1. health and fitness
2. disease
3. aids and hiv

▲ HIV Clinician
▲
DELTA REGION
AIDS EDUCATION
& TRAINING CENTER
Educating
health care providers
about HIV/AIDS
formerly FACULTY NOTES
Ronald D. Wilcox, MD, FAAP
W
hile highly active antiretroviral
therapy (HAART) has been making incredible improvements in
mortality rates from HIV infection, more
information about the effects of HIV
therapy on other aspects of our patients’
health is being found in multiple different studies. HIV therapy has been shown
to have effects on the incidence rate of
heart disease in patients on antiretroviral therapy. This effect has best been
demonstrated in the Data Collection on
Adverse Events of Anti-HIV Drugs (D:A:D)
study.
D:A:D is a huge study with a collaborative effort internationally involving 11
cohorts of investigators, including 212
clinics in 21 countries of Europe, the
United States, and Australia. There were
7 Legal
9 Pharmacy
12 Nutrition
14 Nursing
16 Journal Articles
Summer 2008 • Vol. 20, No. 3
D:A:D study shows that HIV therapy
affects incidence rate of cardiac disease
A PEER-REVIEWED ARTICLE
Inside
ISSN: 1551-885X
a total of 33,347 patients enrolled in
the study between December 1999 and
January 2005 who are being followed
prospectively at their regularly scheduled visits to outpatient clinics. Data
is collected in a standardized format on
sociodemographic features, laboratory
results, treatments (both antiretroviral
and other), and clinical features. All
data is then merged into a central data
set annually.
All incident cases of myocardial infarction (MI) have been reported to the
central office for validation and coding,
with categorization as either definite,
possible, or unclassifiable and as either
fatal or non-fatal. Validation and coding were accomplished without knowledge of the antiretroviral treatment
histories of the affected patients. Poisson regressional analysis was done to
quantify the relationship between antiretroviral exposure history and the inSee Cardiac disease, next page
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From our consultation files
Which immunizations are safe for HIV patients?
Sheryl Thornton, DNS, RN
This article comes as the result of a phone call
regarding immunizations and HIV. The caller was
interested in knowing which vaccines were safe for
HIV patients. Immunizations have been a source
of confusion among clinicians, particularly those
responsible for the care of HIV-infected patients.
Questions remain regarding which vaccines are safe
and which vaccines are contraindicated in certain
circumstances. What are the compositions of these
vaccines that result in these contraindications?
But a more challenging question relates to efficacy. Are these vaccines actually providing
immunity to the HIV-infected recipient?
When a child first registers for school,
evidence must be presented that he/she is “upto-date” on immunizations. This is a complete
series of vaccinations required by respective
states for school entry.17 However, some parents
and other adults refer to these vaccines as
See Immunizations, page 4
Louisiana
State •University
HIV
Clinician
SummerHealth
2008Sciences Center • University of Mississippi Medical Center • Jefferson Comprehensive Care System, Arkansas
1
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Medicine
Benefit may outweigh risk, but informed patient should decide
Cardiac disease, from previous page
cidence of myocardial infarction
and reported in two major publications, the first in the New
England Journal of Medicine in
April 2007, and the second in
The Lancet in April 2008. The
first article reported the association between the use of protease
inhibitors (PIs) and the nonnucleoside reverse transcriptase
inhibitors (NNRTIs) and the
incidence of a myocardial infarction. The primary Poisson
regression model was adjusted
for calendar year, conventional
risk factors for cardiac disease,
and demographic factors. Additional analyses of the effect of
antiretroviral therapy on conventional cardiac risk factors
were also performed, specifically
for diabetes, hypertension, and
lipid abnormalities. Demographics of the subjects of the first article were 24.1% women, 77.9%
white, 16.9% black, 3.3% Hispanic, with a median CD4 count
of 200 cells/mm3 and an AIDS
diagnosis in 26.4%. Additional
demographic data at enrollment
included: 14.4% hypertension,
60.8% current or former smokers, 42.0% with dyslipidemia,
and 3.1% with diabetes. Patients
included in the analysis for the
NEJM article totaled 23,437 and
were enrolled between December
1999 and April 2001.
A total of 150,775 personyears of exposure to antiretroviral therapy were included in
the analysis, based on 93.6% of
patients who received any antiretroviral agents over the study
period. 79.4% had exposure to
HIV Clinician • Summer 2008
protease inhibitors (median 4.0
years) and 63.7% had exposure
to non-nucleoside reverse transcriptase inhibitors (median 2.6
years). A myocardial infarction
occurred in 345 patients with a
29.3% fatality rate. At the time
of the event, 90.4% had been
exposed to PIs and 60.9% to
NNRTIs. Increased exposure to
antiretroviral therapy was consistently shown to be associated
with an increased risk of myocardial infarction (adjusted relative
rate of 1.16 per year of exposure)
with no statistical differences
seen between men and women
and between older and younger
patients. After adjustment for
exposure to calendar year, the
other drug class, and known
cardiac risk factors, the PIs had
a relative rate per year of 1.16
and the NNRTIs a relative rate
of 1.05. Also of significance was
the increased crude incidence of
myocardial infarction in those
who received a PI with an NNRTI
as compared to those in the entire cohort (5.77 versus 3.65 per
1000 person-years); this finding
is thought to be due to the longer
exposure to PIs in this group.
Although the PIs as a class are
known to increase lipid levels,
these changes were not sufficient
to fully explain the increased
risk. Murine models suggest a
possible association between PIs
and atherosclerosis by possible
direct cellular mechanisms. No
relationships between nadir CD4
count or peak HIV RNA level
with myocardial infarction were
found.
The second article, published
in The Lancet, included an evalu-
ation of the effects of the nucleoside- and nucleotide-reverse
transcriptase inhibitor classes
of medications with the risk of
myocardial infarction. This portion of the study involved analysis of 33,347 enrolled patients
and used the Poisson regression
model to determine the relationships between cumulative, recent
(current or within the preceding
six months) and previous use
of abacavir, didanosine, lamivudine, stavudine, and zidovudine;
tenofovir, adefovir, emtricitabine, and zalcitabine were not
included in the analysis. These
five agents were included when a
sufficient follow-up among individuals receiving the drugs was
accrued for a reliable analysis. It
was theorized that stavudine and
zidovudine, previously shown to
be associated with rises in lipid
levels and increases in intimamedia thickness as well as insulin resistance, would be associated with an increased relative rate
of myocardial infarction. Followup time and events that occurred
within the first two months after
commencing therapy with abacavir were excluded to eliminate
the effect of abacavir hypersensitivity. Patients were categorized
as being of high, moderate, low,
or unknown risk for cardiovascular disease using the patient’s
latest predicted 10-year risk as
determined by the Framingham
equation.
A total of 157,912 personyears were included in this analysis with 517 patients having
had a myocardial infarction, giving an event rate of 3.3 per 1000
person-years. Of those who had
2
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an MI, 509 of the patients had
exposure to antiretroviral therapy
with 59 off therapy at the time of
the myocardial infarction. The
median latest CD4 count before
the MI was 420 cells/mm3 and
51% of the patients had an HIV
viral load < 50 copies/ml. As
would be expected, the conventional risk factors for cardiac
disease were found to have an
association with an increased incidence of MI, such as male sex,
current smokers, family history
of coronary disease, diabetes,
and hypertension. There were no
significant data associating exposure to lamivudine, stavudine,
or zidovudine with the occurrence of a myocardial infarction.
Abacavir and didanosine were
both shown to have an increased
association that began very soon
after starting the medication
and remained elevated the entire time the patient was on the
medication. The rate of MI was
increased by 49% in those with
recent use of didanosine and
90% in those with recent abacavir use as compared to those who
had not used the medication ever
or in the preceding six months;
unlike that seen with protease
inhibitors, this risk did not continue to increase with ongoing
use of either agent. The severity
or classification of the myocardial
infarction was not different in
these groups as compared to the
others.
In an editorial in the same issue of The Lancet, Drs. Stein and
Currier bring up some relevant
points for consideration. Patients with elevated lipids or at
high risk for cardiac disease may
have been selected for abacavir
therapy in place of a protease
inhibitor as a response to the
NEJM article. The risk of inadequate viral suppression has been
HIV Clinician • Summer 2008
shown in the SMART study to be
associated with an increased risk
of cardiovascular complications,
so changing from a suppressive
regimen to a less-effective choice
may lead to loss of virologic
control. They stress the need for
patients to modify cardiac risk
factors while awaiting confirmatory research. A letter from Amy
Cutrell et al from GlaxoSmithKline (GSK) in the same issue discussed a summarization of data
from the GSK HIV data repository of 54 clinical trials involving
14,683 HIV-infected patients who
were exposed to abacavir. The
incidence of coronary/myocardial
events was similar between those
who received abacavir and those
who had not. Stein and Currier
point out though that this evaluation includes only 18 patients
who had a myocardial infarction
and the studies were not powered
sufficiently to evaluate the risk
for this complication.
