Transcript Poster presentation

IMPLEMENTATION OF THE
BRAZILIAN HIV/AIDS
ANTIRETROVIRAL PROGRAM AT A
PUBLIC HEALTH POST: ADHERENCE
TO PRESCRIBING GUIDELINES AND
TREATMENT CONTINUITY
Carmody ER*; Diaz T**; Starling P***; Beruth dos
Santos AP***; Sacks HS*
*Mount Sinai School of Medicine, New York, NY, USA
**Global AIDS Program, CDC, PAHO, Rio de Janeiro, Brazil
***Centro de Saude Vasco Barcelos de Nova Iguaçu
Abstract
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IMPLEMENTATION OF THE BRAZILIAN HIV/AIDS ANTIRETROIVRAL PROGRAM AT A PUBLIC
HEALTH POST: ADHERENCE TO PRESCRIBING GUIDELINES AND TREATMENT CONTINUITY.
Authors: Carmody E, Diaz T, Starling P, Beruth dos Santos AP, Sacks HS.
Institutions: Mount Sinai School of Medicine, New York, NY, USA; Global AIDS Program, CDC, PAHO, Rio de
Janeiro, Brazil; Centro de Saude Vasco Barcelos de Nova Iguaçu.
Problem Statement: Since 1996, the Brazilian health system has undertaken a national drug distribution program to
provide antiretroviral (ARV) therapy for all HIV+ individuals needing viral suppressive treatment.
Objectives: To determine practitioner adherence to ARV prescribing guidelines, to assess whether prescriptions were
refilled within appropriate intervals, to outline which patient characteristics were associated with treatment lapses, and
to improve a public health post’s ARV program.
Design: Retrospective pilot study.
Setting and Population: One public health post in a low-income suburb of Rio de Janeiro. Year 2000 data were
abstracted from all non-archived adult patients first registered for HIV care from 1/00-6/00.
Interventions: Subsidized by the Brazilian National Treasury, ARVs are produced in national laboratories or
purchased from private international companies, then distributed from the Ministry of Health to health care facilities.
Outcome Measures: % patients on HAART (highly active antiretroviral therapy) vs two-drug therapy, % regimens
prescribed according to Brazilian guidelines, % patients with medication lapses >1 month during the year 2000.
Results: 59 of 67 patients (88.1%) were prescribed ARV treatment. 42 regimens (71.2%) were HAART vs. 17 (28.8%)
two-drug regimens. No combinations were prescribed that were contraindicated to guidelines, but 33 patients (55.9%)
were prescribed ARVs before CD4+ levels and/or viral loads were obtained. There were delays between health post’s
request and receipt of initial CD4+/viral load results, ranging from 25-107 (mean 66) and 33-139 (mean 86) days
respectively. 14 patients on ARV treatment lacked a supply of medication for >1 month at least once during the year.
11 of these had interruption of treatment due to failure to pick up medications, and 3 due to drug stock shortages.
Medication lapses were associated with being female, hospitalized in 2000, and having >2 drugs in regimen. Lapses
were not associated with age, CD4+ level or previous use of ARVs.
Conclusions: Brazilian practitioners at this health post adhered to prescribing guidelines in the new ARV distribution
program, but demonstrated conservative prescription of HAART therapy. Delays in disease monitoring were identified
as a source of potential mismatch between clinical status and treatment. Problems with preserving treatment
continuity were based primarily on patient inability to collect drug refills within appropriate intervals, but drug
shortages also provoked treatment lapses.
Study funded by: Mount Sinai School of Medicine, New York, and CDC. Abstract is based upon our published work:
An evaluation of antiretroviral HIV/AIDS treatment in a Rio de Janeiro public clinic. Tropical Medicine and
International Health, 2003; 8:378-385.
Background and Setting:
• Brazilian public health system provides free, universal access to
antiretroviral (ARV) therapy for people infected with HIV
• 95,000 received ARV in 2000 at cost $303 million
• Drugs are purchased from international companies and produced in
national laboratories
• Program evaluation is necessary to ensure optimal drug delivery,
prevent treatment failure, curb viral resistance, assess as a model for
low-income countries with high HIV burden
• Study was conducted in poor suburb of Rio de Janeiro at public
outpatient clinic with onsite pharmacy and four HIV/AIDS physicians
• Municipality of study ranked 18th for number of AIDS cases in Brazil
(1998)
Study Objectives:
• Assess feasibility of collecting medical record and
pharmacy data to evaluate ARV provision
• Describe type of ARV therapy used
• Determine practitioner adherence to Brazilian ARV
treatment guidelines
• Assess whether prescriptions were refilled within
appropriate intervals; explore patient
characteristics associated with treatment lapses
• Improve a public health post’s ARV program
Methods:
• Design: Retrospective pilot study
• Data collection: Year 2000 medical record and pharmacy
dispensation review of all active patients who first
registered at clinic for HIV/AIDS care from 1/00-6/00
(n=67 of total 115 registered)
• Data analyses: Frequency analyses, chi-square association
