Differential body composition effects of protease inhibitors recommended for initial treatment of HIV infection: A randomized clinical trial

This article has been accepted for publication in Clinical Infectious Diseases ©2014 The Authors .Published by Oxford University Press on Clinical Infectious Disease 60.5. DOI: 10.1093/cid/ciu898Background. It is unclear whether metabolic or body composition effects may differ between protease inhibitor-based regimens recommended for initial treatment of HIV infection. Methods. ATADAR is a phase IV, open-label, multicenter randomized clinical trial. Stable antiretroviral-naive HIV-infected adults were randomly assigned to atazanavir/ritonavir 300/100 mg or darunavir/ritonavir 800/100 mg in combination with tenofovir/emtricitabine daily. Pre-defined end-points were treatment or virological failure, drug discontinuation due to adverse effects, and laboratory and body composition changes at 96 weeks. Results. At 96 weeks, 56 (62%) atazanavir/ritonavir and 62 (71%) darunavir/ritonavir patients remained free of treatment failure (estimated difference 8.2%; 95%CI -0.6 to 21.6); and 71 (79%) atazanavir/ritonavir and 75 (85%) darunavir/ritonavir patients remained free of virological failure (estimated difference 6.3%; 95%CI -0.5 to 17.6). Seven vs. five patients discontinued atazanavir/ritonavir or darunavir/ritonavir due to adverse effects. Total and HDL cholesterol similarly increased in both arms, but triglycerides increased more in atazanavir/ritonavir arm. At 96 weeks, body fat (estimated difference 2862.2 gr; 95%CI 726.7 to 4997.7; P=0.0090), limb fat (estimated difference 1403.3 gr; 95%CI 388.4 to 2418.2; P=0.0071), and subcutaneous abdominal adipose tissue (estimated difference 28.4 cm2; 95%CI 1.9 to 55.0; P=0.0362) increased more in atazanavir/ritonavir than in darunavir/ritonavir arm. Body fat changes in atazanavir/ritonavir arm were associated with higher insulin resistance. Conclusions. We found no major differences between atazanavir/ritonavir and darunavir/ritonavir in efficacy, clinically-relevant side effects, or plasma cholesterol fractions. However, atazanavir/ritonavir led to higher triglycerides and total and subcutaneous fat than darunavir/ritonavir and fat gains with atazanavir/ritonavir were associated with insulin resistanceThis is an Investigator Sponsored Research study. It was supported in part by research grants from Bristol‐Myers Squibb and Janssen‐Cilag; Instituto de Salud Carlos III (PI12/01217) and Red Temática Cooperativa de Investigación en SIDA G03/173 (RIS‐EST11), Ministerio de Ciencia e Innovación, Spain. (Registration number: NCT01274780; registry name: ATADAR; EUDRACT; 2010‐021002‐38)

ECMO for COVID-19 patients in Europe and Israel

Since March 15th, 2020, 177 centres from Europe and Israel have joined the study, routinely reporting on the ECMO support they provide to COVID-19 patients. The mean annual number of cases treated with ECMO in the participating centres before the pandemic (2019) was 55. The number of COVID-19 patients has increased rapidly each week reaching 1531 treated patients as of September 14th. The greatest number of cases has been reported from France (n = 385), UK (n = 193), Germany (n = 176), Spain (n = 166), and Italy (n = 136) .The mean age of treated patients was 52.6 years (range 16–80), 79% were male. The ECMO configuration used was VV in 91% of cases, VA in 5% and other in 4%. The mean PaO2 before ECMO implantation was 65 mmHg. The mean duration of ECMO support thus far has been 18 days and the mean ICU length of stay of these patients was 33 days. As of the 14th September, overall 841 patients have been weaned from ECMO support, 601 died during ECMO support, 71 died after withdrawal of ECMO, 79 are still receiving ECMO support and for 10 patients status n.a. . Our preliminary data suggest that patients placed on ECMO with severe refractory respiratory or cardiac failure secondary to COVID-19 have a reasonable (55%) chance of survival. Further extensive data analysis is expected to provide invaluable information on the demographics, severity of illness, indications and different ECMO management strategies in these patients

