Preexposure Prophylaxis to Prevent Acquisition of HIV: US Preventive Services Task Force Recommendation Statement.

Importance: An estimated 1.2 million persons in the US currently have HIV, and more than 760 000 persons have died of complications related to HIV since the first cases were reported in 1981. Although treatable, HIV is not curable and has significant health consequences. Therefore, effective strategies to prevent HIV are an important public health and clinical priority. Objective: The US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the benefits and harms of preexposure prophylaxis with antiretroviral therapy for the prevention of HIV acquisition, and the diagnostic accuracy of risk assessment tools to identify persons at increased risk of HIV acquisition. Population: Adolescents and adults who do not have HIV and are at increased risk of HIV. Evidence Assessment: The USPSTF concludes with high certainty that there is a substantial net benefit from the use of effective antiretroviral therapy to reduce the risk of acquisition of HIV in persons at increased risk of acquiring HIV. Recommendation: The USPSTF recommends that clinicians prescribe preexposure prophylaxis using effective antiretroviral therapy to persons at increased risk of HIV acquisition to decrease the risk of acquiring HIV. (A recommendation).

Preventing HIV With PrEP.

In this JAMA Patient Page, the US Preventive Services Task Force provides a guide to determine patient risk for HIV, who should take PrEP, and which PrEP strategies are recommended.

Implementation of a national HIV pre-exposure prophylaxis service is associated with changes in characteristics of people with newly diagnosed HIV: a retrospective cohort study.

OBJECTIVES: To review characteristics of individuals newly diagnosed with HIV following implementation of a national pre-exposure prophylaxis (PrEP) programme (comprehensive PrEP services, delivered in sexual health clinics) to inform future delivery and broader HIV prevention strategies. METHODS: We extracted data from national HIV databases (July 2015-June 2018). We compared sociodemographic characteristics of individuals diagnosed in the period before and after PrEP implementation, and determined the proportion of 'potentially preventable' infections with the sexual health clinic-based PrEP delivery model used. RESULTS: Those diagnosed with HIV before PrEP implementation were more likely to be male (342/418, 81.8% vs 142/197, 72.1%, p=0.005), be white indigenous (327/418, 78.2% vs 126/197, 64.0%, p<0.001), report transmission route as sex between men (219/418, 52.4% vs 81/197, 41.1%, p=0.014), and have acquired HIV in the country of the programme (302/418, 72.2% vs 114/197, 57.9% p<0.001) and less likely to report transmission through heterosexual sex (114/418, 27.3% vs 77/197, 39.1%, p=0.002) than after implementation.Pre-implementation, 8.6% (36/418) diagnoses were 'potentially preventable' with the PrEP model used. Post-implementation, this was 6.6% (13/197), but higher among those with recently acquired HIV (49/170, 28.8%). Overall, individuals with 'potentially preventable' infections were more likely to be male (49/49, 100% vs 435/566, 76.9%, p<0.001), aged <40 years (37/49, 75.5% vs 307/566, 54.2%, p=0.004), report transmission route as sex between men (49/49, 100% vs 251/566, 44.3%, p<0.001), have previously received post-exposure prophylaxis (12/49, 24.5% vs 7/566, 1.2%, p<0.001) and less likely to be black African (0/49, 0% vs 67/566, 11.8%, p=0.010) than those not meeting this definition. CONCLUSIONS: The sexual health clinic-based national PrEP delivery model appeared to best suit men who have sex with men and white indigenous individuals but had limited reach into other key vulnerable groups. Enhanced models of delivery and HIV combination prevention are required to widen access to individuals not benefiting from PrEP at present.

Déficit de vitamina D en una población pediátrica sana. La importancia de una adecuada profilaxis / Vitamin D insufficiency in a healthy pediatric population. The importance of early prophylaxis

