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Many barriers to human immunodeficiency virus (HIV) testing among Black people exist. This study analysed the association between race/skin colour and lifetime HIV testing among adolescent men who have sex with men (AMSM) and transgender women (ATGW) in three Brazilian cities. This cross-sectional study was nested within the PrEP1519 cohort, a multicentre study of AMSM and ATGW aged 15-19 years in Belo Horizonte, Salvador, and São Paulo, Brazil. The outcome variable was the lifetime HIV testing (no or yes). The main exposure variable was self-reported race/skin colour as White and a unique Black group (composed of Pardo-mixed colour and Black, according to the Brazilian classification). Descriptive statistics and bivariate and multiple logistic regression analyses were conducted to estimate the adjusted odds ratios (ORs) and 95% confidence intervals (95% CIs) to determine the association between the main exposure and outcome, adjusted for covariates. White adolescents were tested more frequently than the unique Black group (64.0% vs. 53.7%, respectively; Ρ = 0.001). Multiple logistic regression analysis showed that the unique Black group of AMSM and ATGW had 26% (adjusted OR [aOR], 0.74; 95% CI, 0.55-0.98) and 38% (aOR, 0.62; 95% CI, 0.45-0.87) lower odds of being tested for HIV in a lifetime than Whites in model 1 and 2, respectively. Our findings highlight the role of racism in lifetime HIV testing among AMSM and ATGW. Therefore, an urgent need for advances exists in public policies to combat racism in Brazil., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: This study analyzed the sociodemographic and behavioral characteristics of adolescent men who have sex with men (aMSM) and transgender women (aTGW) initiating oral pre-exposure prophylaxis (PrEP) in human immunodeficiency virus (HIV) prevention clinics., Methods: PrEP1519 is a prospective, multicenter, open-label PrEP demonstration cohort study of aMSM and aTGW aged 15-19 years living in three large Brazilian capital cities. For this analysis, we included adolescents who enrolled in PrEP1519 from February 2019 to August 2021. Adolescents who visited PrEP clinics were classified into four groups based on PrEP eligibility and on their decision to use PrEP: (1) ineligible for same-day PrEP initiation; (2) eligible for same-day PrEP initiation, initiated PrEP at first visit; (3) eligible for PrEP initiation, initiated PrEP after the first visit; and (4) eligible for same-day PrEP initiation but declined. The groups that were eligible for same-day PrEP initiation were compared using the Chi-square and Fisher's exact tests., Results: Of the 1,254 adolescents enrolled in the PrEP1519 study, 61 (4.9%) were considered ineligible for same-day PrEP initiation. Of the 1,193 eligible for same-day PrEP initiation, 1,113 (93.3%) initiated PrEP [1,054 initiated PrEP in the first visit (88.3%) and 59 in subsequent visits (4.9%)] and 80 (6.7%) did not. Despite 90% of the PrEP decliners reporting a low risk of HIV infection, most reported condomless anal sex in the past six months (70%)., Discussion: Same-day PrEP initiation among aMSM and aTGW was high, highlighting that this strategy was important to promote PrEP initiation among adolescents with increased vulnerability to HIV in Brazil., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: This study aimed to describe pre-exposure prophylaxis (PrEP) for HIV discontinuation in adolescent men who have sex with men (aMSM) and adolescent transgender women (aTGW) and to identify factors associated with discontinuation., Methods: The PrEP1519 study included a cohort of aMSM and aTGW aged 15-19 years old, and it was conducted in three large Brazilian capital cities. For this analysis, we included adolescents who initiated PrEP. PrEP discontinuation was defined as no possession of PrEP pills for >90 days. Kaplan-Meier curves were used to analyze the probabilities of discontinuation, and survival distributions stratified by covariates were compared using log-rank or Wilcoxon tests. Cox regression models were used to estimate the adjusted hazard ratio (aHR) with a 95% confidence interval (95% CI)., Results: We included 908 adolescents, 829 (91.30%) aMSM and 79 (8.70%) aTGW, most of whom were 18-19 years (80.29%). The incidence rate of discontinuation was 75.6 per 100 person-years. The probability of discontinuation was 52.61% in the first year. The multivariate analysis demonstrated that the aTGW (aHR = 1.63; 95% CI: 1.02-1.64) and adolescents with a medium (aHR = 1.29; 95% CI: 1.02-1.64) or low (aHR = 1.65; 95% CI: 1.29-2.12) perceived risk of HIV infection had an increased risk of discontinuation, whereas the adolescents with a partner living with HIV had a lower risk of discontinuation (aHR = 0.57; 95% CI: 0.35-0.91)., Discussion: Adolescents with a high risk for discontinuation may need additional support that emphasizes the value of PrEP as a tool for HIV prevention because PrEP discontinuation was associated with a disconnect between HIV risk perception and HIV prevention., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: This study aimed at describing the prevalence of symptoms of depression among 15-19 year old adolescent men who have sex with men (aMSM) and transgender women (aTGW), who were recruited in an HIV pre-exposure prophylaxis cohort study in three Brazilian capital cities. The study also examined potential associations, including violence and discrimination, with severe symptoms of depression among aMSM., Methods: This is a cross-sectional study of baseline data among 730 aMSM and 56 aTGW recruited between February 2019 and February 2021. Sociodemographic and behavioral data were collected. The 20-item Center for Epidemiologic Studies Depression scale was used to screen for symptoms of depression. Scores of ≥22 points indicate the presence of severe symptoms associated with major depression. Logistic regression was used to assess independent associations among aMSM, adjusting for sociodemographic variables., Results: Our findings indicate a high prevalence of symptoms of depression (overall prevalence = 58.5% and 69.6%; 21.2% and 25.0% for mild/moderate, and 37.3% and 44.6% for severe) among these aMSM and aTGW, respectively. Psychological violence (aOR = 1.74; 95% CI = 1.12-2.70), sexual violence (aOR = 1.79; 95% CI = 1.07-2.98), and discrimination due to sexual orientation (aOR = 1.71; 95% CI = 1.23-2.38) were independently associated with severe symptoms of depression in aMSM., Discussion: The high prevalence of severe symptoms of depression and its association with psychological and sexual violence and discrimination creates cycles of vulnerability and carries important public health implications. Thus, our findings indicate public policies should consider assessing depression, psychological and sexual violence, as well as discrimination, especially in populations that will be targeted by interventions, such as the use of pre-exposure prophylaxis., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: To explore legal and ethical challenges related to adolescents' participation in human immunodeficiency virus (HIV) research that may affect their best interests., Methods: We analyzed the ethical principles and legal aspects of the participation of 15-17-year-old men who have sex with men and transgender women in the pre-exposure prophylaxis (PrEP) 1519 study, a PrEP demonstration cohort study in three Brazilian cities. The analyses of ethics review committees' (ERCs) evaluations and court decisions followed ethical and human rights principles. An HIV vulnerability score was created, and descriptive statistics and multivariate logistic regression were performed using data from 347 participants., Results: The ERCs evaluated the benefits and risks of research participation, all finding that the benefits outweighed the risks. ERCs deferred responsibility for decisions about waiving parental consent to the judiciary. State courts reached different decisions about waiving parental consent, reflecting variation in recognition of adolescents' evolving capacities and the adolescent as a subject of sexual rights and the primary agent capable of deciding on their health and best interests. The most vulnerable adolescent participants were found in sites where the blanket waiver was in place., Discussion: Judicializing the ethical review process is detrimental to fulfilling the ethical principle of justice and vulnerable adolescents' access to health research. ERCs must be sufficiently independent and autonomous and have the capacity to respect, protect, and help fulfill the rights of participants while ensuring the generation of adequate evidence to inform public health practice., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the adherence, safety, and feasibility of pre-exposure prophylaxis (PrEP) in real-world settings among adolescent men who have sex with men (AMSM) and transgender women (ATGW)., Methods: PrEP1519 is a single-arm, multicentric demonstration cohort study of daily oral PrEP among AMSM and ATGW aged 15 to 19 years in Brazil. Study visits occurred at baseline, weeks 4, 12, and then quarterly until 96 weeks. Descriptive statistics and a mixed logistic model for longitudinal data evaluated the factors associated with high adherence., Results: One thousand sixteen AMSM and ATGW accessed the PrEP1519 clinics. Of those, 998 (98.2%) underwent clinical triage. Forty one were diagnosed with human immunodeficiency viruses (HIV) at baseline (4.0%) and 79 (7.9%) were not eligible for PrEP. Of the 878, 795 (90.5%) enrolled in PrEP, 82 (10.3%) were lost to follow-up, and 713 were included. There was no significant decrease in creatinine clearance; only two participants had grade-III aspartate aminotransferase elevation. Incident HIV infection occurred in eight participants (incidence rate [IR] = 1.64 per 100 person-years [PY]): two in 15-17 years (IR = 2.24 per 100 PY) and six in 18-20 years (IR = 1.51 per 100 PY). PrEP adherence was higher among those with more years of schooling, those reporting no difficulties in PrEP use due to side effects, and who had low HIV risk perception in the past three months., Discussion: PrEP for AMSM and ATGW was safe and feasible in real-world settings. However, a higher IR among young adolescents and a higher adherence among less vulnerable people indicate the need for greater care, considering the specificities of this age group., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

