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Examining Adherence Barriers in
Pediatric and Adolescent
HIV Patients
PACT Clinic, Women and Children’s
Hospital of Buffalo
University at Buffalo
Melannie Cummings, PharmD Student
Desiree Tomilo, PharmD Student
Linda Catanzaro, PharmD Assistant Professor
School of Pharmacy and Pharmaceutical Sciences
© 2004 CDHS, College Relations Group
BSC/SUNY Research Foundation
Objectives







Provide an overview of HIV infection and treatment options
Discuss opportunistic infections and prophylaxis
Discuss medication adherence and potential barriers to
adherence
Discuss the health consequences of non-adherence
Describe tools and methods used to improve adherence
Discuss what to expect when caring for a child with HIV
Describe the pediatric and adolescent patient population at
the PACT Clinic, at Women’s and Children’s Hospital of Buffalo
Global Estimates for adults and children
end 2003



People living with HIV/AIDS
New HIV infections in 2003
Deaths due to HIV/AIDS in 2003
40 million
5 million
3 million
About 14,000 new HIV infections a day in
2003


Almost 2000 are children under 15 years of age
About 12,000 are 15-49 years of age

About 50% of these are 15 -24 years of age
HIV Global Estimates1

In the year 2003 – estimated
700,000 children under 15 years
old became infected


mostly in sub-Saharan Africa
>90% were due to mother to infant
transmission
1. <AVERT.org> 3/3/04.
Incidence of Children with HIV
in the United States1

Most are living in inner cities
 poverty
 poor housing
 drugs
 limited access to health care
and social services
1. National Institutes of Allergy and Infectious Disease <www.niaid.nih.gov> 2004.
Good News in New York State

1996 - “Baby AIDS Law”


mandatory HIV testing added to
newborn screening program
mother to infant transmission
rates have decreased by 78%1

study of infants born from 19972002
1. NYS Dept. of Health. <www.health.state.ny.us/> May 2004.
Methods of Transmission



sexual contact
contact with infected blood
 needle sticks
 unprotected administration of first aid
mother to child
 perinatally - during delivery of the baby
 through breast milk
Prevention of Perinatal Transmission




Early identification of maternal infection
 goal: keep viral load <10001 to decrease risk
of transmission to baby by up to 70%2
Antiretroviral prophylaxis with zidovudine during
pregnancy, labor, and to newborns2
Cesarean-Section Delivery
 Mother’s viral load >1,000, regardless of
therapy1
Counseling and advisement of infected women
to use an alternative to breast milk
1. Committee on Obstetric Practice. ACOG committee opinion scheduled Cesarean delivery and the prevention of vertical transmission of HIV
infection. Number 234, May 2000. International Journal of Gynaecology & Obstetrics. 2001 Jun;73(3):279-81.
2. Sperling RS, Shapiro DE, Coombs RW et al. “Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency
virus type 1 from mother to infant.” Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Eng J Med, 1996;335(22) :1621-9.
Effects of HIV on the Human Body



HIV attacks and weakens the immune system
If the virus is not suppressed and it continues
to replicate, further damage to the immune
system and progression to AIDS can occur.
The likelihood of developing AIDS or death
within 12 months, when a child is not on
antiretroviral therapy, can be as high as 51%
and 30%, respectively1.
1. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. January 20, 2004.
Diagnosis of HIV in Infants



All newborns are tested for HIV,
regardless of the mother’s status.
In infants born to infected mothers,
diagnostic testing should be done:
 before the infant is 48 hours old
 at 1-2 months old
 at 3-6 months old
Six months after birth, all infected
infants can be definitively diagnosed.
Surrogate Markers as Predictors of
Disease Progression


Surrogate markers are obtained from an
individual’s blood work.
CD4+ T-cells

cells in the immune system that are needed to
fight off infection; higher CD4+ percentages
indicate better immune status
Surrogate Markers

Viral load (HIV-RNA)
measures how much virus is in the body;
the lower the viral load the better
 indicates if medication is effective; lower
viral load limits the potential for
development of resistance to medications

