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Examining Adherence Barriers in Pediatric and Adolescent
HIV Patients
Melannie Cummings, PharmD. Student
Desiree Tomilo, PharmD. Student
School of Pharmacy
New York State University at Buffalo
Linda Catanzaro, PharmD., Clinical Assistant Professor
School of Pharmacy
New York State University at Buffalo
PACT Clinic
Women and Children Hospital of Buffalo, New York
Babette Sullivan, RN
Dawn Melancon, RN
Robert Welliver, MD
Scott Mandel, Director of the CDHS HIV/AIDS Training Institute
HIV/AIDS Training Resource System
Award: 31192
Project: 1037132
Task 2
Meg Brin, Child Welfare Administrative Director
Michelle Barbarossa, Child Welfare Trainer
Child Welfare/Child Protective Services Outcome-Based
Training
Award: 31183
Project: 1037122
Task: 2
Appointment period: January 1, 2004 to June 30, 2004
Funding for this research project was provided by NYS Office of Children and Family Services, Contract
year 2002: Project 1029136, Award: 27267; Contract year 2003: HIV/AIDS 01, Project: 1037132, Award:
31192; CC02, Project: 1037122, Award: 31183 through the Center for Development of Human Services,
College Relations Group, Research Foundation of SUNY at Buffalo State College.
© 2004 CDHS College Relations Group Buffalo State College/SUNY at Buffalo Research Foundation
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Objectives:
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Provide an overview of HIV infection and treatment options
Discuss opportunistic infections and prophylaxis to prevent them
Discuss the importance of 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
Introduction:
Human Immunodeficiency Virus (HIV) is a complex disease state that effects
approximately 40 million people, worldwide, as of 2003 (1). It is estimated that 700,000
children were infected, in 2003 (1). In the United States, most of the children infected
with HIV are living in the inner city, where there is a greater incidence of poverty, poor
housing, exposure to drugs and alcohol, and limited access to healthcare and social
services (2). Along with lack of education and depression, these serve as some of the
potential barriers to medication adherence. Poor medication adherence then leads to the
development of resistance to the antiretroviral medications, and eventually, failure to
suppress viral replication and progression to AIDS.
Transmission:
The virus can be transmitted through unprotected sexual contact with an infected
individual, through contact with contaminated blood, and from mother to infant.
Accidentally being stuck with a needle used by an infected person and careless
administration of first aid to an infected person are examples of transmission through
contaminated blood. Mother-to-infant transmission occurs perinatally, or during delivery
if the baby comes in contact with the mother’s blood, and through breast milk. An
estimated 90% of the 700,000 new infections in children, in 2003, were due to mother-toinfant transmission (1).
Identifying maternal infection early in the pregnancy can prevent perinatal transmission.
By identifying the infection and by trying to keep the viral load below 1000 copies/mL,
the risk of transmission to the infant can be significantly reduced (3). Early identification
of HIV infection in pregnant women would allow the administration of appropriate
antiretroviral prophylaxis, with zidovudine, during pregnancy, during labor, and to
newborns to reduce the risk for HIV transmission from mother to child by up to 66%
(4,5). Unfortunately, HIV screening of pregnant women is not currently mandatory.
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Education, counseling, and advisement of infected women to use an alternative to breast
milk are also important in reducing the chance of mother-to-infant transmission.
Effects of HIV:
HIV attacks and weakens the immune system. If the virus is not suppressed by
antiretroviral medications, it continues to replicate and damage the immune system. If
enough damage occurs, progression to AIDS can occur. The likelihood of developing
AIDS within 12 months, when a child is not on antiretroviral therapy, can be as high as
51% (4).
When the immune system is damaged, it loses its ability to fight off infections.
Infections occur more frequently, are more severe, and can cause death if the immune
system is significantly weakened. The likelihood of death within 12 months, when a child
is not on antiretroviral therapy, can be as high as 30% (4).
Diagnosis of HIV in Infants:
HIV infection can be definitively diagnosed through the use of viral diagnostic assays in
most infected infants by age 1 month and in virtually all infected infants by age 6 months
(4). In infants born to infected mothers, diagnostic testing should be done before the
infant is age 48 hours, at age 1-2 months, and at age 3-6 months (4). Tests for antibodies
to HIV are not used because maternal antibodies are transferred to the infant (4).