What do these two studies mean clinically? They show
that those who are on a protease
inhibitor, either boosted with
ritonavir or not, have a two-fold
increased incidence of MI after 5
years (1.16 RR per year cumulative). Patients who are currently
taking abacavir have nearly a
doubling of risk while on the
medication and those taking
didanosine have nearly a 50% increased risk; increases with these
two medications occur while the
patient is taking the medication
but the risk regresses within a
few months after discontinuation of the medication. Patients
should be assessed for risk of
cardiovascular disease on the
conventional risk factors; those at
high risk should be encouraged
to control those risk factors they
can influence such as tobacco
use or hypertension. The patient
who is to begin a new HIV medication regimen should be counseled about the increased risk
of MI when using these medications and the risk-benefit ratio
has to be discussed with the individual patient; patients at high
risk for coronary disease possibly may wish to avoid a regimen containing a PI or abacavir
or didanosine unless the riskbenefit ratio favors their use due
to limited effective ART choices
and the patient understands the
increased risk. For many patients who are already treatment
experienced, the benefit of these
medications to prolong life will
likely far outweigh the risks, but
the patient needs to be made
aware of the risk in order to
make a reasoned, informed decision. Patients who are currently
on these medications should
also be notified of the risk, with
assessment done as to whether
to continue the same medications or to make changes even
though the risk of changing the
medication with possible viral
rebound may actually increase
the cardiac risk further.v
REFERENCES
The D:A:D Study Group. Class of Antiretroviral Drugs
and the Risk of Myocardial Infarction. NEJM 26 April
2007;356:1723-35.
The D:A:D Study Group. Use of Nucleoside Reverse
Transcriptase Inhibitors and Risk of Myocardial Infarction in HIV-Infected Patients Enrolled in the D:A:D
Study: a Multi-Cohort Collaboration. Lancet 26 April
2008;371:1417-26.
Cutrell A et al. Abacavir and the Potential Risk of
Myocardial Infarction. Lancet 26 April 2008;371:1413.
Stein JH and Currier JS. Risk of myocardial infarction and nucleoside analogues. Lancet 26 April
2008;371:1391-2.
Ronald Wilcox is Director/Principal
Investigator of Delta Region AETC
and Assistant Professor of Internal
Medicine and Pediatrics, Section of
Infectious Diseases, LSU Health Sciences Center.
3
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From our consultation files
Most vaccines can safely be administered to HIV patients
Immunizations, from page 1
“baby shots,” thereby implying that
no further immunizations are needed
in the late teen or adult years. For
adults, the routine health care examination and screening, with evidence
of proper and up-to-date immunizations, are roles assumed by the
health care provider. For adults who
are immunocompromised due to HIV
disease or certain cancers, immunizations may provide a safety measure to
prevent complications. While some immunizations provide a lifetime of immunity, others require “booster” doses
to maintain their ongoing immunity, or
some require annual revision based on
current formulations.
Immunization schedules are
published annually through the
recommendations of the CDC, ACIP
(Advisory Committee on Immunization Practices), and respective state
health departments. In Louisiana, for
example, the Immunization Schedule
is distributed annually by the Department of Health and Hospitals.12 This
schedule is available to health care
providers, clinics and hospitals and
provides vaccine administration tables
and regulations for children between
the ages of birth and 12 years, including accelerated schedules for children
who started immunizations late.
Similarly, a schedule is published for
pediatric age groups aged 0-6 and
7-14 through the CDC.5 The Recommended Adult Immunization Schedule
is published annually by the CDC,
giving guidelines and restrictions
regarding immunizations to three age
groups: 19-49, 50-64, and > 65 years.4
So how does this translate to individuals who are affected by HIV? In
the adult guidelines, specific information is provided regarding the safety of
administration of most vaccines, however these guidelines are not provided
in the state immunization schedule
for the pediatric HIV+ patient. A brief
review of vaccine composition may
reveal which vaccines may or may not be
administered to the HIV+ patient.
Vaccines are usually composed of the
actual virus or bacteria, or some portion thereof. Different terms are used to
indicate the composition of the vaccine,
such as live, attenuated, inactivated; and
toxoid or polysaccharide indicating use
of part of the bacteria, or virus. For example, a vaccine may be labeled “live, attenuated” meaning that the virus is live,
but has been altered or changed in some
way, usually weakened, so that the virus
does not have its full virulent ability.7,23
Two vaccines that use this composition
are the MMR (measles, mumps, and rubella vaccine) and the varicella vaccine.
One major advantage to this type of vaccine is that one or two doses is sufficient
to provide a lifetime of immunity because
they elicit strong antibody responses
within the body. A major disadvantage is
that it cannot be administered to some
groups who are immunocompromised or
to patients with certain forms of cancer.
Most live virus vaccines must be refrigerated to maintain potency, and may be
contraindicated in patients who are HIV
infected.
Another form of vaccine is the inactivated (killed) virus. This vaccine uses
the virus that has been killed, yet the
body is able to form protection against
this virus. Some examples of this type
of vaccine include the inactivated polio
vaccine, the hepatitis A vaccine, and the
trivalent inactivated influenza vaccine.
One of the primary advantages is that it
cannot cause a mild form of the disease
because the virus is dead, therefore it
can be used safely in HIV+ recipients.
Because the virus is killed, several doses
may be required to achieve immunity.
Using part of the virus is another method
used in making vaccines, sometimes
referred to as “subunit vaccines.” It has
been found to be effective in eliciting an
immune response that is sufficient for
protection. By using part of the virus,
the chances of adverse reactions to the
vaccine are lower, and these may be
used in HIV+ patients. The hepatitis B
vaccine is one example; though this
type of vaccine may provide a lifetime
of immunity, it does require administration of more than one dose. Finally,
another form of vaccine composition
is using part of bacteria, such as in
toxoid vaccines after deactivation, or
in conjugate vaccines, which are the
polysaccharide outer coating of the
organism. The diphtheria, tetanus,
pertussis, conjugated polysaccharideHemophilus influenzae B (HiB), pneumococcal, and meningococcal vaccines
are examples.7
Of the 12 most commonly administered vaccines for use in the United
States, three present some precautionary suggestions and should be administered based on CD4 or CD4% levels:
MMR, varicella, and zoster.4,19 Other
vaccines may be administered without
regard to the patient’s CD4. The first
vaccine in this group is the tetanusdiphtheria-pertussis vaccine. There
are at least four different formulations
for this vaccine: 1) The DTaP which
uses acellular pertussis therefore is
less reactogenic. This form of the vaccine is commonly used during the initial series of the vaccine. 2) The DPT,
not used since 2002. 3) The Tdap,
composed of tetanus toxoid, reduced
diphtheria, and acellular pertussis
vaccine, now recommended for adults
19-64 to replace the next booster dose
of the tetanus and diphtheria toxoid.
4) The Td vaccine which must be repeated every ten years. These groups
of vaccines are not contraindicated in
HIV+ patients.3,4,18
Though rarely used in the world today, the OPV or oral polio vaccine is a
live virus that literally wiped out polio
in the Western Hemisphere; however,
its use is contraindicated in the HIVinfected patient. The IPV, or inactivated (killed) polio vaccine, which is in
an injectable form, does not use a live
virus, and may be safely used in HIVinfected patients (22).
The Haemophilus influenzae type
b or HiB is commonly given to young
Back issues are online at deltaaetc.org
HIV Clinician • Summer 2008
4
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children between the ages of 6 weeks
to 70 months. This vaccine has no
apparent effect on older children and
adults, and may safely be used in
HIV-infected children. Another vaccine
targeted for young children is the rotavirus vaccine. Rotavirus is commonly
seen in children under the age of 5, is
considered highly contagious, and is
spread by oral-fecal contact. Administered in three oral doses at ages 2,
4, and 6 months, recommendations
for use of this vaccine among HIVinfected children must be assessed on
a case-by-case basis, determining the
potential benefits against the risks.21
The HPV vaccine is routinely given
to girls 11 and 12 years of age, and
is recommended for all females ages
13-26. This 3-dose vaccine is recommended to be administered before the
onset of sexual activity. It is recommended that the interval between the
first and second dose be eight weeks,
and the third dose should be administered six months after the first dose.
