The HIV-Brazil cohort study: design, methods and participant characteristics.
BACKGROUND
The HIV-Brazil Cohort Study was established to analyze the effectiveness of combination antiretroviral therapy (cART) and the impact of this treatment on morbidity, quality of life (QOL) and mortality. The study design, patients' profiles and characteristics of cART initiation between 2003 and 2010 were described.


RESULTS
Since 2003, the HIV-Brazil Cohort has been following HIV-infected adults receiving cART at 26 public health care facilities, using routine clinical care data and self-reported QOL questionnaires. When not otherwise available, data are obtained from national information systems. The main outcomes of interest are diseases related or unrelated to HIV; suppression of viral replication; adverse events; virological, clinical and immunological failures; changes in the cART; and mortality. For the 5,061 patients who started cART between 2003 and 2010, the median follow-up time was 4.1 years (IQR 2.2-5.9 years) with an 83.4% retention rate. Patient profiles were characterized by a predominance of men (male/female ratio 1.7∶1), with a mean age of 36.9 years (SD 9.9 years); 55.2% had been infected with HIV via heterosexual contact. The majority of patients (53.4%) initiated cART with a CD4+ T-cell count ≤200 cells/mm3. The medications most often used in the various treatment regimens were efavirenz (59.7%) and lopinavir/ritonavir (18.2%). The proportion of individuals achieving viral suppression within the first 12 months of cART use was 77.4% (95% CI 76.1-78.6). Nearly half (45.4%) of the patients presented HIV-related clinical manifestations after starting cART, and the AIDS mortality rate was 13.9 per 1,000 person-years.


CONCLUSIONS
Results from cART use in the daily practice of health services remain relatively unknown in low- and middle-income countries, and studies with the characteristics of the HIV-Brazil Cohort contribute to minimizing these shortcomings, given its scope and patient profile, which is similar to that of the AIDS epidemic in the country.
Department of Preventive Medicine, University of São Paulo School of Medicine, São Paulo, Brazil.
Alexandre
A
Grangeiro
Health Institute, São Paulo State Department of Health, São Paulo, Brazil.
Maria Mercedes
MM
Escuder
Alex Jones Flores
AJ
Cassenote
Postgraduate Program in Infectious and Parasitic Diseases, University of São Paulo School of Medicine, São Paulo, Brazil.
Alex Jones Flores
AJ
Cassanote
STD/AIDS Referral and Training Centre, São Paulo State Department of Health, São Paulo, Brazil.
Rosa Alencar
RA
Souza
STD/AIDS Referral and Training Centre, São Paulo State Department of Health, São Paulo, Brazil.
Artur O
AO
Kalichman
Valdiléa G
VG
Veloso
Evandro Chagas Clinical Research Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
Valdiléa
V
Veloso
Care and Treatment Clinic of the Partenon Sanatorium, Rio Grande do Sul State Department of Health, Porto Alegre, Brazil.
Maria Letícia Rodrigues
ML
Ikeda
Care and Treatment Clinic of the Partenon Sanatorium, Rio Grande do Sul State Department of Health, Porto Alegre, Brazil.
Nêmora Tregnago
NT
Barcellos
Edgar Santos University Hospital Complex, Federal University of Bahia, Salvador, Brazil.
Carlos
C
Brites
Medical School, Federal University of Minas Gerais, Belo Horizonte, Brazil.
Unai
U
Tupinanbás
Tropical Medicine Foundation, Amazonas State Department of Health, Manaus, Brazil.
Noaldo O
NO
Lucena
State Centre for Diagnosis, Treatment and Research, Bahia State Department of Health, Salvador, Brazil.
Carlos Lima
CL
da Silva
Federal University of Pernambuco, Recife, Brazil.
Heloisa Ramos
HR
Lacerda
Evandro Chagas Clinical Research Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
Beatriz
B
Grinsztejn
Department of Preventive Medicine, University of São Paulo School of Medicine, São Paulo, Brazil.
Euclides Ayres
EA
Castilho
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D023241:Antiretroviral Therapy, Highly Active; D001938:Brazil / Q000453:epidemiology; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D015897:Comorbidity; D005260:Female; D005500:Follow-Up Studies; D005843:Geography; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000635:transmission; D006801:Humans; D008297:Male; D008875:Middle Aged; D009017:Morbidity; D009026:Mortality; D011788:Quality of Life; D012307:Risk Factors; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult