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HIV/AIDS in Special
Populations: Management
and Treatment Updates for
Pharmacists
Pamela M. Moye, Pharm.D.,
BCPS, AAHIVP
Clinical Associate Professor/Clinical Specialist
Mercer University College of Pharmacy
Disclosure
I do not have (nor does any immediate family member
have) actual or potential conflict of interest, within the
last twelve months; a vested interest in or affiliation
with any corporate organization offering financial
support or grant monies for this continuing education
activity; or any affiliation with an organization whose
philosophy could potentially bias my presentation.
Learning Objectives
 After completing this course, learners will better
understand:
◦ the epidemiology, replication cycle and sites of drug activity for HIV
virus
◦ the risk and challenges that special populations have with regard to
living with HIV/AIDS
◦ the critical issues and risks factors for HIV/AIDS special populations as
they relate to HIV/AIDS treatment, adherence and care
◦ the common laboratory parameters, key adverse effects, and other
monitoring parameters that are used for disease progression as well
as safety and effectiveness of ARV treatment in special populations
◦ appropriate antiretroviral management strategies for HIV-infected
patients in special populations
◦ the procedures/policies of how to order HIV specialty drugs
Historical Perspective
 June 1981 – 1st cases of PCP
among healthy young men
reported
 April 1984 – HIV isolated
 March 1987 – AZT
approved: first licensed
therapy for HIV
 December 1995 –
Saquinavir approved: first
protease inhibitor
 December 2002 –16 drugs
from 4 classes available for
treatment
Choose Your Weapon…
AZT
Double
No effective therapy monotherapy nucelosides
1980
1990
Early
HAART
Standard of
care HAART
2000
6 1/2
classes
2016
Incidence
 HIV infection has now spread to every country in
the world
 ~40 million people are currently living with HIV
 ~25 million have died from the disease
 In the US ~1 million people are currently infected
EVERY 9.5 MINUTES
SOMEONE IN THE U.S. IS
INFECTED WITH HIV
These are the 10 states or dependent
areas reporting the highest number of
HIV diagnoses in 2014:
 Florida
 Georgia
 Maryland
 Texas
 North Carolina
 California
 New Jersey
 Louisiana
 Illinois
 New York
1. California
2. Florida
3. Texas
4. New York
5. Georgia
6. Illinois
7. New Jersey
8. North Carolina
9. Louisiana
10.Maryland
MS is a 55-yr-old White woman coming
to her first appointment at the
ambulatory care clinic. As you take her
medical history, she mentions that other
than her diabetes and an ovarian cyst a
few years ago she feels great. You ask
her if she has ever been tested for HIV.
She says no and also says that she is
confident that she has not acquired HIV.
Is there a basis for you to
encourage/discourage her to be tested
at this time?
Screening
CDC Recommendations for HIV
Testing of Adult Patients
 In all healthcare settings, screening for HIV infection
should be performed routinely for all patients aged
13-64 years of age unless local prevalence has been
documented to be < 0.1%
 All pregnant women
CDC MMWR Recomm Rep. 2013;62(RR-5):1-17.
Transmission
Modes of Transmission
 Sexual exposure to an HIV-infected person
 Mucocutaneous (e.g. splash in eye, mouth or on broken
skin) parenteral exposure to HIV-infected body fluids
(e.g., needlestick injuries)
 Mother-to-child transmission of HIV infection (MTCT)
◦ Up to 90% of transmission occurs during last 2 months of
pregnancy with up to 65% of MTCT occurring during
intrapartum period
AIDS 2006; 20:805-12
In the United States, HIV is
spread mainly by______________.
Monitoring and
Disease
Progression
Initial Laboratory Evaluations for HIV(+)
Patients
Test
Rationale
Result
Frequency and comments
HIV Staging and Antiretroviral Therapy (ART) Monitoring
CD4 Count
Staging and prognosis
Reported in cells/µL
Repeat every 3 - 6 months
Plasma HIV RNA
Provides marker for pace
of HIV progression
determines indication for
and response to ART
Reported in copies/mL
For patients on new or modified ART regimen:
perform 2 - 8 weeks after initiation or change
in ART
Untreated pts, detectable and
measured upper limit of
detection (>500,000
copies/mL).
Pts taking ART, ideally
suppressed to undetectable
levels (usually <50 or ≤75
copies/mL).
Resistance Testing
Assess ART to which the
pt's HIV virus is likely to
be resistant
ART= antiretroviral therapy, ARV= antiretroviral
For patients on stable ART: perform every 3 - 6
months.
