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1. Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) adults infected with human immunodeficiency virus-1 (HIV-1)

Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) adults infected with human immunodeficiency virus-1 (HIV-1) AWMSG SECRETARIAT ASSESSMENT REPORT Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy ® ) 50 mg/200 mg/25 mg film-coated tablets Reference number: 3414 FULL SUBMISSION This report has been prepared by the All Wales Therapeutics & Toxicology Centre (AWTTC). Please direct any queries to AWTTC: All Wales Therapeutics & Toxicology Centre (AWTTC) University Hospital (...) from the date of the Final Appraisal Recommendation. AWMSG Secretariat Assessment Report Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy ® ? ) 50 mg/200 mg/25 mg film-coated tablets 1.0 KEY FACTS Assessment details Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy ® ? ) for the treatment of adults infected with human immunodeficiency virus-1 (HIV-1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir. ?This medicinal

2018 All Wales Medicines Strategy Group

2. Management of newborns born to women with HIV (Human Immunodeficiency Virus) infection

(ART); - most recent HIV test results (e.g. HIV viral load, HIV Proviral Deoxyribonucleic Acid (DNA) test result, CD4 (T-helper cells) count and HIV resistance tests), if available; - contact details for managing Obstetrician, HIV physician and Paediatrician/Neonatologist. CHQ-GDL-01243 Management of newborns born to women with HIV (Human Immunodeficiency Virus) infection - 3 - • To refer please complete the CHQ Specialist Referral form. CHQ IMPS (team responsible for HIV management) will arrange (...) . In the event of a woman presenting for obstetric management late in pregnancy (e.g. in third trimester or in labour), CHQ IMPS should be contacted urgently before infant is delivered. Figure 1. Referral pathway CHQ-GDL-01243 Management of newborns born to women with HIV (Human Immunodeficiency Virus) infection - 4 - 2. Recommended antiretroviral treatment (ART) for newborn and post-natal care A standard newborn assessment should be performed at birth by the local paediatric / neonatal team. Testing

2019 Queensland Health

3. Human Immunodeficiency Virus (HIV) Infection: Screening

February 2019. Accessed April 9, 2019. 2. Centers for Disease Control and Prevention (CDC). Diagnoses of HIV Infection in the United States and Dependent Areas, 2017. CDC website. . Published November 2018. Accessed April 5, 2019. 3. Singh S, Song R, Johnson AS, McCray E, Hall HI. HIV incidence, prevalence, and undiagnosed infections in U.S. men who have sex with men. Ann Intern Med . 2018;168(10):685-694. 4. Dailey AF, Hoots BE, Hall HI, et al. Vital signs: human immunodeficiency virus testing (...) Rep . 2006;55(RR-14):1-17. 11. DiNenno EA, Prejean J, Irwin K, et al. Recommendations for HIV screening of gay, bisexual, and other men who have sex with men—United States, 2017. MMWR Morb Mortal Wkly Rep . 2017;66(31):830-832. 12. Committee on Obstetric Practice; HIV Expert Work Group. ACOG Committee Opinion No. 752: prenatal and perinatal human immunodeficiency virus testing. Obstet Gynecol . 2018;132(3):e138-e142. 13. US Department of Health and Human Services. Clinical guidelines. AIDSinfo

2019 U.S. Preventive Services Task Force

4. Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure Prophylaxis

Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure Prophylaxis Recommendation | United States Preventive Services Taskforce Toggle navigation Main navigation Main navigation Recommendation Persons at high risk of HIV acquisition The USPSTF recommends that clinicians offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy to persons who are at high risk of HIV acquisition. A View the Clinical Summary in Population Persons at high risk of HIV acquisition (...) Once-daily oral treatment with combined tenofovir disoproxil fumarate and emtricitabine is the only formulation of PrEP currently approved by the US Food and Drug Administration for use in the United States in persons at risk of sexual acquisition of HIV infection. Relevant USPSTF Recommendations The USPSTF has issued recommendations on behavioral counseling to reduce risk of STIs and on screening for HIV infection. Abbreviations: HIV=human immunodeficiency virus; STI=sexually transmitted infection

2019 U.S. Preventive Services Task Force

5. Prenatal and Perinatal Human Immunodeficiency Virus Testing - Expanded Recommendations

Prenatal and Perinatal Human Immunodeficiency Virus Testing - Expanded Recommendations Prenatal and Perinatal Human Immunodeficiency Virus Testing - Expanded Recommendations - ACOG Menu ▼ Prenatal and Perinatal Human Immunodeficiency Virus Testing - Expanded Recommendations Page Navigation ▼ INTERIM UPDATE Number 752 (Replaces Committee Opinion No. 635, June 2015) Committee on Obstetric Practice HIV Expert Work Group This Committee Opinion was developed by the American College of Obstetricians (...) be performed after women have been notified that HIV screening is recommended for all pregnant patients and that they will receive an HIV test as part of the routine panel of prenatal tests unless they decline (opt-out screening). Human immunodeficiency virus testing using the opt-out approach, which is currently permitted in every jurisdiction in the United States, should be a routine component of care for women during prepregnancy and as early in pregnancy as possible. Repeat HIV testing in the third