International Social Survey Programme: Leisure Time and Sports - ISSP 2007

The International Social Survey Programme (ISSP) is a continuous programme of cross-national collaboration running annual surveys on topics important for the social sciences. The programme started in 1984 with four founding members - Australia, Germany, Great Britain, and the United States – and has now grown to almost 50 member countries from all over the world. As the surveys are designed for replication, they can be used for both, cross-national and cross-time comparisons. Each ISSP module focuses on a specific topic, which is repeated in regular time intervals. Please, consult the documentation for details on how the national ISSP surveys are fielded. The present study focuses on questions about leisure time activities and sport.Frequency of leisure activities in respondent`s free time; main purpose of free time activities; enjoyment from reading books, getting together with friends, taking part in physical activities, and watching TV or DVDs; motivation for leisure time activities: establishing useful contacts, relaxing, and developing skills in free time; frequency of feeling bored, feeling rushed, and thinking about work during free time; preference for sharing time with other people or being alone; wishes for: more time in a paid job, more time doing household work, more time with family, and more time in leisure activities; number of nights the respondent stayed away from home for holiday or social visits; days of leave from work; most frequent exercises or physical activity; preferred type of games rather than sports; most important reasons for taking part in sports or games: physical or mental health, meeting other people, competing against others or physical attractiveness; most frequently watched sport on TV; feeling of national pride when respondent`s country does well at international sports or games competition; attitudes towards sport (scale); social and political participation; trust in people; interest in politics; reasons for staying away from doing free time activities: lack of facilities nearby, lack of money and time, personal health or responsibility to take care of someone; perception of happiness; estimation of personal health. Optional items (not stated in all countries): The day before questioning was a working-day or a holiday; time of getting up and going to sleep on the day before; height and weight of respondent; wishes to gain or to lose weight; conception of an ideal shape of a man and a women on the bases of presented pictures. Demography: sex; age; marital status; steady life partner; years of schooling; highest education level; country specific education and degree; current employment status (respondent and partner); hours worked weekly; occupation (ISCO 1988) (respondent and partner); supervising function at work; working for private or public sector or self-employed (respondent and partner); if self-employed: number of employees; trade union membership; earnings of respondent (country specific); family income (country specific); size of household; household composition; party affiliation (left-right); country specific party affiliation; participation in last election; religious denomination; religious main groups; attendance of religious services; self-placement on a top-bottom scale; region (country specific); size of community (country specific); type of community: urban-rural area; country of origin or ethnic group affiliation. Additionally coded: administrative mode of data-collection; weighting factor; case substitution.Das International Social Survey Programme (ISSP) ist ein länderübergreifendes, fortlaufendes Umfrageprogramm, das jährlich Erhebungen zu Themen durchführt, die für die Sozialwissenschaften wichtig sind. Das Programm begann 1984 mit vier Gründungsmitgliedern - Australien, Deutschland, Großbritannien und den Vereinigten Staaten - und ist inzwischen auf fast 50 Mitgliedsländer aus aller Welt angewachsen. Da die Umfragen auf Replikationen ausgelegt sind, können die Daten sowohl für länder- als auch für zeitübergreifende Vergleiche genutzt werden. Jedes ISSP-Modul konzentriert sich auf ein bestimmtes Thema, das in regelmäßigen Zeitabständen wiederholt wird. Details zur Durchführung der nationalen ISSP-Umfragen entnehmen Sie bitte der Dokumentation. Die vorliegende Studie konzentriert sich auf Fragen zu Freizeitaktivitäten und Sport.Häufigkeit ausgewählter Freizeitaktivitäten; Grad der ermöglichten Selbstverwirklichung und Beziehungsstärkung zu anderen Menschen durch die eigenen Freizeitaktivitäten; empfundenes Vergnügen durch: Bücherlesen, Zusammensein mit Freunden, Teilnahme an körperlichen Aktivitäten wie Sport oder Gymnastik sowie fernsehen oder DVDs ansehen; Wichtigkeit der Motivation für die Freizeitbeschäftigung: Festigung nützlicher Kontakte, Entspannung, Erlernen und Entwickeln von Fähigkeiten; Häufigkeit von Langeweile, Hetze und Gedanken über die Arbeit in der Freizeit; Präferenz für eine Freizeitgestaltung mit anderen Menschen oder alleine; Wunsch nach Zunahme oder Abnahme von Berufstätigkeit, Haushaltsarbeiten, Zeit mit der Familie sowie für Freizeitaktivitäten; Abwesenheit von Zuhause in den letzten zwölf Monaten durch Ferien oder Besuche, Anzahl der Urlaubstage in den letzten zwölf Monaten (klassiert); meist betriebene Sportart bzw. körperliche Aktivität; präferiertes (Gesellschafts-)Spiel; Wichtigkeit ausgewählter Gründe für die Teilnahme an Sport oder Spielen (körperliche und geistige Gesundheit, Treffen mit Anderen, Konkurrenz mit Anderen, gutes Aussehen); präferierte Sportarten im Fernsehen; empfundener Nationalstolz bei internationalen Sportveranstaltungen; Einstellung zu Sport (Skala: Sport bildet den kindlichen Charakter, zu viele Sportsendungen im Fernsehen, Sport bringt verschiedene Gruppen und Rassen näher zusammen, internationale Sportveranstaltungen erzeugen Spannungen zwischen Ländern, Wunsch nach einer Erhöhung der Regierungsausgaben für den Sport); Häufigkeit der aktiven Teilnahme an Vereinigungen bzw. Gruppen in den Bereichen: Sport, Kultur, Kirche, Bürgervereinigung sowie politische Partei; Personenvertrauen; Politikinteresse; Hinderungsgründe für die Ausübung gewünschter Freizeitaktivitäten (fehlende Möglichkeiten in der Nähe, Geldmangel, persönliche Gesundheit, Alter oder Behinderung, Betreuungsverpflichtungen sowie fehlende Zeit); Glücksempfinden; Selbsteinschätzung der persönlichen Gesundheit. Optionale Fragen (nicht in allen Ländern gefragt): Befragungsvortag war ein Arbeitstag oder freier Tag; Aufstehzeit und Schlafenszeit am Vortag; Größe; Gewicht; Art der gewünschten Gewichtsveränderung; Vorstellung von der idealen Gestalt eines Mannes und einer Frau anhand von Bildvorlagen. Demographie: Geschlecht; Alter; Familienstand; Zusammenleben mit einem Partner; Anzahl Schuljahre; Schulbildung; Beschäftigungsstatus des Befragten sowie des Partners; Wochenarbeitsstunden; Beruf (ILO/ISCO 1988) des Befragten und des Partners sowie Beschäftigung im öffentlichen Sektor; selbständige Beschäftigung; Anzahl der Beschäftigten; Vorgesetztenstatus; Gewerkschaftsmitgliedschaft; Einkommen; Haushaltseinkommen; Haushaltsgröße; Haushaltszusammensetzung; Parteipräferenz ; Wahlbeteiligung bei der letzten Wahl; Konfession; Kirchgangshäufigkeit; Selbsteinstufung der Schichtzugehörigkeit (Oben-Unten-Skala); Region; Ortsgröße; Urbanisierungsgrad; ethnische oder nationale Zugehörigkeit bzw. Herkunft. Zusätzlich verkodet wurde: Erhebungsmethode; Gewichtungsfaktor; Substitution