Indications for when to initiate therapy in
children > 1 year of age1
Clinical Category
CD4+ %
HIV-RNA
Recommendation
AIDS
OR(severe symptoms)
< 15%
Any value
Treat
Mild-Moderate
Symptoms
OR-
Asymptomatic
AND-
OR15-25%
>100,000
copies/mL
AND>25%
<100,000
copies/mL
1. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. January 20, 2004.
Consider
treatment
May defer therapy
and closely monitor
surrogate markers
Role of Medications

Antiretroviral medications work
by suppressing viral replication
 seen by low viral load
 do not completely eradicate
the virus (not a cure)
Choice of Antiretroviral Medication
Regimens in Pediatric Patients


The first regimen that is chosen has the best
chance of reducing the viral load to undetectable
by assay or test (<50 copies/mL).
It is recommended that a regimen consist of:


2 NRTIs + 1 PI
-orin children >3 years: 2 NRTIs + Efavirenz (a NNRTI)
in children <3 years or who can’t swallow
capsules: 2 NRTIs + Nevirapine (a NNRTI)1
1. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. January 20, 2004.
Classes of Antiretroviral Medications





Nucleoside Analogue Reverse Transcriptase
Inhibitors (NRTIs)
Nucleotide Reverse Transcriptase Inhibitors
(NtRTIs)
Non-Nucleoside Reverse Transcriptase Inhibitors
(NNRTIs)
Protease Inhibitors (PIs)
Fusion Inhibitors- not approved for pediatrics
Nucleoside Analogue Reverse Transcriptase
Inhibitors (NRTIs)


Mechanism of Action (MOA): block an
enzyme that is needed by the virus in order
to make DNA
can be taken without regard to meals
Adverse Effects seen with NRTIs

Common side effects: nausea, vomiting,
diarrhea, fatigue, weakness, headache,
dizziness, loss of appetite, insomnia


with the exception of fatigue, these side effects
usually go away
Severe side effects: pancreatitis, anemia (with
AZT), hypersensitivity reaction/rash (with ABC),
peripheral neuropathy (tingling and/or numbness
in the extremities), liver damage
NRTIs commonly used in pediatrics

zidovudine, AZT (Retrovir)


lamivudine, 3TC (Epivir)


Available in capsules, tablets, syrup (strawberry)
Available in tablets and oral solution (strawberry-banana)
stavudine, d4T (Zerit)

Available in
 capsules
 powder for oral suspension- once mixed, shake before
use, refrigerate and discard after 30 days
NRTIs

didanosine, ddI (Videx)


take on an empty stomach
Available in
 chewable tablets (orange flavored)- Do not swallow
tablets whole, must be chewed or crushed in water
and 1 oz. apple juice; take on empty stomach; many
children do not like these
 powder for solution- mix with 4 oz. water; once mixed,
store in refrigerator; shake well before use and discard
after 30d
 buffered powder packets for solution- mix with 4 oz.
water and discard after 4 hours
 enteric coated capsules- must not be opened, swallow
whole
NRTIs

Abacavir, ABC (Ziagen)
 Available in
 tablets
 oral solution (strawberry-banana)- may be
refrigerated
 A life-threatening allergic reaction can occur in
5% of patients; characterized by rash or flu-like
symptoms; discontinue medication, do not try to
give to patient again, and call MD
Combination NRTIs


lamivudine+zidovudine, 3TC+ZDV (Combivir)
 Available in tablets: 150mg 3TC + 300 mg ZDV
abacavir+lamivudine+zidovudine, ABC+3TC+ZDV
(Trizivir)
 Available in tablets: 300mg ABC + 150mg 3TC +
300mg ZDV
 This drug contains abacavir
 do not give if patient had a previous allergic
reaction to abacavir
NRTIs

These NRTIs do not have sufficient data to
support their use in pediatrics:

ddC- zalcitabine (Hivid)

FTC- emtricitabine (Emtriva)

TFV- tenofovir (Viread)
 currently being studied in pediatrics
Non-Nucleoside Reverse Transcriptase
Inhibitors (NNRTIs)