HIV Pre-exposure prophylaxis (PrEP) is an effective prevention tool, but there are still few studies about PrEP uptake among adolescents. We aimed to analyze the PrEP uptake process and factors associated with daily oral PrEP initiation among adolescent men who have sex with men (aMSM) and transgender women (aTGW) in Brazil. Baseline data from the first demonstration PrEP cohort study among aMSM and aTGW 15-19 years old (yo) ongoing in three large Brazilian cities (PrEP1519). After completing informed consent procedures, participants were enrolled in the cohort from February/2019 to February/2021. A socio-behavioral questionnaire was applied. Factors associated with PrEP initiation were assessed using a logistic regression model with adjusted prevalence ratios (aPR) and 95% confidence intervals (95%CI). Among recruited participants, 174 (19,2%) were aged 15-17 yo and 734 (80,8%) 18-19 yo. The rate of PrEP initiation was 78.2% and 77.4% for 15-17 yo and 18-19 yo, respectively. Factors associated with PrEP initiation were: black or mixed race (aPR 2.31; 95%CI: 1.10-4.84) among the younger adolescents 15-17 yo; experienced violence and/or discrimination due to their sexual orientation or gender identity (aPR 1.21; 95%CI: 1.01-1.46); transactional sex (aPR 1.32; 95%CI: 1.04-1.68); and having had between 2 to 5 sexual partners in the previous three months (aPR 1.39; 95%CI: 1.15-1.68) among those 18-19 yo. Unprotected receptive anal intercourse in the previous six months was associated with PrEP initiation in both age groups (aPR 1.98; 95%CI: 1.02-3.85 and aPR 1.45; 95%CI: 1.19-1.76 among 15-17 yo and 18-19 yo, respectively). The biggest challenge to promoting PrEP use for aMSM and aTGW was in the first steps of the PrEP uptake process. Once they were linked to the PrEP clinic, initiation rates were high., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Soares et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Syphilis has reemerged as a serious public health problem in Brazil and worldwide, disproportionately affecting men who have sex with men (MSM) and travestis and transgender women (TrTGW). Studies on sexually transmitted infections (STI) in adolescents from these key populations are relatively scarce. This is a Brazilian multi-center, cross study with prevalence analysis, using as baseline the PrEP1519 cohort of sexually active MSM and TrTGW adolescents, recruited from April 2019 to December 2020. Analyses were made using the dimensions of vulnerability to STI/HIV and logistic regression models were conducted to estimate the odds ratios of the association between the predictor variables and positive treponemal test for syphilis at the moment of entry in the study. In total, 677 participants were analyzed; participants' median age was 18.9 years (IQR: 18.1-19.5); 70.5% (477) self-declared as black; 70.5% (474), as homosexuals/gays; and 48 (7.1%), as trans women or travestis. The baseline prevalence of syphilis was 21.3%. In the final logistic regression model, higher chance of syphilis was associated with: self-reported episode of STI in the last 12 months (OR = 5.92; 95%CI: 3.74-9.37), sex worker (OR = 3.39; 95%CI: 1.32-8.78), and < 11 years of schooling (OR = 1.76; 95%CI: 1.13-2.74). The prevalence of syphilis among MSM/TrTGW adolescents aged from 15 to 19 years was alarming, much higher than the described for the general population within this age range and associated with vulnerability factors. This reinforces the urgent need to strengthen public health programs to debate about race, gender, sexuality, and prevention.

At the end of 2017, Brazil adopted HIV pre-exposure prophylaxis (PrEP) as part of a combination prevention strategy for the most at-risk populations. However, Brazil does not have specific guidelines for PrEP use among adolescents aged < 18 years. Therefore, researchers from different health disciplines conducted PrEP1519, the first PrEP demonstration cohort study, ongoing in three Brazilian cities - Salvador, Belo Horizonte, and São Paulo - among adolescent men who have sex with men and transgender women, aged 15-19 years. This study aims to evaluate the effectiveness of PrEP in real-world settings. Quantitative and qualitative methods were integrated to obtain data on PrEP acceptability, uptake, use, and adherence. Moreover, comprehensive services and friendly environments were implemented in the PrEP1519 clinics. This study aims to describe the collaborative efforts of interdisciplinary practices in the development of the PrEP1519 study. The articulation of researchers from different institutions and areas is challenging; but it also allows for a broader outlook on questions regarding the direction of the research, while enriching the decisions needed to be taken during the interactions and negotiations among the different individuals, including the youth team and participants. Furthermore, it reflects on the communication process between cultures and languages considering the trans-epistemic arena of knowledge production about HIV, sexually transmitted infections, PrEP, and other combination prevention strategies for adolescents.

Based on the incorporation of pre-exposure prophylaxis (PrEP) as an HIV prevention strategy and considering the need to comprehend the use of medication among young people, this article analyzes narratives of gay men and transgender women from Belo Horizonte, Minas Gerais State, Brazil, participating in the PrEP1519 study. This is a qualitative research, based on the interpretative anthropology, developed by 10 in-depth interviews with PrEP users followed-up for at least three months between October and November 2019. The results showed that the drug was seen as the main motivation for participating in the study and as a strategy combined with the use of condoms, whether as additional prevention, or assuming the leading role. The medication revealed signs built by the gender performances and their relation to other medications, especially the experience of trans girls in hormonal therapy. Regarding the socialization of the use of PrEP, the narratives showed that there was no secret between the couples, which did not meant that stigmas on the association with HIV did not exist, mainly in the virtual context. In the family environment, they reported questions about the preventive function of the medication and the voluntary nature of the participation in the study. The youth's narratives revealed plural meanings of the medication and its social use, composing both the boys' and girls' performances. The signs attributed to the medication indicated that in addition to maintenance of health, the medication improves life and sexual freedom.

Using baseline data from the PrEP1519 cohort, in this article we aimed to analyze: (i) the effectiveness of demand creation strategies (DCS) to enroll adolescent men who have sex with men (AMSM) and adolescent transgender women (ATGW) into an HIV combination prevention study in Brazil; (ii) the predictors of DCS for adolescents' enrollment; and (iii) the factors associated with DCS by comparing online and face-to-face strategies for enrollment. The DCS included peer recruitment (i.e., online and face-to-face) and referrals from health services and non-governmental organizations (NGOs). AMSM and ATGW who agreed to participate in the study could opt to enroll in either PrEP (PrEP arm) or to use other prevention methods (non-PrEP arm). Bivariate and multivariate analyses were conducted and logistic regression odds ratios were estimated. The DCS reached 4529 AMSM and ATGW, the majority of which were derived online (73.8%). Of this total, 935 (20.6%) enrolled to participate (76.6% in PrEP arm and 23.4% in non-PrEP arm). The effectiveness of enrolling adolescents into both arms was greater via direct referrals (235/382 and 84/382, respectively) and face-to-face peer recruitment (139/670 and 35/670, respectively) than online (328/3342). We found that a combination under DCS was required for successful enrollment in PrEP, with online strategies majorly tending to enroll adolescents of a higher socioeconomic status. Our findings reinforce the need for DCS that actively reaches out to all adolescents at the greatest risk for HIV infection, irrespective of their socioeconomic status., (© 2022. The Author(s).)