tests, and logistic regression
• Outcome measures: % patients on HAART, % drug
regimens prescribed according to guidelines, % patients
with medication lapses >1 month in 2000
Characteristics of 67 HIV-infected Patients From Vasco Barcelos
Health Post, Nova Iguaçu, 2000
Characteristic
Gender
Male
Female
No. (%)
Age (years) Mean
20-29
30-39
40-49
50-79
34.9 (SD=10.1)
21 (31.3)
28 (41.8)
15 (22.4)
3 (4.5)
Education
None (Analfabeto)
<8 years
9-12 years
N/A 22 (32.8)
3 (4.5)
32 (47.7)
10 (14.9)
AIDS (Brazilian definition)
Yes
No
N/A 1 (1.5)
54 (80.6)
12 (17.9)
Hospitalized in 2000
Yes
No or N/A
25 (37.3)
42 (62.7)
Previous use of ARVs
Yes
No
N/A 1 (1.5%)
9 (13.4)
57 (85.1)
39 (58.2)
28 (41.8)
Type of ARV Therapy Initiated
40
35.6
35
30
25
33.9
30.5
28.8
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•
•
Percent 20
15
10
5
0
•
1.7
I
I
I
I
d
T
P
P
e
T
g
R
R
n
+1
+2
N
N
a
I
I
h
N
2
T
T
c
1
R
R
n
+
e
2 N RTI
2N
m
i
g
e
N
R
2
59 of 67 patients prescribed
ARV therapy in 2000
Dual combination: 28.8%
HAART: 71.2%
Regimen changed during
2000: 30.5%
Therapeutic
regimen
NRTI=nucleoside analogue
reverse transcriptase inhibitor,
NNRTI=non-nucleoside reverse
transcriptase inhibitor,
PI=protease inhibitor
Practitioner Adherence to Treatment
Guidelines
• No contraindicated regimens were prescribed
• 3.4% of total sample received regimens inadequate for
immunologic measures (n=2)
• 55.9% patients were prescribed ARV before both
immunological or virological parameters known (n=33)
• Delays in monitoring averaged 64 days between request and
notification of first CD4+ level, and 86 days for first viral
load
Treatment Lapses
• 23.7% of sample lacked medication for >1 month
(n=14)
– Example: patient recorded as picking up 30 day supply
of meds 3/4/00 did not return until after 5/4/00
• Medication insufficiencies due to both patient
failure to pick up prescriptions (n=11) and
pharmacy shortages (n=3)
Associations between patient characteristics and
treatment lapses of 59 patients, Vasco Barcelos Health
post, Nova Iguaçu, Brazil 2000
Characteristic
Stratum
n (total number
in stratum)
n (number and %
with insufficiency)
Odds ratio and
95% CI
P value
Gender
Male
Female
36
23
4 (11.1%)
10 (43.5%)
1
6.15 (1.63-23.19)
0.004
Hospitalization
in 2000
Not hospitalized
1 hospitalization
35
24
5 (14.3%)
9 (37.5)
1
3.60 (1.12-12.65)
0.039
Number of
drugs
2
>2
17
42
1 (5.9%)
13 (31.0%)
1
7.17 (0.86-59.97)
0.040
Age
20-29
30-39
40-49
50-70
18
24
15
2
6 (33.3%)
6 (25.0%)
2 (13.3%)
0 (0%)
1
0.67 (0.17-2.56)
0.31 (0.05-1.83)
N/A
0.554
0.181
0.329
CD4+ count
(n=52)
<200
200-349
350-500
>500
20
22
5
5
6 (30.0%)
4 (18.2%)
2 (40.0%)
1 (20.0%)
1
0.52 (0.12-2.20)
1.56 (0.54-2.52)
0.58 (0.05-6.37)
0.369
0.668
0.656
Prior ARV Use
ARV naïve
ARV prior use
50
9
11 (22.0%)
3 (33.3%)
1
1.73 (0.37-8.06)
0.483
Discussion:
• Conservative prescription of HAART in proportion to dual
combination therapy:
– Nova Iguaçu: 70% HAART
– New York City: 89% HAART in 1998 (Sackoff JE et al, 2000)
• High practitioner adherence to ARV guidelines
– Nova Iguaçu: correct therapy in 57 of 59 initial treatments
– U.S.: 85% provider adherence (Kaplan JE et al, 1999)
• Medication insufficiencies suggest adherence short of 90-95%
needed for optimal viral suppression, women more at risk for
treatment lapse than men
• According to pharmacist, adherence hampered by frequent changes
in drug packaging, leading to patient confusion
• Limitations of study include small sample size, significant number of
archived patients among initial registrants, and liberal measure for
medication insufficiencies
Conclusions and Implications:
• Brazilian public health system is providing ARV treatment
according to guidelines at this health post
• Delays in monitoring identified as source of potential
mismatch between clinical status and treatment; improved lab
capabilities may shorten monitoring delays
• Problems exist with maintaining treatment continuity, largely
secondary to patient non-adherence
• Some evidence obtained that resource-poor countries can
deliver successful HIV treatment provided that antiretroviral
drugs are made available
References:
• Carmody ER, Diaz T, Starling P, Beruth dos Santos AP, Sacks HS. An
evaluation of antiretroviral HIV/AIDS treatment in a Rio de Janeiro public
clinic. Tropical Medicine & International Health, 2003; 8: 378-385.
• Ministerio da Saude. Recomendaçoes para terapia antiretroviral em
adultos e adolescentes infectados pelo HIV—1999. Coordenaçao
Nacional de DST e AIDS, Brasilia. (http://www.aids.gov.br/assistencia,
accessed 7 Jan 2003).
• Sackoff JE, McFarland JW, Shin SS. Trends in prescriptions for highly
active antiretroviral therapy in four New York City HIV clinics. Journal of
AIDS, 2000; 23: 178-183.
• Kaplan JE, Parham DL, Soto-Torres L et al. Adherence to guidelines for
antiretroviral therapy and for preventing opportunistic infections in HIVinfected adults and adolescents in Ryan White-funded facilities in the
Unites States. Journal of AIDS, 1999; 21: 228-235.