Determinants of Treatment Access in a Population-based Cohort of HIV-positive Men and Women Living in Argentina.

Abstract

ABSTRACT : OBJECTIVE : To report emerging data on the use of highly active antiretroviral therapy (HAART) in Argentina by assessing patterns of HAART access and late vs early treatment initiation in a population-based cohort of adults infected with HIV type-1. DESIGN : The Prospective Study on the Use and Monitoring of Antiretroviral Therapy (PUMA) is a study of 883 HIV-positive individuals enrolled in the Argentinean drug treatment program. Individuals were 16 years of age and older and were recruited from 10 clinics across Argentina. METHODS : Sociodemographic and clinical characteristics were examined using contingency tables (Pearson chi-square test and Fisher exact test) for categoric variables and Wilcoxon rank-sum test for continuous variables. To analyze time to initiation of HAART we used Kaplan-Meier methods and Cox regression. RESULTS : Patients who initiated HAART were more likely to be older, have an AIDS-defining illness, be an injection drug user (IDU), have a lower median CD4 cell count, have a higher median viral load, and be less likely to be men who have sex with men (MSM). In multivariate analysis, AIDS-defining illness and plasma viral load were significantly associated with time to starting therapy. Patients who received late access were more likely to be diagnosed with AIDS and have higher median plasma viral loads than those receiving early access. CONCLUSION : Our results indicate that despite free availability of treatment, monitoring, and care in Argentina, a significant proportion of men and women are accessing HAART late in the course of HIV disease. Further characterization of the HIV-positive population will allow for a more comprehensive evaluation of the impact of HAART within the Argentinean drug treatment program.

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BioMed Central
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Journal of the International AIDS
Society
Research article
Determinants of Treatment Access in a Population-based Cohort of
HIV-positive Men and Women Living in Argentina
Carlos Zala*1, Clare A Rustad2, Keith Chan2, Nabeela I Khan3,
Marcelo Beltran4, Eduardo Warley5, Mariana Ceriotto6, Eric F Druyts2,
Robert S Hogg7, Julio Montaner2, Pedro Cahn8 for PUMA Study Group
Open Access
Address: 1Medical Director, Fundacion "Dra. Cecilia Grierson", Buenos Aires, Argentina, 2British Columbia Centre for Excellence in HIV/AIDS, St.
Paul's Hospital, Vancouver, British Columbia, Canada, 3University of British Columbia; British Columbia Centre for Excellence in HIV/AIDS, St.
Paul's Hospital, Vancouver, British Columbia, Canada; CIHR-UBC Strategic Training Program for Translational Research in Infectious Diseases,
4Hospital Central de San Isidro, Buenos Aires, Argentina, 5Hospital Paroissien, Buenos Aires, Argentina, 6Hospital Cecilia Grierson, Buenos Aires,
Argentina, 7British Columbia Centre for Excellence in HIV/AIDS, St. Paul's Hospital, Vancouver, British Columbia, Canada and Faculty of Health
Sciences, Simon Fraser University, Burnaby, British Columbia, Canada and 8Hospital Fernandez, Buenos Aires, Argentina
Email: Carlos Zala* - carlos.zala@aclires.com
* Corresponding author
Abstract
Objective: To report emerging data on the use of highly active antiretroviral therapy (HAART)
in Argentina by assessing patterns of HAART access and late vs early treatment initiation in a
population-based cohort of adults infected with HIV type-1.
Design: The Prospective Study on the Use and Monitoring of Antiretroviral Therapy (PUMA) is a
study of 883 HIV-positive individuals enrolled in the Argentinean drug treatment program.
Individuals were 16 years of age and older and were recruited from 10 clinics across Argentina.
Methods: Sociodemographic and clinical characteristics were examined using contingency tables
(Pearson chi-square test and Fisher exact test) for categoric variables and Wilcoxon rank-sum test
for continuous variables. To analyze time to initiation of HAART we used Kaplan-Meier methods
and Cox regression.
Results: Patients who initiated HAART were more likely to be older, have an AIDS-defining illness,
be an injection drug user (IDU), have a lower median CD4 cell count, have a higher median viral
load, and be less likely to be men who have sex with men (MSM). In multivariate analysis, AIDS-
defining illness and plasma viral load were significantly associated with time to starting therapy.