Genotype: detects specific
mutations to ART
Genotype (one time) recommended in all ARV
naive patients
Phenotype: measures HIV viral
replication in the presence of
ART
Modification of ART
Treatment failure
AETC National Resource Center, www.aidsetc.org Accessed April 11, 2016
Initial Laboratory Evaluations for HIV (+)
Patients
Test
Rationale
Result
Frequency and comments
HIV Staging and Antiretroviral Therapy (ART) Monitoring
CBC w Diff
Detects cytopenias,
calculation of CD4.
Normal
Repeat every 3 - 4 months
Abnormal
Requires follow-up evaluation as
indicated; may influence choice of ARTs.
CMP
Renal dysfunction,
electrolytes, LFT to
detect HCV, HIV
nephropathy [assoc.
infections]
Normal/Abnormal
Repeat every 6-12 months, and as
needed to monitor ART.
Lipid Panel
Baseline before
starting ART
Normal
Repeat annually or more frequently
(every 4-8 weeks) based on initial
results, ARVT use, or risk of
cardiovascular disease.
Abnormal
Monitoring during ART
Treat for dyslipidemia
AETC National Resource Center, www.aidsetc.org Accessed April 11, 2016.
Initial Laboratory Evaluations for HIV
(+) Patients
Test
Rationale
Result
Frequency and comments
Other Opportunistic Infection Screening Tests
Toxoplasma gondii IgG
Detects exposure; if (+),
increased risk of
developing CNS
toxoplasmosis if CD4
count <100 cells/µL
Normal/negative
Repeat if patient becomes symptomatic or
when CD4 count drops to ≤100 cells/µL.
PPD (tuberculin skin
test) (if no history of TB
or positive PPD)
Detects latent TB
infection
Normal
Repeat every 6-12 months.
Repeat if CD4 count was <200 cells/µL on
initial test but increases to >200 cells/µL
Abnormal (≥5 mm)
Evaluate for active TB
Hepatitis A, B, and C
Serologies
STD Panel (chlamydia,
gonorrhea, syphillis)
AETC National Resource Center, www.aidsetc.org April 11, 2016
Other Assessment and Monitoring
Studies
 HLA-B*5701 screening
◦ Recommended before starting ABC, to reduce risk
of hypersensitivity reaction (HSR)
◦ HLA-B*5701-positive patients should not receive ABC
◦ Positive status should be recorded as an ABC allergy
◦ If HLA-B*5701 testing is not available, ABC may be initiated
after counseling and with appropriate monitoring for HSR
 Coreceptor tropism assay
◦ Should be performed when a CCR5 antagonist
is being considered
◦ Phenotype assays have been used; genotypic test now available but has been
studied less thoroughly
◦ Consider in patients with virologic failure on a CCR5 antagonist (though does
not rule out resistance to CCR5 antagonist)
AETC National Resource Center, www.aidsetc.org Accessed April 11, 2016.
Health Care Maintenance
 Immunization of patients with HIV (no live virus vaccines
if CD4 count ≤ 200/mm3)
 Influenza virus vaccine: Annually before the influenza
season
 Pneumococcal vaccine: Once (ideally, before CD4 count
< 200/mm3)
 Tetanus and diphtheria toxoid – same indication and
schedule as patients without HIV infection
 Hepatitis B vaccine: For all susceptible patients
 Hepatitis A vaccine: For all at-risk patients
AETC National Resource Center, www.aidsetc.org Accessed April 13, 2015
Goals of ART and Strategies
to Achieve Goals
 Maximal and durable
suppression of viral load
 Restoration and/or
preservation of immunologic
function
 Selection of ART
 Maximizing adherence
 Reduction of HIV-related
morbidity and mortality
 Use of resistance testing in
selected clinical settings
 Improvement of quality of life
 Prevent transmission
ART= antiretroviral therapy
AETC National Resource Center, www.aidsetc.org Accessed April 11, 2016.
A 41-year-old woman was recently diagnosed with HIV
infection, and the initial laboratory studies showed a CD4
count of 238 cells/mm3 and an HIV RNA level of 112,000
copies/ml. After several visits to the clinic and repeat
laboratory studies that show similar results, she starts on
an ART regimen of tenofovir-emtricitabine-elvitegravircobicistat (Stribild).
According to the most recent update of DHHS
antiretroviral guidelines, which of the following is TRUE
regarding laboratory monitoring after starting this patient
on antiretroviral therapy?
A. The CD4 cell count is the most important laboratory test to
obtain at 1 month after starting ART.
B. A follow-up HIV RNA value should first be checked 10 to 12
weeks after starting therapy.
C. A follow-up HIV RNA value should first be checked 2 to 4
weeks after starting therapy.
