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Pharmacist on the Front Lines: Responding to HIV

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Title: Pharmacist on the Front Lines: Responding to HIV


1
Pharmacist on the Front Lines Responding to HIV
  • Eric K Farmer, PharmD, BCPS, AAHIVP
  • Indiana University Health, LifeCare Program
  • April 20, 2016

2
Disclosures
  • I have no actual or potential conflicts of
    interest to disclose.

3
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

4
HIV Transmission
  • Transmission modalities
  • Bodily fluids blood, semen, vaginal fluid,
    breast milk
  • Mother to child (Vertical Transmission)
  • Intravenous drug use
  • Transfusions
  • Transmission risk

Blood transfusion 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
MMWR 54, Jan 2005
5

https//aidsinfo.nih.gov
6
DHHS Criteria to Start ART
CD4 count 1996 2001 2006 2008 2009 2012 - present
gt 500 Offer if VL gt 20k Offer if VL gt 20k Consider if VL 100k Consider in certain groups Consider Treat
350-500 Offer if VL gt 20k Consider if VL gt 55k Consider if VL 100k Consider in certain groups Treat Treat
200-350 Offer if VL gt 20k Offer, but controversy exists Consider Treat Treat Treat
lt 200 or symptoms Treat Treat Treat Treat Treat Treat
Pregnant women, HBV co-infection, HIVAN,
compelling indication
www.clinicalcareoptions.com/HIV
7
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 Indications for increased urgency to start ART
CD4lt350 or high VL (gt100k) 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
8
Balancing When to Start ART
  • ? 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
  • Drug toxicity
  • Preservation of limited Rx options
  • Risk of resistance (and transmission of resistant
    virus)

Early ART
Delayed ART
www.clincalcareoptions.com/HIV
9
START Study
Immediate ART ART initiated immediately
following randomization (n 2326)

HIV-positive, ART-naive adults with CD4
cell count gt 500 cells/mm3 (N 4685)
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
10
HIV Care Continuum
Mugavero MJ et al. CID 2013
11

http//crine.org/
12
Antiretroviral Timeline
13
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

14
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
Regimen-specific characteristics
Potential side effects
Inherent genetic barrier to resistance
Potential drug interactions
Convenience
Pill burden
Cost
Patient characteristics
Pre-treatment CD4 and VL
Presence of drug resistance
Patient preferences
Anticipated adherence
DHHS guidelines 2015 http//aidsinfo.nih.gov
15
Recommended Initial ART Regimens
DHHS guidelines 2016 http//aidsinfo.nih.gov
16
Alternative ART Regimens
DHHS guidelines 2016 http//aidsinfo.nih.gov
17
Alternative ART Regimens
Tolerability association with exacerbation of
psych issues
Pre-treatment HIV viral load lt 100,000 and CD4
gt200
400 calorie requirement Drug interaction with
PPIs
Pre-treatment Crcl 70 mL/min
Hyperbilirubinemia
Hyperbilirubinemia
HLA-B5701 negative
HSR Possible association with ? CV disease (ABC)
Pre-treatment Crcl 70 mL/min
DHHS guidelines 2016 http//aidsinfo.nih.gov
18
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
19
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
20
Assessing Regimen Failure
DHHS guidelines 2016 http//aidsinfo.nih.gov
21
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

22
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

23
Celebration of Learning Question 1
  • Which of the following single-tablet regimens is
    recommended by the DHHS as an initial ART
    regimen?
  • Elvitegravir/cobicistat/emtricitabine/tenofovir
  • Abacavir/zidovudine/lamivudine
  • Emtricitabine/tenofovir/efavirenz
  • Emtricitabine/tenofovir/rilpivirine
  • Emtricitabine/tenofovir

24
Practical Strategies to Improve Medication
Adherence
  • Adherence is a Journey, Not a Destination
  • -E Farmer

25
Dr. Seusss Pill Drill
  • For your Pill Drill youll go to Room Six
    Sixty-three,
  • where a voice will instruct you, Repeat after
    me
  • This small pill is what I munch
  • at breakfast and right after lunch.
  • I take the pill thats kelly green
  • before each meal and in between.
  • These loganberry-colored pills
  • I take for early morning chills.
  • I take the pill with ZEBRA STRIPES
  • to cure my early evening gripes.
  • These orange-tinted ones, of course,
  • I take to cure my charley horse.
  • I take three BLUES at half past eight
  • to slow my exhalation rate.
  • On alternative nights at nine p.m.
  • I swallow PINKIES. Four of them.
  • The reds, which make my eyebrows strong,
  • I eat like popcorn all day long.
  • The speckled browns are what I keep
  • beside my bed to help me sleep.
  • This long flat one is what I take
  • if I should die before I wake.