Patients who received late access were more likely to be diagnosed with AIDS and have higher
median plasma viral loads than those receiving early access.
Conclusion: Our results indicate that despite free availability of treatment, monitoring, and care
in Argentina, a significant proportion of men and women are accessing HAART late in the course
of HIV disease. Further characterization of the HIV-positive population will allow for a more
comprehensive evaluation of the impact of HAART within the Argentinean drug treatment
program.
Published: 2 April 2008
Journal of the International AIDS Society 2008, 10:78
This article is available from: http://www.jiasociety.org/content/10/4/78

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Introduction
Highly active antiretroviral therapy (HAART) has been
shown to substantially reduce mortality and morbidity for
individuals infected with HIV type-1 since the introduc-
tion of these regimens in 1996.[1-4] A recently published
comparative analysis on the impact of HAART in low- vs
high-income countries suggests that HAART is highly
effective in both settings;[5] however, little is known
regarding access to and impact of HAART in intermediate
countries.
Of the nearly 40 million people living with HIV/AIDS
worldwide, approximately 1.7 million people are living
with HIV in South America.[6] In Argentina, there are cur-
rently 130,000 people infected with HIV, and the preva-
lence among adults is estimated to range from 0.3% to
1.9% of the population.[6] HIV predominantly affects
injecting drug users (IDU) and men who have sex with
men (MSM);[7-10] however, more recently, heterosexual
transmission has become the fastest growing transmission
group.[7] The majority of people living with HIV/AIDS
reside in Buenos Aires, Cordoba, and Santa Fe.[6]
In Argentina, antiretroviral drugs are provided free of
charge to eligible HIV-positive individuals. Since 1990,
the National Program has covered the cost of antiretrovi-
ral drugs, both generic and nongeneric formulations, as
well as patient care, including tests for viral load, CD4 cell
counts, and more recently, drug resistance. Currently, it is
estimated that 68% of those in need of antiretroviral ther-
apy in South America (315,000 individuals) are provided
with medication by established drug treatment pro-
grams.[11]
The objectives of this study were to briefly characterize the
determinants of access to HAART and to assess late vs
early initiation of HAART in a population-based cohort of
HIV-positive Argentinean men and women.
Methods
PUMA is an ongoing multicenter cohort study designed to
monitor access to and impact of HAART in Argentina
using prospectively collected sociodemographic, clinical,
and morbidity and mortality data for HIV-positive indi-
viduals 16 years and older, who were antiretroviral-naive.
Ethical approval was obtained from the institutional
review boards of each collaborating center.
Data Collection
Data were collected from 10 public health facilities in
Argentina from January 1, 2003, to August 31, 2006, and
pooled together at a coordinating center. Participants
were recruited from treatment centers located in Rosario,
Cordoba, Mar del Plata, and Buenos Aires, which repre-
sent the provinces with the highest prevalence of HIV in
Argentina. HAART eligibility and the HAART regimens
available from the National Program remain consistent
with those recommended by the International AIDS Soci-
ety (IAS)-USA guidelines.[2] The date of therapy initiation
was known and participants were required to have at least
one documented plasma viral load measurement and one
CD4 cell count performed within 6 months prior to the
initiation of HAART. Additional data were extracted from
enrollment notes, laboratory reports, central microbio-
logical laboratories, pharmacy records, and patient charts.
Deaths that occurred during the study period were identi-
fied via clinic notes and patient charts. HAART regimens
included 2 nucleoside reverse transcriptase inhibitors plus
either of the nonnucleoside reverse transcriptase inhibi-
tors efavirenz or nevirapine, or a ritonavir-boosted pro-
tease inhibitor (indinavir,
atazanavir, or fosamprenavir).
saquinavir, lopinavir,
Statistical Analysis
The first analysis evaluated participant characteristics
associated with initiation of HAART. Baseline variables
were measured within 3 months before starting HAART
and included age (years), sex (male and female), trans-
mission group (MSM, IDU, and heterosexual), CD4 cell
count (cells/microliter [mcL]), plasma HIV-1 viral load
(copies/mL), and AIDS-defining illness. The second anal-
ysis was restricted to individuals who started HAART dur-
ing the follow-up period, rather than at baseline, and
examined time to initiation of therapy. The final analysis
included all individuals who initiated HAART during the
study, and evaluated characteristics associated with late
(CD4 ≤ 200 cells/mcL vs early (CD4 > 200 cells/mcL) ini-
tiation of HAART. All of the previously mentioned varia-
bles were included in the final 2 analyses.