In 1996, New York State passed the “Baby AIDS Law”, requiring mandatory HIV testing
as part of the newborn screening program, regardless of the mother’s status. In a study of
infants born in New York State, between 1997 and 2002, the rate of mother-to-infant
transmission decreased by 78% (6). This is evidence of the importance of early detection
of infection in infants.
Surrogate Markers:
Surrogate markers are obtained from an individual’s blood work and help to track the
progression of the disease.
CD4+ T-cells are needed by the immune system to fight off infection. In pediatric
patients, the CD4+ percentage is used to determine the status of the immune system.
Higher CD4+ percentages indicate better immune function.
Viral load (HIV-RNA) is a measure of the amount of virus in the body. It also indicates
if an antiretorviral regimen is effective. A low viral load shows the virus is being
suppressed from replicating and that the potential for the development of resistance to the
medication is limited. The most sensitive assays can detect a viral load as low as 50
copies/mL. Less than 50 copies/mL is considered undetectable and is the goal.
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Antiretroviral Medications:
Antiretroviral medications work by suppressing replication of the virus. The virus can
not be completely eradicated by antiretrovirals. Medications do not cure an individual of
HIV; they only decrease the viral load and prevent the virus from multiplying.
The first medication regimen that is chosen has the best chance of reducing viral load to
undetectable by assay (<50 copies/mL) because the virus has not had the chance to
develop resistance to any antiretrovirals. The term used to describe the virus when it
does not have resistance to medications is wildtype virus.
There are five classes of antiretroviral medications, but only three are commonly used in
the treatment of pediatric patients. Those used in pediatrics are Nucleoside Analogue
Reverse Transcriptase Inhibitors (NRTIs), Non-Nucleoside Reverse Transcriptase
Inhibitors (NNRTIs), and Protease Inhibitors (PIs).
Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs). Drugs in this class
work by blocking an enzyme needed by the virus in order to make the DNA required for
replication.
Common side effects associated with these drugs include nausea, vomiting, diarrhea,
fatigue, weakness, headache, dizziness, loss of appetite, and insomnia. With the
exception of fatigue, these side effects usually subside as the body adjusts to the
medication.
Severe side effects associated with these drugs include pancreatitis, anemia (with AZT),
hypersensitivity reaction and rash (with ABC), peripheral neuropathy (tingling and/or
numbness in the extremities), and liver damage.
With the exception of Videx, which must be taken on an empty stomach, the drugs in this
class can be taken without regard to meals.
NRTIs commonly used in pediatrics include:
 zidovudine, AZT (Retrovir)- This drug is given as prophylaxis in infected
pregnant women and newborns born to infected mothers to decrease the
chance of transmission.
 lamivudine, 3TC (Epivir)
 stavudine, d4T (Zerit)
 didanosine, ddI (Videx)- Many children do not like the taste of the orangeflavored chewable tablets. Other formulations are available.
 abacavir, ABC (Ziagen)- This drug causes a life-threatening allergic reaction
in 5% of patients, characterized by rash or flu-like symptoms. If this occurs,
the medication should be discontinued immediately, and the patient’s
physician should be notified. This drug should never be given to the patient
again. If it is, the reaction will be more severe, and has a greater risk of death.
 Combination NRTIs:
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lamivudine and zidovudine- 3TC+ZDV (Combivir)
abacavir, lamivudine, and zidovudine- ABC+3TC+ZDV (Trizivir)- This
drug contains abacavir, which can cause the life-threatening allergic
reaction. If the patient had a previous hypersensitivity reaction to
abacavir, do not give this combination drug.
NRTIs without sufficient data for use in pediatrics:
 zalcitabine, ddC (Hivid)
 tenofovir, TFV (Viread)
 emtricitabine, FTC (Emtriva)
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs). Drugs in this class work
by blocking an enzyme needed by the virus in order to make the DNA required for
replication.
Common side effects associated with these drugs include rash, depression, insomnia, and
vivid dreams. These symptoms usually resolve within the first few weeks of treatment.
If rash occurs with one of the drugs, it does not mean it will occur with all other drugs in
this class. Nevirapine (Viramune) is associated with a higher incidence of rash as a side
effect.
These drugs are associated with numerous drug interactions. The prescribing physician
should be aware of all other medications being taken by the patient, including both
prescription and over-the-counter medications.