This vaccine offers no contraindications for women who are HIV infected,
have a history of genital warts, or a
history of an abnormal pap smear. The
incidence of squamous intraepithelial lesions of any grade and the risk
for invasive cervical cancer are more
prevalent in HIV-infected women, yet
another reason for recommending the
HPV vaccine.8
The conjugate pneumococcal vaccine is used in children <2 years of
age given at 2, 4, 6, and 12-15 months
of age. The polysaccharide vaccine is
used in those over the age of 2 years
and is also used in patients with
chronic medical conditions, including
HIV. One note regarding this vaccine:
Adults below the age of 65 may require
re-vaccination and it is suggested that
vaccination should occur as close to
the initial diagnosis of HIV as possible.1
Hepatitis A and B vaccines are both
recommended for use in the HIVinfected patient. Hepatitis A vaccine
is also recommended for patients with
chronic liver disease, those receiving clotting factors, IVDUs, MSMs,
children, and travelers to endemic
regions. The vaccine is given in two
doses six months apart, It is recommended that an HAV screen be performed before administering vaccine.9
Hepatitis B is administered to all
HIV Clinician • Summer 2008
infants and children born after November
21, 1991, especially to mothers who are
HBsAg+. It is further recommended for
health care workers, morticians, those
requiring frequent transfusions, HIV+
and hepatitis C+ patients, those patients
who are recently starting hemodialysis,
IVDUs, high risk sexual practitioners,
household contacts of those with active
hepatitis B, and populations where hepatitis B is endemic.
Hepatitis B vaccine can be administered in two forms, according to the
ACIP Recommendations for HIV-infected
adults. Engerix-B is administered in
20 ug/ml x 2 (40 ug total) on a 4-dose
schedule of 0, 1, 2 and 6 months, or
Recombivax-HB 40 ug/ml x 1 on a 3-dose
schedule of 0, 1 and 6 months.1,19
The meningococcal vaccines are scheduled to be administered to children ages
11 and 12 who are on “track” with their
immunization schedule. Other groups
targeted for administration include first
year college students living in dorms,
military recruits, and asplenic patients.
According to ACIP, administer MCV4 at
age 11-12 and at age 13-18 years if not
previously vaccinated, with MPSV4 being
an acceptable alternative.1,5 This vaccine
may be safely used in the HIV-infected
patient.
The influenza vaccine, according to the
2007 ACIP Recommendations, should be
administered annually to HIV-infected
patients, with the trivalent inactivated
vaccine. Two forms of the vaccine exist,
the trivalent inactivated vaccine (TIV)
and the live, attenuated, trivalent vaccine
(LAIV). The latter (LAIV) is contraindicated in patients with HIV. Vaccinations
in HIV-infected patients should occur
between October and December and
regardless of CD4 cell count.1,4,18,19
The three vaccines with precautionary
warnings for HIV-infected patients are
MMR, varicella, and zoster. The MMR is
composed of live virus and is contraindicated in children who are immunosuppressed by diseases such as cancer or
HIV infection with a CD4% count below
15. It is contraindicated in HIV-infected
adults with CD4 counts < 200 and it may
not be administered to pregnant women
or those planning a pregnancy within
four weeks of receiving the vaccine. The
varicella vaccine should not be administered to HIV-infected clients with CD4
< 200 or CD4 percent < 15% and it is
not required in those with a history of
varicella based on diagnosis. It too, is
contraindicated in women who are
pregnant or may become pregnant
within four weeks of receiving the
vaccine. Lastly, the zoster vaccine is
used in the prevention of “shingles”
and is contraindicated in HIV-infected
patients, those on steroid therapy,
patients with active and/or untreated
tuberculosis, individuals who are
pregnant or planning a pregnancy,
and those with life-threatening allergies to gelatin or neomycin. Those
patients who may be contemplating
international travel may want to check
with their HIV specialist to determine
other international vaccines required
prior to leaving the United States that
may be contraindicated in the HIVinfected patient (yellow fever, typhoid
Ty21a).16,19
The questions remain whether
administration of immunizations will
have the desired effect and whether
there are efficacy reports indicating that vaccines do indeed help
in combating the disease for which
they were developed to prevent. In a
review of the literature on the use of
immunizations, these reports examined immunization use in adults and
children, the formation of antibodies,
and viral load responses as a measure
of reaction. Melvin and Mohan (2003)
examined subject response in children
on HAART and the formation of antibodies for HiB, tetanus, and measles
vaccines. Their findings indicated that
in most of the subjects, antibody levels remained detectable one year after
immunization if being treated with
HAART.14
Tasker et al (1999) examined the
effects of the influenza vaccine in HIVinfected adults. Their findings indicated that those who received the vaccine
had far fewer reports of respiratory illness and no lab-confirmed diagnoses
of influenza. Further, they reported no
change in HIV RNA or CD4 cell count
among vaccine recipients.21 Anema et
al. (2008) examined the efficacy of the
influenza vaccine via meta-analysis,
and concluded that there was insufficient evidence supporting effectiveness of the vaccine based on poorly
quantified data and methodological
shortcomings in the studies reviewed.2
A study in the New England Journal
of Medicine (Klug, et al, 2003) examined the effects of the conjugate
See Immunizations, next page
5
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Clinicians are invited to contact us with HIV questions
Immunizations, from previous page
pneumococcal vaccine in both HIV+ and
HIV- children, finding that both groups
benefitted by an overall decrease in the
incidence of pneumonia and invasive
pneumococcal disease.11 However, a
study from Uganda (2000) indicated
that HIV+ patients actually had a higher
incidence of pneumonia post vaccination.10 A later study (2003) examined the
safety and efficacy of the pneumococcal
vaccine in infants and children at a pediatric AIDS Clinical Trials Group Study.
Findings by Nachman et al indicated
that the pneumococcal vaccine was
safe and immunogenic for preventing
invasive pneumococcal disease in HIV+
infants and children.15
Despite these and other findings, the
final decisions regarding immunizations
are based on the clinical judgment of the
care provider and the CDC recommendations which include the following:
1. Most vaccines can safely be administered to children and adults who are
HIV infected.
2. Many preventive vaccines are encouraged in HIV-infected patients, for
example, influenza, pneumococcal,
hepatitis A and B.
3. The recipients should be assessed
to determine if initial vaccines were
given during childhood, via history,
titer reports, etc.
4. The CD4 count must be above certain
levels prior to administration of certain live viruses.
5. Absolute contraindications can exist
when the CD4 counts are below 200
or the CD4 percent is less than 15%.
REFERENCES
1. Advisory Committee on Immunization Practices
(2007) Recommended Adult Immunization Schedule:
United States, October 2007-September 2008. Annals
of Internal Medicine, 147, 10, 725-129.
2. Anema, A., Montaner, J., Brownstein, J., &
Cooper, C. (2008) Efficacy of influenza vaccination in
HIV-positive Patients: A Systematic Review and MetaAnalysis. HIV Medicine, 9, (1), 57-61.
3. Broder, K., Cortese, M, Idkander, J., et al (2006).
Preventing Tetanus, Diphtheria, and Pertussis
among Adolescents: Use of Tetanus Toxoid, Reduced
Diphtheria Toxoid and Acellular Pertussis Vaccines.
MMWR, 55, (RR03: 1-34.
4. CDC (2007) Recommendations and Guidelines:
Adult Immunization Schedule. www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm
5. CDC (2007) Recommendations and Guidelines:
2008 Child & Adolescent Immunization Schedules.
www.cdc.gov/vaccines/rec/schedules/child-schedule.
htm
6. CDC (2007). Vaccines & Immunizations: Who
HIV Clinician • Summer 2008
Should Not Get Vaccinated with these Vaccines. www.
cdc.gov/vaccines/vpd/should-not-vacc.htm 12
7. Children’s Hospital of Philadelphia (2007). Vaccine
Education Center: How Are Vaccines Made? www.chop.
edu/consumer/jsp/division/generic
8. DeVuyst, H & Franceschi, S. (2007) Human papillomavirus vaccines in HIV-positive Men and Women.
Current Opinion in Oncology, 19, (5) 470-475
9. Flower, S. (2003) Performing Initial Assessment of
the HIV-Positive Patient. Physician Assistant, 27, 8,
25-37.
10.French, et al (2000) 23-Valent Pneumococcal polysaccharide vaccine in HIV-1 Infected Ugandan Adults:
Double-blind, Randomized and Placebo Controlled Trial.
Lancet, 35, (9221) 2106-11.
