as
prescribed.
2. Medications affect everyone differently.
3. Medications work as a team. It is essential to
take all medications as prescribed to achieve
the desired, optimal outcome.
4. Ongoing communication is needed with
healthcare providers and between providers.
5. Every dose matters.
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Adherence is so “Simple”
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Celebration of Learning Question #2
Which of the following would be the most
appropriate initial strategy to enhance the
adherence of an elderly patient who frequently
forgets if she has taken her morning dose of
medications?
A. Provide disease education
B. Refer her for a home health aide
C. Suggest an adherence app for her smart phone
D. Set up a pill box
E. Sign her up for a refill reminder program
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Questions?
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Pharmacist on the Front Lines:
Responding to HIV
Eric K Farmer, PharmD, BCPS, AAHIVP
Indiana University Health, LifeCare Program
[email protected]
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