Standardized treatment regimens for chronic hepatitis B (CHB) are crucial in suppressing viral replication, disease progression and the development of complications. However, information on routine compliance with such therapeutic recommendations in medical practice is rare. Aim: To evaluate the application of Brazilian therapeutic guidelines for CHB within the scope of the Unified Health System in Minas Gerais state. Four key recommendations from the national guidelines were compared with data from treated patients: (i) eligibility to start treatment; (ii) type of treatment applied; (iii) rescue antiviral therapy; and (iv) monitoring of virological response. Most physicians (69.8%) declared to adopt these guidelines, while 10 of them were unaware. However, according to the criteria established by the guidelines, only 39.5% of treated patients should have been considered "truly" eligible to start treatment and only 67.6% of these underwent the recommended pharmacological treatment. The virological response was laboratory monitored in just over a third of patients. Rescue therapy was adequately supplanted in 41.2% of patients previously treated with lamivudine. There was low compliance with national guidelines by public service physicians in Brazil, highlighting the need to raise awareness of the importance of its adherence to expand the control of CHB. Thus, increasing the adherence of health professionals to this tool is a current challenge for health institutions and managers.

Background: Chronic hepatitis B (CHB) affects 257 million people worldwide. However, the proportion of patients eligible for treatment in the public health system has not been established. This study describes the clinical and laboratory profiles of untreated CHB patients and estimates the eligibility rate for antiviral therapy in accordance with the Brazilian Clinical Protocol and Therapeutic Guidelines., Methods: Records of 670 CHB patients were collected from May 2012 to September 2013 in Minas Gerais. Data from each patient were analyzed by hepatitis B virus (HBV) management., Results: 461 CHB patients were treatment-naive. Of these, 23 were HBeAg-positive, 352 were HBeAg-negative, and 14 were clinically diagnosed with cirrhosis. Periodic monitoring was performed in only three patients. However, 9.3% of untreated patients met the eligibility criteria for HBV treatment., Conclusions: Few CHB patients were active carriers and eligible candidates for antiviral therapy. This study revealed inadequate pre-treatment conduct in the Brazilian public health system, emphasizing the need for regular laboratory follow-up for patients initially not eligible for treatment. Such information may indirectly subsidize the planning and improvement of actions and services related to optimal HBV management in the public sphere.

While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper: [All members of the WHO Access to COVID-19 Tools Accelerator Ethics and Governance Working Group declared their interests according to WHO standard procedures. None of the interests declared were found to be significant.]., (Copyright © 2022. Published by Elsevier Ltd.)

The Access to COVID-19 Tools Accelerator (ACT-A) is a multistakeholder initiative quickly constructed in the early months of the COVID-19 pandemic to respond to a catastrophic breakdown in global cooperation. ACT-A is now the largest international effort to achieve equitable access to COVID-19 health technologies, and its governance is a matter of broad public importance. We traced the evolution of ACT-A's governance through publicly available documents and analysed it against three principles embedded in the founding mission statement of ACT-A: participation, transparency, and accountability. We found three challenges to realising these principles. First, the roles of the various organisations in ACT-A decision making are unclear, obscuring who might be accountable to whom and for what. Second, the absence of a clearly defined decision making body; ACT-A instead has multiple centres of legally binding decision making and uneven arrangements for information transparency, inhibiting meaningful participation. Third, the nearly indiscernible role of governments in ACT-A, raising key questions about political legitimacy and channels for public accountability. With global public health and billions in public funding at stake, short-term improvements to governance arrangements can and should now be made. Efforts to strengthen pandemic preparedness for the future require attention to ethical, legitimate arrangements for governance., Competing Interests: Declaration of interests All authors are members of a WHO-led ACT-A Ethics and Governance Working Group set up to advise WHO on ethics and governance issues related to its role as a partner in the ACT-A. SM reports grants paid to her institution from the WHO Regional Office for Europe, UNICEF–UNDP–WB–WHO Special Program for Research and Training in Tropical Disease, and the Bill and Melinda Gates Foundation; reports paid membership with the Unitaid Proposal Review Committee; reports unpaid cochairmanship of the WHO Fair Pricing Forum; and is an unpaid member of the WHO ACT-A Governance and Ethics Working Group. JA reports paid WHO consultancy for work with the ACT-A Ethics and Governance Working Group, a paid consultancy with Wellcome, and unpaid board membership with Médecins sans Frontières Switzerland. EE declares payments, honoraria, or travel fees from Greenwall Foundation, RAND Corporation, Medical Home Network, Healthcare Financial Management Association, Ecumenical Center–UT Health, American Academy of Optometry, Associação Nacional de Hospitais Privados, National Alliance of Healthcare Purchaser Coalitions, Optum Labs, Massachusetts Association of Health Plans, District of Columbia Hospital Association, Washington University, Goldman Sachs, Brown University, The Atlantic, McKay Lab, American Society for Surgery of the Hand, Association of American Medical Colleges, American Essential Hospitals, Johns Hopkins University, National Resident Matching Program, Shore Memorial Health System, Tulane University, Oregon Health & Science University, United Health Group, Blue Cross Blue Shield, Center for Global Development, Informa, and Galien Foundation; and declares a leadership or fiduciary role in VillageMD, Oncology Analytics, Embedded Health Care, Oak HC/FT, and COVID-19 Recovery Partners. RF declares participation as a member of the WHO Strategic Advisory Group of Experts and the Immunization Working Group on COVID-19 Vaccines. GOS reports individual funding from WHO. SK is a member of the WHO Strategic Advisory Group of Experts on Immunization and the WHO SAGE Working Group on COVID-19 vaccines. JAS declares participating as a member of the WHO Technical Advisory Group on COVID-19 vaccines. MJS reports grants paid to their institution from the Canadian Institutes of Health Research (grant number #C150-2019-11), and travel fees to attend WHO and Global Research Collaboration for Infectious Disease Preparedness Global Research and Innovation Forum. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

This systematic review aims to estimate the prevalence of sarcopenia in people living with HIV (PLHIV) and to assess whether there is a difference between the muscle mass of PLHIV and people living without HIV. A systematic review of randomized controlled trials, cohort studies, cross-sectional and case-control studies was carried out. PLHIV over 18 years of age and that had their muscle mass evaluated by dual-energy X-ray absorptiometry were included. Overall, 4,376 studies were found, of which 118 had their full texts evaluated. A total of 5,532 people living with HIV and 2,986 people living without HIV were identified in 41 studies. The frequency of sarcopenia defined by low muscle mass (Baumgartner's operational definition) alone was 30.3% (95%CI 24.3%, 37.1%) and the frequency of sarcopenia defined by low muscle mass with low muscle strength (EWGSOP definition) was 4.5% (95%CI 1.3%, 13.9%), p-value = 0.0006. The standardized mean differences of muscle mass between PLHIV and controls was -0.211 units of standard deviation (95%CI -0.419, -0.003). In the meta-regression analysis muscle mass mean difference was associated with BMI, CD4, percentage of subjects on ART, and study design. PLHIV have a lower muscle mass when compared to people living without HIV. This difference appears to be attenuated by higher BMI, CD4 levels, and the percentage of subjects using ART. Furthermore, the frequencies of sarcopenia assessed by the operational definition of Baumgartner and the EWGSOP are not comparable and cannot be interchanged in PLHIV., (Copyright © 2021 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.)