11.Klug, K., Madhi, S., Huebner, R., Kohberger, R.,
Mbelle, N., Pierce, N. (2003). A
���������������������������
Trial of a 9-Valent Pneumococcal Conjugate Vaccine in Children and Those without HIV Infection. The New England Journal of Medicine,
349, (14), 1341-1348
12.Louisiana Department of Health and Hospitals. Preventive Health: Immunization Schedule-2008. www.dhh.
state.la.us/offices/publications
13.Mast et al (2006) A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B
Virus Infection in the United States. MMWR, 55, RR-16,
12/8/06
14.Melvin, A. & Mohan, K. (2003) Response to Immunization with Measles, Tetanus, and Haemophilus
influenzae Type b Vaccines in Children Who Have
Human Immunodeficiency Virus Type 1 Infection and
Are Treated with Highly Active Antiretroviral Therapy.
Pediatrics, lll, (6) 641-644.
15.Nachman, S., Kim, S., King, J., Abrams, E., Margolis,
D., et al for the Pediatric AIDS Clinical Trials Group
Study 292 Team. (2003) Safety and Immunogenicity of a
Heptavalent Pneumococcal Conjugate Vaccine in Infants
with Human Immunodeficiency Virus Type 1 Infection.
Pediatrics, 112, (1), 66-73.
16.Pancheron, C, Anaworanich, J., & Thisyakorn, U.
(2004). Immunization for Persons Infected with Human
Immunodeficiency Virus. Current HIV Research, 2,
293-299.
17.Salmon, D., Moulton, L. Omer, S., Chace, L., Klassen, A., Talebian, P., & Halsey, N., (2004) Knowledge,
Attitudes, and Beliefs of School Nurses and Personnel
and Associations with Nonmedical Immunization Exemptions. Pediatrics, 113, (6), 552-559.
18.Spach, D., (2007) Immunizations for HIV-Infected
Patients: Indications, Timing and Response. 9th Annual
Ryan White Care Act Clinical Update, sli presentation
(Aug.28-30)
19.Spach, D., (2008) “Immunizations for HIV-Infected
Patients”, slide presentation (April 30), New York.
20.Tasker, S, Treanor, J., Paxton, W., & Wallace, M.
(1999) Efficacy of Influenza Vaccination in HIV-Infected
Person: A Randomized, Double-Blind, Placebo-Controlled
Trial. Annals of Internal Medicine, 131, (6), 430-433.
21.The Journal Weekly Epidemiological Record (2007).
Rotavirus Vaccines. (32), 82, 254-296.
22.U.S. Department of Health and Human Services
(2007). Polio Immunization. www.cispinmmunize.org/
ill/polio.html
23.US. Department of Health and Human Services
(2003). Understanding Vaccines: What They Are? How
They Work? NIH Publication # 03-4219.
(The author would like to acknowledge the
invaluable assistance of David Spach, MD,
Northwest AETC, and Ronald Wilcox, MD,
Delta AETC.)
Summary of
Recommended Vaccines
for HIV-Infected Adults
Pneumococcal polysaccharide
Revaccinate x 1 after 5 years;
better responses with higher CD4
Tetanus-Diphtheria
Every 10 years; Tdap for next
booster
Influenza
Yearly with trivalent inactivated
vaccine
Hepatitis A
Better responses with higher CD4
Hepatitis B
Use “double-dose” for each
immunization; better response
with higher CD4
Human Papillomavirus
Immunize all females age 13-26
MMR
Contraindicated with CD4 <200
cells/mm3
Varicella
Contraindicated with CD4 <200
cells/mm3
Zoster
Contraindicated with CD4 <200
cells/mm3
Sheryl Thornton is Nurse Educator,
Delta Region AETC.
6
▲
Legal
Legal questions can arise when treating HIV-infected minors
Stacey LaFleur, JD
In 2006, the CDC reported
that the estimated number of
persons living with HIV/AIDS in
the thirty-three states and dependent areas with confidential
name-based reporting was 9,144
for children under the age of
thirteen.1 One of the issues surrounding the treatment of minors
who are HIV-positive is the rights
of parents to make medical decisions for their child. Does a parent have a right to withhold their
child’s HIV status from him/her?
At what point can minor children
make medical decisions for themselves?
The rights of parents
to make decisions for
their minor child2
The Supreme Court of the
United States has established
that the Due Process Clause
of the Fourteenth Amendment
protects “the fundamental right
of parents to make decisions
concerning the care, custody and
control of their children.”3 The
concept of family under the law
“rests on a presumption that parents possess what a child lacks
in maturity, experience, and capacity for judgment required for
making life’s difficult decisions”
and recognizes that “natural
bonds of affection lead parents to
act in the best interests of their
children.”4 Parents have the right
to make decisions regarding the
care of their children, including
medical care, as long as the decision made is informed and in the
child’s best interest.
Informed consent laws in
Louisiana allow parents to make
HIV Clinician • Summer 2008
all decisions involving care for
the minor independent of input
from the child.5 Those categories
of persons capable of consenting for health care for a child
include: a judicially appointed
tutor or curator of the patient;
any parent whether adult or minor, for his child; and any person
temporarily standing in loco parentis (in the place of the parent)
for the minor. 6
Mississippi laws closely mirror Louisiana’s in that health
care decisions on behalf of the
unemancipated minor can be
made by the guardian, parent,
adult sibling, or grandparent.7
The Arkansas statute specifically states that, with regard to
informed consent for treatment
of minors being obtained from a
parent for his minor child, the
parent has consent whether “the
child is of the parent’s blood, an
adopted child, a stepchild, or a
foster child.”8 Those standing in
loco parentis, whether formally
or not, also have the power to
consent for a minor.9 The statute
does make an exception regarding informed consent in the
case of a father of an illegitimate
child.10
The rights of minors to
make decisions regarding
their medical care
The American Academy of
Pediatrics Committee on Bioethics stated in its 1995 report that
“although, impasses regarding
the interests of minors and the
expressed wishes of their parents
or guardians are rare, the pediatrician’s responsibilities to his
or her patient exist independent
of parental desires.”11 However,
as has already been established,
parents have broad discretion in
choosing how they will raise their
children and this report indicates that careful consideration
must be taken before choosing to
legally override a parent’s right to
raise his/her child.12
Louisiana allows for special
considerations to be made in regard to consent for treatment of
venereal diseases, including HIV.
Louisiana statute protects clinicians when testing and treating a
minor who has reason to believe
he or she is HIV positive. Furthermore, no member of a medical team is obligated to inform a
parent or guardian of any treatment; however, the statute allows
a clinician to inform a parent or
guardian over the objections of
the minor.
Similarly, in Mississippi, no
physician or nurse practitioner
who performs medical care on an
HIV-infected minor is obligated
to tell the parent or guardian of
such treatment. However, the
Mississippi statute differs in that
it does not directly confirm that
the wishes of the minor child
can be overridden in regards to
revealing the child’s HIV-positive
status to the parent.
Arkansas informed consent
laws take into account the concept of a “mature minor” where
“any unemancipated minor of
sufficient intelligence to understand and appreciate the consequences of the proposed surgical
or medical treatment or procedures, for himself or herself.”
Furthermore, for treatment of
venereal diseases, minor children
are allowed to consent for them-
See HIV+ minors, next page
7
▲
Legal
State statutes are inconclusive in some cases involving minors
HIV+ minors, from previous page
selves regardless of any other
provisions, but similar to the
Louisiana statute, it expressly
allows for clinicians to reveal
the HIV status to a parent over
the wishes of the minor child. If
a minor is concerned about the
possibility of parental notification of medical treatment, he/
she may begin judicial emancipation proceedings (in Arkansas
and Mississippi it is known as
the “removal of disability of a
minor”). An emancipated minor
in Louisiana or Arkansas has
the ability to transact business
in the same manner as a person who has attained majority.
However, the Mississippi statute
regarding emancipation only
applies to the ability to contract
for real property or the rights of
married minors and therefore
would not be applicable to a
minor being emancipated for all
other purposes, including medical treatment.
Conclusion
The case law and state
statutes are inconclusive as to
whether a parent may withhold a
child’s HIV status from him/her.
Although there are state laws
requiring the disclosure of one’s
positive HIV status to a physician or dentist, this disclosure
can be handled by the parent in
the child’s stead. If a clinician
is placed in an untenable situation, there are currently no laws
within the three states that make
it punishable for the clinician
to disclose the disease status to
the HIV-infected patient. However, the clinician should take
into consideration the fact that
a disclosure to the minor of his/
her HIV-positive status without
parental permission may damage
the relationship between the parent and the child.
If a minor child is mature
enough, he/she may seek and be
treated for symptoms relating to
the HIV-positive status without
the knowledge of his/her parents. However, the child patient
should be made aware that the
law does not prohibit the clinician from revealing such treatment information to the parents.