MOA: block an enzyme needed by the virus in order
to make DNA
Side effects: rash, depression, insomnia, vivid
dreams,
 These symptoms usually resolve within the first
few weeks
 numerous drug interactions
A single mutation can cause resistance to the
entire NNRTI class.
NNRTIs

Efavirenz (Sustiva)


Available in
 tablets
 capsules - can be opened and added to liquids
or foods
Take on an empty stomach and give at bedtime
NNRTIs


Nevirapine (Viramune)
 once daily for 14 days, then titrated to 2x/day
 increased risk of rash
 Available in
 tablets
 suspension - sweetened, shake before using
Delaviridine (Rescriptor)
 Insufficient data to support use in pediatrics
Protease Inhibitors
(PIs)


MOA: block an enzyme needed to assemble
the infectious virus particles
Side effects: fat maldistribution, liver
damage, elevated triglycerides, diabetes


These usually occur over long periods of time.
numerous drug interactions
PIs

Nelfinavir (Viracept)


Available in
 tablets - may be crushed and added to 3 oz.
water or a small amount of food
 powder - may be mixed in a small amount of
food, milk, formula, soy milk or formula, dietary
supplements, or soft foods; refrigerate
solution and discard after 6 hours
Should be given with a meal or light snack.
PIs

Ritonavir (Norvir)


children 2-16 years of age
Available in
 soft gelatin capsules - store in refrigerator or use
within 30 days if at room temperature
 solution - shake before use; can mix with milk,
chocolate milk, Ensure and give within 1 hour of
mixing; do not refrigerate
PIs

Amprenavir (Agenerase)




children >3 years of age
Available in
 Soft gelatin capsules
 Solution (grape-bubblegum-peppermint)
 Keep both at room temperature
Do not give with a high fat meal
Avoid using supplements containing vitamin E
PIs

Lopinavir/ritonavir (Kaletra)



Children >6 months
Available in
 capsules
 solution
 Keep both in refrigerator; if at room
temperature, use within 2 months.
Give with food
PIs

These PIs do not have sufficient data to
support their use in pediatrics:




Indinavir (Crixivan)
Saquinavir (Fortovase)
Fosamprenavir (Lexiva)
Atazanavir (Reyataz)

currently being studied in pediatrics
Opportunistic Infections




Cause of 90% of deaths in HIV infected
patients
Caused by common organisms
Develop due to loss of cell-mediated
immunity
Development can be predicted by CD4+
lymphocyte levels
1. Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy A Pathophysiologic Approach, 5 th
edition. The McGraw-Hill Companies, Inc. 2002.
Opportunistic Infections
HAART (Highly Active Anti-Retroviral
Therapy) was introduced in the United
States in 1995 1

From 1996-1998


1.
2.
PCP rates decreased 21% per year 2
MAC rates decreased 39.9% per year 2
2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons
Infected with HIV - November 28, 2001
Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy A
Pathophysiologic Approach, 5th edition. The McGraw-Hill Companies, Inc. 2002.
Opportunistic Infections


Appropriate treatment of
HIV is essential
Prevention and
management of
opportunistic infections is
still a very important part of
the care of HIV infected
patients
1. Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM.
Pharmacotherapy A Pathophysiologic Approach, 5th edition. The
McGraw-Hill Companies, Inc. 2002.
Opportunistic Infections



Pneumocystis carinii Pneumonia (PCP)
Mycobacterium avium Complex (MAC)
Vaccinations
 Pneumococcal
 H. influenzae type b (Hib)
Pneumocystis carinii
Pneumonia (PCP)
Who Should Receive PCP
Prophylaxis?



Infants 1-12 months old - if HIV-infected or HIVindeterminate
Children 1-5 years old - with a CD4+ count
<500 cells/µL or CD4+ percentage <15%
Children 6-12 years old - with a CD4+ count
<200 cells/µL or CD4+ percentage <15%
1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in
Persons Infected with HIV - November 28, 2001
Who Should Receive PCP
Prophylaxis?