In the space of four decades, Brazil has faced two serious pandemics: human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) and Coronavirus disease 2019 (COVID-19). The country's response to HIV/AIDS was coordinated by several stakeholders and recognised the importance of scientific evidence in guiding decision-making, and a network offering monitoring and antiretroviral treatment was provided through coordinated efforts by the country's universal health system. Conversely, the lack of a centrally coordinated strategy and misalignment between government ministries regarding the COVID-19 pandemic response, together with the denial of scientific evidence, promotion of ineffective treatments and insufficient vaccination efforts, have all led to the uncontrolled spread of infection, the near-total collapse of the health system and excess deaths.

Competing Interests: Competing interests: None declared.

The world is currently facing another severe pandemic, Covid-19, just four decades after the start of AIDS, and the still increasing incidence of HIV infection continues to be one of the greatest global health challenges. The way the latter was confronted is of fundamental importance for a serious discussion on global health, ethics and human rights, and this experience could and can still be applied to Covid-19. The Covid-19 pandemic has specific characteristics and these will be discussed, in relation to vaccine research and especially to the global right to equal access to products proven to be safe and effective. The article focusses primarily on issues related to Covid-19 vaccines, especially the appropriate use and limits on placebo, the right to post-trial access to placebo arm participants, and the use of an active control for subsequent Phase-3 trials after the approval of other safe and efficacious vaccines. Most importantly, it will emphasise that access to Covid-19 vaccines is a human right, which presupposes the establishment of appropriate ethical standards to ensure universal, equal, and affordable access to healthcare and to vaccines for all, and the imperative need for suspension of patents for products developed for Covid-19. It will consider the role of social determinants that contribute to the severity of Covid-19 and that must be addressed to effectively curb the current syndemic.

Background: In February 2020, international controversy arose about the ethical acceptability of the WHO Malaria Vaccine Implementation Program (MVIP). Whereas some have argued that this program must be seen as research that is not in line with international ethical standards, notably regarding informed consent and local ethical review, some WHO representatives consider the MVIP as a public health implementation program that need not adhere to these standards., Methods: We performed a case analysis in light of the 2016 CIOMS International Ethical Guidelines for Health-related Research involving Humans., Findings: We argue that the MVIP has a substantial research component, and that it is prudent to therefore apply ethical norms for research involving humans, such as the CIOMS guidelines. Accordingly, we agree that the ethical requirements of informed consent and independent ethical review have not been met. In addition, we are concerned that the study might not meet CIOMS's social value requirement., Recommendations: We urge WHO to release more details about the process that led to the MVIP program and make the MVIP protocol publicly available. The full protocol should be assessed by the relevant ethics committees, new and already enrolled parents should be informed about the uncertainties under investigation and given a real opportunity to consent or refuse (continued) participation, communities should be engaged, and aspects of MVIP that require alteration in light of ethical review should be altered, if possible. Furthermore, in order to improve good ethical practices, it is necessary to engage in international debate regarding the integration of research and public health programs. Procedurally, vaccine implementation programs that combine both prevention and research should involve the wider international ethics community and ensure participation of the target populations in setting the proper conditions for launching such programs., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: RG is a member of the independent Bioethics Advisory Committee to Sanofi. The other authors declare no competing interests., (Published by Elsevier Ltd.)

Detection of the SARS-CoV-2 virus in stools and sewage has recently been reported, raising the hypothesis of faecal-oral transmission. If confirmed, this could have far-reaching consequences for public health and for pandemic control strategies. In this paper, we argue that a comprehensive and more nuanced analysis is required to test this hypothesis, taking into consideration both environmental dynamics and the persistence of viral infectivity. First, we examine the evidence regarding the presence of the virus in stools and sewage. Then we discuss the current framework of disease transmission through water and excreta and how the transmission of a respiratory disease fits into it. Against this background, we propose a framework to test the faecal-oral hypothesis, unpacking the different environmental routes from faeces to the mouth of a susceptible person. This framework should not be seen as a confirmation of the hypothesis but rather as an expanded view of its complexities, which could help shaping an agenda for research into a number of unanswered questions. Finally, the paper briefly discusses practical implications, based on current knowledge, for containment of the pandemic., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier B.V. All rights reserved.)

HIV infection may be considered a chronic condition for people living with HIV with access to antiretrovirals and this has effectively increased survival. Moreover, this has also facilitated the emergence of other comorbidities increasing the risk for drug-drug interactions and polypharmacy. The profile of these interactions as well as their consequences for people living with HIV are still not completely elucidated. The objectives of this study were to describe the profile of these interactions, their prevalence and their classification according to the potential for significant or non-significant drug-drug interactions. From June 2015 to July 2016, people living with HIV on follow-up at an Infectious Diseases Referral Center in Belo Horizonte, Brazil have been investigated for the presence of drug-drug interactions. A total of 304 patients were included and the majority (75%) had less than 50 years of age, male (66.4%), and 37.8% self-defined as brown skinned. Approximately 24% were on five or more medications and half of them presented with drug-drug interactions. Patients older than 50 years had a higher frequency of antiretrovirals drug-drug interactions with other drugs compared to younger patients (p=0.002). No relationship was found between the number of drug-drug interactions and the effectiveness of antiretrovirals. As expected, the higher the number of non-HIV medications used (OR=1.129; 95%CI 1.004-1.209; p=0.04) was associated with an increase in drug-drug interactions. The high prevalence of drug-drug interactions found and the data collected should be useful to establish measures of quaternary prevention and to increase the medication security for people living with HIV., (Copyright © 2020 Sociedade Brasileira de Infectologia. Published by Elsevier España, S.L.U. All rights reserved.)

Frequent contact with hazardous materials makes waste collection a potentially unhealthy activity. This article assesses the perception of waste management workers regarding work-related accidents in domestic and health service contexts in Brazil. Six focus groups were performed between June 2014 and August 2015. The aims of this study were to apprehend different aspects of the participants' health, workers' experiences of work-related accidents and perception of risks. Cuts and puncture injuries were reported most frequently in the line of work and were often considered as irrelevant. Immunization against hepatitis B was not common among all workers, which increases the risk of infection for those individuals. Finally, it is considered urgent to consolidate an inclusive space in which workers can have discussions on their health.

The lipid accumulation product (LAP) index is an emerging cardiovascular risk marker. We aimed to assess the accuracy of this index as a marker of cardiovascular risk in HIV-infected patients. A cross-sectional study of 133 HIV-infected patients on antiretroviral drugs and 20 non-infected controls was conducted at the outpatient clinic of a referral center of infectious and parasitic diseases. Evaluations included LAP index, homeostasis model assessment (HOMA) index, anthropometric measurements, blood pressure, glucose tolerance test, and cholesterol and triglyceride levels. Body mass index (BMI) was similar in both groups; however, waist circumference was greater in the HIV-infected patients. Triglyceride levels were significantly higher (p<0.001) and HDL cholesterol levels were lower in HIV-infected patients (p<0.001). Plasma glucose (p=0.01) and insulin (p=0.005) levels two hours after a glucose load, HOMA-IR index (p<0.001) and LAP index (p<0.001) were higher in the HIV-infected patients. A positive and significant correlation was found between HOMA-IR index and LAP (r=0.615; p<0.01), BMI (r=0.334; p<0.01) and waist circumference (r=0.452; p<0.01) in the HIV-infected patients. In male HIV-infected patients and controls, ROC curve analyses revealed that the best cut-off value of LAP to define the presence of insulin resistance was 64.8 (sensitivity 86%, specificity 77% and area under the curve 0.824). These results confirm that insulin resistance is more common in HIV-patients on antiretroviral drugs than in HIV-negative controls. A positive and significant correlation was found between the LAP index and the HOMA index, with LAP≥64.8 constituting an additional risk factor for cardiovascular disease in male HIV patients., (Copyright © 2018. Published by Elsevier Editora Ltda.)