Introducción: la vitamina D mantiene la concentración de calcio y fósforo dentro del rango fisiológico, permitiendo un metabolismo normal y la correcta mineralización de los huesos. Recientemente, la deficiencia de vitamina D se ha relacionado no solo con el raquitismo sino también con el aumento del riesgo de otras patologías. El objetivo de este estudio descriptivo, observacional y transversal fue conocer los niveles de concentración de vitamina D en una población pediátrica sana y la situación actual en cuanto a la profilaxis. La determinación de la vitamina D se midió mediante la concentración sérica de 25-hidroxivitamina D (25(OH)D). Material y métodos: se inscribieron 258 pacientes sanos de entre 3 meses y 15 años (6,77 ± 3,95 años; 73,6 % de hombres). Resultados: el valor medio de 25(OH)D fue de 26,60 ng/ml ± 8,02 ng/ml; el 20,9 % de la población mostró un nivel insuficiente. Se observaron diferencias estadísticamente significativas entre los niveles de vitamina D de las distintas edades (p = 0,002), grupos étnicos (p = 0,038) y fototipos (p = 0,000). Además, se observó una mayor prevalencia de la insuficiencia de vitamina D en los niños que nunca antes habían recibido suplementos de vitamina D (41,6 %) en comparación con los que habían tomado suplementos en el primer año de vida (16,7 %). Conclusiones: el presente estudio muestra una alta prevalencia del déficit de vitamina D en los niños sanos y el beneficio de una correcta profilaxis en edades tempranas con suplementos de vitamina D. (AU)

Introduction: vitamin D maintains the concentration of calcium and phosphorus within the physiological range, allowing normal metabolism and bone mineralization. Recently, vitamin D deficiency has been related not only with rickets but also with an increased risk of other pathologies. The aim of this descriptive, observational, cross-sectional study was to assess vitamin D concentration levels in a healthy pediatric population, as well as the current situation of prophylaxis. Vitamin D determination was measured by serum 25-hydroxyvitamin D (25(OH)D) concentration. Material and methods: a total of 258 healthy patients between 3 months and 15 years of age were enrolled (6.77 ± 3.95 years; 73.6 % were male). Results: the mean value of 25-hydroxyvitamin D was 26.60 ng/mL ± 8.02 ng/mL, and up to 20.9 % of the population showed insufficient levels. Statistically significant differences in vitamin D levels were observed between ages (p = 0.002), ethnicity groups (p = 0.038), and skin types (p = 0.000). In addition, a higher prevalence of vitamin D insufficiency in children who had never previously received vitamin D supplementation (41.6 %) was observed compared to those that had taken supplementation in the first year of life (16.7 %). Conclusion: our study shows a high prevalence of vitamin D deficiency among healthy children, and the benefit of prophylaxis with vitamin D supplementation. (AU)

Social Impact of Prophylactic Migraine Treatments in Germany: A State-Transition and Open Cohort Approach.

OBJECTIVES: Migraine is a highly prevalent neurological disorder. The most characteristic symptom of migraine is moderate to severe recurrent headache along with other neurological symptoms. In this study, we modeled the potential reduction in migraine days and corresponding avoided productivity losses if erenumab was prescribed to the patient population indicated for prophylactic migraine treatment (≥ 4 monthly migraine days [MMDs]) in Germany from 2020 to the end of 2027. METHODS: We simulated the incremental benefits of erenumab against the standard of care. Response rates, transition probabilities, discontinuation rates, and productivity estimates were derived from the erenumab clinical trial program. Patients had a probability of residing in 1 of 7 states, given the MMDs in addition to the probability of death. Based on accrued MMDs in every cycle, days of absenteeism and presenteeism for paid and unpaid work were derived. Paid work was monetized according to gross value added using the human capital approach, whereas unpaid work was valuated according to the proxy good method. In addition, downstream macroeconomic effects were captured using value-added multipliers. Direct medical costs were concomitantly calculated. RESULTS: Our results show that prescribing erenumab for the indicated population in Germany could lead to a reduction of 166 million migraine days annually and reduce productivity losses in the range of €27 billion. This includes €13.1 billion from direct productivity and €13.5 billion from economic value chain effects. CONCLUSIONS: This study highlights the macroeconomic effects of a systematic introduction of novel inhibitors of the calcitonin gene-related peptide pathway for migraine in Germany.

[Vitamin D insufficiency in a healthy pediatric population. The importance of early prophylaxis]. / Déficit de vitamina D en una población pediátrica sana. La importancia de una adecuada profilaxis.

