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PLoS Medicine

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https://www.readbyqxmd.com/read/29149179/postmenopausal-hormone-therapy-and-risk-of-stroke-a-pooled-analysis-of-data-from-population-based-cohort-studies
#1
Germán D Carrasquilla, Paolo Frumento, Anita Berglund, Christer Borgfeldt, Matteo Bottai, Chiara Chiavenna, Mats Eliasson, Gunnar Engström, Göran Hallmans, Jan-Håkan Jansson, Patrik K Magnusson, Peter M Nilsson, Nancy L Pedersen, Alicja Wolk, Karin Leander
BACKGROUND: Recent research indicates a favourable influence of postmenopausal hormone therapy (HT) if initiated early, but not late, on subclinical atherosclerosis. However, the clinical relevance of timing of HT initiation for hard end points such as stroke remains to be determined. Further, no previous research has considered the timing of initiation of HT in relation to haemorrhagic stroke risk. The importance of the route of administration, type, active ingredient, and duration of HT for stroke risk is also unclear...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29145404/core-outcome-set-standards-for-development-the-cos-stad-recommendations
#2
Jamie J Kirkham, Katherine Davis, Douglas G Altman, Jane M Blazeby, Mike Clarke, Sean Tunis, Paula R Williamson
BACKGROUND: The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR])...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29136037/safety-pharmacokinetics-and-immunological-activities-of-multiple-intravenous-or-subcutaneous-doses-of-an-anti-hiv-monoclonal-antibody-vrc01-administered-to-hiv-uninfected-adults-results-of-a-phase-1-randomized-trial
#3
Kenneth H Mayer, Kelly E Seaton, Yunda Huang, Nicole Grunenberg, Abby Isaacs, Mary Allen, Julie E Ledgerwood, Ian Frank, Magdalena E Sobieszczyk, Lindsey R Baden, Benigno Rodriguez, Hong Van Tieu, Georgia D Tomaras, Aaron Deal, Derrick Goodman, Robert T Bailer, Guido Ferrari, Ryan Jensen, John Hural, Barney S Graham, John R Mascola, Lawrence Corey, David C Montefiori
BACKGROUND: VRC01 is an HIV-1 CD4 binding site broadly neutralizing antibody (bnAb) that is active against a broad range of HIV-1 primary isolates in vitro and protects against simian-human immunodeficiency virus (SHIV) when delivered parenterally to nonhuman primates. It has been shown to be safe and well tolerated after short-term administration in humans; however, its clinical and functional activity after longer-term administration has not been previously assessed. METHODS AND FINDINGS: HIV Vaccine Trials Network (HVTN) 104 was designed to evaluate the safety and tolerability of multiple doses of VRC01 administered either subcutaneously or by intravenous (IV) infusion and to assess the pharmacokinetics and in vitro immunologic activity of the different dosing regimens...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29136032/virological-response-and-resistance-among-hiv-infected-children-receiving-long-term-antiretroviral-therapy-without-virological-monitoring-in-uganda-and-zimbabwe-observational-analyses-within-the-randomised-arrow-trial
#4
Alexander J Szubert, Andrew J Prendergast, Moira J Spyer, Victor Musiime, Philippa Musoke, Mutsa Bwakura-Dangarembizi, Patricia Nahirya-Ntege, Margaret J Thomason, Emmanuel Ndashimye, Immaculate Nkanya, Oscar Senfuma, Boniface Mudenge, Nigel Klein, Diana M Gibb, A Sarah Walker
BACKGROUND: Although WHO recommends viral load (VL) monitoring for those on antiretroviral therapy (ART), availability in low-income countries remains limited. We investigated long-term VL and resistance in HIV-infected children managed without real-time VL monitoring. METHODS AND FINDINGS: In the ARROW factorial trial, 1,206 children initiating ART in Uganda and Zimbabwe between 15 March 2007 and 18 November 2008, aged a median 6 years old, with median CD4% of 12%, were randomised to monitoring with or without 12-weekly CD4 counts and to receive 2 nucleoside reverse transcriptase inhibitors (2NRTI, mainly abacavir+lamivudine) with a non-nucleoside reverse transcriptase inhibitor (NNRTI) or 3 NRTIs as long-term ART...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29136030/prospects-for-passive-immunity-to-prevent-hiv-infection
#5
Lynn Morris, Nonhlanhla N Mkhize
In a Perspective, Lynn Morris and Nonhlanhla Mkhize discuss the prospects for broadly neutralizing antibodies to be used in preventing HIV infection.
