Thinking out of the box: revisiting health surveillance based on medical records.

Despite the considerable advances in the last years, the health information systems for health surveillance still need to overcome some critical issues so that epidemic detection can be performed in real time. For instance, despite the efforts of the Brazilian Ministry of Health (MoH) to make COVID-19 data available during the pandemic, delays due to data entry and data availability posed an additional threat to disease monitoring. Here, we propose a complementary approach by using electronic medical records (EMRs) data collected in real time to generate a system to enable insights from the local health surveillance system personnel. As a proof of concept, we assessed data from São Caetano do Sul City (SCS), São Paulo, Brazil. We used the "fever" term as a sentinel event. Regular expression techniques were applied to detect febrile diseases. Other specific terms such as "malaria," "dengue," "Zika," or any infectious disease were included in the dictionary and mapped to "fever." Additionally, after "tokenizing," we assessed the frequencies of most mentioned terms when fever was also mentioned in the patient complaint. The findings allowed us to detect the overlapping outbreaks of both COVID-19 Omicron BA.1 subvariant and Influenza A virus, which were confirmed by our team by analyzing data from private laboratories and another COVID-19 public monitoring system. Timely information generated from EMRs will be a very important tool to the decision-making process as well as research in epidemiology. Quality and security on the data produced is of paramount importance to allow the use by health surveillance systems.

WHO guidelines on biosimilars: Toward improved access to safe and effective products.

The World Health Assembly resolution on access to biotherapeutics in 2014 urges WHO and Member States to facilitate access to biotherapeutics while ensuring their quality, safety, and efficacy. While efforts to date have contributed to increased availability and better access to biotherapeutics, including biosimilars, huge gaps still remain, with lack of product access identified as a problem in many countries. A thorough review of the WHO guidelines on biosimilars issued in 2009 in view of technical developments, accumulated and emerging scientific evidence as well as experience in biosimilar evaluation since the release of the guidelines provided an opportunity to introduce greater flexibility and to reduce regulatory requirements in biosimilar development where possible. Based on the identification, draft revisions of the WHO guidelines were prepared with input from extensive consultation with various stakeholders and the broader public. The move toward a greater emphasis on quality and functional in vitro assessment enables the reduction of cost and timelines of development and supports streamlined regulatory approval as a first critical step toward product availability. This article includes the key updates that have been incorporated in the revised guidelines but are not restricted to these alone and should be read in conjunction with the guidelines.

Scaling-up the use of generic antiretrovirals in resource-limited countries: generic drugs for health.

The number of people living with HIV (PLHIV) continues to increase around the world because of the increasing number on antiretroviral therapy (ART) and their associated increase of life expectancy, in addition to the number of people newly infected with HIV each year. Unless a 'cure' can be found for HIV infection, PLHIV can anticipate the need to take antiretroviral drugs (ARVs) for the rest of their lives. Because ARVs are now being used for HIV prevention, as well as for therapeutic purposes, the need for effective, affordable ARVs with few adverse effects will continue to rise. It is important to note that the dramatic growth in treatment coverage of PLHIV seen during the past decade has been primarily due to the increased use of generic ARVs. Thus, there will be a need to scale-up the research and development, production, distribution and access to generic ARVs and ART regimens. However, these processes must occur within national and international regulated free-market economic systems and must deal with increasingly multifaceted patent issues affecting the price while ensuring the quality of the ARVs. National and international regulatory mechanisms will have to evolve, which will affect broader national and international economic and trade issues. Because of the complexity of these issues, the Editors of this Supplement conceived of asking experts in their fields to describe the various steps from relevant research and development, to production of generic ARVs, their delivery to countries and subsequently to PLHIV in low- and middle-income countries. A main objective was to highlight how these steps are interrelated, how the production and delivery of these drugs to PLHIV in resource-limited countries can be made more effective and efficient, and what the lessons are for the production and delivery of a broader set of drugs to people in low- and middle-income countries.

Scaling up HIV treatment and prevention through national responses and innovative leadership.