To fully protect their rights,
minors in Arkansas and Louisi-
ana must go through a judicial
emancipation.v
REFERENCES
1. Centers for Disease Control and Prevention.
HIV/AIDS Surveillance Report, 2006. Vol. 18. P.
14, Rev ed. Atlanta: US Department of Health and
Human Services, Centers for Disease Control and
Prevention; 2008.
2. This article primarily focuses on the rights of
parents. For more information regarding the rights
of minors to make their own medical decisions,
please see HIV Clinician articles “Consent law
differ in Louisiana, Mississippi and Arkansas,”
Stacey Evans, July/August 1999 and “Clinicians
Faced with More Women of Child-bearing Age,”
Stacey LaFleur-Spawn, Vol 13 No. 4, Fall 2001.
3. Troxel v. Granville, 530 U.S. 57, 66, 120 S.Ct.
2054, 2060 (2000).
4. Parham v. J.R., et al., 442 U.S. 584, 602, 99
S.Ct. 2493 (1977).
5. La.R.S. 40:1299.40(A)
6. La.R.S. 40:1299.53(A)
7. Miss. Code Ann §41-41-3
8. A.C.A. §20-9-602
9. Id.
10. Id.
11. “Informed Consent, Parental Permission, and
Assent in Pediatric Practice.” Committee on Bioethics. Pediatrics: Vol. 95, No. 2 February 1995,
(315)
12. Id.
13. La.R.S. 40:1065.1(A)-(D)
14. Id.
15. Miss. Code Ann §41-41-13
16. Id.
17. Id.
18. A.C.A. §20-16-508
19. ARK 9-26-104; LA CC Title VIII Ch.2 Sec. 4 Art
385; and MS Title 93 Ch. 19.
20. A.C.A §20-15-903
Stacey LaFleur is Executive Director
of AIDSLaw of Louisiana. The author
wishes to acknowledge the assistance of law clerks Angelica Journagin and Julia Lesh.
Submit an article to HIV Clinician
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HIV Clinician • Summer 2008
8
▲
Pharmacy
An in-depth look at the challenges of prescribing maraviroc
Tina Edmunds-Ogbuokiri, RPh,
PharmD, FASCP
This article will highlight
maraviroc (Selzentry™), the single
drug that has generated numerous interesting consultations and
provider interactions due to its
unique background and challenging dosing, adverse events profile,
and drug-drug interaction issues.
Future articles will highlight two
other medications recently approved by the FDA, raltegravir
(Isentress®), the first available
oral integrase inhibitor, and
etravirine (Intelence™), the first
of the second generation nonnucleoside reverse transcriptase
inhibitors (NNRTIs).
CCR5 antagonism and
the concept of tropism
In an effort to provide a background for HIV care providers to
understand and appreciate maraviroc, the newly FDA-approved
CCR5 antagonist, it is important
that we review the processes vital
to the HIV virus’s invasion and
takeover of the CD4+ positive
cells. In order for the HIV virus
to enter the CD4 lymphocyte or
monocyte cell, a complex process
occurs that involves sequential
attachment to the CD4 receptor
followed by co-receptor binding to
either the CCR5 or CXCR4 receptor and subsequent fusion of the
viral and cellular membranes.
Advances in the understanding of the process of attachment
of the HIV virus to susceptible
cells, and the role of chemokine
co-receptors CCR5 and CXCR4,
have led to the production of new
HIV Clinician • Summer 2008
targets for antiretroviral therapy
and new drug treatments. During
acute or recent seroconversion, a
vast majority of patients harbor
a CCR5-utilizing virus (R5 virus)
compared with the CXCR4 (X4
virus or variants). However viruses in the majority of untreated
patients ultimately exhibit a shift
in coreceptor tropism from CCR5
to either CXCR4 or to a mixture
of both viruses, hence described
as dual or mixed tropic viruses
(DM tropic viruses). This shift
is temporally associated with a
more rapid decline in CD4+ cell
counts. Whether this shift is a
cause or a result of progressive
immunodeficiency remains to be
determined.
CCR5 antagonist
Maraviroc is a CCR5
chemokine receptor antagonist
granted accelerated FDA-approval in August of 2007 based on 24
week data from two on-going trials. Maraviroc binds to the CCR5
coreceptor, thereby preventing
HIV from binding to this receptor. When CCR5 is not available,
CCR5-tropic HIV virus cannot
engage a CD4+ cell to infect the
cell. In Phase II efficacy studies, maraviroc showed no efficacy
towards CXCR4, dual or mixed
–tropic virus. Maraviroc is approved for use in combination
with other antiretroviral agents
for the treatment of CCR5-tropic
HIV-1 (R5) virus in adults whose
viral loads remain detectable
despite existing antiretroviral
treatment or who have multiple
drug-resistant HIV-1 viruses. Approximately 50-60% of treatmentnaïve patients harbor the R5-
tropic virus. Safety and efficacy
of maraviroc in treatment-naïve
patients or patients with dual or
mixed-tropic or CXCR4-tropic
virus have not been established
and it is therefore not recommended for this patient population at this time.
Maraviroc is metabolized by
the CYP3A enzyme system in the
liver to inactive metabolites. It is
moderately protein-bound (76%)
and renal clearance accounts
for 25% of total clearance. It is
also a substrate of both CYP3A
and P-glycoprotein (Pgp) and
may require dosage adjustments
when administered with CYP- or
Pgp-modulating medications.
Drug-drug interactions
of clinical significance
CYP3A/Pgp inhibitors such
as ketoconazole, lopinavir/ritonavir, saquinavir and atazanavir
increase maraviroc Cmax (maximum concentration) and overall
serum concentrations (AUC).
On the other hand, CYP3A/Pgp
inducers such as carbamazepine,
phenytoin, phenobarbital, rifampin and efavirenz decrease
maraviroc Cmax and AUC.
When used with CYP3A inducers
such as efavirenz and etravirine,
maraviroc dosages may need to
be increased to 600 mg twice
daily while use of ritonavir and
other PIs may require dosage
adjustments downwards to 150
mg twice daily. Boosted tipranavir, a CYP3A inhibitor but a Pgp
inducer, does not affect the blood
levels or pharmacokinetics of
maraviroc.
See Maraviroc, next page
9
▲
Pharmacy
Drug provides another choice for patients with limited options
Maraviroc, from previous page
Dosing recommendation
for maraviroc
Maraviroc is available as
150mg and 300mg tablets to be
taken with or without food. The
oral bioavailability for a 100mg
dose is 23% while this is predicted to be 33% for the 300mg
tablets. The serum half-life of
the drug is between 14-18 hours
and it is recommended for twice
daily dosing. The package insert
recommends 150mg twice daily
when given with strong CYP3A
inhibitors (with or without
CYP3A inducers) including PIs
(except tipranavir/ritonavir). It
also recommends 300mg twice
daily when given with the NRTIs,
enfuvirtide, tipranavir/ritonavir,
nevirapine and other drugs that
are not strong CYP3A inhibitors.
The third dosage recommendation is 600mg twice daily when
maraviroc is given with CYP3A
inducers including efavirenz,
etravirine, rifampin, phenobarbital, phenytoin, carbamazepine
etc. (without a CYP3A inhibitor).
In order to enhance adherence
to the dosage recommendations
and to promote a better understanding of the use of this agent,
an FDA-approved medication
guide is available at http://www.
selzentry.com/content/selzentry_MedicationGuide.pdf to be
distributed to each patient for
whom the medication is prescribed.
Warnings/precautions
(U.S. Boxed Warning)
Possible drug-induced hepatotoxicity with allergic-type
HIV Clinician • Summer 2008
features has been reported.
Hepatotoxicity to maraviroc may
be preceded by allergic-type
reactions such as pruritic rash,
eosinophilia, increased IgE and
hepatic adverse events such as
increase in transaminases or
signs and symptoms of hepatitis. Maraviroc should be discontinued in patients with possible
hepatitis or elevated transaminases combined with systemic
allergic events. Such patients
may develop an immune reconstitution syndrome, resulting in
the occurrence of an inflammatory response to an indolent or
residual opportunistic infection.
Further evaluation and treatment for such infections may be
indicated. Such patients should
be monitored closely for signs
and symptoms of developing
infections. During clinical trials,
maraviroc use was associated
with a small increase of certain
upper respiratory tract infections and herpes virus infections. Maraviroc should be used
with caution in patients with
cardiovascular diseases or cardiac risk factors. In phases II/III
of the MOTIVATE 1 and 2 studies for maraviroc, a small increase in cardiovascular events
(myocardial infarction or ischemia) was reported in treated
patients compared to placebo,
although a causal relationship
relative to maraviroc use is unknown. Safety and efficacy has
not been adequately assessed in
patients with hepatic and renal
impairment, therefore caution is
advised for patients with hepatic dysfunction or concomitant
viral hepatitis B or C, as well
as in renally-impaired patients.