What Happens with untreated
HIV-1 Infection
Plasma Levels
Plasma Viral Load
Peripheral Blood
CD4+ T-Cell Count
AIDS = CD4<200
Weeks
Acute Infection
Years
Chronic Infection
The Drugs
The Ideal Antiretroviral
Potent
Easily administered
Low cost
High resistance barrier
Effective as monotherapy
Few adverse effects
Few drug interactions
Disturb latent HIV reservoirs
Current ARV Medications
NRTI
PI
 Abacavir (ABC)
 Atazanavir (ATV)
Fusion Inhibitor
 Didanosine (ddI)
 Darunavir (DRV)
 Enfuvirtide
(ENF, T-20)
 Emtricitabine (FTC)
 Fosamprenavir
(FPV)
CCR5 Antagonist
 Indinavir (IDV)
 Maraviroc (MVC)
 Lamivudine (3TC)
 Stavudine (d4T)
 Tenofovir DF (TDF)
 Tenofovir alafenamide (TAF)
 Zidovudine (AZT, ZDV
NNRTI
 Lopinavir (LPV)
 Nelfinavir (NFV)
Pharmacokinetic (PK)
booster
Saquinavir (SQV)
 Ritonavir (RTV)
 Tipranavir (TPV)
 Cobicistat (COBI)
 Delavirdine (DLV)
Integrase Inhibitor
(INSTI)
 Efavirenz (EFV)
 Dolutegravir (DTG)
 Etravirine (ETR)
 Elvitegravir (EVG)
 Nevirapine (NVP)
 Raltegravir (RAL)
 Rilpivirine (RPV)
Available Combination Products
 Quad Therapy
◦ Stribild®: (elvitegravir, EVG/
cobicistat, COBI/ emtricitabine,
FTC/ tenofovir, TDF)
◦ Genvoya®: (EVG/COBI/tenofovir
alafenamide, TAF/FTC
 Triple Therapy
◦ Atripla®: (efavirenz,
EFV/FTC/TDF)
◦ Complera®: (FTC/ rilpivirine,
RPV/TDF)
◦ Odefsey®: (FTC/RPV/TAF)
◦ Triumeq®: (abacavir, ABC/
dolutegravir, DTG/ lamivudine,
3TC)
◦ Trizivir ®: (ABC/ lamivudine,
3TC/ zidovudine, ZDV)
 Dual Therapy
◦ Combivir®: (3TC/ZDV)
◦ Epzicom®: (ABC/3TC)
◦ Truvada®: (FTC/TDF)
 PI with Boosting Agent
◦ Evotaz®: (atazanavir, ATV/COBI)
◦ Kaletra®: (lopinavir/ritonavir)
◦ Prezcobix®: (darunavir,
DTV/COBI)
HIV Replication Cycle and Sites of Drug Activity
Adapted:Levy JA. HIV and the Pathogenesis of AIDS. 2nd ed. Washington, DC: American Society for Microbiology; 1998:9-11
Integrase Inhibitors
NRTIs
NNRTIs
Cellular DNA
Protease Inhibitors
Attachment Inhibitors
New HIV
particles
Nucleus
HIV Virions
Reverse
Integrase
Transcriptase
Protease
Capsid
proteins
and viral
RNA
Entry
Inhibitors
Viral RNA
Unintegrated
double stranded
Viral DNA
CCR5
or
CXCR4
co-receptor
Integrated
viral DNA
Attachment
3
2
1
Uncoating
Reverse
Transcription
Integration
Viral
mRNA
4
Transcription
gag-pol
polyprotein
5
Translation
6
Assembly and Release
The Guidelines
Initial ART Regimens: DHHS
Categories
 Recommended
◦ Randomized controlled trials show optimal efficacy and
durability
◦ Favorable tolerability and toxicity profiles
 Alternative
◦ Effective but have potential disadvantages
◦ May be the preferred regimen for individual patients
 Other
◦ May be selected for some patients but are less satisfactory
than preferred or alternative regimens
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults
and adolescents. Department of Health and Human Services. Available
at http://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf. Accessed April 11, 2016.
Initial Regimens:
Recommendations
PI
based
INSTI
based

DRV/r (daily) + TDF/FTC1 (AI)



DTG/ABC/3TC2; only if HLA-B*5701 negative (AI)
DTG (daily) + TDF/FTC1 (AI)
EVG/COBI/TDF/FTC1; only if pre-ART CrCl >70
mL/min (AI)
EVG/COBI/TAF/FTC1; only if pre-ART CrCl ≥30
mL/min (AI)
RAL + TDF/FTC1 (AI)


1. 3TC can be used in place of FTC and vice versa. TDF: caution if renal insufficiency.
2. Caution if HIV RNA >100,000 copies/mL, or if high risk of cardiovascular disease.
TDF = tenofovir, FTC = emtricitabine, DRV/r = darunavir/ritonavir, RAL = raltegravir, EVG/COBI = Elvitegravir/cobicistat, DTG =
dolutegravir, ABC = abacavir, 3TC = lamivudine, TAF= tenofovir alafenamide
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1infected adults and adolescents. Department of Health and Human Services. Available
at http://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf. Accessed April 11, 2016.