Over the past decade, there has been an unprecedented global response to the AIDS epidemic. This infusion of new funding has led to a rapid scale-up of HIV treatment and prevention and consequently has saved millions of lives and transformed communities around the world. However, as clearly demonstrated by a review of national responses, successes have been due in large part to strong and innovative leadership from governments, the private sector, and nongovernmental organizations. Examples from Brazil, Botswana, Nigeria, Uganda, and India illustrate the vital role played by bold and collaborative leadership in the global and local scale-up of HIV prevention and treatment.

Antiretroviral therapy in prevention of HIV and TB: update on current research efforts.

There is considerable scientific evidence supporting the use of antiretroviral therapy (ART) in prevention of human immunodeficiency virus (HIV) and tuberculosis (TB) infections. The complex nature of the HIV and TB prevention responses, resource constraints, remaining questions about cost and feasibility, and the need to use a solid evidence base to make policy decisions, and the implementation challenges to translating trial data to operational settings require a well-organised and coordinated response to research in this area. To this end, we aimed to catalogue the ongoing and planned research activities that evaluate the impact of ART plus other interventions on HIV- and/or TB-related morbidity, mortality, risk behaviour, HIV incidence and transmission. Using a limited search methodology, 50 projects were identified examining ART as prevention, representing 5 regions and 52 countries with a global distribution. There are 24 randomised controlled clinical trials with at least 12 large randomised individual or community cluster trials in resource-constrained settings that are in the planning or early implementation stages. There is considerable heterogeneity between studies in terms of methodology, interventions and geographical location. While the identified studies will undoubtedly advance our understanding of the efficacy and effectiveness of ART for prevention, some key questions may remain unanswered or only partially answered. The large number and wide variety of research projects emphasise the importance of this research issue and clearly demonstrate the potential for synergies, partnerships and coordination across funding agencies.

Brazilian Network for HIV Drug Resistance Surveillance: a survey of individuals recently diagnosed with HIV.

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.

Brazilian policy of universal access to AIDS treatment: sustainability challenges and perspectives.

INTRODUCTION: The Brazilian AIDS Programme success is recognized worldwide, due to its integrated approach of prevention, respect for human rights and to free of charge universal access to state of the art antiretrovirals. CURRENT SITUATION: As of 2006, 180,000 people living with AIDS are on HAART with 17 drugs available, receiving medical and laboratory care through the public health system. Costs for ART drugs reached US$ 400 million in 2006 and will increase steeply if the current trends are maintained: uptake of approximately 20,000 new patients/year and the need for more expensive, patent-protected second and third line drugs. DISCUSSION: We discuss the strengths and weaknesses of the programme, budgetary pressures, the need for more intense preventive efforts, for boosting local production of new drugs, for more investment in research and development and the issue of voluntary and compulsory licensing. There are many hurdles in pursuing long-term sustainability, which depends on country driven initiatives and international collaboration and participation. CONCLUSION: We conclude that the Brazilian experience demonstrated the capability of a developing country to treat people with equity, independently of race, gender or economic power and that this equality "seed" has already spread to other countries. Internally this experience must be used to tackle other endemic diseases, such as leprosy, malaria, dengue and leishmania. The Brazilian political will has been proven but, once again, there will be the need for concerted action by civil society, researchers, health professionals, people living with HIV/AIDS and the government to convince the world that health needs should not be treated as commercial issues, and that progress in research and development must be shared throughout the world if we expect to survive as a civilization.

[Proposed UNGASS indicators and the monitoring of the AIDS epidemic in Brazil]. / Indicadores propostos pela UNGASS e o monitoramento da epidemia de Aids no Brasil.