A single mutation of the virus can result in resistance to the entire NNRTI class of
medications. Adherence is especially important to prevent resistance from developing to
these drugs.
NNRTIs commonly used in pediatrics:
 efavirenz (Sustiva)- This drug must be taken on an empty stomach and should
be taken at bedtime
 nevirapine (Viramune)- The starting dose is low, taken once daily for 14 days,
and then increased to twice daily in order to reduce the chance of adverse side
effects.
 NNRTI without sufficient data for use in pediatrics:
 delavirdine (Rescriptor)
Protease Inhibitors (PIs). Drugs in this class work by blocking an enzyme needed to
assemble infectious virus particles.
Common side effects associated with these drugs include fat maldistribution, liver
damage, elevated triglycerides, and diabetes. These usually occur over long periods of
time.
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These drugs are associated with numerous drug interactions. The prescribing physician
should be aware of all other medications being taken by the patient, including both
prescription and over-the-counter medications.
PIs commonly used in pediatrics:
 nelfinavir (Viracept)- This drug should be taken with a meal or light snack
 ritonavir (Norvir)- This drug is given to children age 2-16 years
 amprenavir (Agenerase)- This drug is given to patients over 3 years of age. It
should not be taken with a high fat meal, and supplements containing vitamin
E should be avoided.
 lopinavir and ritonavir (Kaletra)- This drug is given to patients over 6 months.
It should be taken with food. Both formulations of this drug should be kept in
the refrigerator; if kept at room temperature, use within 2 months.
 PIs without sufficient data for use in pediatrics:
 indinavir (Crixivan)
 saquinavir (Fortovase)
 atazanavir (Reyataz)
 fosamprenavir (Lexiva)
Opportunistic Infections:
The HIV virus itself is not responsible for most of the morbidity and mortality that is seen
with AIDS. Opportunistic infections are responsible for 90% of deaths in HIV+ patients.
These infections are caused by common organisms that people with competent immune
systems do not get sick from; however, patients with HIV have a compromised immune
system. They have a loss of their T-cell-mediated immunity and therefore cannot fight off
common infections. The decline in a patient’s immune system can be tracked through
their CD4+ count. It is possible to predict the development of opportunistic infections by
looking at the CD4+ count (7). This allows practitioners to start patients on prophylactic
therapy when they are at risk.
HAART (Highly Active Antiretroviral Therapy) has played a key role in decreasing the
development of opportunistic infections in HIV+ patients. HAART therapy was
introduced in the United States in 1995 (8). From 1996-1998, PCP rates dropped 21%
each year, and MAC rates dropped 39.9% each year (7). This shows that effectively
suppressing a patient’s viral load through appropriate antiretroviral therapy is very
important; however, prophylaxis and treatment of opportunistic infections also remain an
important part in the care of HIV infected patients (7).
The most common opportunistic infections requiring prophylaxis are Pneumocystis
carinii (PCP) and Mycobacterium avium Complex (MAC). Vaccinations are also
important in the prevention of disease in HIV+ patients. Important vaccinations include
Pnuemococcal and H. influenzae type B (HiB). There are guidelines concerning the
initiation of prophylactic therapy. These guidelines are specific for patients based on age.
© 2004 CDHS College Relations Group Buffalo State College/SUNY at Buffalo Research Foundation
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PCP Prophylaxis:
Opportunistic infection guidelines for children state that infants 1-12 months old should
receive PCP prophylaxis if they are HIV-infected or HIV-indeterminate. Children 1-5
years old should receive prophylaxis if their CD4+ count is less than 500 cells/µL or their
CD4 percentage is less than 15%. Children 6-12 years old should receive prophylaxis if
their CD4+ count is less than 200 cells/µL or their CD4 percentage is less than 15%.
Adults and adolescents should receive prophylaxis for PCP when their CD4+ count is
less than 200 cell/µL or if they have a history of orophangeal candidiasis. Prophylaxis is
considered in adults or adolescents with a CD4+ percentage less than 14 percent or if
they have a history of an AIDS defining illness (8), including PCP, MAC, and Kaposi’s
sarcoma (9).
Medications that are utilized for PCP prophylaxis in children, adults, and adolescents
include varying doses of trimethoprim/sulfamethoxazole, dapsone (with or without
pyrimethamine in adults and adolescents), aerosolized pentamidine and atovaquone (8).