Special Populations
Special Populations
 Adolescents
 Women and Pregnancy
 Older Patient
 Preventing Secondary Transmission
The Adolescent
The HIV-Infected Adolescent
 Heterogeneous group in numerous respects
 Most acquired HIV though sexual risk behaviors
◦ 26% of new HIV infections in United States are estimated to
occur in youth aged 13-26 (2010)
◦ 57% of these are in young black/African Americans
◦ 75% in young MSM
◦ In 2010, CDC estimated that 60% of HIV-infected youth were
undiagnosed
 Some infected perinatally or via blood products
◦ Usually heavily treatment experienced
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
The HIV-Infected Adolescent
 ART recommended for all
 Readiness and ability to adhere to ART should be
carefully considered
 Support is needed to reduce barriers to
adherence and maximize ART success
 Adult guidelines for ART usually appropriate for
postpubertal adolescents
ART= antiretroviral therapy
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
Why do youth have lower
rates of viral suppression,
higher rates of virologic
rebound and loss to
follow-up?
The HIV-Infected Adolescent
Challenges to adherence:
 Denial and fear of HIV infection
 Misinformation
 Distrust of the medical establishment
 Fear and lack of belief in the effectiveness of medications
 Low self-esteem
 Unstructured and chaotic lifestyles
 Lack of familial and social support
 Unavailable or inconsistent access to care
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
The HIV-Infected Adolescent
Special considerations:
 Preventing (and screening for) STDs (including HPV)
 Family planning counseling
 For females, gynecologic care, contraception (including
interactions with ARVs); avoid EFV
 For transgender youth, sensitive psychosocial and health
supports
 Prevention of HIV transmission
ARV= antiretroviral
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
Women and
Pregnancy
HPTN 064
HIV Prevalence 8% or
greater in selected
US populations
40
HIV-Infected Women
 In general, no sex differences in virologic efficacy
of ART
 Some evidence of sex differences in metabolism
and response to some ARVs
 Increased risk of certain ARV adverse effects:
◦ NVP-associated hepatotoxicity (especially if initiated at
CD4 count >250 cells/µL)
◦ Lactic acidosis: avoid d4T + ddI, if possible
◦ Metabolic complications (eg, lipoaccumulation, elevated
triglycerides, osteopenia/osteoporosis)
d4T= stavudine, ddI= didanosine, ARV= antiretroviral
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
HIV-Infected Women
 Women of childbearing potential
◦ Offer preconception counseling and care
◦ Offer effective counseling and contraception to
prevent unintended pregnancy
◦ For HIV-infected women who wish to conceive:
◦ inform as to options for preventing sexual transmission of
HIV while attempting conception
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
HIV-Infected Women:
Contraception
 ARV interactions with hormonal contraceptives:
◦ Oral agents: PIs and NNRTIs may increase or decrease
levels of ethinyl estradiol, norethindrone, and
norgestimate, and may cause contraceptive failure or
estrogen or progestin adverse effects
◦ Consider alternative or additional contraceptive method if used
with interacting ARVs
◦ Few data on transdermal patch, vaginal ring: cautions as
above
◦ DMPA: few data; no significant interactions with EFV,
NVP, NFV, NRTIs
 IUD: safe and effective
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
What % of all pregnancies
that occur in the United
States are unplanned?
ART for Pregnant Women*
 Consistent use of condoms (male or female)
recommended to reduce risk of HIV transmission and
STD acquisition, regardless of contraceptive use
 Combination ART recommended for all HIV-infected
pregnant women, regardless of CD4 count, HIV viral load,
or clinical status
 Counsel on known benefits and risks of ART during
pregnancy
* See also the U.S. Public Health Services Task Force Recommendations for Use
of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health
and Interventions to Reduce Perinatal HIV-1 Transmission in the United States.
