Use of antiretrovirals is widespread in Brazil, where more than 200,000 individuals are under treatment. Although general prevalence of primary antiretroviral resistance in Brazil is low, systematic sampling in large metropolitan areas has not being performed.The HIV Threshold Survey methodology (HIV-THS, WHO) was utilized, targeting Brazil's four major regions and selecting the six most populated state capitals: Sao Paulo, Rio de Janeiro, Salvador, Porto Alegre, Brasilia and Belem. We were able to sequence samples from 210 individuals with recent HIV diagnosis, 17 of them (8.1%) carrying HIV isolates with primary antiretroviral resistance mutations. Five, nine and four isolates showed mutations related to resistance to nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs), respectively. Using HIV-THS, we could find an intermediate level of transmitted resistance (5% to 15%) in Belem/Brasilia, Sao Paulo and Rio de Janeiro. Lower level of transmitted resistance (<5%) were observed in the other areas. Despite the extensive antiretroviral exposure and high rates of virologic antiretroviral failure in Brazil, the general prevalence of primary resistance is still low. However, an intermediate level of primary resistance was found in the four major Brazilian cities, confirming the critical need to start larger sampling surveys to better define the risk factors associated with transmission of resistant HIV.

In Brazil, where three distinct HIV-1 subtypes (B, F, and C) cocirculate, a significant portion of the HIV-infected population has been exposed to antiretroviral drugs. This study analyzes the antiretroviral resistance profiles of HIV-1-infected individuals failing antiretroviral therapy. Genotypic resistance profiles of 2474 patients presenting virologic failure to antiretroviral therapy in the city of Sã o Paulo, Brazil, were generated and analyzed. Resistance mutations to protease inhibitors and nucleoside reverse transcriptase inhibitors were less common in subtype C viruses, whereas nonnucleoside reverse transcriptase inhibitor resistance mutations were less common in subtype F viruses. The thymidine analog mutation pathway known as pathway 1 was more prevalent in subtype B viruses than in subtype C viruses, whereas pathway 2 was more prevalent in subtype C viruses. Selected resistance mutations varied according to subtype for all three classes of antiretrovirals. We describe two distinct pathways of nonnucleoside reverse transcriptase inhibitor resistance (to nevirapine and efavirenz). Although cross-resistance to etravirine should occur more frequently among individuals failing nevirapine treatment, the prevalence of cross-resistance to etravirine, darunavir, and tipranavir was found to be low. We found that increases in the number of resistance mutations will be related to increases in the viral load. Special attention should be given to resistance profiles in non-B subtype viruses. The accumulation of knowledge regarding such profiles in the developing world is desirable.

BackgroundImmunological and virological status of HIV-infected individuals entering the Brazilian public system over time was analyzed. We evaluated the impact of ART on virological, immunological and antiretroviral resistance over time.MethodsCD4+ T cell counts, viral loads and genotypes from patients over 13 years old from 2001–2011 were analyzed according to demographic data. We compared groups using parametric t-tests and linear regression analysis in the R statistical software language.ResultsMean baseline CD4+ T cell counts varied from 348 (2003) to 389 (2009) and was higher among women (p = 1.1 x 10−8), lower in older patients (p< 1 x 10−8) and lower in less developed regions (p = 1.864 x 10−5). Percentage of treated patients with undetectable viral loads increased linearly from 46% (2001) to 77% (2011), was lower among women (p = 2.851 x 10−6), younger ages (p = 1 x 10−3), and in less developed regions (p = 1.782 x 10−4). NRTI acquired resistance was 86% in 2001–3 and decreased over time. NNRTI resistance increased from 2001-3(50%) to 2006–9 (60%), PI resistance decreased from 2001–3 (60%) to 2009 (40%), and 3-class resistance was stable over time around 25%. Subtype prevalence comprised B (75.3%), B/F recombinants (12.2%), C (5.7%), F (5.3%) and B/C recombinants (1.5%), with regional variations. Three-class resistance was 26.5% among Bs, 22.4% among Fs and 17.2% among Cs.ConclusionsHIV diagnosis occurs late, especially among elderly Brazilians. Younger individuals need special attention due to poor virological response to treatment. Antiretroviral Resistance profile is subtype related.

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK

Objectives: The Brazilian Constitution establishes that the State must ensure integral, universal and free health care. The financing of this model is impacted by judicial decisions that require the supply of medicines, in spite of the guidelines and lists. Knowledge of the impact of these court decisions is essential to the development of strategies that ensure the provision of evidence-based treatment and protect the sustainability of the system. Legal decisions determine that the Ministry of Health (MH) treat patients outside established guidelines. Miglustate is available in the Brazilian public health system (SUS) to treat Gaucher disease. This paper aims to measure the relevance and impact of judicialization on miglustate distributions in 2019. Methods: From MH administrative information, was identified the number of miglustate that was sent to patients who were in accordance with official ("regular") guidelines and for who weren't in accordance with official ("judicial order") guidelines were identified in 2019. Cost and quantity of miglustate sent to each group were established and the exchange rate of US$1: BRL 3.30. Results: In the evaluation period, 46 patients used miglustate distributed by the MH, being 25 (54%) "regular" and 21 (46%) "judicial". These patients received 18,750 tablets and 13,770 miglustate tablets, respectively, bringing a total cost of $ 849,514/year. Judicial order accounted for 38% of total spending and treated patients with: Niemann Pick C Disease (71%), Tay-Sachs Syndrome (19%), and Gangliosidosis (10%). In Brazil, the use of miglustate for Tay-Sachs Syndrome and Gangliosidosis is not approved, characterized as offlabel use. Conclusions: Court decisions accounted 38% of MH spending on miglustate in 2019 and subject patients to treatment without systematic guidance in official protocols. Using miglustate outside official indications endangers patient safety and has a significant budgetary impact on the SUS. The technical qualification of the judiciary is required from the perspective public and evidence-based medicine.