Adolescents and Adults - with a CD4+ count
<200 cells/µL or a history of orophangeal
candidiasis
Consider prophylaxis for adolescents and adults
with a CD4+ percentage <14% or with a history
of AIDS defining illness
1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected
with HIV - November 28, 2001
Recommended PCP Prophylaxis
Children



Trimethoprim/Sulfamethoxazole (TMP/SMZ)
 150/750 mg/m2/d in 2 divided doses given by
mouth three times a week on consecutive days
Other options: varying doses of
 Trimethoprim/Sulfamethoxazole (TMP/SMZ)
 Dapsone
 Aerosolized Pentamadine
 Atovaquone
1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons
Infected with HIV - November 28, 2001
Recommended PCP Prophylaxis

Adolescents and Adults


Trimethoprim/Sulfamethoxazole (TMP/SMZ)
one double strength tablet per day
Other options: varying doses of
 Trimethoprim/Sulfamethoxazole (TMP/SMZ)
 Dapsone (with or without pyrimethamine)
 Aerosolized Pentamadine
 Atovaquone
1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons
Infected with HIV November 28, 2001
Discontinuation of PCP Prophylaxis
Children



Continue through first year of life
Children with a history of PCP infection should
receive lifelong prophylaxis
Safety and efficacy of discontinuation has not
been studied thoroughly
1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with
HIV - November 28, 2001
Discontinuation of PCP Prophylaxis
Some clinicians consider discontinuing if:
a child 1-5 years old has had a CD4+ count
>500 cells/µL or CD4+ percentage >15% for
at least three months
 A child 6-12 years old has had a CD4+ count
>200 cells/µL or CD4+ percentage >15% for
at least three months

1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic
Infections in Persons Infected with HIV - November 28, 2001
Discontinuation of PCP Prophylaxis
Adolescents and Adults

1.
Discontinue when the CD4+ count has
been >200 cells/µL for at least three
months
2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in
Infected with HIV - November 28, 2001
Persons
Mycobacterium avium Complex
(MAC)
Who Should Receive MAC
Prophylaxis?


Children
 <1 year old: CD4+ count
<750 cells/µL
 1-2 years old: CD4+ count
<500 cells/µL
 2-6 years old: CD4+ count
<75 cells/µL
 ≥6 years old: CD4+ count
<50 cells/µL
Adolescents and Adults

CD4+ count <50 cells/µL
1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected
with HIV - November 28, 2001
Recommended MAC Prophylaxis


1.
2.
Children
 Clarithromycin 7.5mg/kg (max 500mg) by mouth
twice daily
 Azithromycin 20mg/kg (max 1200mg) by mouth every
week 1
Adolescents and Adults
 Clarithromycin 500 mg by mouth twice daily 2
 Azithromycin 1200 mg by mouth once weekly 2
2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons
Infected with HIV - November 28, 2001
Lexi-Comp Online, 2004. Available at: http://www.crlonline.com/crlsql/servlet/crlonline
Discontinuation of MAC Prophylaxis
Children
 Safety has not been studied in children
 Children with a history of MAC infection should
receive lifelong prophylaxis
1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with
HIV - November 28, 2001
Discontinuation of MAC Prophylaxis
Some clinicians consider discontinuing MAC
prophylaxis in children if:




<1 year old: CD4+ count >750 cells/µL for at least
three months
1-2 years old: CD4+ count >500 cells/µL for at
least three months
2-6 years old: CD4+ count >75 cells/µL for at least
three months
≥6 years old: CD4+ count >50 cells/µL for
at least three months
1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV November 28, 2001
Discontinuation of MAC Prophylaxis
Adolescents and Adults
 CD4+ count >100 cells/µL for at
least three months
1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with
HIV - November 28, 2001
Vaccinations
Children

Should receive all of the typical
childhood vaccines

<5 years old: H. influenzae type b
(Hib) and pneumococcal
conjugate vaccine

>2 years old: should also receive
the 23-valent polysaccharide
pneumococcal vaccine
 Revaccincate after 3-5 years if
child ≤10 years old and after 5
years if >10 years old
1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected
with HIV - November 28, 2001
Vaccinations
Adolescents and Adults