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
ART for Pregnant Women
To reduce risk of perinatal transmission:
 Combination ART, with maximal and sustained
suppression of HIV RNA levels during pregnancy
 Perform resistance testing before starting ART,
and for women on ART with detectable HIV RNA
◦ ART may be initiated before results are
available; modify ARV regimen if indicated
based on resistance test results
ART= antiretroviral therapy, ARV= antiretroviral
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
ART for Pregnant Women
Efavirenz
Teratogenic in nonhuman primates
Risk of neural tube defects occurs during the first 5-6
weeks of pregnancy, and pregnancy usually is not
recognized before 4-6 weeks of pregnancy
Do pregnancy test before starting EFV (women of
childbearing potential)
Counsel about potential risk to fetus and desirability of
avoiding pregnancy while on EFV
Use alternative ARV agent in women who are trying to
conceive or who are not using effective contraception, if
feasible
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
ART for Pregnant Women
Zidovudine:
IV ZDV infusion recommended during labor if maternal
HIV RNA is ≥400 copies/mL (or is unknown) near time of
delivery
Consider omitting IV ZDV during labor if maternal HIV RNA
is <400 copies/mL, but continue combination ART regimen
during labor
Report cases of prenatal ARV exposure to the
Antiretroviral Pregnancy Registry
(http://www.apregistry.com)
See U.S. PHS Task Force Guidelines for Use of
Antiretroviral Drugs in Pregnant HIV-1-Infected Women
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
Postpartum Management
 Continuation of ART for maternal health should
be determined on same basis as for nonpregnant
persons
 Note that ART adherence may worsen
postpartum; specifically address and support
adherence
 Breast-feeding is not recommended, owing to
risk of postnatal transmission
 HIV-infected women should avoid
premastication of food for the infant: associated
with HIV transmission to child
ART= antiretroviral therapy
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
A 20-year-old woman presents in early labor with no
prenatal care and no prior HIV testing.
She has a history of injection drug use for the past 18
months, but none in the past 3 weeks. After obtaining
informed consent, a rapid HIV test is performed and it
is positive; a confirmatory HIV test is ordered.
Which one of the following would you recommended
this woman in labor who has received no prior
antiretroviral therapy?
A. It is too late to offer antiretroviral therapy for the mother
B. Begin zidovudine (Retrovir) by intravenous infusion
C. Immediately start the mother on a combination oral ART
The Older Patient
HIV and the Older Patient
 In the U.S., approximately 30% of HIV-infected
persons are ≥50 years of age
 Aging-related comorbidities may complicate
management of HIV
 HIV may increase risk of comorbidities and may
accelerate the aging process
 Limited data on effects of ARVs in older persons
(eg, adverse effects, drug-drug interactions)
ARV= antiretroviral
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
Interplay of Age With
Morbidity
HIV
infection
Risk of “comorbidities”
increases as individuals
get older
Aging
Antiviral
treatment
ART= antiretroviral therapy
HIV does not cause these
illnesses
However, HIV and/or ART
may increase the risk
HIV and the Older Patient:
HIV Risk, Diagnosis, and Prevention
 Reduced mucosal and immunologic defenses and
changes in risk behaviors may lead to increased risk
of HIV acquisition and transmission
 HIV screening rates in older persons are low
 Older persons may have more advanced HIV at
presentation and ART initiation
◦ Screen for HIV per CDC recommendations
◦ Sexual history, risk-reduction counseling, screening for STIs
(as indicated) are important to general health care for HIVinfected and HIV-uninfected older persons
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
HIV and the Older Patient:
ART
 “ART is recommended in patients >50 years of
age, regardless of CD4 cell count” (BIII)
 Older persons have ↓ immune recovery and ↑
risk of non-AIDS events
 No data on specific ARVs in older persons;
individualize ARV selection
 Monitor ART effectiveness and safety per general
guidelines, but give special attention to renal,
liver, cardiovascular, metabolic, and bone health
ART= antiretroviral therapy, ARV= antiretroviral
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
HIV and the Older Patient: ART
 CD4 cell recovery on ART may be less robust in
older patients (though virologic response
appears to be the same as in younger patients)
 Starting ART at younger age may result in
better outcomes (immunologic and perhaps
clinical)
 Interactions between ARVs and other
medications, as well as polypharmacy, may
complicate care
ART= antiretroviral therapy, ARV= antiretroviral
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
HIV and the Older Patient:
ART
 Adherence:
◦ Some data suggest older HIV-infected patients
may be more adherent to ART than younger
patients
◦ However, many issues (eg, complex dosing
requirements, cost, limited health literacy,
neurocognitive impairment) may impact
adherence
◦ Assess adherence regularly; facilitate adherence
ART= antiretroviral therapy
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
HIV and the Older Patient:
Complications and
Comorbidities
 Non-AIDS illnesses (eg, cardiovascular disease,
liver disease, cancer, bone fragility, and
neurocognitive impairment) may have ↑ disease
burden in aging HIV-infected persons
 Current primary care recommendations advise
to identify and manage risks in HIV-infected as in
HIV-uninfected individuals
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
Example: Newly Diagnosed 61Year-Old Female Patient
HIV infection
◦ CD4+ count: 275 cells/mm³; HIV-1 RNA: 97,234 copies/mL
Osteopenia
◦ Wrist fracture
Hypertension (lisinopril)
Moderately reduced renal function
◦ eGFR 72 mL/min
Hyperlipidemia (simvastatin)
Anxiety/depression
Migraines (ergotamine)
Recommended Agents:
Considerations for This Patient
Agent
Considerations for This Patient
 EFV
 Drug interactions with migraine medications
 DRV/RTV
 EVG/COBI
 Drug interactions with some statins
 Drug interactions with some migraine medications
 RAL
 Twice-daily administration
 TDF
 Osteopenia
 Decreased renal function
 ABC
 Borderline baseline HIV-1 RNA
 Cardiovascular risk
ABC, abacavir; ATV, atazanavir; COBI cobicistat, DRV, darunavir; EVG elvitegravir; RAL,
raltegravir; RTV, ritonavir; TDF, tenofovir.