Children should continue PCP prophylaxis throughout the first year of life. If a child has
a history of PCP he or she should receive lifelong PCP prophylaxis. The safety and
efficacy of discontinuing PCP prophylaxis in children has not been studied. Some
clinicians consider discontinuing medications when a child 1-5 years old has had a CD4+
count greater than 500 cells/µL or a CD4+ percentage greater then 15% for at least three
months or when a child 6-12 years old has had a CD4+ count greater then 200 cells/µL or
a CD4+ percentage greater than 15% for at least three months (8).
Discontinuation of PCP prophylaxis has been studied in adults and adolescents. When
their CD4+ count has been greater then 200 cells/µL for at least three months, PCP
prophylaxis is stopped. This is done to decrease pill burden, drug toxicities, drug
interactions, bacterial resistance and cost (8).
MAC Prophylaxis:
Opportunistic infection guidelines say children less than one year old should start MAC
prophylaxis when their CD4+ count is less than 750 cells/µL, children 1-2 years old when
their CD4+ count is less than 500 cells/µL, children 2-6 years old when their CD4+ count
is less than 75 cells/µL and children greater than 6 years old when their CD4+ count is
less than 50 cells/µL. Adults and adolescents also start MAC prophylaxis when their
CD4+ count is less then 50 cells/µL (8).
Medications used in children, adults, and adolescents for MAC prophylaxis include
azithromycin and clarithromycin. As with PCP, children who have a history of MAC
infection should receive lifelong MAC prophylaxis. The safety of stopping MAC
prophylaxis in children has not been studied; however, some clinicians consider stopping
prophylaxis when CD4+ counts have been above 750 cell/µL in children less than one
year old, 500 cells/µL in children 1-2 years old, 75 cells/µL in children 2-6 years old and
© 2004 CDHS College Relations Group Buffalo State College/SUNY at Buffalo Research Foundation
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50 cells/µL in children greater than 6 years old, for at least three months. In adults and
adolescents, MAC prophylaxis is stopped when their CD4+ count has been greater then
100 cells/µL for at least three months (8).
Vaccinations:
There are specific guidelines concerning the administration of vaccinations in HIV+
patients as well. All HIV+ children should receive all of the typical childhood
vaccinations. Children less than 5 years old should receive the H. influenzae type b (Hib)
and pneumococcal conjugate vaccines. If children are greater than 2 years old, they
should also receive the 23-valent-polysaccharide pneumococcal vaccine. Revaccination
should occur after 3-5 years if the child is less then or equal to 10 years old and after 5
years if the child is greater than 10 years old (8)
Adults and adolescents with a CD4+ count greater than or equal to 200 cells/µL should
receive a single dose of 23-valent polysaccharide pneumococcal vaccine, if they have not
received it in the past five years. The vaccine can be considered for patients with a CD4+
count less than 200 cells/µL but there is no proof of efficacy. The H. influenzae type b
(Hib) vaccine is not recommended in adults and adolescents because the rate of infection
is very low (8).
Adherence:
It has been shown that greater than or equal to 95% adherence is necessary for
antiretroviral therapy to be successful and lead to adequate viral suppression (10). There
are many potential barriers to adherence including pill burden, drug use/alcohol abuse,
depression, lack of education (10), unwillingness to disclose HIV status, unstable
environment, side effects and lack of palatability of medications (4). There is a special
concern about adherence with pediatric patients because a caregiver is involved. This
caregiver is often completely in charge of giving the child his or her medications or is at
least helping with medication administration. The status of the child and the caregiver has
to be taken into account when assessing adherence in the pediatric population.
There are many consequences of poor adherence. These include virologic failure, which
is incomplete or lack of HIV-RNA response. There is also incomplete virologic response,
where the viral load does not decrease to goal, and virologic rebound, where the viral
load initially decreases but then comes back up (11).
Resistance can develop if a patient is not being adherent to their medications. This
happens because there are not adequate levels of the medication to suppress viral
replication. Selective pressure is placed on the resistant virus. This leads to suppression
of non-resistant virus and replication of resistant virus, causing the patient to be
repopulated with the resistant virus. Resistance causes antiretroviral medications to be
ineffective in patients. As resistance develops, future medication choices are decreased
(12). When a patient develops resistance and has virologic failure, the likelihood of
developing co-morbidities, such as opportunistic infections, is increased and thus the
© 2004 CDHS College Relations Group Buffalo State College/SUNY at Buffalo Research Foundation
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chance of death is increased. It has been shown that high HIV-RNA levels and low CD4+
counts are associated with an increased progression to AIDS (4).