INTRODUCTION: Introduction: vitamin D maintains the concentration of calcium and phosphorus within the physiological range, allowing normal metabolism and bone mineralization. Recently, vitamin D deficiency has been related not only with rickets but also with an increased risk of other pathologies. The aim of this descriptive, observational, cross-sectional study was to assess vitamin D concentration levels in a healthy pediatric population, as well as the current situation of prophylaxis. Vitamin D determination was measured by serum 25-hydroxyvitamin D (25(OH)D) concentration. Methods: a total of 258 healthy patients between 3 months and 15 years of age were enrolled (6.77 ± 3.95 years; 73.6 % were male). Results: the mean value of 25-hydroxyvitamin D was 26.60 ng/mL ± 8.02 ng/mL, and up to 20.9 % of the population showed insufficient levels. Statistically significant differences in vitamin D levels were observed between ages (p = 0.002), ethnicity groups (p = 0.038), and skin types (p = 0.000). In addition, a higher prevalence of vitamin D insufficiency in children who had never previously received vitamin D supplementation (41.6 %) was observed compared to those that had taken supplementation in the first year of life (16.7 %). Conclusion: our study shows a high prevalence of vitamin D deficiency among healthy children, and the benefit of prophylaxis with vitamin D supplementation.

INTRODUCCIÓN: Introducción: la vitamina D mantiene la concentración de calcio y fósforo dentro del rango fisiológico, permitiendo un metabolismo normal y la correcta mineralización de los huesos. Recientemente, la deficiencia de vitamina D se ha relacionado no solo con el raquitismo sino también con el aumento del riesgo de otras patologías. El objetivo de este estudio descriptivo, observacional y transversal fue conocer los niveles de concentración de vitamina D en una población pediátrica sana y la situación actual en cuanto a la profilaxis. La determinación de la vitamina D se midió mediante la concentración sérica de 25-hidroxivitamina D (25(OH)D). Material y métodos: se inscribieron 258 pacientes sanos de entre 3 meses y 15 años (6,77 ± 3,95 años; 73,6 % de hombres). Resultados: el valor medio de 25(OH)D fue de 26,60 ng/ml ± 8,02 ng/ml; el 20,9 % de la población mostró un nivel insuficiente. Se observaron diferencias estadísticamente significativas entre los niveles de vitamina D de las distintas edades (p = 0,002), grupos étnicos (p = 0,038) y fototipos (p = 0,000). Además, se observó una mayor prevalencia de la insuficiencia de vitamina D en los niños que nunca antes habían recibido suplementos de vitamina D (41,6 %) en comparación con los que habían tomado suplementos en el primer año de vida (16,7 %). Conclusiones: el presente estudio muestra una alta prevalencia del déficit de vitamina D en los niños sanos y el beneficio de una correcta profilaxis en edades tempranas con suplementos de vitamina D.

Preferences for pre-exposure prophylaxis among U.S. military men who have sex with men: results of an adaptive choice based conjoint analysis study.

BACKGROUND: Pre-exposure prophylaxis (PrEP) prevents human immunodeficiency virus (HIV) infection, but its use remains low among U.S. military men who have sex with men (MSM), likely due to mis-matching with personal preferences. We conducted a study to characterize preferences to PrEP measures within this population. METHODS: HIV-negative military MSM were recruited through a closed, Lesbian, Gay, Bisexual, and Transgendered (LGBT) military social media group. The survey was anonymous, and consisted of five experimentally varied attributes in service delivery: dosing method, provider type, visit location, lab work evaluation location, and dispensing venue. Relative importance and part-worth utility scores were generated using hierarchical bayes (HB) estimation, and the randomized first choice model was used to examine participation interest across eight possible PrEP program scenarios. RESULTS: A total of 429 participants completed the survey. Among the eight scenarios with varying attributes, the most preferred scenario featured a daily tablet, PrEP injection or implant, along with a military provider, smartphone/telehealth visit, and on-base locations for lab evaluation and medication pick-up. The results also emphasized the importance for providers to be familiar with PrEP prescription knowledge, and to provide interactions sensitive to sexual identity and mental health. CONCLUSION: A PrEP program consisting of daily tablet is preferred in military healthcare settings is preferred. Long-acting implants and injections are also desired.

Drug dosing in the critically ill obese patient: a focus on medications for hemodynamic support and prophylaxis.