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29136014/treatment-guidelines-and-early-loss-from-care-for-people-living-with-hiv-in-cape-town-south-africa-a-retrospective-cohort-study
#6
Ingrid T Katz, Richard Kaplan, Garrett Fitzmaurice, Dominick Leone, David R Bangsberg, Linda-Gail Bekker, Catherine Orrell
BACKGROUND: South Africa has undergone multiple expansions in antiretroviral therapy (ART) eligibility from an initial CD4+ threshold of ≤200 cells/μl to providing ART for all people living with HIV (PLWH) as of September 2016. We evaluated the association of programmatic changes in ART eligibility with loss from care, both prior to ART initiation and within the first 16 weeks of starting treatment, during a period of programmatic expansion to ART treatment at CD4+ ≤ 350 cells/μl...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29136007/perinatal-mortality-associated-with-induction-of-labour-versus-expectant-management-in-nulliparous-women-aged-35-years-or-over-an-english-national-cohort-study
#7
Hannah E Knight, David A Cromwell, Ipek Gurol-Urganci, Katie Harron, Jan H van der Meulen, Gordon C S Smith
BACKGROUND: A recent randomised controlled trial (RCT) demonstrated that induction of labour at 39 weeks of gestational age has no short-term adverse effect on the mother or infant among nulliparous women aged ≥35 years. However, the trial was underpowered to address the effect of routine induction of labour on the risk of perinatal death. We aimed to determine the association between induction of labour at ≥39 weeks and the risk of perinatal mortality among nulliparous women aged ≥35 years...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29136001/a-combination-intervention-strategy-to-improve-linkage-to-and-retention-in-hiv-care-following-diagnosis-in-mozambique-a-cluster-randomized-study
#8
Batya Elul, Matthew R Lamb, Maria Lahuerta, Fatima Abacassamo, Laurence Ahoua, Stephanie A Kujawski, Maria Tomo, Ilesh Jani
BACKGROUND: Concerning gaps in the HIV care continuum compromise individual and population health. We evaluated a combination intervention strategy (CIS) targeting prevalent barriers to timely linkage and sustained retention in HIV care in Mozambique. METHODS AND FINDINGS: In this cluster-randomized trial, 10 primary health facilities in the city of Maputo and Inhambane Province were randomly assigned to provide the CIS or the standard of care (SOC). The CIS included point-of-care CD4 testing at the time of diagnosis, accelerated ART initiation, and short message service (SMS) health messages and appointment reminders...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29135993/bioequivalence-between-innovator-and-generic-tacrolimus-in-liver-and-kidney-transplant-recipients-a-randomized-crossover-clinical-trial
#9
Rita R Alloway, Alexander A Vinks, Tsuyoshi Fukuda, Tomoyuki Mizuno, Eileen C King, Yuanshu Zou, Wenlei Jiang, E Steve Woodle, Simon Tremblay, Jelena Klawitter, Jost Klawitter, Uwe Christians
BACKGROUND: Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, "brand") product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29135985/evidence-based-restructuring-of-health-and-social-care
#10
Aziz Sheikh
In this Perspective, Aziz Sheikh discusses research to evaluate health policy changes in the provision of care, commenting on a study by James Lopez Bernal and colleagues that examined specialist-dominated hospital care versus community-based care in the United Kingdom.
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29135980/bioequivalence-of-twice-daily-oral-tacrolimus-in-transplant-recipients-more-evidence-for-consensus
#11
Simon Ball
In this Perspective on the clinical trial by Rita Alloway and colleagues, Simon Ball explains the benefits to healthcare systems and individual patients of the bioequivalence established between generic and brand-name formulations of an immunosuppressive drug in transplant recipients.
