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      Integrase Strand Transfer Inhibitors and Weight Gain in Children and Youth With Perinatal Human Immunodeficiency Virus in the DC Cohort

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          Abstract

          We conducted a retrospective analysis of 38 children and youth with human immunodeficiency virus (aged 0–19 years) in the United States and report an increased rate of change of BMI-for-age z score after initiating integrase strand transfer inhibitors (+0.19 z score units/year [95% confidence interval, .01–.37]; P = .036) for a median follow-up of 527.5 days.

          Abstract

          Children and youth with HIV in the United States (n=38) have an increased rate of change of BMI-for-age z-score (+0.19 z-score units/year) after initiating integrase strand transfer inhibitors for a median follow-up of 527.5 days.

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          Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV

          Two drugs under consideration for inclusion in antiretroviral therapy (ART) regimens for human immunodeficiency virus (HIV) infection are dolutegravir (DTG) and tenofovir alafenamide fumarate (TAF). There are limited data on their use in low- and middle-income countries.
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            Childhood body-mass index and the risk of coronary heart disease in adulthood.

            The worldwide epidemic of childhood obesity is progressing at an alarming rate. Risk factors for coronary heart disease (CHD) are already identifiable in overweight children. The severity of the long-term effects of excess childhood weight on CHD, however, remains unknown. We investigated the association between body-mass index (BMI) in childhood (7 through 13 years of age) and CHD in adulthood (25 years of age or older), with and without adjustment for birth weight. The subjects were a cohort of 276,835 Danish schoolchildren for whom measurements of height and weight were available. CHD events were ascertained by linkage to national registers. Cox regression analyses were performed. In 5,063,622 person-years of follow-up, 10,235 men and 4318 women for whom childhood BMI data were available received a diagnosis of CHD or died of CHD as adults. The risk of any CHD event, a nonfatal event, and a fatal event among adults was positively associated with BMI at 7 to 13 years of age for boys and 10 to 13 years of age for girls. The associations were linear for each age, and the risk increased across the entire BMI distribution. Furthermore, the risk increased as the age of the child increased. Adjustment for birth weight strengthened the results. Higher BMI during childhood is associated with an increased risk of CHD in adulthood. The associations are stronger in boys than in girls and increase with the age of the child in both sexes. Our findings suggest that as children are becoming heavier worldwide, greater numbers of them are at risk of having CHD in adulthood. Copyright 2007 Massachusetts Medical Society.
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              Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial

              Background Tenofovir alafenamide shows high antiviral efficacy and improved renal and bone safety compared with tenofovir disoproxil fumarate when used for HIV treatment. Here, we report primary results from a blinded phase 3 study evaluating the efficacy and safety of pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir alafenamide versus emtricitabine and tenofovir disoproxil fumarate for HIV prevention. Methods This study is an ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial done at 94 community, public health, and hospital-associated clinics located in regions of Europe and North America, where there is a high incidence of HIV or prevalence of people living with HIV, or both. We enrolled adult cisgender men who have sex with men and transgender women who have sex with men, both with a high risk of acquiring HIV on the basis of their self-reported sexual behaviour in the past 12 weeks or their recent history (within 24 weeks of enrolment) of bacterial sexually transmitted infections. Participants with current or previous use of PrEP with emtricitabine and tenofovir disoproxil fumarate were not excluded. We used a computer-generated random allocation sequence to randomly assign (1:1) participants to receive either emtricitabine (200 mg) and tenofovir alafenamide (25 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir alafenamide group), or emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir disoproxil fumarate group). As such, all participants were given two tablets. The trial sponsor, investigators, participants, and the study staff who provided the study drugs, assessed the outcomes, and collected the data were masked to group assignment. The primary efficacy outcome was incident HIV infection, which was assessed when all participants had completed 48 weeks of follow-up and half of all participants had completed 96 weeks of follow-up. This full analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug and had at least one post-baseline HIV test. Non-inferiority of emtricitabine and tenofovir alafenamide to emtricitabine and tenofovir disoproxil fumarate was established if the upper bound of the 95·003% CI of the HIV incidence rate ratio (IRR) was less than the prespecified non-inferiority margin of 1·62. We prespecified six secondary bone mineral density and renal biomarker safety endpoints to evaluate using the safety analysis set. This analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug. This trial is registered with ClinicalTrials.gov , NCT02842086, and is no longer recruiting. Findings Between Sept 13, 2016, and June 30, 2017, 5387 (92%) of 5857 participants were randomly assigned and received emtricitabine and tenofovir alafenamide (n=2694) or emtricitabine and tenofovir disoproxil fumarate (n=2693). At the time of the primary efficacy analysis (ie, when all participants had completed 48 weeks and 50% had completed 96 weeks) emtricitabine and tenofovir alafenamide was non-inferior to emtricitabine and tenofovir disoproxil fumarate for HIV prevention, as the upper limit of the 95% CI of the IRR, was less than the prespecified non-inferiority margin of 1·62 (IRR 0·47 [95% CI 0·19–1·15]). After 8756 person-years of follow-up, 22 participants were diagnosed with HIV, seven participants in the emtricitabine and tenofovir alafenamide group (0·16 infections per 100 person-years [95% CI 0·06–0·33]), and 15 participants in the emtricitabine and tenofovir disoproxil fumarate group (0·34 infections per 100 person-years [0·19–0·56]). Both regimens were well tolerated, with a low number of participants reporting adverse events that led to discontinuation of the study drug (36 [1%] of 2694 participants in the emtricitabine and tenofovir alafenamide group vs 49 [2%] of 2693 participants in the emtricitabine and tenofovir disoproxil fumarate group). Emtricitabine and tenofovir alafenamide was superior to emtricitabine and tenofovir disoproxil fumarate in all six prespecified bone mineral density and renal biomarker safety endpoints. Interpretation Daily emtricitabine and tenofovir alafenamide shows non-inferior efficacy to daily emtricitabine and tenofovir disoproxil fumarate for HIV prevention, and the number of adverse events for both regimens was low. Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate. Funding Gilead Sciences.
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                Author and article information