This meta-analysis, which is based on a previously published systematic review, aims to contribute to the scientific discussion on hepatitis B virus (HBV) infection in workers who are exposed to domestic and healthcare wastes. Publications were sought which had been made available on the data used by December 2013 and updated to December 2016. The quality of the included studies was assessed according to the guidelines of Loney et al. for the critical appraisal of studies on the prevalence or incidence of a health problem. To verify the presence of heterogeneity between the papers, we used the Chi-squared test based on a Q statistic. A funnel plot was used to test for publication bias. All included studies had across-sectional study design. The association between exposure to waste and positive serology for the HBV surface antigen (HBsAg) showed a significant association [odds ratio (OR) 1.89, 95% confidence interval (CI) 1.27-2.86; p = 0.0019]. The prevalence rates of HBsAg and anti-HBc seropositivity was 0.04 (95% CI 0.03-0.05) and 0.21 (95% CI 0.14-0.28), respectively (p <0.0001). We found no evidence of publication bias. The results of this meta-analysis indicate a statistically significant association between exposure to solid waste, whether healthcare or domestic, and positive HBV infection markers. Therefore, the working conditions of waste collectors should be analyzed more closely. Immunization against HBV is recommended as the chief preventive measure for all solid waste workers.

As more urban solid waste is generated, managing it becomes ever more challenging and the potential impacts on the environment and human health also become greater. Handling waste - including collection, treatment and final disposal - entails risks of work accidents. This article assesses the perception of waste management workers regarding work-related accidents in domestic and health service contexts in Belo Horizonte, Brazil. These perceptions are compared with national data from the Ministry of Social Security on accidents involving workers in solid waste management. A high proportion of accidents involves cuts and puncture injuries; 53.9% among workers exposed to domestic waste and 75% among those exposed to health service waste. Muscular lesions and fractures accounted for 25.7% and 12.5% of accidents, respectively. Data from the Ministry of Social Security diverge from the local survey results, presumably owing to under-reporting, which is frequent in this sector. Greater commitment is needed from managers and supervisory entities to ensure that effective measures are taken to protect workers' health and quality of life. Moreover, workers should defend their right to demand an accurate registry of accidents to complement monitoring performed by health professionals trained in risk identification. This would contribute to the improved recovery of injured workers and would require managers in waste management to prepare effective preventive action.

Infection with the hepatitis B and C viruses may occur through contact with infected body fluids, including injury with infected sharps. Collectors of domestic or healthcare wastes are potentially exposed to these infections. The aim of this article is to investigate the risk factors associated with the prevalence of hepatitis B and C viruses (HBV and HCV) infection among domestic and healthcare waste workers in Belo Horizonte, Brazil. A cross-sectional study of hepatitis B and C infection was conducted from November 2014 to January 2015, through blood sample collection and interviews about socio-demographic factors with 61 workers exposed to healthcare waste ('exposed') and 461 exposed only to domestic wastes ('unexposed'). The prevalence of antibodies to HCV (Anti-HCV) antibodies was 3.3% in 'exposed' workers and 0.9% in 'unexposed', and of antibody to hepatitis B core antigen (Anti-HBc) was 9.8% and 5.6% in 'exposed' and 'unexposed' workers, respectively. Only 207 (44.9%) of those exposed to domestic waste and 45 (73.8%) of those handling healthcare waste were effectively immunised against hepatitis B virus (HBV). Exposures to domestic waste and to healthcare wastes were associated with similar risks of infection with HBV. The risk of hepatitis C virus (HCV) infection was marginally higher among healthcare waste workers compared with domestic waste workers, probably because of needlestick accidents owing to deficient sharps management systems. Immunisation against hepatitis B and screening tests to ensure the success of vaccination should be a condition for recruitment for both groups of waste workers., (© The Author(s) 2016.)

The Brazilian response to AIDS started in 1985, with government, civil society and academic community coming together with common goals. This was strengthened with the establishment in 1988 of an universal public health system (SUS), pivotal to a comprehensive and human rights-based national STD/AIDS programme, aiming at achieving equality, integrality, inclusion and fighting prejudice and discrimination. In 1996 Brazil was a pioneer in providing treatment free-of-charge to all PLHA. This article depicts achievements and setbacks that occurred in these 30 years and the perspectives for controlling and eventually eliminating HIV/AIDS. It is fair to affirm that it is possible to defeat prejudice and discrimination and to confront the unacceptable levels of disparity, fertile ground for dissemination of HIV/AIDS and other epidemics. Tools to eliminate transmission, to adequately treat PLHA, to protect their rights, to eliminate discrimination and to end AIDS are already at hand. However, the needed changes for this to happen involve expansion of access to education, including sexual education and to quality public health care to all. It is also necessary to constant confront conservatism and to combat violence and discrimination. Brazil's track record in the confrontation of AIDS is an invaluable asset to achieve these goals.

Human contact with solid waste poses biological, chemical, and physical health risks for workers involved in waste collection, transportation, and storage. The potential risk to human health resulting from contact with health services waste or household waste still sparks considerable controversy. The aim of this study was to identify the context of scientific discussions on risk/infection from the hepatitis B and C viruses in workers that collect solid waste from health services or households. The search covered publications up to 2013 in Brazilian and international databases, and 11 articles were selected through a literature review. Of these, six conclude that there is an increased risk of infection in workers that collect household waste when compared to those unexposed to waste, three point to greater risk for workers that collect health services waste as compared to those that collect ordinary waste, and the other two found no difference between exposed and unexposed individuals.

Background: There has recently been an increase in HIV infection rates among men who have sex with men (MSM). This study aimed at investigating risk factors associated with incident HIV infection in a MSM cohort-Project Horizonte, Belo Horizonte, Minas Gerais, Brazil., Methodology: This is a nested case-control study in an ongoing open cohort of homosexual and bisexual men, carried out in 1994-2010, during which 1,085 volunteers were enrolled. Each HIV seroconverted volunteer (case) was compared with three randomly selected HIV negative controls, matched by admission date and age (±3 years). During follow-up, 93 volunteers seroconverted and were compared with 279 controls., Principal Findings: The risk factors associated with HIV seroconversion were: contact with partner's blood during sexual relations (OR 3.7; 95% CI 1.2-11.6), attendance at gay saunas in search for sexual partners (OR 2.6; 95% CI 1.3-5.4), occasional intake of alcohol when flirting and engaging in sexual activity (OR 2.5; 95% CI 1.3-5.1), inconsistent use of condoms in receptive anal sex (OR 2.4; 95% CI 1.1-5.4), little interest to look up information about AIDS (OR 2.6; 95% CI 1.0-6.7) particularly in newspapers (OR 3.4; 95% CI 1.4-8.1)., Conclusions: This study shows that MSM are still engaging in risk behavior, such as unprotected anal intercourse, despite taking part in a cohort study on various preventive measures. New preventive strategies in touch with the epidemic's development and the specificities of this particular population are needed.

Understanding the social conditions and immunological characteristics that allow some human immunodeficiency virus (HIV)-exposed patients to remain uninfected represents an on-going challenge. In this study, the socio-demographic and sexual behaviour characteristics and immune activation profiles of uninfected individuals exposed to HIV-infected partners were investigated. A confidential and detailed questionnaire was administered and venous blood was tested using HIV-1/enzyme immunoassays, plasma HIV-1 RNA levels/bDNA and immunophenotyping/flow cytometry to determine the frequencies of CD4 and CD8 T cells expressing activation markers. The data analysis showed significant differences (p < 0.05) for immune parameters in individuals who were uninfected, albeit exposed to HIV-infected partners, compared with unexposed individuals. In particular, the exposed, uninfected individuals had a higher frequency (median, minimum-maximum) of CD4⁺HLA-DR⁺ (4.2, 1.8-6.1), CD8⁺HLA-DR⁺ (4.6, 0.9-13.7), CD4⁺CD45RO⁺ (27.5, 14.2-46.6), CD4⁺CD45RO⁺CD62L⁺ (46.7, 33.9-67.1), CD8⁺CD45RA⁺HLA-DR⁺ (12.1, 3.4-35.8) and CD8⁺CD45RO⁺HLA-DR⁺ (9.0, 3.2-14.8) cells, a decreased percentage of CD8⁺CD28⁺ cells (11.7, 4.5-24.0) and a lower cell-surface expression of Fcγ-R/CD16 on monocytes (56.5, 22.0-130.0). The plasma HIV-1 RNA levels demonstrated detectable RNA virus loads in 57% of the HIV-1⁺ female partners. These findings demonstrate an activation profile in both CD4 and CD8 peripheral T cells from HIV-1 exposed seronegative individuals of serodiscordant couples from a referral centre in Belo Horizonte, state of Minas Gerais.