Medical Management Issues
That May Affect ART Choices
Osteoporosis
Hyperlipidemia (statin)
◦ Interactions with PIs and COBI
Hypertension (slightly decreased renal function)
Migraine (ergotamine)
◦ Interactions with some PIs and COBI
Preventing
Secondary
Transmission
Preventing Secondary
Transmission of HIV
Prevention interventions are a key part of HIV care
In the United States, the rate of new HIV infections stable
Risk behaviors have ↑ since availability of effective ART
STIs, genital irritation, substance and alcohol use,
noncircumcision in men, and other conditions, ↑ risk of
HIV transmission
Recent data show that ART substantially ↓ risk of sexual
transmission of HIV
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
Preventing Secondary
Transmission of HIV
Essential components of HIV patient care:
◦
◦
◦
◦
◦
◦
Reinforce prevention messages
Assess patient’s understanding of HIV transmission
Assess patient’s HIV transmission behaviors
Discuss strategies to prevent transmission (individualize)
Detect and treat STIs
For women:
◦ Pregnancy prevention counseling with those who wish to avoid
pregnancy
◦ Preconception counseling with those who wish to become pregnant
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
Preventing Secondary
Transmission of HIV
 Tools for prevention of sexual and bloodborne HIV
transmission:
◦ Consistent and effective use of ART (with sustained suppression of HIV
RNA)
◦ Consistent condom usage
◦ Safer sexual and drug-use practices
◦ Detection and treatment of STIs
 Interventions in clinic settings are effective in changing sexual
risk behavior
◦ CDC training materials:
http://www.cdc.gov/hiv/topics/research/prs/index.htm
 Interventions also effective in reducing risky injection drug-use
behavior
◦ Behavioral interventions and opiate substitution with
◦ methadone
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
Preventing Secondary
Transmission
of HIV: ART as Prevention
ART may reduce risk of HIV transmission
HIV viral load directly related to probability of HIV transmission; increased
ART use and lower community viral load associated with lower HIV incidence
Observational studies show lower rates of HIV transmission among
serodiscordant heterosexual couples after viral suppression on ART
In a large RTC of HIV-discordant heterosexual couples, those on ART had 96%
reduction in HIV transmission to uninfected partners
No RTC data in MSM and IDUs
But, HIV has been detected in genital secretions of persons with controlled
plasma HIV RNA
Belief in efficacy of ART may lead to increases in risk behavior
AETC National Resource Center, www.aidsetc.org Accessed April 21, 2016.
Pre-exposure
Prophylaxis (PrEP)
PrEP Studies:
HIV transmission risk lowest when participants took PrEP consistently
STUDY
POPULATION
OVERALL
Reduction in risk of HIV
infection
iPrEx
MSM
44% reduction in the risk of
HIV acquisition (95% CI, 15-63)
>90%
High
TDF2
1219 heterosexual
men and women in
Botswana
62% reduction risk (22-83%)
---
Moderate
Partners
PrEP
4,718 HIV-discordant
heterosexual couples
in Uganda and Kenya
90%
High
FEM-PrEP
High risk women
Stopped early due interim analysis predicted no stat
diff would likely to occur
Low
BTS
2413 IDU in Bangkok,
20% women
TDF was 48.9% (95% CI, 9.672.2; P = .01
High
Among women, efficacy 71%
for TDF & 66% for TDF/FTC.
Among men, efficacy 63% for
TDF & 84% for TDF/FTC
Detectable level of
medication in the
blood
Reduction in risk of
HIV infection
74%
QUALITY OF
EVIDENCE
Adapted from summary of research at http://www.cdc.gov/hiv/prevention/research/prep/
PrEP: Pre-exposure
Prophylaxis
How does it work?
◦ Uninfected person takes antiretrovirals
◦ May prevent replication of virus & infection
300mg TDF/ 200mg FTC
◦ 1 tab po daily
◦ ≤90 day supply
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
Should this patient receive
PrEP?
Case #1:
24 year old white MSM who presents 4 hours after
unprotected receptive anal sex, for the first time, with
his HIV-infected partner.
Should this patient receive
PrEP?
Case #2:
24 year old MSM on nPEP, day 27/28. Struggles with
consistent condom use and regularly has unprotected
receptive anal intercourse with his HIV-infected
partner.