WHITE
Youre Only Old Once -Dr. Suess
26
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 doctors
    recommendations
  • How many have made recommendations to patients to
    which you have not or would not be adherent?
  • 290 Billion Dollar Question WHY?

27
Financial Implications of Adherence
http//pharmacy.ucsd.edu/pmt/mtm/benefits.shtml
28
Relative Adherence

Briesacher Pharmacotherapy 2008
29
CHD Adherence
plt0.0001
plt0.0001
R Kazerooni Pharmacotherapy 2013
30
Dose Frequency Effect on Adherence

Parienti, Clin Infect Dis 200948484
31
Dosing Frequency Effect on VL

Parienti, Clin Infect Dis 200948484-488
32
Gender Differences in Adherence?
33
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

34
Adherence at Every Visit

Readiness Health literacy Adherence
barriers Education
Self-report Pill count Refill data Provider
estimate
Hardy H, J Pharmacy Practice 200518(4)247
35
Readiness to Commit to Adherence

I dont want to
I am ready to start
Its too stressful
I guess Ill give it a try
I am OK with it
36
Adherence Barriers

37
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 199914267-273.
Stone VE JAIDS 200128124-131
38
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 199914267-273.
Stone VE JAIDS 200128124-131
39
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 199914267-273.
Stone VE JAIDS 200128124-131
40
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 199914267-273.
Stone VE JAIDS 200128124-131
41
Approaches to Enhance Adherence
  • Identify nonadherence
  • Involve patient and family/partner in care
  • Tailor treatment or schedule to patients
    lifestyle
  • Anticipate and coordinate pharmacy-related issues
  • Make appropriate medical or social referrals
  • Resist adherence attrition
  • Disease education

42
Easy Adherence Interventions
43
Making the Right Choice
  • Put a CHOICE in healthcare

44
Motivational Interviewing
45
Health Literacy
46
Swallowing Medications Tip 1
47
Swallowing Medications Tip 2



48
Swallowing Medications Tip 3


49
Swallowing Medications Tip 4


50
Medication Access
  • Patient Assistance Programs (PAP)
  • Copay Assistance
  • 4 dollar lists
  • Social workers
  • Pharmacists
  • Refill reminder programs
  • Auto-refill programs
  • Rx delivery programs

51
MedCoach for iPhone Android
https//itunes.apple.com/us/app/medcoach-medicatio
n-reminder/id443065594?mt8
52
MyMedSchedule for iPhone Android
J Am Pharm Assoc. 201353(2)172-181
http//www.mymedschedule.com/
53
Care4Today App

54
Wearables

55
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.

56
Adherence is so Simple
57
Summary
  • Address medication adherence at every visit.
    EVERY DOSE MATTERS
  • Many dynamic patient-, medication-, social-, and
    provider-related factors may affect adherence
    throughout a patients life.
  • Goal of entire healthcare team is to advise and
    motivate patients to take medications that are
    safe, tolerable, and effective.

58
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?
  • Provide disease education
  • Refer her for a home health aide
  • Suggest an adherence app for her smart phone
  • Set up a pill box
  • Sign her up for a refill reminder program

59
Questions?
60
Pharmacist on the Front Lines Responding to HIV
  • Eric K Farmer, PharmD, BCPS, AAHIVP
  • Indiana University Health, LifeCare Program
  • efarmer1_at_iuhealth.org

61
Recommended Laboratory Monitoring
Entry into care ART initiation or switch 2-8 weeks after ART initiation Q3-6 months Q6 months Q12 months Tx Failure Clinically Indicated If ART delayed
CD4 count X X X X X X X
HIV viral load X X X X X X X
Resistance Testing X X X X X
Hepatitis B serology X X X X
Hepatitis C serology X X X X
BMP X X X X X X
LFTs X X X X X X
CBC with diff X X X X X X
FLP X X X X X X
Fasting BG or AiC X X X X X X
Urinalysis X X X X X X
DHHS guidelines 2016 http//aidsinfo.nih.gov
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