Categoric variables were compared using contingency
tables (Pearson chi-square test and Fisher exact test).
Comparisons of continuous variables were carried out
using Wilcoxon rank sum test. Kaplan-Meier methods and
Cox regression were used to analyze time to initiation of
HAART. Analyses were performed using SAS software ver-
sion 8.02 (SAS, Cary, NC). All significance tests were 2-
sided and P values < .05 were considered statistically sig-
nificant.
Results
Between January 1, 2003, and August 31, 2006, a total of
883 patients were enrolled in PUMA, 648 (78%) of whom
were eligible for HAART based on the IAS-USA guide-
lines.[2] A total of 47 (9%) of the treatment-naive individ-
uals at baseline did not return for follow-up visits for
greater than 6 months after baseline measurements and
were never treated. These individuals were excluded from
further analysis.

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The baseline sociodemographic and clinical characteris-
tics of all enrolled patients who initiated HAART vs those
who did not initiate HAART at baseline are summarized in
Table 1 . Compared with individuals who remained
HAART-naive at baseline, those who initiated therapy
were more likely to be older (P < .0001), have an AIDS-
defining illness (P < .0001), have a lower median CD4 cell
count (P < .0001), and have a higher median viral load (P
< .0001). Proportionally more MSM (P = .04) and more
IDU (P = .02) initiated HAART at baseline.
Cox proportional hazard analysis was conducted among
those who were not receiving HAART at baseline (n = 303)
to assess factors associated with time to starting HAART
during the follow-up period. Table 2 provides the results
of the univariate and multivariate Cox analyses. In the
univariate model, age (risk ratio [RR] = 1.31 per 10 years,
95% confidence interval [CI] 1.091.57), AIDS-defining
illness (RR = 6.74, 95% CI 4.2110.80), and plasma viral
load (RR = 2.59 per log10 increase, 95% CI 1.873.58) were
significantly associated with the incidence of HAART ini-
tiation during the follow-up period. In multivariate anal-
ysis, AIDS-defining illness (adjusted risk ratio [ARR] =
4.28, 95% CI 2.497.37) and plasma viral load (ARR = 2.17
per log10 increase, 95% CI 1.563.02) were included in the
model, both of which remained statistically significant.
Table 1: Baseline Sociodemographic and Clinical Characteristics of HIV-positive Individuals Who Initiated HAART at Baseline vs.
Those Who Did Not Initiate HAART at Baseline
HAART Initiation
Variable No (n = 188)Yes (n = 648)
P value
Sex
Male140 (74)444 (69) .15
Female48 (26%) 202 (31%)
Age† (years)33 (26.539) 36 (3143)< .001
MSM (n = 263)*
No117 (62%) 456 (70%) .03
Yes 71 (37)192 (30)
IDU (n = 109)*
No 173 (92%) 554 (85%).02
Yes 15 (8%)94 (15%)
Heterosexual transmission (n = 426)*
No 97 (52)313 (48) .43
Yes91 (48)335 (52)
Prior AIDS-defining illness*
No176 (94)426 (66) < .001
Yes 12 (6)222 (34)
CD4† (cells/mcL)468 (316700) 133 (48255)< .001
HIV RNA† (copies/mL)17,197 (465155,396) 68,505 (7370236,000) < .001
*Number (percentage)
†Median (interquartile range)
HAART = highly active antiretroviral therapy; IDU = injection drug use; mcL = microliter; MSM = men who have sex with men

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Table 2: Univariate and Multivariate Cox Proportional Hazard Analysis of Factors Associated With Time to Initiation of Therapy
Among Persons Starting HAART During the Follow-up Period (n = 303)
Time to Initiation of Therapy Unadjusted Hazard Ratio (95% CI)Adjusted Hazard Ratio (95% CI)
Sex (male vs female)0.92 (0.621.37)--
Age (per 10 years) 1.31 (1.091.57)--
MSM Risk (yes vs no)0.77 (0.521.12)--
IDU Risk (yes vs no)1.67 (0.932.99)--
Prior AIDS-defining illness (yes vs no)* 6.74 (4.2110.80)4.28 (2.497.37)
pVL (per log10 copies/mL increase)2.59 (1.873.58)2.17 (1.563.02)
CD4 (per 100 cell/mcL decrease)*1.00 (0.991.01) --
*Evaluated from baseline value onward
HAART = highly active antiretroviral therapy; IDU = injection drug use; mcL = microliter; MSM = men who have sex with men; pVL = plasma viral
load
Table 3: Sociodemographic and Clinical Characteristics of HIV-positive Individuals by Early or Late Start of Treatment
Treatment Initiation at Baseline
VariableEarly Access
(CD4 > 200 cells/mcL)(n = 181)
Late Access (CD4 ≤ 200 cells/mcL)
(n = 397)
P value
Sex*
Male 118 (66)277 (70) .33
Female62 (34)119 (30)
Age (years)†
35 (3042) 36 (3143) .20
MSM (n = 178)*60 (33)118 (30).44
IDU (n = 79)* 18 (10)61 (15).09
Heterosexual transmission (n = 300)* 95 (52) 205 (52)1.00
Prior AIDS-defining illness*
No155 (86)233 (59) < .0001
Yes26 (14)164 (41)
HIV RNA (copies/mL)†
60,559 (16,323181,700)133,824 (48,541383,000) < .0001
Note: Documented results of CD4 cell count within 1 year prior to starting treatment were missing for 69 patients, and these patients were
eliminated from analysis.
*Number (percentage)
†Median (interquartile range)
IDU = injection drug use; mcL = microliter; MSM = men who have sex with men

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Table 3 summarizes the factors contributing to late (CD4
≤ 200 cells/mcL) vs early (CD4 > 200 cells/mcL) access to
HAART. This analysis was restricted to 578 of the 648
patients, because 69 (11%) individuals did not have CD4
measurements within 12 months prior to the initiation of
HAART. Compared with those receiving early access to
HAART, patients who received late access were more likely
to have an AIDS-defining illness (P < .0001) and have
higher median plasma viral loads (P < .0001).
Discussion
This is the first report on selected determinants of treat-
ment access within a prospective multisite cohort in
Argentina. We observed that primarily clinical factors
were associated with eligibility for HAART, and a signifi-
cant proportion of patients received late access to therapy.
Age, AIDS-defining illness, CD4 count, and plasma viral
load were associated with HAART initiation. AIDS-defin-
ing illness and viral load were also associated with time to
initiation of and late access to HAART.
As expected, those who started HAART in this study had
lower median CD4 counts and higher median plasma
viral loads. The majority of individuals in PUMA present-
ing with an AIDS-defining illness were also given HAART.
According to the established guidelines, it is recom-
mended that those presenting with symptomatic HIV
should be immediately provided treatment.[2] It is there-
fore of concern that 6% of individuals with an AIDS-
defining illness were not provided therapy. There was no
indication as to why these individuals were not treated. It
should be noted, however, that tuberculosis is a leading
AIDS-defining illness in Argentina) and many treating
physicians may elect to delay initiation of HAART in HIV/
tuberculosis co-infected individuals who have CD4
counts > 200 cells/mcL.[12]
Proportionally more IDU initiated HAART at baseline
rather than remaining HAART-naive. A high risk for HIV
infection has previously been observed in this group of
individuals.[8,13-16] In Buenos Aires, a previous study
demonstrated that the prevalence of HIV among IDU was
44.3% in 2001.[8] As IDU was formerly the most com-
mon mode of transmission in Argentina, it is expected
that individuals belonging to this group would have been
infected for a longer period of time compared with other
more recently prevalent modes of transmission, such as
heterosexual contact. These individuals may therefore
have been at greater risk for more advanced disease and
thus have required antiretroviral therapy.
MSM have also traditionally been regarded as a high-risk
group for HIV infection in Argentina with the prevalence
of infection among this group ranging from 7% to
15%.[6,17,18] One interesting observation of the present
analysis was the number of MSM present in the popula-
tion. There were nearly twice as many individuals infected
with HIV via heterosexual transmission. It may be that
MSM in the Argentinean population were aware of their
increased risk and the progression of HIV. Those with
more advanced disease may have sought treatment prior
to the initiation of the present study, thus making them
ineligible for inclusion. This could explain why there are
more individuals infected via heterosexual transmission
in this cohort. Although a stigma for MSM does exist in
Argentina, as in other Latin American countries, it is
unlikely that any significant underreporting of this varia-
ble would occur in the clinical setting of this cohort.