There are many adherence interventions that can be employed to help a patient. These
include pillboxes, calendars, alarm watches, home visits, refill checks, phone calls, and
adherence visits or clinic appointments (4).
Education of Foster Parents of HIV+ Children:
The education of foster parents who are going to be caring for an HIV+ child is very
important. They need to be provided disease education, which will most likely come from
the healthcare provider involved in the care of the child. They also need to be educated
on universal precautions, for example avoiding contact with the child’s blood and any
stool or vomit which may contain blood. An understanding of the patient’s medication
regimen and the importance of adherence are critical.
PACT Clinic Baseline Characteristics:
At baseline, 24 children were included in our patient population. Baseline data collection
forms were filled out about each of the children. Information collected included their
most recent CD4+counts, their current living situation, history of depression and
substance abuse in the patient and the caregiver, patient reported adherence, who was in
charge of medication administration and reasons that the patient reported missing doses.
The CD4+ count or percentage determines immune suppression. The CD4+ percentage is
used most often in pediatrics. If a patient’s CD4+ percentage is greater then 25%, they
have no immune suppression. A CD4+ percentage of 15-24% is considered moderate
immune suppression and a CD4+ percentage less then 15% is considered severe immune
suppression. When looking at the entire patient population, 14 of the 24 patients had no
immune suppression. Six patients had moderate immune suppression, 3 had severe
immune suppression and 1 patient was unknown. Overall, a majority of the patients seen
at the PACT clinic had no immune suppression and only a small number of patients were
severely immunocompromised.
Immune suppression was then divided by age. There were 4 children ages 1-5 years old.
Half of the patients had no immune suppression and half had moderate suppression.
There were 11 patients who were 6-12 years old. Seven (70%) of these patients had no
immune suppression, 3 (20%) have moderate suppression and 1 (10%) has severe
suppression. There were 10 patients who were greater then 12 years old. Five (50%) of
these patients had no immune suppression, 2 (20%) had moderate suppression, 2 (20%)
had severe suppression and 1 (10%) was unknown. Due to the small patient population, it
is difficult to extrapolate from this data whether there is a trend toward increased immune
suppression in one age group over the others.
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When looking at the living situations it was found that a majority of the children (79.2%)
lived with a biological relative. Non-kinship foster placement accounted for 12.5% of the
children, and 8.3% were living on their own.
Depression and substance abuse were evaluated at baseline due the potential role that
both may play in poor adherence. It was found that 8 of the children had a history of
depression, but their caregivers did not. Four of the children’s caregivers had a history of
depression, while the child did not. Three of the children had depression, and their
caregiver did as well. In eight of the children, neither the child nor the caregiver had any
documented history of depression. One patient was unknown. Also, two of the children
had a history of substance abuse with no history documented in the caregiver. Ten of the
caregivers had a history of substance abuse with no history in the patient. There were no
children where both the child and the caregiver had a history of substance abuse, and
there were 11 children where neither had a history of substance abuse. There was 1
unknown patient.
Adherence is documented as reported by the patient. At baseline, 12 of the patients
reported good adherence, which we defined as missing 0 to 2 doses in one month. One
patient had fair adherence, missing 3 to 5 doses in one month, and 2 patients had poor
adherence, missing more than 5 doses in one month. Three patients were not on
antiretroviral therapy and six patients were unknown. Overall, patients seen at the PACT
clinic were reporting very good adherence.
Medication adherence was then split by age. There were three children from 1-5 years
old. One patient had good adherence, one was not on therapy, and one was unknown.
There were 11 children aged 6-12 years old. Five reported good adherence, one reported
poor adherence, two were not on therapy, and three were unknown. There were 10
patients greater than 12 years old. Six children reported good adherence, 1 reported fair
adherence, 1 reported poor adherence, and two were unknown. Again, due to the small
patient population it cannot be determined that one age group had poorer adherence than
another did.