The objective of this study was to analyze, on the national level, the process of monitoring the proposed UNGASS indicators through the use of the Brazilian National Program for STD/AIDS indicators. Two groups of proposed indicators were analyzed in 2002 and 2005 respectively, as part of the monitoring of the progress of the UNGASS Declaration of Commitment. The availability of information and limitations in calculating the proposed indicators in Brazil were analyzed and the appropriateness of the indicators for monitoring the epidemic in Brazil was discussed. Of the 13 quantitative indicators originally proposed by UNGASS, five were not included in the National Program. One was not included due to its qualitative nature. Two of the indicators were considered to be of little use and two were not included due to the lack of available data needed for their calculation. As the epidemic in Brazil is characterized as being concentrated, within the second group of proposed UNGASS indicators those that refer to the accompaniment of epidemic among high-risk population groups were prioritized. The study highlights that the National Program concentrates its efforts in the development, adaptation, and sharing of sampling methodologies for hard to reach populations. Such activities are geared towards estimating the size of vulnerable population groups, as well as obtaining more information regarding their knowledge, attitudes, and practices. The study concludes that by creating the possibility of international comparisons between advances achieved, the proposal of supranational indicators stimulates countries to discuss and make their construction viable. In a complementary way, the national monitoring systems should focus on program improvement by covering areas that permit the evaluation of specific control and intervention actions.

Indicadores propostos pela UNGASS e o monitoramento da epidemia de Aids no Brasil / Proposed UNGASS indicators and the monitoring of the AIDS epidemic in Brazil

O objetivo do estudo foi analisar o processo de monitoramento de indicadores centrais propostos pela UNGASS, em nível nacional, vis-à-vis aos indicadores do Programa Nacional de DST e Aids. Foram avaliados os dois conjuntos de indicadores propostos, respectivamente, em 2002 e 2005, para o monitoramento de progresso da Declaração de Compromisso da UNGASS. Foram analisadas a disponibilidade de informações e as limitações para o cálculo dos indicadores propostos no Brasil, incluindo discussão sobre a adequação dos indicadores propostos para o monitoramento da epidemia brasileira. Dos 13 indicadores quantitativos inicialmente propostos pela UNGASS, cinco não estão incluídos no sistema de monitoramento do Programa Pacional. Um deles não foi incluído por ser um indicador qualitativo. Dois dos indicadores foram considerados de pouca utilidade e dois não foram contemplados pela falta de dados disponíveis para o seu cálculo. Como o Brasil é caracterizado por ter uma epidemia concentrada, no segundo conjunto de indicadores propostos pela UNGASS, prioriza-se o acompanhamento da epidemia entre as populações sob maior risco. Destacou-se que o Programa Nacional centra seus esforços no desenvolvimento, adaptação e transferência de metodologias de amostragem em populações de difícil acesso. Tais ações são voltadas para a estimação do tamanho dos grupos vulneráveis, bem como para obter mais informações sobre seu comportamento, atitudes e práticas. Concluiu-se que, pela possibilidade de comparações internacionais dos avanços conseguidos, a proposição de indicadores supranacionais estimula os países a discutir e viabilizar sua construção. De maneira complementar, os sistemas nacionais de monitoramento devem ser focados na melhoria do programa, cobrindo áreas que permitam avaliar as ações de controle e intervenções específicas.

Programa mãe curitibana: avançando na humanização da atenção materno-infantil / Mae curitibana program: progress on humanizing maternal and child care

Historicamente, no pais, as coberturas do pre-natal tem sido baixas e as gestantes peregrinam em trabalho de parto pelas maternidades, sem garantia de atendimento. Em marco de 1999, com a implantacao do Programa Mae Curitibana, a Secretaria Municipal da Saude (SMS) quebra este paradigma e reafirma a Unidade de Saude (US) como a porta de entrada e de acolhida as gestantes. A US fornece os medicamentos, coleta material para realizacao dos exames laboratoriais, em especial atestagem para o HIV, toxoplasmose e VDRL. A SMS avanca no respeito e humanizacao, garantindo o acesso ao parto, conforme o grau de risco. Implementa o planejamento familiar, viabilizando os metodos preconizados no protocolo e inova atraves da realizacao da vasectomia no nivel ambulatorial, extra-hospitalar. Os resultados aferidos apontam para o incremento na cobertura do pre-natal que, atualmente, encontra-se na faixa de 96 por cento das gestantes atendidas pelo Sistema Unico de Saude (SUS)