Medications used for supportive care or prophylaxis constitute a significant portion of drug utilization in the intensive care unit. Evidence-based guidelines are available for many aspects of supportive care but drug doses listed are typically for patients with normal body habitus and not morbid obesity. Failure to account for the pharmacokinetic changes that occur with obesity can lead to an incorrect dose and treatment failure or toxicity. This paper is intended to help clinicians design initial dosing regimens in critically ill obese patients for medications commonly used for hemodynamic support or prophylaxis. A detailed literature search of medications used for supportive care or prophylaxis listed in practice guidelines was conducted with an emphasis on obesity, pharmacokinetics and dosing. Relevant manuscripts were reviewed and strategies for dosing are provided. For medications used for hemodynamic support, a similar strategy can be used as in non-obese patients. Similarly, medications for stress ulcer prophylaxis do not need to be adjusted. Anticoagulants for venous thromboembolism prophylaxis, on the other hand, require an individualized approach where higher doses are necessary.

Prophylaxis of ibuprofen in acute mountain sickness: A protocol for systematic review and meta-analysis.

BACKGROUND: Acute mountain sickness (AMS) is the effect when people accessing high altitude in a short period of time. As a cyclooxygenase (COX) inhibitor, ibuprofen could alleviate the symptoms of AMS. However, whether it can prevent AMS or not is still controversial. It is necessary to perform a meta-analysis to evaluate the role of ibuprofen in AMS prophylaxis. METHODS: PubMed, EMBASE, Medline, ISI Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI) will be searched for the relevant published studies that explored the value of ibuprofen in AMS prophylaxis from inception to October 2020. The data will be independently extracted by 2 researchers. Risk of bias will be evaluated based on Cochrane risk of bias assessment tool. Heterogeneity among the included studies will be evaluated by χ and I values. The meta-analysis was conducted by RevMan software version 5.3. RESULTS: This study will evaluate the role of ibuprofen in AMS prophylaxis. CONCLUSION: This study will summarize the current evidence of ibuprofen in AMS prophylaxis, which could further guide the recommendation in prevention of AMS.Open Science Framework (OSF) registration number: October 8, 2020. osf.io/n3mjt.

Roles for Pharmacists in the "Ending the HIV Epidemic: A Plan for America" Initiative.

In 2019, President Trump announced a new initiative, Ending the HIV Epidemic: A Plan for America (EHE). EHE will use 3 key strategies-diagnose, treat, and prevent-to reduce new HIV infections at least 90% by 2030, as well as new laboratory methods and epidemiological techniques to respond quickly to potential outbreaks. Partnerships are an important component in the initiative's success. Pharmacists and pharmacies can play important roles in EHE, including dispensing antiretroviral therapy and providing HIV screening, adherence counseling, medication therapy management, preexposure prophylaxis, and nonprescription syringe sales. The objective of this report is to discuss potential roles that pharmacists and pharmacies can play under the key strategies of EHE.

Perceptions of African American Women and Health Care Professionals Related to Pre-Exposure Prophylaxis to Prevent HIV.

OBJECTIVE: To describe the perceptions of African American women and health care professionals (HCPs) about factors that likely influence the use of pre-exposure prophylaxis (PrEP) to prevent HIV among African American women. DESIGN: Prospective mixed methods. SETTING: Chicago, IL. PARTICIPANTS: Fifty-eight participants included HCPs (n = 10) and African American women (n = 48). METHODS: Following the six steps of concept mapping, participants identified and rated factors they perceived to influence decisions to use PrEP among African American women. RESULTS: African American women generated a list of statements, and we grouped the statements into eight clusters: access, financial, best benefits, protection, medication, setbacks, network, and fear. HCPs ranked having an HIV-positive partner as the most influential factor that affected African American women's decisions to use PrEP (network cluster). African American women ranked ability to prevent HIV when condom use cannot be negotiated as their top reason (best benefits cluster) for using PrEP. CONCLUSION: African American women wanted to know how they could protect themselves and were open to using PrEP. For African American women considering the use of PrEP, the most influential factors were related to the benefits and accessibility of PrEP. HCPs should know that African American women are not afraid to discuss HIV risk and testing.

How to Build the Plane While Flying: VTE/PE Thromboprophylaxis Clinical Guidelines for COVID-19 Patients.