The effectiveness of switching from enfuvirtide to raltegravir in HIV-1-infected patients on a suppressive antiretroviral regimen has been poorly studied in the clinical practice of developing countries. We conducted a multicenter retrospective cohort study in HIV-1-infected, multidrug-experienced adults (≥18 years old) with plasma HIV-1-RNA <400 copies/ml for at least 4 months on an enfuvirtide-containing therapy between 2005 and 2010, in whom the attending physician switched from enfuvirtide to raltegravir. Effectiveness endpoints were measured at week 48 after switch. Analyses were conducted on an intent-to-treat basis and two strategies for handling missing outcome data were used (hereafter, strategies 1 and 2). Overall, 87 patients were eligible for analysis. At baseline, the median CD4(+) T cell count was 400 cells/μl and 91.9% of patients had <50 HIV-1-RNA copies/ml. At week 48, the proportions of patients with plasma HIV-1-RNA <50 and <400 copies/ml were, respectively, 86.2% (95% CI=77.1; 92.7%) and 88.5% (95% CI=79.9; 94.3%) (strategies 1 and 2) and 89.7% (95% CI=81.3; 95.2%) and 90.8% (95% CI=82.7; 95.9%) (strategies 1 and 2). This was a -10.3% (95% CI=-2.8; -17.9%) and -9.2% (95% CI=-2; -16.4%) difference from baseline in the proportion of patients with plasma HIV-1-RNA <400 copies/ml. The median increase in CD4(+) T cell counts was 41 and 64 cells/μl (p<0.001) (strategies 1 and 2). No patient withdrew raltegravir or developed opportunistic infections, but one was diagnosed with HIV-related dementia. In conclusion, switching from enfuvirtide to raltegravir in patients on a virologically suppressive regimen is an effective strategy even in a Brazilian clinical setting.

Background: Darunavir has been proven efficacious for antiretroviral-experienced HIV-1-infected patients in randomized trials. However, effectiveness of darunavir-based salvage therapy is understudied in routine care in Brazil., Methods: Retrospective cohort study of HIV-1-infected patients from three public referral centers in Belo Horizonte, who received a darunavir-based therapy between 2008 and 2010, after virologic failure. Primary endpoint was the proportion of patients with viral load<50 copies/mL at week 48. Change in CD4 cell count was also evaluated. Outcome measures were analyzed on an intent-to-treat basis applied to observational studies. Sensitivity analysis was conducted to evaluate the impact of missing data at week 48. Predictors of virologic failure were examined using rare-event, finite sample, bias-corrected logistic regression., Results: Among 108 patients, the median age was 44.2 years, and 72.2% were male. They had long-standing HIV-1 infection (median 11.6 years) and advanced disease (76.9% had an AIDS-defining event). All patients had previously received protease inhibitors and nucleoside reverse transcriptase inhibitors, 75% nonnucleoside reverse transcriptase inhibitors, and 4.6% enfuvirtide. The median length of protease inhibitor use was 8.9 years, and 90.8% of patients had prior exposure to unboosted protease inhibitor. Genotypic resistance profile showed a median of three primary protease inhibitor mutations and 10.2% had three or more darunavir resistance-associated mutations. Virologic success at week 48 was achieved by 78.7% (95% CI=69.7-86%) of patients and mean CD4 cell count increase from baseline was 131.5 cells/μL (95% CI=103.4-159.6). In multiple logistic regression analysis, higher baseline viral load (RR=1.04 per 10,000 copies/mL increase; 95% CI=1.01-1.09) and higher number of darunavir resistance-associated mutations (RR=1.23 per each; 95% CI=0.95-1.48) were independently associated with virologic failure., Conclusion: Virologic suppression is a realistic endpoint for most treatment-experienced patients who begin a darunavir-based therapy outside the controlled conditions of a randomized trial, at routine care settings., (Copyright © 2013 Elsevier Editora Ltda. All rights reserved.)

Introduction: Published data addressing the effectiveness of darunavir-ritonavir (DRV/r)-based therapy for multiexperienced patients in developing countries are scarce. This study evaluated the 48-week virologic and immunologic effectiveness of salvage therapy based on DRV/r for the treatment of multidrug-experienced HIV-1-infected adults in Brazil., Materials and Methods: A multicenter retrospective cohort study was carried out with multidrug-experienced adults who were on a failing antiretroviral therapy and started a DRV/r-based salvage therapy between 2008 and 2010. The primary effectiveness end point was the proportion of patients with virologic success (plasma HIV-1 RNA <50 copies/mL at week 48)., Results: At 48 weeks, 73% of the patients had HIV-RNA <50 copies/mL and a mean increase of 108 CD4 cells/mm(3). Higher baseline viral load, lower baseline CD4 count, younger age, and 3 or more DRV/r-associated resistance mutations were significantly predictive of virologic failure. Concomitant use of raltegravir was strongly associated with virologic success., Conclusion: The use of DRV/r-based regimens for salvage therapy is an effective strategy in the clinical care setting of a developing country.

Introduction: This study evaluated the efficacy of retreatment of pulmonary tuberculosis (TB) with regard to treatment outcomes and antimicrobial susceptibility testing (ST) profiles., Methods: This retrospective cohort study analyzed 144 patients treated at a referral hospital in Brazil. All of them had undergone prior treatment, were smear-positive for TB and received a standardized retreatment regimen. Fisher’s 2-tailed exact test and the χ² test were used; RRs and 95% CIs were calculated using univariate and multivariate binary logistic regression., Results: The patients were cured in 84 (58.3%) cases. Failure was associated with relapsed treatment and abandonment (n=34). Culture tests were obtained for 103 (71.5%) cases; 70 (48.6%) had positive results. ST results were available for 67 (46.5%) cases; the prevalence of acquired resistance was 53.7%. There were no significant differences between those who achieved or not therapeutic success (p=0.988), despite being sensitive or resistant to 1 or more drugs. Rifampicin resistance was independently associated with therapeutic failure (OR: 4.4, 95% CI:1.12-17.37, p=0.034). For those cases in which cultures were unavailable, a 2nd model without this information was built. In this, return after abandonment was significantly associated with retreatment failure (OR: 3.59, 95% CI:1.17-11.06, p=0.026)., Conclusions: In this cohort, the general resistance profile appeared to have no influence on treatment outcome, except in cases of rifampicin resistance. The form of reentry was another independent predictor of failure. The use of bacterial culture identification and ST in TB management must be re-evaluated. The recommendations for different susceptibility profiles must also be improved.

The presence of transmitted human immunodeficiency virus (HIV)-1 drug-resistance (TDR) at the time of antiretroviral therapy initiation is associated with failure to achieve viral load (VL) suppression. Here, we report TDR surveillance in a specific population of men who have sex with men (MSM) in Belo Horizonte, Brazil. In this study, the rate of TDR was evaluated in 64 HIV-infected individuals from a cohort of MSM between 1996-June 2012. Fifty-four percent had a documented recent HIV infection, with a seroconversion time of less than 12 months. The median CD4+T lymphocyte count and VL were 531 cells/mm3 and 17,746 copies/mL, respectively. Considering the surveillance drug resistance mutation criteria, nine (14.1%) patients presented TDR, of which three (4.7%), five (7.8%) and four (6.2%) had protease inhibitors, resistant against nucleos(t)ide transcriptase inhibitors and against non-nucleoside reverse-transcriptase inhibitors mutations, respectively. Two of the patients had multi-drug-resistant HIV-1. The most prevalent viral subtype was B (44, 68.8%), followed by subtype F (11, 17.2%). This study shows that TDR may vary according to the population studied and it may be higher in clusters of MSM.