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29135978/association-between-the-2012-health-and-social-care-act-and-specialist-visits-and-hospitalisations-in-england-a-controlled-interrupted-time-series-analysis
#12
James A Lopez Bernal, Christine Y Lu, Antonio Gasparrini, Steven Cummins, J Frank Wharham, Steven B Soumerai
BACKGROUND: The 2012 Health and Social Care Act (HSCA) in England led to among the largest healthcare reforms in the history of the National Health Service (NHS). It gave control of £67 billion of the NHS budget for secondary care to general practitioner (GP) led Clinical Commissioning Groups (CCGs). An expected outcome was that patient care would shift away from expensive hospital and specialist settings, towards less expensive community-based models. However, there is little evidence for the effectiveness of this approach...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29117196/validity-of-a-minimally-invasive-autopsy-for-cause-of-death-determination-in-maternal-deaths-in-mozambique-an-observational-study
#13
Paola Castillo, Juan Carlos Hurtado, Miguel J Martínez, Dercio Jordao, Lucilia Lovane, Mamudo R Ismail, Carla Carrilho, Cesaltina Lorenzoni, Fabiola Fernandes, Sibone Mocumbi, Zara Onila Jaze, Flora Mabota, Anelsio Cossa, Inacio Mandomando, Pau Cisteró, Alfredo Mayor, Mireia Navarro, Isaac Casas, Jordi Vila, Maria Maixenchs, Khátia Munguambe, Ariadna Sanz, Llorenç Quintó, Eusebio Macete, Pedro Alonso, Quique Bassat, Jaume Ordi, Clara Menéndez
BACKGROUND: Despite global health efforts to reduce maternal mortality, rates continue to be unacceptably high in large parts of the world. Feasible, acceptable, and accurate postmortem sampling methods could provide the necessary evidence to improve the understanding of the real causes of maternal mortality, guiding the design of interventions to reduce this burden. METHODS AND FINDINGS: The validity of a minimally invasive autopsy (MIA) method in determining the cause of death was assessed in an observational study in 57 maternal deaths by comparing the results of the MIA with those of the gold standard (complete diagnostic autopsy [CDA], which includes any available clinical information)...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29112963/effectiveness-of-a-combination-strategy-for-linkage-and-retention-in-adult-hiv-care-in-swaziland-the-link4health-cluster-randomized-trial
#14
RANDOMIZED CONTROLLED TRIAL
Margaret L McNairy, Matthew R Lamb, Averie B Gachuhi, Harriet Nuwagaba-Biribonwoha, Sean Burke, Sikhathele Mazibuko, Velephi Okello, Peter Ehrenkranz, Ruben Sahabo, Wafaa M El-Sadr
BACKGROUND: Gaps in the HIV care continuum contribute to poor health outcomes and increase HIV transmission. A combination of interventions targeting multiple steps in the continuum is needed to achieve the full beneficial impact of HIV treatment. METHODS AND FINDINGS: Link4Health, a cluster-randomized controlled trial, evaluated the effectiveness of a combination intervention strategy (CIS) versus the standard of care (SOC) on the primary outcome of linkage to care within 1 month plus retention in care at 12 months after HIV-positive testing...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29112958/cardiovascular-disease-cvd-and-chronic-kidney-disease-ckd-event-rates-in-hiv-positive-persons-at-high-predicted-cvd-and-ckd-risk-a-prospective-analysis-of-the-d-a-d-observational-study
#15
Mark A Boyd, Amanda Mocroft, Lene Ryom, Antonella d'Arminio Monforte, Caroline Sabin, Wafaa M El-Sadr, Camilla Ingrid Hatleberg, Stephane De Wit, Rainer Weber, Eric Fontas, Andrew Phillips, Fabrice Bonnet, Peter Reiss, Jens Lundgren, Matthew Law
BACKGROUND: The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study has developed predictive risk scores for cardiovascular disease (CVD) and chronic kidney disease (CKD, defined as confirmed estimated glomerular filtration rate [eGFR] ≤ 60 ml/min/1.73 m2) events in HIV-positive people. We hypothesized that participants in D:A:D at high (>5%) predicted risk for both CVD and CKD would be at even greater risk for CVD and CKD events. METHODS AND FINDINGS: We included all participants with complete risk factor (covariate) data, baseline eGFR > 60 ml/min/1...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29112956/hiv-1-persistence-following-extremely-early-initiation-of-antiretroviral-therapy-art-during-acute-hiv-1-infection-an-observational-study
#16