Human immunodeficiency virus continuum of care in 11 european union countries at the end of 2016 overall and by key population: Have we made progress?

Background. High uptake of antiretroviral treatment (ART) is essential to reduce human immunodeficiency virus (HIV) transmission and related mortality; however, gaps in care exist. We aimed to construct the continuum of HIV care (CoC) in 2016 in 11 European Union (EU) countries, overall and by key population and sex. To estimate progress toward the Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 target, we compared 2016 to 2013 estimates for the same countries, representing 73% of the population in the region. Methods. A CoC with the following 4 stages was constructed: number of people living with HIV (PLHIV); proportion of PLHIV diagnosed; proportion of those diagnosed who ever initiated ART; and proportion of those ever treated who achieved viral suppression at their last visit. Results. We estimated that 87% of PLHIV were diagnosed; 92% of those diagnosed had ever initiated ART; and 91% of those ever on ART, or 73% of all PLHIV, were virally suppressed. Corresponding figures for men having sex with men were: 86%, 93%, 93%, 74%; for people who inject drugs: 94%, 88%, 85%, 70%; and for heterosexuals: 86%, 92%, 91%, 72%. The proportion suppressed of all PLHIV ranged from 59% to 86% across countries. Conclusions. The EU is close to the 90-90-90 target and achieved the UNAIDS target of 73% of all PLHIV virally suppressed, significant progress since 2013 when 60% of all PLHIV were virally suppressed. Strengthening of testing programs and treatment support, along with prevention interventions, are needed to achieve HIV epidemic control

Relationship between method of anastomosis and anastomotic failure after right hemicolectomy and ileo-caecal resection: an international snapshot audit

Aim The anastomosis technique used following right-sided colonic resection is widely variable and may affect patient outcome. This study aimed to assess the association between leak and anastomosis technique (stapled vs handsewn). Method This was a prospective, multicentre, international audit including patients undergoing elective or emergency right hemicolectomy or ileo-caecal resection operations over a 2-month period in early 2015. The primary outcome measure was the presence of anastomotic leak within 30 days of surgery, determined using a prespecified definition. Mixed effects logistic regression models were used to assess the association between leak and anastomosis method, adjusting for patient, disease and operative cofactors, with centre included as a random-effect variable. Results This study included 3208 patients, of whom 78.4\% (n = 2515) underwent surgery for malignancy and 11.7\% (n = 375) underwent surgery for Crohn's disease. An anastomosis was performed in 94.8\% (n = 3041) of patients, which was handsewn in 38.9\% (n = 1183) and stapled in 61.1\% (n = 1858). Patients undergoing hand-sewn anastomosis were more likely to be emergency admissions (20.5\% handsewn vs 12.9\% stapled) and to undergo open surgery (54.7\% handsewn vs 36.6\% stapled). The overall anastomotic leak rate was 8.1\% (245/3041), which was similar following handsewn (7.4\%) and stapled (8.5\%) techniques (P = 0.3). After adjustment for cofactors, the odds of a leak were higher for stapled anastomosis (adjusted OR = 1.43; 95\% CI: 1.04-1.95; P = 0.03). Conclusion Despite being used in lower-risk patients, stapled anastomosis was associated with an increased anastomotic leak rate in this observational study. Further research is needed to define patient groups in whom a stapled anastomosis is safe

In-hospital and 6-month outcomes in patients with COVID-19 supported with extracorporeal membrane oxygenation (EuroECMO-COVID): a multicentre, prospective observational study

Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with COVID-19, but uncertainty remains about the determinants of in-hospital mortality and data on post-discharge outcomes are scarce. The aims of this study were to investigate the variables associated with in-hospital outcomes in patients who received ECMO during the first wave of COVID-19 and to describe the status of patients 6 months after ECMO initiation

The value of open-source clinical science in pandemic response: lessons from ISARIC

International audienc