Objectives: The aim of this study was to learn more about people diagnosed with acquired immunodeficiency syndrome (AIDS) at age 60 and above in Brazil, and to compare them with people diagnosed at a younger age., Methods: This study was based on the analysis of secondary data from the Brazilian AIDS Program. The study population consisted of people diagnosed with AIDS at age 60 and above. The comparison group was comprised of a 20% random sample of people diagnosed at age 18 to 59, frequency-matched by year of diagnosis., Results: 544,846 cases of AIDS were reported in Brazil from 1980 until June 2009. Over 90% of cases were diagnosed between 18 and 59 years of age, and 13,657 (2.5%) at age 60 and above. The first case of AIDS among the elderly was reported in 1984. The comparison group consisted of 101,528 patients. Gender proportion was similar for both groups, and the proportion of people identified with AIDS after death in the Brazilian Mortality Information System (SIM) was 4% higher among the elderly. Both groups were also similar regarding the region of residence; a markedly higher proportion lived in Southeastern Brazil. Older people were more likely to have lower education and to have contracted AIDS by heterosexual contact, and less likely to be intravenous drug users. Male to female ratio among those diagnosed with AIDS at or above age 60 decreased over the years, in the same way as observed for the whole cohort. Mortality was higher among men in both groups. CD4 category (taken closest to the date of AIDS diagnosis) was very similar in both groups., Conclusion: The characteristics of the epidemic among the elderly show similarities to the younger group considering gender distribution and CD4 category, but differ regarding educational level and exposure category. Also, the elderly were more likely not to have their AIDS condition promptly diagnosed., (Copyright © 2012 Elsevier Editora Ltda. All rights reserved.)

This study aims at estimating the prevalence of Leishmania infection among HIV-infected patients through the use of non-invasive tests. The study was conducted in three Infectious Diseases Services in two large Brazilian cities, both endemic areas for visceral leishmaniasis. Three hundred and eighty-one asymptomatic patients were enrolled whose ages ranged from 19 to 58 years old; 63.5% were men; mean TCD4+ was 380 cells/μl; and mean viral load was 153800 copies/ml. All individuals were tested for Leishmania infection through: ELISA using crude Leishmania infantum (ELISA), ELISA using the recombinant K39 antigen (rK39), indirect fluorescent antibody test (IFAT) and PCR targeted to kDNA region. The tests' positivity were: 10.8% (ELISA), 3.9% (IFAT), 0.8% (rK39), 6.3% PCR and 20.2% (overall, at least one positive test), with no statistical correlation between positivity and clinical and laboratorial variables. Concordance among tests was low (Kappa <0.20). Prevalence of Leishmania asymptomatic infection was high in this population, reinforcing the need for attention in the evaluation of HIV patients from endemic areas. New efforts are needed to develop more specific and sensitive tests to diagnose Leishmania asymptomatic infection. Highly active antiretroviral therapy (HAART) seems to have a protective role against disease progression in co-infected individuals., (Copyright © 2012 Royal Society of Tropical Medicine and Hygiene. Published by Elsevier Ltd. All rights reserved.)

Background: Human immunodeficiency virus type 1 (HIV-1) subtype B predominates in Brazil, but in the southern region subtype C is the most frequent, followed by subtypes B, F1 and recombinant forms. In southern Brazil, these subtypes co-circulate in subjects with homogeneous demographic and clinical features, enabling a better understanding of the role of HIV-1 subtypes on the characteristics of infection., Objectives: To evaluate the prevalence of different HIV-1 subtypes in subjects with recent diagnosis for HIV infection in the extreme south of Brazil, and to study their association with demographic, behavioral, clinical and laboratorial characteristics., Study Design: We have determined the genetic sequence of viral protease and reverse transcriptase (polymerase, connection and RNase H domains) isolated from studied subjects. Viral subtype was inferred by comparison with reference HIV sequences, and recombination was determined with Simplot analysis. The association of HIV-1 subtypes with studied characteristics was evaluated by chi-square, Fisher's exact, Student's t and Kruskal-Wallis tests., Results: Two hundred and forty-five HIV isolates were molecularly characterized, and the association with variables was studied for 233 (95.1%) patients. Of those, 46.8% followed AIDS defining criteria. HIV-1C was responsible for 56.3% of infections, and was associated with heterosexual transmission (p=0.001) and with higher CD4(+) T-cell counts (p=0.02)., Conclusions: The molecular epidemiology of HIV-1 in the southernmost Brazil is currently steady with predominance of HIV-1C. This is the first study showing a robust association of the infection by this subtype and heterosexual transmission in the state of Rio Grande do Sul, Brazil., (Copyright © 2012 Elsevier B.V. All rights reserved.)

Introduction: In Brazil there is a large area of overlap of visceral leishmaniasis (VL) and HIV infection, which favored a increased incidence of coinfection Leishmania/HIV., Methods: This study evaluated 65 consecutive patients with VL and their clinical response to treatment in two health care settings in Belo Horizonte, Brazil., Results: At baseline, the clinical picture was similar between both groups, although diarrhea and peripheral lymphadenomegaly were more frequent in HIV-infected subjects. HIV-positive patients had lower median blood lymphocyte counts (686/mm³ versus 948/mm³p = 0.004) and lower values of alanine aminotransferase (ALT) (48IU/L versus 75.6IU/L p = 0.016) than HIV-negative patients. HIV-positive status (hazard ratio = 0.423, p = 0.023) and anemia (HR = 0.205, p = 0.002) were independent negative predictors of complete clinical response following antileishmanial treatment initiation., Conclusions: This study reinforces that all patients with VL should be tested for HIV infection, regardless of their clinical picture. This practice would allow early recognition of coinfection with initiation of antiretroviral therapy and, possibly, reduction in treatment failure.

The purpose of this study is to estimate the survival probability of patients following their first admission for the treatment of AIDS to an infectious disease reference hospital in Belo Horizonte, Brazil, during 2005. Study subjects were monitored during a 12-month period to identify factors associated with survival probability. Late diagnosis was recorded among many of the 250 study subjects: almost half (44.8%) were diagnosed less than 30 days prior to or during their hospitalization. A high mortality rate was also detected: 39.6% of the subjects died during the 12 months of monitoring. The cumulative survival probability of the cohort group was estimated at 68.0% after 3 months and at 61.2% after 12 months. However, certain patient subgroups analyzed had even lower cumulative survival probabilities after 12 months of monitoring: if diagnosed during hospitalization, it was estimated at only 48.0% and those with no record of antiretroviral treatment had a 48.5% cumulative survival probability. Patients with severe anemia had the lowest survival probability, similar among the two lymphocyte count groups (<1000 mm(3) and ≥1000 mm(3)), the former with a 45.5% survival probability and the latter with a 46.7% one. The proportional death risk was 2.5-fold higher for men residing in other area than the capital city of the State of Minas Gerais and greater metropolitan region when compared with women residing there. The findings of this study highlight the importance of early diagnosis for predicting patient survival and reinforce the necessity of facilitating HIV diagnosis.

Finding a better first antiretroviral regimen is one of the strategies used to improve span and quality of life of HIV/AIDS patients. 891 patients were followed during 24 months or until interruption/abandonment of treatment, changing regimen or death. At the end of 6 months, 69% of the patients were still being treated with the first regimen, 54% at 12 months, 48% at 18 months and 39% at 24 months. AZT-3TC-EFV was the most prescribed regimen and with the lesser discontinuation. NNRTI regimens showed high effectiveness and durability compared to PI regimens. Irregular medication dispensation was the only risk factor for failure/interruption of treatment in multivariate analyses. Intolerance/adverse effects were mainly responsible for first regimen discontinuation, followed by abandonment/non-adherence and virologic failure. Results showed significant difference between causes of interruption of first HAART with higher percentage of intolerance/adverse effects with PI regimens and higher immunologic failure with NNRTI regimens. Even with the availability of more potent and tolerable drugs, lack of adherence to HAART and high level of adverse effects are still the most important barriers to prolonged success of treatment. This study adds relevant information about durability and effectiveness of HAART in the first decade of its use in Brazil.