                Journal
                Open Forum Infect Dis
                Open Forum Infect Dis
                ofid
                Open Forum Infectious Diseases
                Oxford University Press (US )
                2328-8957
                July 2021
                01 July 2021
                01 July 2021
                : 8
                : 7
                : ofab308
                Affiliations
                [1 ] Department of Infectious Diseases, Children’s National Hospital , Washington, District of Columbia, USA
                [2 ] School of Medicine and Health Sciences, George Washington University , Washington, District of Columbia, USA
                [3 ] School of Medicine, Case Western Reserve University , Cleveland, Ohio, USA
                [4 ] University Hospitals Cleveland Medical Center , Cleveland, Ohio, USA
                [5 ] Pediatric Infectious Diseases, Rainbow Babies and Children’s Hospital , Cleveland, Ohio, USA
                [6 ] Milken Institute School of Public Health, George Washington University , Washington, District of Columbia, USA
                [7 ] Westat , Rockville, Maryland, USA
                [8 ] Elizabeth Glaser Pediatric AIDS Foundation , Washington, District of Columbia, USA
                Author notes
                Correspondence: Wei Li Adeline Koay, MBBS, MSc, Children’s National Hospital, Department of Infectious Diseases, 111 Michigan Ave NW, West 3.5, Suite 100, Washington, DC 20010, USA ( wkoay@ 123456childrensnational.org ).
                Author information
                https://orcid.org/0000-0002-8825-7067
                Article
                ofab308
                10.1093/ofid/ofab308
                8291625
                34295943
                a72ceafd-c2d5-485a-a83b-45dc6e7e3ff9
                © The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                : 22 March 2021
                : 01 June 2021
                : 08 June 2021
                : 20 July 2021
                Page count
                Pages: 5
                Funding
                Funded by: National Institute of Allergy and Infectious Diseases, DOI 10.13039/100000060;
                Award ID: 5UM1AI069503–14
                Award ID: 1R24AI152598–01
                Funded by: National Institutes of Health, DOI 10.13039/100000002;
                Award ID: P30AI117970
                Funded by: National Cancer Institute, DOI 10.13039/100000054;
                Funded by: Eunice Kennedy Shriver National Institute of Child Health and Human Development, DOI 10.13039/100009633;
                Funded by: National Heart, Lung, and Blood Institute, DOI 10.13039/100000050;
                Funded by: National Institute on Drug Abuse, DOI 10.13039/100000026;
                Funded by: National Institute of Mental Health, DOI 10.13039/100000025;
                Funded by: National Institute on Aging, DOI 10.13039/100000049;
                Funded by: Fogarty International Center, DOI 10.13039/100000061;
                Funded by: National Institute of General Medical Sciences, DOI 10.13039/100000057;
                Funded by: National Institute of Diabetes and Digestive and Kidney Diseases, DOI 10.13039/100000062;
                Funded by: Office of AIDS Research, DOI 10.13039/100006084;
                Categories
                Brief Reports
                AcademicSubjects/MED00290
                Editor's Choice

                adolescents,body mass index,hiv,integrase inhibitors,youth
                adolescents, body mass index, hiv, integrase inhibitors, youth

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