CD4+ count ≥200 cells/µL: single dose of 23-valent
polysaccharide pneumococcal vaccine (if they have
not received it in the past five years)
Pneumococcal vaccine can be considered in
patients with a CD4+ count <200 cells/µL but there
is no proof of efficacy
H. influenzae type b (Hib) is not recommended
1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with
HIV - November 28, 2001
Medication Adherence
> 95% adherence is needed to
adequately suppress viral
replication
1. Esch LD. “Issues in Human Immunodeficiency Virus (HIV) Pharmacotherapy Practice. The Emerging Role of
Pharmacotherapy Specialists in Enhancing Antiretroviral Success.” J Inform Pharmacother 2001;4:306-316.
Potential Barriers to Adherence








Pill burden
Drug use/alcohol abuse
Depression
Lack of education1
Unwillingness to disclose HIV status2
Unstable environment 2
Side effects
Lack of palatability of medications2
1. Esch LD. “Issues in Human Immunodeficiency Virus (HIV) Pharmacotherapy Practice. The Emerging
Role of Pharmacotherapy Specialists in Enhancing Antiretroviral Success.” J Inform Pharmacother
2001;4:306-316.
2. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infections-January 20, 2004
Adherence
Pediatric adherence is
of special concern
because the status of
the caregiver as well as
the patient has to be
taken into account
Consequences of poor adherence

Virologic failure-incomplete (or lack of) HIVRNA response

Incomplete virologic response

Virologic rebound
1. Guidelines for the Use of antiretroviral agents in HIV Infected Adults and Adolescents – March 23, 2004
Consequences of poor adherence


1.
Development of resistance
 inadequate levels of medication to suppress
viral replication
 selective pressure-resistant virus is able to
replicate and repopulate patient1
Regimen changes
 decreased medication choices for the future
Luber AD. “Pharmacotherapy of Human Immunodeficiency Virus Infection”. In: Koda-Kimble
M, Young LY, Kradjan WA, Guglielmo BJ, editors. Applied Therapuetics. The Clinical Use of
Drugs. Seventh Edition. New York: Lippincott Williams and Wilkins; 2001.
Consequences of poor adherence


Resistance and virologic failure increase
the risk of comorbidities and death
High HIV-RNA levels and low CD4+
lymphocyte counts - increased risk of
progression to AIDS (see Table 1)
1. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infections-January 20, 2004
Potential Adherence Interventions








Pill boxes
Calendars
Alarm watches
Home visits
Refill checks
Phone calls
Adherences visits/clinic appointments
See table 2
1. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infections-January 20, 2004
Education of foster parents
of HIV+ children

Universal precautions



Avoid contact with child’s blood
Use caution if child is vomiting or has diarrhea
Guidelines:




NIH (http://www.nih.gov/)
CDC (http://www.cdc.gov/)
Disease education
Education on medication regimens
PACT Clinic
Baseline Characteristics
(Total Number of
Patients=24)
CD4+ T Cell Percentage
No
Suppression
(>25%)
Moderate
Suppression
(15-24%)
Severe
Suppression
(<15%)
Unknown
<12 months
0
0
0
0
1–5 years
old
2
2
0
0
6–12 years
old
7
2
1
0
>12 years
old
5
2
2
1
Total
14
6
3
1
CD4+ T Cell Percentage
Immune Suppression in all Children
at the PACT Clinic
Severe
Unknown, 1, 4%
Suppression
No Suppression (>25%)
(<15%), 3, 13%
Moderat e Suppression (1524%)
Severe Suppression (<15%)
Moderat e
Suppression (15-
No Suppression
24%), 6, 25%
(>25%), 14, 58%
Unknown
CD4+ T Cell Percentage
Immune Suppression in Children
1-5 years old
Severe
Suppression
(<15%), 0, 0%
Unknown, 0,
0%
No Suppression (>25%)
Moderate Suppression
(15-24%)
Moderate
Suppression
(15-24%), 2,
50%
No
Suppression
(>25%), 2, 50%
Severe Suppression
(<15%)
Unknown
CD4+ T Cell Percentage
Immune Suppression in Children 612 years old
Severe
Suppression
(<15%), 1, 10%
Unknown, 0, 0%
Moderat e
No Suppression (>25%)
Moderat e Suppression (1524%)
Suppression (1524%), 2, 20%
Severe Suppression (<15%)
No Suppression
(>25%), 7, 70%
Unknown
CD4+ T Cell Percentage
Immune Suppression in Children
>12 years old
No Suppression (>25%)
Unknown, 1, 10%
Severe
Moderat e Suppression (1524%)
Suppression
(<15%), 2, 20%
No Suppression
(>25%), 5, 50%
Severe Suppression (<15%)
Unknown
Moderat e
Suppression (1524%), 2, 20%
Living Situations

