title: Effectiveness of highly active antiretroviral therapy using non-brand name drugs in Brazil.
abstract: In Brazil, HIV-infected individuals receive drugs (including non-brand name drugs which comprise locally produced generics and drugs that have not been tested in bioequivalence trials) free of charge from the government. The objective of the present study was to evaluate the effectiveness of highly active antiretroviral therapy (HAART) in Rio de Janeiro, Brazil, where non-brand drugs are widely used. For this purpose, we estimated the proportion of subjects with virologic failure (plasma HIV viral load greater than 400 copies/mL at 6 months after initiation of treatment). This was a retrospective cohort study of drug-naive HIV-infected subjects who initiated HAART. Subjects were included in the analysis if they were 18 years of age or older, were treatment naive, started HAART with a minimum of 3 drugs, and had available information on blood plasma HIV-1 viral load after 6 months on therapy. All subjects used antiretrovirals in dosing regimens recommended by the Brazilian National Advisory Committee for Antiretroviral Therapy. Chart reviews were conducted in three settings: at two public health outpatient units, at one clinical trial unit and at one private office. No comparisons of the effectiveness of non-brand name with the effectiveness of brand name drugs were made. We present results for 485 patients; of these, 354 (73%), 55 (11%), and 76 (16%) were seen at the public health outpatient units, private office, and clinical trial unit, respectively. Virologic failure was observed in 119 (25%) of the subjects. This study demonstrates the effectiveness of HAART in a setting where non-brand name drugs are widely used.
authors.affiliation: Serviço de Doenças Infecciosas e Parasitárias, Departamento de Medicina Preventiva, Hospital Universitário Clementino Fraga Filho, Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.
authors.forename: S B
authors.initials: SB
authors.lastname: May
authors.forename: P F
authors.initials: PF
authors.lastname: Barroso
authors.forename: E P
authors.initials: EP
authors.lastname: Nunes
authors.forename: H S
authors.initials: HS
authors.lastname: Barcaui
authors.forename: M M T
authors.initials: MM
authors.lastname: Almeida
authors.forename: M D
authors.initials: MD
authors.lastname: Costa
authors.forename: J C
authors.initials: JC
authors.lastname: Faulhaber
authors.forename: G
authors.initials: G
authors.lastname: Santoro-Lopes
authors.forename: M
authors.initials: M
authors.lastname: Schechter
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D001938:Brazil; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D016568:Drugs, Generic