Individuals receiving late access to therapy were more
likely to have an AIDS-defining illness. This observation
was anticipated because AIDS-related illnesses are, by def-
inition, associated with decreased immune response and
thus lower CD4 counts.[19,20] Similarly, the association
between late access to therapy and high plasma viral load
indicates that those with the most advanced disease were
treated immediately upon entry into the program. Treat-
ment guidelines suggest consideration of increased viral
load in decisions about when to initiate HAART.[2]
Several features of our study should be highlighted. First,
because access to HAART in Argentina is free of charge, all
HIV-infected individuals should have equal access to ther-
apy. It is therefore unlikely that this study had any of the
selection biases that may be introduced when therapy is
not free of charge. Furthermore, the comprehensive geo-
graphic representation of our study reduces any possible
bias that may be introduced by focusing on a single site.
Individuals at a single site may have unusual characteris-
tics associated with their eligibility for HAART. Including
a variety of clinics from different regions of Argentina
reduced the possible effect of random variation between
sites and any other outlying characteristics. Finally, read-
ers should be cautious about the limitations of the present
study. Patients excluded from analysis because of either
lack of attendance for follow-up or missing CD4 measure-
ments may bias the analysis of outcome measures. For
example, the excluded individuals may have had consist-
ently low CD4 counts and thus may have been too ill to
return for follow-up visits. Alternatively, these individuals
could have had consistently high CD4 counts and consid-
ered their attendance unnecessary. In addition, the small
number of active patients in our cohort limits our capacity
to generalize our results to all HIV-infected individuals in
Argentina. Finally, other variables including income, edu-
cation, other co-infections or comorbidities, and availa-
bility of healthcare services cannot be excluded as other
determinants of access to antiretroviral therapy in Argen-
tina. The proportion of patients with AIDS at enrollment
suggests that a late HIV diagnosis appears to be common

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in Argentina. Seroprevalence studies in middle-income
countries indicate that approximately one third of indi-
viduals with HIV are unaware of their infection.[21] Con-
sidering the wide availability of free HIV testing and
treatment in Argentina, a late diagnosis of HIV is more
likely associated with underutilization and/or missing
opportunities for HIV detection within the healthcare sys-
tem.
In conclusion, our results indicate that men and women
in Argentina are accessing HAART according to estab-
lished treatment guidelines.[2] However, a considerable
number of people initiated therapy late in the course of
HIV disease. Further characterization of the population of
HIV-positive individuals eligible for HAART in Argentina,
in terms of co-infections or socioeconomic status for
example, is necessary to better understand the sociodemo-
graphic and clinical characteristics of the HIV-infected
population as a whole and to perform a more comprehen-
sive evaluation of the HAART treatment program.
Funding Information
This work was partially funded by a grant from the Univer-
sity of Buenos Aires (M014).
Authors and Disclosures
Carlos Zala, MD, has disclosed no relevant financial rela-
tionships.
Clare A Rustad, MPhil, has disclosed no relevant financial
relationships.
Keith Chan, MSc, has disclosed no relevant financial rela-
tionships.
Nabeela I. Khan, BSc, has disclosed no relevant financial
relationships.
Marcelo Beltran, MD, has disclosed no relevant financial
relationships.
Eduardo Warley, MD, has disclosed no relevant financial
relationships.
Mariana Ceriotto, MD, has disclosed no relevant financial
relationships.
Eric F Druyts, MSc, has disclosed no relevant financial
relationships.
Robert S Hogg, PhD, has disclosed no relevant financial
relationships.
Julio Montaner, MD, has disclosed that he has received
grants from, has served as an ad hoc advisor to, or has spo-
ken at various events sponsored by: Abbott, Argos Thera-
peutics, Bioject Inc., Boehringer Ingelheim, Bristol-Myers
Squibb, Gilead Sciences, GlaxoSmithKline, Hoffmann-
LaRoche, Janssen-Ortho, Merck Frosst, Panacos, Pfizer,
Schering, Serono Inc., TheraTechnologies, Tibotec (J&J),
and Trimeris.
Pedro Cahn, MD, PhD, has disclosed no relevant financial
relationships.
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