Of the 24 patients:
 79.2% (19) are living with a
biological relative
 12.5% (3) are in non-kinship
foster placements
 8.3% (2) are living alone
History of Depression in
Patients and Caregivers
History of Depression
Child Only
Caregiver Only
Both
8
4
3
No Documented
History
8
Unknown
1
History of Substance Abuse in
Patient and Caregivers
History of Substance Abuse
Child Only
Caregiver Only
Both
No Documented
History
Unknown
2
10
0
11
1
Adherence



Good Adherence = 0-2 missed doses/month
Fair Adherence = 3-5 missed doses/month
Poor Adherence = >5 missed doses/month
Patient Reported Medication Adherence in all
Children at the PACT Clinic
Good
Adherence
12
Fair
Adherence
No ART
3
1
Total
N=24
Poor
Adherence
2
Unknown
6
Patient Reported Medication Adherence in
Children Ages 1-5 years old
Good
adherence
1
Fair
Adherence
No ART
1
1-5
years
old
0
Poor
adherence
0
Unknown
2
Patient Reported Medication Adherence in
Children Ages 6-12 years old
Good
Adherence
5
Fair
Adherence
No ART
2
6-12
years
old
0
Poor
Adherence
1
Unknown
2
Patient Reported Medication Adherence in
Children > 12 years old
Good
Adherence
6
Fair
Adherence
No ART
0
> 12
years
old
1
Poor
Adherence
1
Unknown
2
Reasons for Missed Doses
away from home
2 (14%)
4 (30%)
1 (7%)
side effects
1 (7%)
ran out
confidentiality
1 (7%)
2 (14%)
fell asleep
3 (21%)
substance use
other
Reasons for Missed Doses

Other commons reasons for missed doses
include:



forgetting
pill burden
At baseline no one in this population reported
these reasons.
Medication Administration
Unknown-2
(8%)
No ART-3
(13%)
Both-9
(37%)
Patient-3
(13%)
Patient
Caregiver
Caregiver-7
(29%)
Both
No ART
Unknown
Patient Reported Adherence vs.
Medication Administration
Good Adherence (0-2 missed
doses/month)
Patient, 2,
17%
Patient
Caregiver
Both, 6,
50%
Both
Caregiver,
4, 33%
Patient Reported Adherence vs.
Medication Administration
Fair Adherence
(3-5 missed doses/month)
Caregiver, 0, 0%
Patient, 0, 0%
Patient
Caregiver
Both
Both, 1, 100%
Patient Reported Adherence vs.
Medication Administration
Poor Adherence
(>5 missed doses/month)
Patient, 1, 50%
Both,1, 50%
Patient
Caregiver
Both
Caregiver, 0,
0%
Patient Reported Adherence vs.
Medication Administration
• 3 patients were not on antiretroviral therapy
• 6 patients were unknown
Association between fair or poor adherence and
depression and/or substance abuse

Fair Adherence

Patient 1:
 Patient-depression, Caregiver-no documented
depression
 No documented substance abuse in patient or
caregiver
 Patient and caregiver are involved in
medication administration
Association between fair or poor adherence and
depression and/or substance abuse

Poor adherence

Patient 1:
 Patient-Depression, Caregiver-no
documented depression
 Patient-Substance abuse, Caregiver-no
documented substance abuse
 Patient is in charge of medication
administration
Association between fair or poor adherence and
depression and/or substance abuse