Timothy J Henrich, Hiroyu Hatano, Oliver Bacon, Louise E Hogan, Rachel Rutishauser, Alison Hill, Mary F Kearney, Elizabeth M Anderson, Susan P Buchbinder, Stephanie E Cohen, Mohamed Abdel-Mohsen, Christopher W Pohlmeyer, Remi Fromentin, Rebecca Hoh, Albert Y Liu, Joseph M McCune, Jonathan Spindler, Kelly Metcalf-Pate, Kristen S Hobbs, Cassandra Thanh, Erica A Gibson, Daniel R Kuritzkes, Robert F Siliciano, Richard W Price, Douglas D Richman, Nicolas Chomont, Janet D Siliciano, John W Mellors, Steven A Yukl, Joel N Blankson, Teri Liegler, Steven G Deeks
BACKGROUND: It is unknown if extremely early initiation of antiretroviral therapy (ART) may lead to long-term ART-free HIV remission or cure. As a result, we studied 2 individuals recruited from a pre-exposure prophylaxis (PrEP) program who started prophylactic ART an estimated 10 days (Participant A; 54-year-old male) and 12 days (Participant B; 31-year-old male) after infection with peak plasma HIV RNA of 220 copies/mL and 3,343 copies/mL, respectively. Extensive testing of blood and tissue for HIV persistence was performed, and PrEP Participant A underwent analytical treatment interruption (ATI) following 32 weeks of continuous ART...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29112693/comparison-of-two-cash-transfer-strategies-to-prevent-catastrophic-costs-for-poor-tuberculosis-affected-households-in-low-and-middle-income-countries-an-economic-modelling-study
#17
COMPARATIVE STUDY
William E Rudgard, Carlton A Evans, Sedona Sweeney, Tom Wingfield, Knut Lönnroth, Draurio Barreira, Delia Boccia
BACKGROUND: Illness-related costs for patients with tuberculosis (TB) ≥20% of pre-illness annual household income predict adverse treatment outcomes and have been termed "catastrophic." Social protection initiatives, including cash transfers, are endorsed to help prevent catastrophic costs. With this aim, cash transfers may either be provided to defray TB-related costs of households with a confirmed TB diagnosis (termed a "TB-specific" approach); or to increase income of households with high TB risk to strengthen their economic resilience (termed a "TB-sensitive" approach)...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29112692/contemporary-disengagement-from-antiretroviral-therapy-in-khayelitsha-south-africa-a-cohort-study
#18
Samantha R Kaplan, Christa Oosthuizen, Kathryn Stinson, Francesca Little, Jonathan Euvrard, Michael Schomaker, Meg Osler, Katherine Hilderbrand, Andrew Boulle, Graeme Meintjes
BACKGROUND: Retention in care is an essential component of meeting the UNAIDS "90-90-90" HIV treatment targets. In Khayelitsha township (population ~500,000) in Cape Town, South Africa, more than 50,000 patients have received antiretroviral therapy (ART) since the inception of this public-sector program in 2001. Disengagement from care remains an important challenge. We sought to determine the incidence of and risk factors associated with disengagement from care during 2013-2014 and outcomes for those who disengaged...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29112691/reaching-global-hiv-aids-goals-what-got-us-here-won-t-get-us-there
#19
Wafaa M El-Sadr, Katherine Harripersaud, Miriam Rabkin
In a Perspective, Wafaa El-Sadr and colleagues discuss tailored approaches to treatment and prevention of HIV infection.
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29112689/hiv-prevalence-and-behavioral-and-psychosocial-factors-among-transgender-women-and-cisgender-men-who-have-sex-with-men-in-8-african-countries-a-cross-sectional-analysis
#20
Tonia Poteat, Benjamin Ackerman, Daouda Diouf, Nuha Ceesay, Tampose Mothopeng, Ky-Zerbo Odette, Seni Kouanda, Henri Gautier Ouedraogo, Anato Simplice, Abo Kouame, Zandile Mnisi, Gift Trapence, L Leigh Ann van der Merwe, Vicente Jumbe, Stefan Baral
INTRODUCTION: Sub-Saharan Africa bears more than two-thirds of the worldwide burden of HIV; however, data among transgender women from the region are sparse. Transgender women across the world face significant vulnerability to HIV. This analysis aimed to assess HIV prevalence as well as psychosocial and behavioral drivers of HIV infection among transgender women compared with cisgender (non-transgender) men who have sex with men (cis-MSM) in 8 sub-Saharan African countries. METHODS AND FINDINGS: Respondent-driven sampling targeted cis-MSM for enrollment...
November 2017: PLoS Medicine
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