Concomitant therapy with CYP3A
inhibitors in the presence of renal
impairment is expected to further
increase levels and may lead to increased adverse events, therefore
avoid maraviroc in patients with
concomitant CYP3A inhibitors
whose creatinine clearance is less
than 50 ml/minute. Safety and
efficacy have not been established
in treatment-naïve patients and
also in children less than 16 years
of age.
Adverse events associated
with maraviroc
Adverse events reported in
clinical trials in >10% of patients
include central nervous system
events such as fever (12%), upper respiratory tract infections
(20%) and cough (13%). Other
adverse events reported in 2% to
10% of patients include cardiovascular (vascular hypertensive
disorder) (3%), dizziness (8%),
insomnia (7%), disturbance of
consciousness (4%), depression
(4%) and pain (4%). Dermatological adverse events included rash
(10%), pruritus (4%), and folliculitis (3%), benign skin neoplasms
(3%), dermatitis (3%). Gastrointestinal adverse events included
abdominal pain (8%), appetite
disorders (7%), constipation (5%),
dyspepsia (3%), stomatitis (3%).
Genitourinary (urinary tract/bladder) adverse events occurred in
3% to 5% of patients and genital
warts in 2% of patients. Other
important or life-threatening adverse events that were reported in
<2% of patients in clinical trials
included abdominal neoplasms,
acute cardiac failure, anal cancer, angina, basal cell carcinoma,
10
▲
rhabdomyolysis, squamous cell
carcinoma, syncope, neoplasm of
the tongue, viral meningitis and
others. (For a more comprehensive listing, see reference number 6 at the end of this article).
Tropism assays for maraviroc
In order to characterize
the viruses of patients that are
CCR5-tropic and so remain
susceptible to CCR5 antagonism
and use of maraviroc, Monogram
Sciences developed the Trofile
assay. In the Trofile assay, the
coreceptor tropism of the patient-derived virus is confirmed
by testing the susceptibility of
the virus to specific CCR5 or
CXCR4 inhibitors in vitro. The
Trofile assay takes about two
weeks to perform and requires
that the patient’s plasma viral
load be greater than 1000 copies/ml. Following in vitro mixing experiments of R5 and X4
variants, it has been established
that the Trofile assay can detect
a minor variant with 100% sensitivity if the variant is present
at a frequency of 10% although
this sensitivity is reduced to
83% when the variant is present at a frequency of 5%. This
sensitivity may not be sufficient
to rule out the presence of clinically meaningful levels of X4- or
D/M-tropic virus in patients who
are initiating a CCR5 inhibitorbased regimen. As a result of
this, a more sensitive assay
which will improve detection of
minor variants is under development at the present time.
The approval and availability of maraviroc as part of the
HIV/AIDS armamentarium are
providing additional choices for
patients in deep salvage and
for HIV-infected persons with
limited options due to resistance to previously available
antiretroviral agents. In many
HIV Clinician • Summer 2008
instances, use of this new agent,
along with an optimized background regimen consisting of at
least two and ideally three active
agents based on genotypic and
phenotypic testing, has made it
possible for such patients to suppress their viremia below levels of
detection.v
REFERENCES
1. Moore JP, Kitchen SG, Pupach P, et al. The CCR5
and CXCR4 coreceptors-central to understanding the
transmission and pathogenesis of human immunodeficiency virus type 1 infection. AIDS Res Hum Retroviruses, 2004, 20(1):111-26.
2. Connor RJ, Sheridan KE, Ceradini D, et al. Change
in coreceptor use correlates with disease progression in HIV-1 infected individuals. J. Exp Med 1997,
185(4):621-8.
3. Whitcomb JM, Huang W, Fransen S, et al. Develop��������
ment and characterization of a single cycle recombinant
virus assay to determine human immunodeficiency type
1 coreceptor tropism. Antimicrob Agents and Chemother,
2007. 51(2): 566-75.
4. Koot M, Keet JP, Vos AH, et al. Prognostic value of
HIV-1 syncytium-inducing phenotype for rate of CD4+
depletion and progression to AIDS. Ann Intern Med
1993. 118(9): 681-8.
5. Reeves JD, Han D, Wrin T, et al. Enhancements to
the Trofile HIV Coreceptor Tropism Assay enable reliable detection of CXCR4-using subpopulations at less
than 1%. International CONFERENCE ON Antimicrobial Agents and Chemotherapy; September 17-20, 2007,
Chicago, Il. Abstract # H-1026.
6. Maraviroc (Selzentry). Drug Information Handbook: a Comprehensive Resource for all Clinicians and
Healthcare Professionals. Lexi-Comps Drug Reference
Handbooks, 16th Edition, 2008-2009, p 975.
7. Package insert for maraviroc (Selzentry). Pfizer Laboratories 2007.
Information for this article
was drawn from the annual
pharmacology update offered
by Dr. Edmunds-Ogbuokiri via
teleconference in a collaboration
between the National Minority AETC (NMAETC) and Delta
Region AETC. A total of 17 participating sites, including LSUaffiliated clinics and hospitals, as
well as correctional institutions
in the state of Louisiana, were
represented at this program.
Tina Edmunds-Ogbuokiri is Co-Pi,
National Minority AIDS Education and
Training Center (NMAETC); Pharmacy
Faculty, Delta Region AIDS Education and Training Center; Associate
Professor of Clinical Pharmacy, Xavier
College of Pharmacy; and Consultant
Clinical Pharmacist, HIV Outpatient
Program (HOP) of the Medical Center
Make plans now
to attend HIV/AIDS
conferences
▲ August 1, 2008
3rd International Workshop on
HIV Transmission: Principles
of Intervention
Mexico City, Mexico
www.virology-education.com/
▲ August 3-8, 2008
XVII International AIDS
Conference
Mexico City, Mexico
www.aids2008.org
▲ September 18-21, 2008
2008 United States Conference
on AIDS
Miami, Florida
www.nmac.org/index/2008-usca
▲ October 16, 2008
World HIV/AIDS Conference
Johannesburg, South Africa
www.mcquireglobalrecruitment.
com
▲ November 30, 2008
IAPAC 08: Stronger Together
New Orleans, Louisiana
www.iapac08.org
For information about
treatment guidelines,
drug information,
and clinical trials, visit
aidsinfo.nih.gov
11
▲
Nutrition
Starvation then binge-eating can cause obesity in the homeless
Ginger Bouvier, MEd, LDN, RD
Lack of affordable housing
is a critical problem facing a
growing number of people living with HIV/AIDS across the
United States. Studies indicate
that the prevalence of HIV infection among homeless people
is between 3% and 20%, with
higher rates found in certain
subgroups.1
Homeless people represent
an extremely disadvantaged
group. The problems that lead
to homelessness are variable.
Unfortunate circumstances (e.g.,
unemployment, poverty, abuse,
alcohol or drug problems, physical abuse, and mental illness)
often precipitate and perpetuate
homelessness. It is clear that
substance abuse and mental
illness are more prevalent in
homeless populations than in
those who have stable housing.2
Additionally, HIV prevalence
has been found to be highest in
patients with dual diagnoses of
severe mental illness and substance abuse disorder.3
In general, people who are
homeless have higher rates of
chronic illness than those who
have stable housing, due in part
to the effects of lifestyle factors (alcohol, drug and tobacco
abuse), exposure to extreme
weather, and nutritional deficiencies. Nutritional deficiencies
among the homeless are common
as a result of food insecurity,
which is defined as the limited or
uncertain availability of nutritionally adequate and safe foods
or limited or uncertain ability to
HIV Clinician • Summer 2008
acquire acceptable foods in socially acceptable ways. Homeless
persons across the U.S. report
significant problems obtaining
food. Reported sources of food
include soup kitchens, fast food
restaurants, shelters, grocery
stores, restaurant leftovers,
trashcans, relatives, and food
pantries.4
While food insecurity and
hunger are undoubtedly serious problems among the homeless, physical evidence of inadequate caloric intake has not
been consistently documented in
published studies. In fact, multiple studies suggest homeless
persons in the U.S. are as likely
as housed persons to be overweight or obese. One reason for
this paradox lies in the pattern
of food scarcity and hunger, and
the development of binge eating
behavior when food is available.