Poor adherence

Patient 2:
 Patient-Depression, Caregiver-Depression
 Patient-no documented substance abuse,
Caregiver-substance abuse
 Patient and caregiver are in charge of
medication administration
Conclusions


Adherence appears to be better when both the
caregiver and the patient are involved in
medication administration
Substance abuse and depression in the patient
and/or the caregiver appears to negatively
effect adherence
Due to the small patient population of the PACT
Clinic, the assessment of the baseline
characteristics should not be extrapolated to
the general population
PACT Clinic
Follow-up Interventions
During the appointed period (September
2003-May 2004) one patient was added,
making our total number of patients 25
Methods:
Standard of Care




Bi-weekly or as needed adherence appointments
 Patient interviews using follow-up questionnaires
Monthly case conferences with PACT nurses
Pharmacist and RN available by pager for questions
Adherence interventions
 Pill boxes
 Home visits and refill checks by adherence nurse
 Medication administration schedule
PACT Clinic Interventions

Of the 25 patients:


96% (24) were seen during the appointed time
Of the 24 patients seen:

12.5% (Cases 1,2, and 3) required interventions



Treatment of depression
Intensive follow-up (including home visits and refill
checks)
Supplying adherence tools
 Pillboxes
Case 1

History





13 year old HIV+ male presented to clinic in January
Patient had previously seen a psychiatrist and was
diagnosed with major depression. An antidepressant
was prescribed.
Based on patient’s CD4+ count, PCP prophylaxis was
also previously prescribed
After questioning it was determined that the patient
was non-adherent to both medications
Currently not on ART and was being deferred until
improvement was seen in depression and adherence
Case 1

Intervention


Pharmacist and patient came to written agreement
stating that the patient would be adherent to both
his medications
Results



At two week and six week follow-up visits, patient
demonstrated significant improvements in mood and
adherence
Patient showed interest in helping to choose an ART
regimen
Currently waiting for most recent surrogate markers
to evaluate need for starting ART
Case 2

History



13 year old HIV+ male presented to clinic reporting
excellent adherence
Surrogate markers suggested current regimen was
failing and a change was considered
Intervention

Adherence nurse made a home visit and discovered
multiple vials of all of his antiretroviral medications

Adherence was inaccurately reported by the patient
Case 2

Results
 Change in ART deferred until patient
demonstrates willingness to adhere to
current regimen
 Home visits and follow-up phone calls are
still being used to evaluate adherence
Case 3

History



18 year old HIV+ female
Unstable home environment, was living with sister
 Friends over every night
 Drinking alcohol frequently
Patient reported poor adherence for various reasons
 Alcohol, confidentiality issues, oversleeping
Case 3

Intervention




Patient was given a pillbox and counseled to fill it at
the beginning of each week
It was suggested to keep the pillbox in her dresser
drawer so that she could take her medications
privately
Good adherence was encouraged and consequences
of poor adherence were discussed
Results

Currently waiting for follow-up visit to assess
adherence
Case 4
The following case is an example of the impact
the home environment and the caregiver can
have on a child’s HIV status
Case 4

History


Five year old HIV+ male with increasingly
elevated viral load (as high as 300,000
copies/mL), which suggested non-adherence to
regimen
Living with mother during this period
 Unstable home environment
 Mother not giving patient medications
Case 4


Child went to live with father
Father took an interest in caring for child’s HIV




Attended adherence visits at PACT Clinic
Was educated on patient’s medications and the
importance of adherence
At follow-up appointments, reported good adherence
Viral load has dramatically decreased to goal of
undetectable (<50 copies/mL)
Overall Conclusions



Adherence barriers include being away from
home, sleeping through doses, side effects,
forgetting, running out of medication and
confidentiality
Depression and substance abuse may be
significant barriers to adherence
Pharmacy-based interventions potentially
improve adherence
Overall Conclusions

Basic education of potential caregivers
regarding the disease itself and the
medications used is crucial.




Universal precautions
Adherence education
Comprehension of regimen
Involvement of primary healthcare provider
Caring for a child with HIV can be challenging, but
with the support of members of the healthcare
team and social services, a caregiver can
provide everything that is needed for the child to
live a normal, healthy life.
Questions?