Effectiveness and safety of generic version of abacavir/lamivudine and efavirenz in treatment naive HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2011-2012

Background: Generic drug policies are often associated with concerns about the quality and effectiveness of these products. Phase IV clinical trials may be a suitable design to assess the effectiveness and safety of generic drugs. The objective of this study was to describe the effectiveness and the safety of the generic abacavir/lamivudine and efavirenz in treatment-naïve HIV-infected patients. Methods: A monocentric, nonrandomized, open-label, phase IV study in treatment naïve HIV-infected patients 18 years or older with indication to receive abacavir/lamivudine and efavirenz were recruited from a program that provides comprehensive outpatient consultation and continuing care. The primary end-point was to achieve viral load <40 copies/mL at 12 months after baseline to assess effectiveness. Secondary end-point of the study were 1) to asses increasing in T-CD4 lymphocytes levels as accompaniment to asses effectiveness, and 2) to assess both gastrointestinal, skin, and central nervous system symptoms, and lipid profile, cardiovascular risk, renal, and hepatic function as safety profile. Data were determined at baseline, 3, 6, and 12 months. Close clinical monitoring and pharmaceutical care were used for data collection. Wilcoxon matched-pairs signed-rank test was used to compare proportions or medians. Results: Sixty patients were invited to participate in the study; 42 were enrolled and 33 completed the follow-up. Of the nine patients excluded from the study, only one was withdrawn due to adverse events. At 12 months, 31 of 42 patients (73.8 % in intention-to-treat analysis) achieved a viral load of HIV1 RNA <40 copies/mL. There was a significant increase (172 cells/mm3) in the median for CD4 T lymphocyte count. The adverse events were mild and met the safety profile for this antiretroviral regimen, mainly of central nervous system symptoms, skin rash, lipid abnormalities, and an increase of 2 % in the median of the percentage of cardiovascular risk. Conclusions: The clinical outcomes of generic version of abacavir/lamivudine and efavirenz in HIV treatment naïve patients showed the expected safety and effectiveness profile of proprietary ARV drugs. Trial registration: Registro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000202. Registered 19 November 2015.This research was made possible by contribution from the Corporación de Lucha Contra el SIDA, Cali-Colombia, and Comité para el Desarrollo de la Investigación (CODI), Universidad de Antioquia, Medellín, Colombia. In addition, Humax Pharmaceutical S.A. provided the antiretroviral drugs

Impact of PGL-I Seropositivity on the Protective Effect of BCG Vaccination among Leprosy Contacts: A Cohort Study

Although leprosy has become a neglected disease, it is an important cause of disability, and 250,000 new cases are still diagnosed worldwide every year. The current study was carried out in Brazil, where almost 40,000 new cases of leprosy are diagnosed every year. The study targeted contacts of leprosy patients, who are at the highest risk of contracting the disease. We studied 2,135 contacts who were diagnosed at the Leprosy Outpatient Clinic at the Oswaldo Cruz Foundation in Rio de Janeiro, RJ, Brazil, between 1987 and 2007. The presence of antibodies against a specific Mycobacterium leprae antigen (PGL-I) at the first examination and BCG vaccination status were evaluated. PGL-I-positive contacts had a higher risk of developing leprosy than PGL-I-negative contacts. Among the former, vaccinated contacts were at higher risk than unvaccinated contacts. Our results indicate that contact examination combined with PGL-I testing and BCG vaccination appears to justify the targeting of PGL-I-positive individuals for enhanced surveillance. Furthermore, it is highly recommended that PGL-I-positive contacts and contacts with a high familial bacterial index (i.e., the sum of results from index and co-prevalent cases), regardless of serological response, should be monitored. This group could be considered as a target for chemoprophylaxis

Familial hypercholesterolaemia in children and adolescents from 48 countries: a cross-sectional study