Specialty Drugs
Specialty Drugs
 Fastest growing pharmaceuticals in the U.S. and Canada
 Spending in 2012 in US ~$87 billion (25%)
◦ 2020 estimates suggest ~$400 billion
 About half of spending is funded as a pharmacy benefit;
the other half is funded as a medical benefit
◦ HIV drugs usually fully funded as pharmacy benefit
 HIV Drugs
◦ UnitedHealthcare fully insured commercial plan about 8%
◦ Medicaid health plans, account for about 18%
American Pharmacists Association: http://www.pharmacist.com/specialty-pharmacy-unique-and-growing-industry. Accessed April 27, 2016.
What is a Specialty Drug?
 There is no regulated definition
 Processes around distribution and use set up to manage
costs, ensure appropriate use and adherence, minimize
waste, and optimize utilization
 Cost
◦ CMS categorizes as one with a minimum monthly cost of $600 with
respect to the Medicare Part D drug benefit
◦ Other organizations utilize a higher cost threshold for specialty
classification that may be as much as double that of CMS
 Complexity
◦ Encompass a number of factors and affect various groups, including
patients, payers, manufacturers, and the pharmacy itself
American Pharmacists Association: http://www.pharmacist.com/specialty-pharmacy-unique-and-growing-industry. Accessed April 27, 2016.
Factors Determining
Specialty Drug Designation
0
20
40
60
80 100
Requires Patient Training to Use
Limited Manufacturer Distribution
Special Handling or Distribution
Factors
Orphan, Uncommon, Rare Disease
Complex Disease/Special
Monitoring
High Cost
Source: EMD Serono Specialty Digest, 10th Edition, p. 10.
Specialty Drugs
 Insurance companies and manufacturers designate a drug
as specialty and can restrict its availability to authorized
specialty pharmacies
 FDA does not designate medications as specialty drugs
 Many specialty drugs require a PA that may be facilitated
by specialty pharmacies
 Pharmacies should process Rx claim prior to ordering
medications
 Many payers and manufacturers may choose to have their
medication dispensed by a specialty pharmacy
American Pharmacists Association: http://www.pharmacist.com/specialty-pharmacy-unique-and-growing-industry. Accessed April 27, 2016.
Specialty Pharmacy
 Offer comprehensive services







Support to clinics and prescribers
Insurance claim processing, PA, financial assistance
programs, appeals, etc.
Data collection/reporting for manufacturers, including
adherence, distribution, etc.
Completion of REMS requirements
Specially trained pharmacists and technicians
Benefit and billing staff
IT staff
American Pharmacists Association: http://www.pharmacist.com/are-you-ready-embrace-speciality. Accessed April 27, 2016.
Your colleague, David, asks you
what a key characteristic of a
specialty drug would be.
Which of the following would be
a feature of a specialty drug?
A. Must be given by an intravenous infusion
B. Costs on average $300 per month
C. Needs close monitoring and education
D. Treats acute conditions like an upper
respiratory infection
Specialty Pharmacy
 Many have extensive and robust systems:








Call centers for 24/7 support
Operational processes
Data analysis systems
Clinical protocols to manage specific diseases
Educational programs
Monitoring procedures
Adherence management
Reporting and outcome measurement systems
 Insurers have created own specialty pharmacy
divisions
American Pharmacists Association: http://www.pharmacist.com/are-you-ready-embrace-speciality. Accessed April 27, 2016.
Specialty Pharmacy
 Top 10 specialty pharmacies in 2014 were CVS Specialty
parent company CVS Health with $20.5B in sales
 Express Scripts's Accredo at $15B
 Walgreens Boots Alliance's Walgreens Specialty at $8.5B
 UnitedHealth Group's OptumRx at $2.4B
 Diplomat Pharmacy at $2.1B
 Catamaran's BriovaRx at $2.0B
 Specialty Prime Therapeutics at $1.8B
 Omnicare's Advanced Care Scripts at $1.3B
 Humana's RightsourceRx at $1.2B
 Avella at $0.8B
”The Biggest in a Booming Pharmacy Field". New York Times. 15 July 2015. Accessed April 27, 2016.
Specialty Pharmacy: Challenges
 Pharmacists in retail setting need to be aware of
any specialty drugs a patient is receiving
 “Specialty at retail” programs
◦ Retail pharmacies that partner with specialty pharmacies
to streamline patient care
◦ Pharmacists can provide ongoing, comprehensive care to
the patient
 Not all specialty pharmacies can dispense all
specialty drugs
 Patients must manage care between different
pharmacies
American Pharmacists Association: http://www.pharmacist.com/are-you-ready-embrace-speciality. Accessed April 27, 2016.
