Abstract:
Objectives: We assessed mortality associated with immunologic
and virologic patterns of response at 6 months of highly active
antiretroviral therapy (HAART) in HIV-infected individuals from
resource-limited countries in Africa and South America.
Methods: Patients who initiated HAART between 1996 and 2007,
aged 16 years or older, and had at least 1 measurement (HIV-1 RNA
plasma viral load or CD4 cell count) at 6 months of therapy (3–9
month window) were included. Therapy response was categorized
Received for publication March 19, 2009; accepted August 16, 2009.
From the *Departamento de Epidemiologia e Bioestatı́stica, Universidade
Federal Fluminense, Niterói, Brazil; †Programa de Computac x ão Cientı́fica
(PROCC)-Fiocruz, Rio de Janeiro, Brazil; ‡Infectious Diseases Epide-
miology Research Unit, Graduate School of Public Health and School of
Medicine, University of Pittsburgh, Pittsburgh, PA, USA; §Department of
Biostatistics, Graduate School of Public Health, University of Pittsburgh,
Pittsburgh, PA, USA; k Department of Social Medicine, Bristol University,
UK; {Department of Social and Preventive Medicine, University of Bern,
Bern, Switzerland; #Unité INSERM 897, Institut de Santé Publique,
Epidémiologie et Développement (ISPED) Université Victor Segalen,
Bordeaux, France; **Department of Social and Preventive Medicine,
University of Bern, Bern, Switzerland; ††International Center of AIDS
Care and Treatment Programs, Columbia University, Mailman School of
Public Health, New York, NY, USA; ‡‡Center for Global Health,
Massachusetts General Hospital, Global Health Scholars, Harvard
Initiative for Global Health, Boston, MA, USA; §§Indiana University
School of Medicine, Indianapolis, USA; Moi University School of
Medicine, Eldoret, Kenya; Regenstrief Institute for Informatics, Indian-
apolis, IN, USA; kk Division of Biostatistics, Indiana University School of
Medicine, Indianapolis, IN, USA; {{Institute of Infectious Disease and
Molecular Medicine and Department of Medicine, University of Cape
Town, Cape Town, South Africa; ##Hospital de Clinicas de Porto Alegre,
Universidade Federal do Rio Grande do Sul, Brazil; and ***Hospital
Universitario Clementino Fraga Filho Universidade Federal do Rio de
Janeiro, Rio de Janeiro, Brazil.
The ART-LINC collaboration of the International epidemiological Databases
to Evaluate AIDS (IeDEA) is funded by the US National Institutes of
Health (Office of AIDS Research and National Institute of Allergy and
Infectious Diseases) and the French Agence Nationale de Recherches sur
le Sida et les hepatitis virales (ANRS). This study was partially supported
by the Fogarty International Center, NIH (grant 3 D43 TW01038).
ART-LINC of IeDEA central coordinating team and the Collaborating centers
are listed in Appendix 1.
Correspondence to: Dr. Mauro Schechter, MD, PhD, Hospital Universitario
Clementino Fraga Filho Universidade Federal do Rio de Janeiro, Rua
Professor Rodolpho Paulo Rocco, n 255, Ilha do Fundão, Rio de
Janeiro—RJ, Brazil 21941.590. (e-mail: maurosch@hucff.ufrj.br).
Copyright Ó 2009 by Lippincott Williams & Wilkins
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as complete, discordant (virologic only or immunologic only),
and absent. Associations between 6-month response to therapy and
all-cause mortality were assessed by Cox proportional hazards
regression. Robust standard errors were calculated to account for
intrasite correlation.
Results: A total of 7160 patients, corresponding to 15,107 person-
years, were analyzed. In multivariable analysis adjusted for age at
HAART initiation, baseline clinical stage and CD4 cell count, year of
HAART initiation, clinic, occurrence of an AIDS-defining condition
within the first 6 months of treatment, and discordant and absent
responses were associated with increased risk of death.
Conclusions: Similar to reports from high-income countries,
discordant immunologic and virologic responses were associated
with intermediate risk of death compared with complete and no
response in this large cohort of HIV-1 patients from resource-limited
countries. Our results support a recommendation for wider avail-
ability of plasma viral load testing to monitor antiretroviral therapy in
these settings.
Key Words: antiretroviral therapy, cohort, CD4 lymphocyte count,
highly active, low-income population, mortality, treatment outcome,