Transcript An evaluation of HIV/AIDS antiretroviral treatment in

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 Saúde Vasco Barcelos de Nova Iguaçu
Background:
• Since 1996, Brazilian public health system has
provided free, universal access to antiretroviral
(ARV) therapy for people infected with HIV
• 95,000 patients received ARV in 2000 at $303
million
• Drugs purchased from international companies and
produced in national laboratories
Background (continued):
Evaluation necessary to:
• ensure optimal delivery of medicines
• prevent drug resistance at individual and
population levels
• appraise program as model for low to lowmiddle income countries with high HIV
burden
Setting: Centro de Saúde Vasco
Barcelos de Nova Iguaçu
• Public outpatient health post in suburb of Rio de
Janeiro with onsite pharmacy and four HIV
physicians
• Patient population drawn from low
socioeconomic status
• Nova Iguaçu ranked 18th among municipalities
for number of AIDS cases in Brazil
Centro de Saúde Vasco Barcelos de Nova
Iguaçu, Brazil
Study Objectives:
• Assess feasibility of collecting medical record and
pharmacy data to evaluate the provision of ARVs
• Determine practitioner adherence to Brazilian ARV
treatment guidelines
• Assess whether prescriptions were refilled in timely
manner; 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
Results:
Patient Demographics
• 58.2% male (n=39); 41.8% female (n=28)
• Age: mean=34.9; Range=20 to 70
• Education: 4.5% none; 48% 1-8 years; 15% 9-12
years; 33% n/a
• Most common occupations: domestic servant,
mechanic, carpenter, homemaker, manicurist,
unemployed
Patient Clinical Characteristics
• 80.6% of sample had AIDS: clinical symptoms or
CD4<350 as per Brazilian definition (n=54)
• 85.1% were ARV naïve
• Date of HIV+ diagnosis:
– 2000: 50.7%
– 1999: 38.8%
– 1998 or earlier: 7.5%; N/a 3%
• Mean initial CD4+ level 276 cell/mm3, initial viral
load 237,517 copies/ml
Antiretroviral Use
• 88.1% of patients sampled were prescribed
ARV in 2000 (n=59)
• 30.5% of patients prescribed ARV changed
regimens during 2000 (n=18)
Type of Initial ARV Therapy
40
35.6
35
30
33.9
28.8
25
• Dual combination: 28.8%
• HAART: 71.2%
Percent 20
15
10
Therapeutic
regimen
5
1.7
0
I
I
I
T
P
P
R
1
+
+2
N
I
I
N
T
T
1
R
R
+
N
I
T
2N
2
R
N
2
I
T
R
N
2
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
immunologic or virologic parameters known
(n=33)
Average Monitoring Delays Between
Request and Notification of Lab Results
140
127
120
101
100
80
Days
86
64
CD4
Viral load
60
40
20
0
1st result
2nd result
Lab exams
Treatment Lapses
• 23.7% of sample lacked medication for >1
month (n=14)
– Example: patient recorded as picking up 30-day
supply 3/4/00 did not return until after 5/4/00
• Medication insufficiencies primarily due to
patient failure to pick up prescriptions (n=11),
less so to pharmacy shortages (n=3)
Predictors of Medication Insufficiency
in Multivariate Analysis
• Women nearly 6 times more likely to experience
medication insufficiencies than men (OR=5.81, CI
1.41-23.86)
• Univariate association between medication
insufficiencies and hospitalization in 2000 not
significant in multivariate analysis
• Not associated with patient age, baseline CD4 count,
or prior ARV use in univariate or multivariate logistic
regression models
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
Discussion: Factors Contributing to
Medication Insufficiencies as Discussed
with Practitioners and Pharmacist:
• Patient non-adherence
– Use of multiple drug manufacturers led to frequent
changes in packaging, creating patient confusion
• Drug shortages
– Transportation hurdles
– Manual feedback system to estimate demand (delays,
calculation errors)
Study Limitations:
• Small sample size
• High proportion of archived initial registrants
(35%)
• Liberal, non-specific measure for medication
insufficiencies
Conclusions:
• Brazilian public health system is providing ARV
treatment according to guidelines at this health post
• Delays in monitoring were identified as source of
potential mismatch between clinical status and
treatment
• Problems exist with maintaining treatment continuity,
largely due to patient non-adherence
• Some evidence obtained that resource-poor countries
can deliver successful HIV treatment provided that
antiretroviral drugs are made available
Recommendations:
• Improved lab capabilities are needed to shorten
monitoring delays
• Adherence interventions addressing women may
reduce treatment lapses
• Standardization of labeling may facilitate
medication use
• Further adherence research using more standard
markers is required
• 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: 378385.
• 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).
• 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
HIV-infected adults and adolescents in Ryan White-funded facilities in
the Unites States. Journal of AIDS, 1999; 21: 228-235.