Specialty Pharmacy: Challenges
 Restricted access to specialty meds, from either
manufacturers or payers, can prevent a retail
pharmacist from being able to order or dispense a
med if the pharmacy isn't in the "network.“
 A retail pharmacist’s ability to dispense a specialty
med will depend on the drug itself and the
pharmacy
 Hospitals may not have access to order specialty
drugs
American Pharmacists Association: http://www.pharmacist.com/are-you-ready-embrace-speciality. Accessed April 27, 2016.
Rebecca comes into your community pharmacy on a busy
Tuesday morning. He drops off a new prescription for
enfuvirtide (Fuzeon) for HIV. You don't usually dispense the
med, and you don't have it in your pharmacy refrigerator.
You enter the prescription and it comes back with a
rejection from Rebecca's insurance stating it requires a
prior authorization. There's also a note that only one fill is
allowed before the med must be filled at a specialty
pharmacy. It gives the name and phone number of a
specialty pharmacy where the med is covered.
How would you handle this situation? What would you tell
Rebecca? How can you help Rebecca get started with this
med? Why is the insurance requiring that Rebecca fill the
drug at a specialty pharmacy?
You see that the insurance is requiring Rebecca to get future
refills of her Fuzeon from a specialty pharmacy. Rebecca
asks you why the med can only be filled once at your
pharmacy, and what a specialty pharmacy is.
How would you respond? What are some of the potential
benefits of a specialty pharmacy? What are some of the
potential downsides of getting a med through a specialty
pharmacy?
Specialty Drugs: RPH’s Role
Be aware: Taking a specialty medication, along with
managing the disease itself, can have a significant negative
impact on the patient's quality of life.
Effective communication with patients improves outcomes
and builds good rapport-regardless of the meds the patient
is taking.
Identify barriers to adherence your specific patient may
have, and then work with the patient to come up with a
plan.
Notify prescribers early about PAs, and clearly explain the
process or insurance limitations to patients
Specialty Drugs: RPH’s Role
Consider spreading the word to local prescribers and
patients about meds stocked that other pharmacies may
not, such as HIV/AIDS drugs.
Order specialty meds judiciously based on patients' needs,
and watch inventory closely.
Advise patients to keep on top of their medication supply.
Consider having a pharmacy technician or other colleague
keep close tabs on ordering and inventory of specialty
meds.
Appropriate storage of specialty meds is key
to avoid waste.
Specialty Drugs: RPH’s Role
Confirm that patients have any additional equipment
needed to administer the med properly.
Prevent and manage side effects and interactions.
Keep patient profiles up-to-date.
Make sure patients stay up-to-date with
immunizations.
Take Home Points
HIV infection has now spread to every country in the
world
Screening for HIV infection should be performed
routinely for all patients aged 13-64 yrs
Laboratory tests should be performed at initial
diagnosis and for ART monitoring including CD4 and
viral load
Receptive anal intercourse is the #1 mode of HIV
transmission in the United States
All HIV infected patients may benefit from the initiation
of ART regardless of the CD4 count
Take Home Points
Use at LEAST two different classes of antiretrovirals
EFV should be avoided in pregnant women during 1st
trimester due to teratogenic effects
Most adolescents acquired HIV though sexual risk
behaviors
Youth have lower rates of viral suppression, higher
rates of virologic rebound and loss to follow-up
Take Home Points
EFV should be avoided in pregnant women during 1st
trimester due to teratogenic effects
Women who have not received ART during pregnancy
should receive ZDV during labor and the baby should
receive
All cases of prenatal ARV exposure should be reported
in the ARV pregnancy registry (www.apregistry.com)
Take Home Points
Older patients generally have a shorter time to
virological suppression but have a blunted immune
response taking longer to achieve an appropriate CD4
response
Polypharmacy and co-morbidities play a large role in
management of HIV in older patients
Renal function must be monitored closely in older
patients with HIV
Prevention interventions are a key part of
HIV care
Take Home Points
Interventions in clinic settings are effective in changing
sexual risk behavior
ART may reduce risk of HIV transmission
300mg TDF/ 200mg FTC daily recommended for preexposure prophylaxis, adherence is key
Specialty drugs are the fastest growing pharmaceuticals
in the U.S. and Canada
Take Home Points
2 main factors affect a drug’s designation as specialty:
cost and complexity
Insurance companies and manufacturers designate a
drug as specialty and can restrict its availability to
authorized specialty pharmacies
Specialty pharmacies offer comprehensive services to
help create a high level of “care coordination and
patient support” to help ensure adherence to therapy
and reduce overall costs related to this medication
Websites to Access the
Guidelines
 http://www.aidsetc.org
 http://aidsinfo.nih.gov
Questions
Pamela M. Moye, Pharm.D., BCPS, AAHIVP
[email protected]
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