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.
Highlights
Studies conducted in developed countries using brand name drugs have demonstrated that early virologic response after introduction of highly active antiretroviral therapy (HAART) is an important predictor of long-term treatment efficacy [1]
Study subjects came from 3 different settings: 2 public health outpatient units (PHU) (HUCFF, a large teaching hospital of the Universidade Federal do Rio de Janeiro, and Centro Municipal de Saúde João Barros Barreto, a primary care facility run by the City of Rio de Janeiro Health Department), one clinical trial unit (CTU) (Projeto Praça Onze, Universidade Federal do Rio de Janeiro), and the private office (PO) of one of the authors (MS)
The primary endpoint of this study was virologic failure (VF) at 6 months on HAART, which was defined as a plasma HIV load greater than 400 copies/mL 6 months after initiation of treatment
Summary
Studies conducted in developed countries using brand name drugs have demonstrated that early virologic response after introduction of highly active antiretroviral therapy (HAART) is an important predictor of long-term treatment efficacy [1]. In June 2005, the World Health Organization estimated that approximately one million individuals in developing countries were receiving HAART. This represents 15% of the estimated 6.5 million people in need of HAART in low- and middle-income countries [2,3,4]. In Brazil, since 1996 virtually all HIV-infected individuals that are on treatment, including patients treated in private practice, receive their drugs free at public dispensaries. Drugs that are protected by patents are purchased exclusively from the patent holders. Brand name and non-brand name zidovudine, lamivudine, didanosine, stavudine, nevirapine, saquinavir, indinavir, and ritonavir might be dispensed to patients, depending on the results of public bids by the suppliers
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