The reasons patients gave for missing doses were recorded. The most common reason
given was being away from home. Next was falling asleep, then running out of
medication, confidentiality and substance abuse. Forgetting and pill burden were not
reported as reasons for missed doses by any of the patients. One patient reported being
sick of taking medications, and one patient gave no reason.
The person responsible for medication administration was documented. In three cases the
patient was completely in charge of their own medication administration, and in eight
cases the caregiver was completely in charge. In nine cases both the patient and the
caregiver played a role in medication administration. There were two children who were
not on any antiretroviral medications, and two patients were unknown. In this population,
shared responsibility for medication administration appeared to be fairly common.
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Medication adherence was then split based on who was in charge of medication
administration. Of the 12 patients with good adherence, two took care of their
medications alone, four of the caregivers took care of medications alone, and in six of the
patients, both the patient and the caregiver were involved in medication administration.
There was only one patient with fair adherence, and both the patient and the caregiver
were involved in medication administration. There were two patients with poor
adherence. In one case, the patient was in charge of medication and in the other, both the
patient and the caregiver were involved.
It appears that having both the patient and the caregiver involved in medication
administration can be beneficial. In many of the instances where both the child and the
caregiver were involved, the children would report that they usually remembered to take
their medications but when they forgot their caregiver would remind them. It seems that
having a support system where the child and the caregiver work together to remember
medications would help to improve adherence.
In the one patient who reported fair adherence, the patient had a history of depression,
and both the patient and caregiver were involved in medication administration. In the two
patients who reported poor adherence, one patient had a history of depression and
substance abuse, and the patient was completely in charge of medication administration.
There was no documented depression or substance abuse in the caregiver. In the other
patient, both the patient and the caregiver had a history of depression, and the caregiver
had a history of substance abuse. Both the patient and the caregiver were involved in
medication administration.
Due to the small size of the PACT patient population, no results should be extrapolated
and applied to the general population of HIV+ pediatric patients. However, it does appear
that having both the patient and the caregiver involved in medication administration
could improve adherence. It also appears that having a history of depression or substance
abuse in the person involved in medication administration could negatively affect
adherence.
Follow-up Interventions:
During the appointed period of this project, one patient was added to the population,
making the total number of patients 25.
At the PACT Clinic, there are standards of care that are followed to help ensure
adherence to medications. Adherence appointments with a PharmD are held every other
week or as needed. For this project, at these appointments, patients were interviewed
using follow-up questionnaires, and monthly case conferences were held with other
members of the healthcare team, including PACT nurses. The pager numbers of the
pharmacist and the RN are made available to all patients for any questions they may
have.
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Specific interventions. Some of the specific adherence interventions used included
giving patients pillboxes to organize their medications, home visits by an adherence
nurse, calling patients’ pharmacies to check on the status of refills, treatment of
depression, and developing a medication administration schedule and contract.
Of the 25 PACT patients, 96% (24) were seen during the appointed time for this project.
Of the 24 that were seen, 12.5% (3) required intensive interventions. One was treated for
depression. An adherence nurse made visits to one patient’s home, did “pill counts” to
determine if he was taking his medications, and made phone calls to his pharmacy. The
third patient was given a pillbox and was shown how to fill it to keep her doses
organized.
Case 1. A 13-year-old HIV+ male presented to the PACT Clinic in January. He had
previously seen a psychiatrist and was diagnosed with major depression. An
antidepressant was prescribed. Based on his CD4+ count, PCP prophylaxis was also
previously prescribed.
After questioning the patient and talking to his father, it was determined he was nonadherent to both medications. The patient said he didn’t feel like the anti-depressant was
working and that he didn’t feel a difference. His father reported the patient was quiet,
withdrawn, and often confrontational. At appointments, the patient kept his hood on and
his head down, and mumbled when asked a question.
The patient was not on antiretroviral therapy, at that time, because of concerns that his
depression would cause him to be non-adherent.
After talking to the patient and explaining to him it that takes time for the anti-depressant
to work, a written agreement was signed by both the patient and the PharmD.
At his 2 and 6-week follow-up appointments, the patient demonstrated a significant
improvement in his mood, and he reported missing no doses of the anti-depressant or the
PCP prophylaxis. The patient was willing to talk, made eye contact, and smiled. He
showed interest in helping to choose an antiretroviral regimen, in the future.
We are currently waiting for the results of his most recent bloodwork to evaluate his
surrogate markers and the need to start HIV therapy.
Case 2. A 13-year-old HIV+ male presented to the PACT Clinic reporting excellent
adherence. His lab work and surrogate marker values suggested the current regimen was
failing, and a change in medications was considered.
An adherence nurse made a home visit and discovered multiple vials of all of his
antiretrovirals. The patient had inaccurately reported adherence. The reason for the
virologic failure was because he had developed resistance to his current regimen as a
result of poor adherence.
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A change in therapy is being deferred until the patient demonstrates willingness to adhere
to the current regimen. Home visits and follow-up phone calls are still being used to
track his progress.
Case 3. An 18-year-old HIV+ female presented to the PACT Clinic for a routine
adherence appointment. At that time, the patient was living with her sister, and they were
having friends over every night and were drinking frequently. She reported poor
adherence because she did not want her friends to see her take her medications and
because she often slept in late and would miss her morning dose.
The patient was given a pillbox and was counseled to fill it at the beginning of each
week. It was suggested she keep the pillbox in her dresser drawer so she could go in her
room, alone, and take her medications privately. Good adherence was encouraged and
the consequences of poor adherence were discussed.
We are currently waiting for her to come in for a follow-up visit to assess adherence.
Case 4. A 5-year-old HIV+ male presented to the PACT Clinic for a routine adherence
appointment. Recent lab results showed an increasingly elevated viral load over the past
year. At one point, the viral load was as high as 300,000 copies/mL, suggesting nonadherence to his current regimen. At this time, he was living with his mother and had
limited contact with his father. It appeared the home environment was unstable, and his
mother was not correctly giving the patient his medications.
The patient’s parents decided he would live with his father, who took an active interest in
his HIV healthcare. He brought the patient to all of his scheduled adherence
appointments and asked questions about the child’s medications and the importance of
adherence. At follow-up appointments, excellent adherence was always reported.
Since the patient has been living with his father, his viral load has dramatically decreased
to the goal of undetectable (<50 copies/mL).
Overall Conclusions:
In this patient population, the most common adherence barriers include being away from
home, sleeping through doses, adverse side effects, forgetting to take doses, running out
of medication, and fear of lack of confidentiality. Counseling patients on how to avoid
these situations appears to have a positive effect on patient adherence.
Depression and substance abuse, in either the patient or caregiver, appear to be
significant barriers to medication adherence. Treatment of depression may be critical in
ensuring willingness and desire to be adherent to antiretroviral regimens.
Pharmacy-base interventions have improved adherence in this population. Giving
pillboxes, making phone calls, educating patients, and signing agreements have all been
successful.
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Basic education of potential caregivers of HIV+ children, concerning the disease itself
and the medications used, is crucial. The importance of adherence should be stressed and
the regimen should be understood by the caregiver. Universal precautions should be
discussed, such as avoiding direct contact with the child’s blood or any body fluids that
may contain blood. The child’s primary healthcare provider should work closely with the
caregiver to ensure the child is well taken care of.
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.
References:
(1) The AIDS Education and Research Trust (AVERT). <www.avert.org>, June 2004.
(2) National Institute of Health, National Institute of Allergy and Infectious Disease.
<www.niaid.nih.gov>, 2004.
(3) Committee on Obstetric Practice. ACOG committee opinion scheduled Cesarean
delivery and the prevention of vertical transmission of HIV infection. Number 234,
May 2000 (replaces number 219, August 1999). International Journal of Gynaecology
& Obstetrics. 73(3):279-81, 2001 Jun.
(4) Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infections-January
20, 2004.
(5) Reference: Sperling RS, Shapiro DE, Coombs RW et al. Maternal viral load,
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virus type 1 from mother to infant. Pediatric AIDS Clinical Trials Group
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(9) 1993 Revised Classification System for HIV Infection and Expanded Surveillance
Case Definition for AIDS Among Adolescents and Adults – December 18, 1992.
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(10) 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.
(11) Guidelines for the Use of Antiretroviral Agents in HIV Infected Adults and
Adolescents – March 23, 2004.
(12) Luber AD. “Pharmacotherapy of Human Immunodeficiency Virus Infection”. In:
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Williams and Wilkins; 2001.
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© 2004 CDHS College Relations Group Buffalo State College/SUNY at Buffalo Research Foundation
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