Background: Major and accessory drug resistance mutations have been recently characterized in the C-terminal RT subdomains of HIV-1, connection and RNase H. However, their presence in treatment-naïve patients infected with HIV-1 non-B subtypes remains largely unknown., Objectives: To characterize the patterns of primary resistance at the C-terminal RT subdomains of HIV-1 infecting subjects in the southern region of Brazil, where HIV-1 subtypes B and C co-circulate., Study Design: Plasma viral RNA was extracted from patients recently diagnosed for HIV infection (2005-2008). The protease and reverse transcriptase regions were PCR-amplified and sequenced. Infecting HIV subtypes were assigned by phylogenetic inference and drug resistance mutations were determined following the IAS consensus and recent reports on C-terminal RT mutations., Results: The major mutation to NNRTI T369I/V was found in 1.8% of patients, while A376S was present in another 8.3%. In the RNase H domain, the compensatory mutation D488E was more frequently observed in subtype C than in subtype B (p=0.038), while the inverse was observed for mutation Q547K (p<0.001). The calculated codon genetic barrier showed that 22% of subtype B isolates, but no subtype C, carried T360, requiring two transitions to change into the resistance mutation 360V., Conclusions: Major resistance-conferring mutations to NNRTI were detected in 10% of RT connection domain viral sequences from treatment-naïve subjects. We showed for the first time that the presence of specific polymorphisms can constrain the acquisition of definite resistance mutations in the connection and RNase H subdomains of HIV-1 RT., (Copyright © 2011 Elsevier B.V. All rights reserved.)

The emergence of resistance-associated mutations to the antiretroviral agents and the genetic variability of HIV-1 impose challenges to therapeutic success. We report the results of genotype testing assays performed between 2002 and 2006 in 240 antiretroviral-experienced patients followed up in an HIV reference center in Brazil. Drug resistance mutations and viral subtypes were assessed through the algorithms from the Brazilian Genotyping Network (RENAGENO-Brazil) and from Stanford University. Mutation 184VI was the most prevalent (70%) and the thymidine analogue mutations that appeared most frequently were 215FY, 41L, 67N, and 210W, in this order. Among nonnucleoside reverse transcriptase inhibitor mutations, 103NS (32.5%) stood out. HIV subtype B was identified in 184 patients (76.7%). A significant increasing trend in the prevalence of non-B subtypes was observed during the study period (p=0.004). The main differences in prevalence of mutations among HIV-1 subtypes were related to viral protease, with 20MRI, 36I, and 89IMT more prevalent among non-B subtypes, and 84V, 10FR, 63P, 71LTV, and 77I more common in subtype B (p<0.05). Most mutations to etravirine had a prevalence lower than 10%, but at least one mutation to this drug was observed in 45% of the patients. In only 11 patients (4.6%) three mutations to etravirine were verified. Regional surveillance of the resistance profile and HIV-1 subtypes is crucial in the context of public health, to prevent the transmission of resistant strains and to guide the introduction of new drugs in a specific population.

Nonnucleoside reverse transcriptase inhibitors (NNRTIs) are potent and well tolerated. In Brazil, the first-generation NNRTI efavirenz is included in the majority of first-line antiretroviral treatment regimens. In this study, we evaluated the effectiveness of etravirine, a new second-generation NNRTI, among patients failing antiretroviral regimens containing first-generation NNRTIs. We assessed single resistance mutations to etravirine as well as complex resistance mutations profile and discuss the potential of introducing etravirine as salvage therapy.

The question of whether HIV-1 RNA in cerebrospinal fluid (CSF) is derived from viral replication in the central nervous system or simply reflects the transit of infected lymphocytes from the blood compartment has long been a matter of debate. Some studies found no correlation between CSF and plasma viral load, whereas others did. The lack of a correlation between the two compartments suggests that the presence of HIV-1 RNA is not simply due to the passive passage of the virus from blood to CSF but rather due to intrathecal replication. To evaluate the correlation between plasma and CSF HIV-1 RNA levels and to identify situations in which there is no correlation between the two compartments, seventy patients were prospectively studied. The association between CSF and plasma viral load was evaluated in the total population and in subgroups of patients with similar characteristics. A correlation between the CSF and plasma compartments was observed for patients undergoing highly active antiretroviral therapy (HAART), those with a CD4 T lymphocyte count lower than 200 cells/mm³, and those with increased CSF protein content. On the other hand, no correlation was observed for patients without adequate virological control, who had a CD4 count higher than 200 cells/mm³ and who did not use HAART. The correlation between the two compartments observed in some patients suggests that CSF HIV-1 RNA levels may reflect plasma levels in these subjects. In contrast, the lack of a correlation between the two compartments in patients who were not on HAART and who had normal CSF proteins and a poor virological control possibly indicates compartmentalization of the virus in CSF and, consequently, plasma-independent intrathecal viral replication.

Chemokines are chemoattractant cytokines involved in the immune response of a wide variety of diseases. There are few studies assessing their role in opportunistic infections in HIV-infected patients. In this study, we measured CC and CXC chemokines in cerebrospinal fluid (CSF) samples obtained from 40 HIV-infected patients with or without opportunistic infections of the central nervous system (CNS). CSF samples were also analyzed for quantification of total protein, cell count and HIV-1 RNA. HIV+ patients with cryptococcal meningitis had higher levels of CCL2, CCL3, CCL5, CXCL9 and CXCL10 when compared to patients without opportunistic neurological infections. Furthermore, HIV+ patients with associated cryptococcal meningitis had higher levels of CCL3, CXCL9 and CXCL10 when compared to HIV+ patients with associated toxoplasmic encephalitis. CCL3 and CXCL9 levels were positively correlated with CSF HIV-1 RNA levels, CSF protein concentration, and CSF cell count. CXCL10 level was correlated with the CSF viral load and the CSF cell count and CCL5 level was correlated with the CSF cell count. In conclusion, the profile of chemokines in CSF of HIV patients may differ according to the modality of the presented opportunistic infection and according to other biological markers, such as viral load in CSF. These differences are probably related to different patterns of neuroinflammatory responses displayed by patients with different opportunistic neurological infections.

Aims: To compare high-sensitivity C-reactive protein (hsCRP) in HIV-infected patients treated or not with antiretroviral (ARV) drugs and to correlate hsCRP levels with traditional cardiovascular risk factors and parameters of HIV infection., Methods: One hundred and seventy-one HIV-infected patients were included (129 ARV-treated and 42 ARV-naïve). Evaluations included anthropometric measurements, blood pressure, laboratory tests, ultrasonographic measurement of fat thickness and impedance analysis., Results: hsCRP levels were higher in ARV-treated compared to ARV-naïve patients (p<0.001). Seventy-two (56%) ARV-treated patients and 11 (26%) ARV-naïve patients had hsCRP concentrations >3 mg/dl (high risk for cardiovascular complications) (OR 3.56; 95%CI: 1.55-8.29; p=0.001, chi(2) test). hsCRP levels correlated positively with waist measurement (p=0.004), waist-to-hip ratio (p<0.001), systolic (p=0.05) and diastolic (p=0.03) blood pressure, intra-abdominal fat thickness (p=0.02), triglycerides (p=0.001), total cholesterol (p=0.01), fasting glucose (p=0.01), and glucose (p<0.001) and insulin levels (p=0.02) measured 2 h after load. No correlation was found between hsCRP levels and CD4 cell counts and HIV-viral load. Independent factors associated with hsCRP levels were therapy with current non-nucleoside reverse transcriptase inhibitors (NNRTI) (p=0.003), waist-to-hip ratio (p=0.006), fasting glucose (p=0.049) and glucose levels 2 h after load (p=0.003) in multivariate analysis model 1 and current NNRTI therapy (p<0.001), protease inhibitor therapy (p=0.016) and cardiometabolic syndrome (p=0.022) in multivariate analysis model 2., Conclusion: hsCRP in HIV-infected patients is associated with traditional cardiovascular risk factors, principally in ARV-treated patients. hsCRP levels are not associated with CD4 cell counts and HIV-viral load and may constitute a marker for cardiovascular risk related to HIV infection and ARV therapy.