Alternating periods of starvation
and overeating frequently lead to
obesity in many people. Therefore, an individual’s weight does
not provide any information on
the quality or adequacy of his/
her diet. Additionally, alcohol
may account for a major percentage of the caloric intake in some
alcoholics. Alcohol is a concentrated source of calories, providing seven calories per gram,
however it is essentially void of
nutrients. The empty calories of
alcohol may mask the signs of
malnutrition, however extremely
heavy drinkers may be more likely to develop vitamin deficiencies,
particularly thiamine deficiency
(beriberi) and niacin deficiency
(pellagra).2
Practical suggestions
Clinicians can take several steps
to assist homeless patients with
their nutrition. First, assess the
available food resources in the
community. Social services departments and case management
agencies are typically very knowledgeable about existing community resources. Second, advocate
for appropriately funded food
programs such as soup kitchens
and food pantries. Third, have
a dialogue with your homeless
patient about how he or she
obtains food, and when, where,
and how it is eaten. Evaluate the
patient’s knowledge of available
food resources (pantries, soup
kitchens, delivered meals, food
stamps, and vitamins). If the
homeless patient is not eating
well, try to determine the reasons why (e.g., limited access to
nourishing food, poor dentition,
use of financial resources to
purchase tobacco, alcohol, illicit
drugs, or prescribed medications
instead of food). Inquire about
access to clean water and other
liquids, especially in hot summer months. If possible, assist
homeless patients in obtaining multivitamin supplements.
It is important to understand
as much as possible about the
patient’s situation and establish
a relationship of trust in order to
provide the most useful suggestions.
The federal government
provides access to food stamps
to citizens, certain non-citizens,
and most legal immigrants who
meet specific income and asset
requirements. Homeless people
12
▲
can get food stamps even if they
do not have an address, a place
to stay, or a place to cook food.
Food stamp benefits are provided on an electronic benefit
transfer card and can be used
to buy food at most groceries.
Food stamps cannot be used to
buy non-food items, vitamins, or
prepared hot foods. Applications
for the Food Stamp Program can
generally be obtained through a
state benefits office.v
REFERENCES
1. Accessed online at www.nationalhomeless.org/
publication/facts/HIV.pdf
2. The Health Care of Homeless Persons - A Manual
of Communicable Diseases and Common Problems in
Shelters & in the Streets. Stefan G. Kertesz, MD, MSc.
3. Cournos, F and McKinnon, K. (1997). Substance
use and HIV risk among people with severe mental
illness. National Institute on Drug Abuse Research
Monograph Series,172,110-129.
4. Coppenrath, W. (2001). Problems in Nutritional
Status Among Homeless Populations: An Introduction.
Nutrition Bytes: Vol 7: No.1, Article 1.
Ginger Bouvier is nutrition specialist at HIV Outpatient Program (HOP)
Clinic of Medical Center of Louisiana,
and faculty of Delta Region AETC.
Need to find
HIV resources
in Louisiana,
Mississippi and
Arkansas? See
state listings at
deltaaetc.org
HIV Clinician • Summer 2008
Clinical Consultation
for
Health Care Providers
Delta AETC consultants
are HIV specialists at state
university medical centers.
Requests for consultation
are taken from 9:00-4:00 CST
on weekdays and by voicemail
on weekends. Consultants return calls within two business
days.
If you are a clinician and
wish to discuss a case with
one of our consultants, use
these numbers to contact your
state warmline:
In Louisiana:
504-903-0623
In Mississippi:
601-984-5542
In Arkansas:
870-535-3062 x104
National HIV Telephone
Consultation Service (Warmline):
800-933-3413
National Perinatal HIV
Consultation and Referral Service
(Perinatal Hotline):
888-448-8765
National Clinicians’
Post-Exposure Prophylaxis
Hotline (PEPline):
888-448-4911
Earn your CEs
at Delta’s Clinical
HIV Preceptorships
For physicians, nurse
practitioners, physician assistants:
CARE AND MANAGEMENT OF
THE PATIENT WITH HIV DISEASE
A 2-day clinical course with curriculum developed by LSUHSC Infectious
Diseases faculty. This program is held
twice a year in New Orleans.
For nurses and clinical service
providers:
COMPREHENSIVE MANAGEMENT
OF THE PATIENT WITH HIV DISEASE
A 2-day clinical training and skillsbuilding course in HIV disease. This
program is held twice a year in New
Orleans.
For physicians, nurse practitioners
and pharmacists:
COMPREHENSIVE MANAGEMENT
OVERVIEW OF HIV INFECTION
A 2-day course held twice a year in
Jackson, Mississippi.
For physicians, nurse practitioners,
pharmacists, dentists:
ADVANCED HIV CLINICAL TRAINING
A 2-day clinical course for clinicians
who have taken our basic course. This
program is held twice a year in Jackson, Mississippi.
By request:
INDIVIDUAL CLINICAL
PRECEPTORSHIPS IN ARKANSAS
To request a preceptorship, contact
Derrick Newby at 870-535-3062.
CONTACT DANIELLE PIERCE
AT 504-903-0788
FOR CURRENT DATES
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Nursing
Personal reflections on a 25-year career in HIV nursing
Carole Pindaro, APRN-BC, MSN,
MPH
I use the word “career” with
some trepidation and for lack
of a better word. I associate
this word with business people
scaling the corporate ladder in
search of higher annual incomes
and corporate profits. Don’t get
me wrong; these people have
a place in society. In nursing,
however, at least when I started
out by attending a diploma program in Boston in 1975, it was
somewhere between going into a
convent and entering the military. Students wearing impractical dresses, silly hats and white
shoes with soles stiff as boards
were lined up each morning for
inspection. The slightest bit of
grime on one’s shoelace could
be cause for being sent for a
replacement. Hair, nails and too
little starch in one’s cap could
lead to similar consequences.
The first few clinical weeks of
the program were spent on the
proper way to make a bed. By
now you may be saying: What is
the point? At the time, so did I.
It was not until much later that I
realized that all of this seemingly
useless activity was preparing
us for the rigors of a profession
in caring—one where people’s
lives depended on our thoughtout, deliberate actions. OCD, it
seemed, was a trait to be instilled
in us, if not already genetically
present.
I had no idea when I started
nursing school that there would
one day be a fatal disease called
AIDS…initially called GRID (Gay
Related Immune Deficiency). But
HIV Clinician • Summer 2008
by the time I graduated in 1978,
I had seen several very unusual
cases of patients dying with rare,
invasive, untreatable infectious
diseases: a young gay man with
unrelenting voluminous watery
diarrhea and dehydration that
killed within days, another with
a disseminated fungal infection
who also met a rapid demise.
I cared for those patients and
never forgot how helpless I felt
that they should die so young
and in a time of such medical
“enlightenment”—after all, it was
the late ‘70s and we were in a
medical mecca. These cases was
filed away into a compartment in
my brain and soul labeled “memorable patients.”
The work of bedside nursing went on as usual, starting
IV with bare hands, washing off
that trickle of blood with soap
and water. In my volunteer work
at Fenway Community Health
Center, which served a largely
gay male population, I witnessed
ever increasing numbers of
sexually transmitted diseases,
with little concern for repeated
infections. For a gay male, it was
almost as if getting an STD was a
rite of passage. As providers, our
message was not so much one of
prevention as of frequent testing, as we now expected to find
the many STDs we knew were
being shared in the community.
It sounds shocking by today’s
standards, but recall (or imagine) that you are in the 70s, the
sexual revolution is in full swing,
and an antibiotic shot or pills
will cure just about everything.
Move forward in time to
1981. I was now living in New
Orleans and vividly recall the
specific moment that those early
patients who had met their untimely demise resurfaced in my
consciousness. The news was on
TV in the background as I was
getting ready for my hospital
shift. Something was said about
a new, deadly disease called
GRID that was affecting gay men.
One sentence was all I heard.
Being in the pre-internet era, it
was difficult to get more information. Some time passed and
I continued to be alert for more
information about this horrible
new disease affecting members of
my community. Slowly, painfully,
it came.
I recall with remarkable clarity the first American Journal of
Nursing article reporting on a
deadly new cancer in gay men.
The photos of young men disfigured by florid Kaposi sarcoma
were shocking. In other now historical articles, KS in a cluster of
gay men from San Francisco was
described, as was the increased
request for pentamidine, an orphan drug available at that time
only from the CDC to treat cases
of a rare pneumonia called PCP.
By about 1983, New Orleans
saw its first few cases of AIDS.
The hysteria surrounding this
was as rampant as was the lack
of care providers. At the time, I
was in graduate school in public
health and realized that we were
on the cusp of an epidemic of a
new infectious disease. Although
it was a sad and devastating disease, I saw a rare opportunity to
care for patients in dire need, as
well as to eclipse my professional
path.