Background: Approximately 450 000 children are born with familial hypercholesterolaemia worldwide every year, yet only 2·1% of adults with familial hypercholesterolaemia were diagnosed before age 18 years via current diagnostic approaches, which are derived from observations in adults. We aimed to characterise children and adolescents with heterozygous familial hypercholesterolaemia (HeFH) and understand current approaches to the identification and management of familial hypercholesterolaemia to inform future public health strategies. Methods: For this cross-sectional study, we assessed children and adolescents younger than 18 years with a clinical or genetic diagnosis of HeFH at the time of entry into the Familial Hypercholesterolaemia Studies Collaboration (FHSC) registry between Oct 1, 2015, and Jan 31, 2021. Data in the registry were collected from 55 regional or national registries in 48 countries. Diagnoses relying on self-reported history of familial hypercholesterolaemia and suspected secondary hypercholesterolaemia were excluded from the registry; people with untreated LDL cholesterol (LDL-C) of at least 13·0 mmol/L were excluded from this study. Data were assessed overall and by WHO region, World Bank country income status, age, diagnostic criteria, and index-case status. The main outcome of this study was to assess current identification and management of children and adolescents with familial hypercholesterolaemia. Findings: Of 63 093 individuals in the FHSC registry, 11 848 (18·8%) were children or adolescents younger than 18 years with HeFH and were included in this study; 5756 (50·2%) of 11 476 included individuals were female and 5720 (49·8%) were male. Sex data were missing for 372 (3·1%) of 11 848 individuals. Median age at registry entry was 9·6 years (IQR 5·8-13·2). 10 099 (89·9%) of 11 235 included individuals had a final genetically confirmed diagnosis of familial hypercholesterolaemia and 1136 (10·1%) had a clinical diagnosis. Genetically confirmed diagnosis data or clinical diagnosis data were missing for 613 (5·2%) of 11 848 individuals. Genetic diagnosis was more common in children and adolescents from high-income countries (9427 [92·4%] of 10 202) than in children and adolescents from non-high-income countries (199 [48·0%] of 415). 3414 (31·6%) of 10 804 children or adolescents were index cases. Familial-hypercholesterolaemia-related physical signs, cardiovascular risk factors, and cardiovascular disease were uncommon, but were more common in non-high-income countries. 7557 (72·4%) of 10 428 included children or adolescents were not taking lipid-lowering medication (LLM) and had a median LDL-C of 5·00 mmol/L (IQR 4·05-6·08). Compared with genetic diagnosis, the use of unadapted clinical criteria intended for use in adults and reliant on more extreme phenotypes could result in 50-75% of children and adolescents with familial hypercholesterolaemia not being identified. Interpretation: Clinical characteristics observed in adults with familial hypercholesterolaemia are uncommon in children and adolescents with familial hypercholesterolaemia, hence detection in this age group relies on measurement of LDL-C and genetic confirmation. Where genetic testing is unavailable, increased availability and use of LDL-C measurements in the first few years of life could help reduce the current gap between prevalence and detection, enabling increased use of combination LLM to reach recommended LDL-C targets early in life

Factores asociados a la neumon?a asociada a la ventilaci?n mec?nica en una unidad de cuidados intensivos en Ibagu?, 2016.

70 p. Recurso Electr?nicoIntroducci?n: Las Infecciones Asociadas a la Atenci?n en Salud (IAAS), son complicaciones durante una atenci?n en salud, que en la mayor?a de casos son prevenibles. Dentro de estas, las Neumon?as Asociadas a la ventilaci?n Mec?nica (NAVM) son las m?s frecuentes en las Unidades de Cuidados Intensivos y generan aumento de la mortalidad de los pacientes que cursan con este evento, el cual debe ser estudiado en cada contexto espec?fico y con la mayor?a de factores posibles teniendo en cuenta su complejidad, motivo por el cual se hace necesario establecer la asociaci?n de la Neumon?a Asociada a la Ventilaci?n Mec?nica con los factores sociodemogr?ficos, Cl?nicos-patol?gicos y relacionados con la atenci?n en salud. Dise?o: Se realiz? un Estudio Observacional, anal?tico de casos y controles, que permite asegurar la temporalidad entre las asociaciones de los factores seg?n la literatura y estudiar el efecto de diferentes exposiciones relacionadas con la Neumonia Asociada a la Ventilaci?n Mec?nica. Esto permite dar mayor certeza en la identificaci?n de los factores que predisponen, facilitan y limitan la NAVM. Resultados: Para el a?o 2016 se reportaron 9 casos de Neumon?a Asociada a la Ventilaci?n Mec?nica, por lo que se incluy? el total de los pacientes con respecto a 27 controles para una relaci?n de 1:3. No se pudieron asociar significativamente ninguna de las variables agrupadas en las caracter?sticas sociodemogr?ficas, Cl?nico-Patol?gicas y relacionadas con la atenci?n en salud. Conclusiones/Recomendaciones: Se hace necesario incluir otras variables importantes como la medici?n de la Escala de Severidad APACHE, ya que es de vital importancia como factor pron?stico en los pacientes criticamente enfermos. Palabras Clave: Neumon?a Asociada al Ventilador, Infecci?n Hospitalaria, Transmisi?n de enfermedad infecciosa de profesional a paciente, Cuidados Cr?ticos.Introduction: The infections associated with the health care (IAHC), they are the result of complications that occurred during a health care situation, and most of the cases these complications could be prevented. Among these infections, pneumonia ventilatorassociated (PVA) is the most frequent case in the intensive care unit and it increased the mortality of patients that pursue this event. That it must be studied in each specific context and with the majority of the possible factors according to its complexity, therefore it is necessary to establish the relationship between the pneumonia ventilator-associated with the sociodemography factors, clinical diseases and the health care. Design: it was realized an observational study, analytical of cases and control that allows to ensure the temporary nature between the factors associated according to the literature and study the effect of different expositions related to the pneumonia ventilator-associated (PVA). This study allows to have a better certainty in the identification of the factors that predisposes, facilitates and restricts the PAV. Results: In 2016, 9 pneumonia ventilator-associated cases were reported, therefore it was included the total patients in relation to 27 controls for a 1:3 relationship. It was not possible to associate significantly none of the grouped variables in the sociodemography characteristics, clinical diseases and related to the health care. Conclusions/Recommendations: it was necessary to include another important variables like the Severity Scale measurement APACHE II, due to it is a vital importance as a prognostic factor to patients with critical care. Keywords: Peumonia Ventilator-Associated, Cross Infection, Infectious Disease Transmission, Professional-to-patient, Critical Care