Over the years, the practice of medicine has evolved from authority-based to experience-based to evidence-based with the introduction of the scientific process, clinical trials, and outcomes-based data analysis (Tebala GD. Int J Med Sci. 2018;15(12):1397-1405). The time required to perform the necessary randomized controlled trials, a systematic literature review, and meta-analysis of these trials to then create, accept, promulgate, and educate the practicing clinicians to use the evidence-based clinical guidelines is typically measured in years. When the severe acute respiratory syndrome novel coronavirus-2 (SARS-nCoV-2) pandemic commenced in Wuhan, China at the end of 2019, there were few available clinical guidelines to deploy, let alone adapt and adopt to treat the surge of coronavirus disease 2019 (COVID-19) patients. The aim of this study is to first explain how clinical guidelines, on which bedside clinicians have grown accustomed, can be created in the midst of a pandemic, with an evolving scientific understanding of the pathophysiology of the hypercoagulable state. The second is to adapt and adopt current venous thromboembolism diagnostic and treatment guidelines, while relying on the limited available observational reporting of COVID-19 patients to create a comprehensive clinical guideline to treat COVID-19 patients.

Improving venous thromboembolism prophylaxis through critical thinking and health informatics.

Venous thromboembolism (VTE) is a leading cause of preventable morbidity and mortality in hospitalised patients. Mafraq Hospital, a 450-bed tertiary-level hospital in Abu Dhabi, United Arab Emirates, has identified VTE prevention as a critical patient safety measure and VTE prophylaxis as a key performance indicator (KPI). Mafraq Hospital VTE prevention policy states that all admitted adult patients 18 years and above should receive a VTE risk assessment, and all patients identified at risk of VTE with no contraindications should receive appropriate VTE prophylaxis within 24 hours of admission. In a move towards safer practices, our governing body, Abu Dhabi Health Services SEHA, has raised the VTE prophylaxis KPI target from 85% to 95% for all admitted adult patients within 24 hours of admission. Our average VTE prophylaxis rate was 87%, and achieving this new target was a challenge. We conducted this study on Mafraq Hospital Medical and Surgical wards. The study period was 12 months, from July 2018 to June 2019, and a total of 5475 patients were evaluated. Our aim was to improve VTE prophylaxis rates in order to ensure patient safety and reduce preventable harm. We used Caprini Model electronic VTE risk assessment computerised decision support tool to help identify VTE risk. A multidisciplinary task force team was formed and led this quality improvement project. The purpose of this publication was to indicate the quality improvement interventions implemented to enhance compliance with VTE prophylaxis using integrated critical thinking and health informatics and the outcomes of those interventions. Through implementing critical thinking and health informatics interventions, our VTE prophylaxis within 24 hours of admission rates improved from an average 87% in July 2018 to above 98%, and this improvement was sustained over the last 3 months of the study period April through June 2019.

Acidified sodium chlorite solution: A potential prophylaxis to mitigate impact of multiple exposures to COVID-19 in frontline health-care providers.

Limited availability of personal protective equipment is endangering first-line health-care providers treating patients with presumed or confirmed COVID-19 infections. This editorial has multiple objectives in regard to this reality: First, to raise awareness of the need for safe and effective prophylaxis to protect health-care providers with insufficient personal protective equipment from repeated exposures to COVID-19. Second, to summarize the scientific evidence in support of solutions of acidified sodium chlorite (ASC) and its daughter compounds, chlorous acid and chlorine dioxide, as potential targets for said prophylactic use. Third, to propose a regimented protocol using commercially available solutions of ASC having sufficient concentrations of chlorine dioxide for virucidal activity to support safe and effective prophylactic use. And fourth, to raise awareness of and compare other potential prophylactic options currently under investigation.

PrEP rollout in Africa: status and opportunity.

Following recommendations by the World Health Organization in 2015, and key clinical trials, countries in sub-Saharan Africa, the region with the highest burden of human immunodeficiency virus (HIV), developed policies that incorporate pre-exposure prophylaxis (PrEP) into national HIV-prevention strategies. By the end of 2019, more than one third of people receiving PrEP globally were in Africa. Crucial understandings gained from early rollout among at-risk populations, such as HIV-serodiscordant couples, adolescent girls and young women, female sex workers, and men who have sex with men, include the importance of strategies for maintaining persistent adherence to PrEP and novel approaches to making PrEP services accessible, simplified and efficient. This Perspective will discuss the current status of these programs and how to further widen their implementation.