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▲
As a home care nurse, I was
among the first care providers
in New Orleans to be involved.
Quickly a core group of nurses,
physicians, social workers and
others was formed. This involvement led to many lasting collegial and personal relationships,
and as the AIDS service provider
population slowly grew, organizations such as NO/AIDS Task
Force and MCLNO’s HOP Clinic
were established.
Over the quarter century that
AIDS has been part of our societal landscape, patients’ prognoses have gone from 100% fatal
with absolutely no way to alter
the course of the virus (once it
was discovered that AIDS was of
viral origin) to the expectation of
a nearly normal life expectancy
if one engages in self-care and
treatment adherence.
I feel advantaged to have witnessed first hand the evolution
of this epidemic—from before
the disease was recognized and
named (and then re-named) to
discovery of the viral etiology of
AIDS, to exquisite understanding of the complex viral life cycle
and replication, to development
of nearly two dozen drugs in five
classes to combat the virus. I’ve
also seen first hand the ravages of opportunistic infections,
which thankfully are less common now. And I’ve seen people
come together to research, lobby,
advocate, educate, and build
resources.
In my professional life, I’ve
seen HIV transform from a fatal
nameless disease of unknown
etiology to an entity whose workings are intimately known and
can be managed much like other
chronic illnesses. There is no
teacher like experience and HIV
has taught me not only about
taking care of people with HIV,
but also about life and what really is important. I am proud to
be among the senior generation
of HIV providers and I am happy
to share my experiences.v
Carole Pindaro is a nurse practitioner
at NO/AIDS Task Force Primary Care
Services and faculty of Delta Region
AETC.
Our HIV trainings can be individualized for your facility
CHOOSE FROM THESE OPTIONS AND CONTACT US AT THE NUMBER LISTED BELOW
▲ CUSTOMIZED WORKSHOPS
Delta AETC can provide a training customized to meet the specific needs of your agency, clinic, or other group of health care
workers. You simply choose the format that will work best for the clinicians at your agency and let us know. Trainings can
occur either at our central site or at your clinical setting. Possible formats can include:
• 1-2 hours
• Half day
• Full day
• Dinner meeting (with pharmaceutical co-sponsorship)
A needs assessment will be conducted to determine the preferred topics. Continuing education credits may be available if
programs are planned in time for application to be made and accreditation received.
▲ CASE CONFERENCES
Individualized case conferences can be scheduled at your agency. Participants present cases for discussion by our HIV specialists. Expert consultation is provided with the additional goal of educating the audience about important HIV issues.
▲ CHART REVIEW
This format is a tool to help medical providers evaluate the use of standards of care in their practices. Our HIV specialists
review randomly selected charts to identify clinician strengths and pinpoint areas where quality improvement is needed.
▲ MINI-RESIDENCIES
Each mini-residency is tailored specifically to an individual clinician’s needs and interests. Open to physician, nurse practitioners, physician assistants, nurses and other clinical service providers, this option is formatted so the clinician learns about
the diagnosis, early management, and ongoing treatment of HIV disease. This opportunity is also available to clinicians in the
form of preceptorships.
To request an individualized program, contact Dana Gray at 504-903-0266 or [email protected]
HIV Clinician • Summer 2008
15
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Stay current with the latest HIV/AIDS journal articles
s Wang SH. Menon A. Hyslop NE. Cardiac tamponade:
an unusual complication of simultaneous treatment
of tuberculosis and HIV. Southern Medical Journal.
101(5):558-60, 2008 May.
s Proof of HIV infection not necessary to uphold
testing order. AIDS Policy & Law. 2007 Oct 5; 22(19): 8.
s Soria A. Cavarelli M. Sala S. Alessandrini AI. Scarlatti
G. Lazzarin A. Castagna A. Unexpected dramatic increase in CD4+ cell count in a patient with AIDS after enfuvirtide treatment despite persistent viremia
and resistance mutations. Journal of Medical Virology.
80(6):937-41, 2008 Jun.
s Berry M. Raymond HF. Kellogg T. McFarland W. The
Internet, HIV serosorting and transmission risk
among men who have sex with men, San Francisco.
AIDS. 22(6):787-9, 2008 Mar 30.
s Hanson DL. Sullivan PS. Novak RM. Moorman AC.
Tong TC. Holmberg SD. Brooks JT. Incidence of types
of cancer among HIV-infected persons compared
with the general population in the United States,
1992-2003. Annals of Internal Medicine. 2008 May 20;
148(10): 728-36.
s Organ transplantation more readily available to
HIV-positive patients. AIDS Policy & Law. 2007 Oct 5;
22(19): 1, 4.
s Pontali E. Ferrari F. Prevalence of Hepatitis B virus
and/or Hepatitis C virus co-infections in prisoners
infected with the Human Immunodeficiency Virus.
International Journal of Prison Health.. 4(2):77-82, 2008
Jun.
s Berger S. Schad T. von Wyl V. Ehlert U. Zellweger C.
Furrer H. Regli D. Vernazza P. Ledergerber B. Battegay
M. Weber R. Gaab J. Effects of cognitive behavioral
stress management on HIV-1 RNA, CD4 cell counts
and psychosocial parameters of HIV-infected persons. AIDS. 22(6):767-75, 2008 Mar 30.
s Kovacs A. Al-Harthi L. Christensen S. Mack W. Cohen M. Landay A. CD8(+) T cell activation in women
coinfected with human immunodeficiency virus
type 1 and hepatitis C virus. Journal of Infectious
Diseases. 197(10):1402-7, 2008 May 15.
s Sheth PM. Sunderji S. Shin LY. Rebbapragada A.
Huibner S. Kimani J. Macdonald KS. Ngugi E. Bwayo
JJ. Moses S. Kovacs C. Loutfy M. Kaul R. Coinfection
with herpes simplex virus type 2 is associated with
reduced HIV-specific T cell responses and systemic
immune activation. Journal of Infectious Diseases.
197(10):1394-401, 2008 May 15.
s Svicher V. Aquaro S. D’Arrigo R. Artese A. Dimonte
S. Alcaro S. Santoro MM. Di Perri G. Caputo SL. Bellagamba R. Zaccarelli M. Visco-Comandini U. Antinori
A. Narciso P. Ceccherini-Silberstein F. Perno CF.
Specific enfuvirtide-associated mutational pathways
in HIV-1 Gp41 are significantly correlated with an
increase in CD4(+) cell count, despite virological
failure. Journal of Infectious Diseases. 197(10):1408-18,
2008 May 15.
s Henry M. Thuret I. Solas C. Genot S. Colson P.
Tamalet C. Vertical transmission of multidrugresistant Q151M human immunodeficiency virus
type 1 strains. Pediatric Infectious Disease Journal.
27(3):278-80, 2008 Mar.
s Angus B. Lampe F. Tambussi G. Duvivier C. Katlama
C. Youle M. Williams I. Clotet B. Fisher M. Post FA.
Babiker A. Phillips A. TILT Trial Steering Committee.
TILT: a randomized controlled trial of interruption of antiretroviral therapy with or without
interleukin-2 in HIV-1 infected individuals. AIDS.
22(6):737-40, 2008 Mar 30.
s Little SJ. Frost SD. Wong JK. Smith DM. Pond SL.
Ignacio CC. Parkin NT. Petropoulos CJ. Richman DD.
Persistence of transmitted drug resistance among
subjects with primary human immunodeficiency
virus infection. Journal of Virology. 82(11):5510-8,
2008 Jun.
s Leligdowicz A. Rowland-Jones S. Tenets of protection from progression to AIDS: lessons from the
immune responses to HIV-2 infection. Expert Review
of Vaccines. 7(3):319-31, 2008 Apr.
s Garbino J. Inoubli S. Mossdorf E. Weber R. Tamm
M. Soccal P. Aubert JD. Bridevaux PO. Tapparel C.
Kaiser L. and the Swiss HIV Cohort Study. Respiratory
viruses in HIV-infected patients with suspected respiratory opportunistic infection. AIDS. 22(6):701-5,
2008 Mar 30
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HIV Clinician is published four times a year by
Delta Region AIDS Education and
Training Center (AETC), 136 S. Roman St.,
New Orleans, LA 70112.
Phone 504-903-0623, Fax 504-903-7186
Executive Editor
Ronald D. Wilcox, MD
Editor
Toni Newton
Non-commercial reproduction of this newsletter
is encouraged. The opinions expressed are
those of the authors and are not necessarily those of Delta AETC. Delta AETC is funded
through the Ryan White Care Act by HRSA Grant
6-H4AHA00059-04-04.
HIV Clinician • Summer 2008
HIV Clinician
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