2018 American College of Obstetricians and Gynecologists

6. The clinical effectiveness of individual behaviour change interventions to reduce risky sexual behaviour after a negative human immunodeficiency virus test in men who have sex with men: systematic and realist reviews and intervention development

of acquiring a human immunodeficiency virus (HIV) infection. Guidance relating to both HIV infection prevention, in general, and individual-level behaviour change interventions, in particular, is very limited. The objective of this review was to conduct an evidence synthesis of the clinical effectiveness of behaviour change interventions to reduce risky sexual behaviour among MSM after a negative HIV infection test. To identify effective components within interventions in reducing HIV risk-related (...) The clinical effectiveness of individual behaviour change interventions to reduce risky sexual behaviour after a negative human immunodeficiency virus test in men who have sex with men: systematic and realist reviews and intervention development The clinical effectiveness of individual behaviour change interventions to reduce risky sexual behaviour after a negative human immunodeficiency virus test in men who have sex with men: systematic and realist reviews and intervention development

2017 Health Technology Assessment (HTA) Database.

7. Technical specifications series for submission to WHO prequalification: diagnostic assessment: Human Immunodeficiency Virus (HIV) rapid diagnostic tests for professional use and/or self-testing

Technical specifications series for submission to WHO prequalification: diagnostic assessment: Human Immunodeficiency Virus (HIV) rapid diagnostic tests for professional use and/or self-testing Human Immunodeficiency Virus (‎HIV)‎ rapid diagnostic tests for professional use and/or self-testing JavaScript is disabled for your browser. Some features of this site may not work without it. Toggle navigation Toggle navigation Search Browse Statistics Related Links Human Immunodeficiency Virus (‎HIV (...) )‎ rapid diagnostic tests for professional use and/or self-testing View/ Open Rights View Statistics Altmetrics Share Citation World Health Organization . (‎2016)‎. Human Immunodeficiency Virus (‎HIV)‎ rapid diagnostic tests for professional use and/or self-testing. World Health Organization. . License: CC BY-NC-SA 3.0 IGO Relation Technical specifications series for submission to WHO prequalification: diagnostic assessment, TSS-1 Description 26 p. ISBN 9789241511742 Collections Language English

2016 WHO

8. Seroprevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) among human immunodeficiency virus (HIV)-infected patients in an HBV endemic area in Brazil. Full Text available with Trip Pro

Seroprevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) among human immunodeficiency virus (HIV)-infected patients in an HBV endemic area in Brazil. Hepatitis B virus (HBV) and hepatitis C virus (HCV) are a common cause of complications in liver disease and immunological impairment among human immunodeficiency virus (HIV)-infected patients. The aim of this study was to assess the seroprevalence of HBV and HCV and their correlation with CD4+ T-cells among HIV-infected patients (...) in an HBV endemic area.A cross-sectional observational and retrospective study was carried out in a reference center in Southern Brazil between January 2005 and December 2016. Socio-demographic data were collected by using a structured questionnaire. Serological tests and analysis of CD4+ T-cell count levels were performed using standard procedures.The seroprevalence of HIV-HBV, HIV-HCV, and HIV-HBV-HCV coinfections was 3.10%, 3.10%, and 0.16%, respectively. At baseline, anti-hepatitis B surface

2018 PLoS ONE

9. False-negative Results of Human Immunodeficiency Virus (HIV) Rapid Testing in HIV Controllers. (Abstract)

False-negative Results of Human Immunodeficiency Virus (HIV) Rapid Testing in HIV Controllers. Serological assays were performed on 85 human immunodeficiency virus-controller samples . 6% presented a negative rapid screening test 7% presented an indeterminate Western blot. The enzyme immunoassay ratio decreased in controllers who had continual negative ultrasensitive HIV RNA results since inclusion.© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society

2019 Clinical Infectious Diseases

10. Efficacy of a Clinic-Based Safer Sex Program for Human Immunodeficiency Virus-Uninfected and Human Immunodeficiency Virus-Infected Young Black Men Who Have Sex With Men: A Randomized Controlled Trial. (Abstract)

Efficacy of a Clinic-Based Safer Sex Program for Human Immunodeficiency Virus-Uninfected and Human Immunodeficiency Virus-Infected Young Black Men Who Have Sex With Men: A Randomized Controlled Trial. To test the efficacy of a single-session, clinic-based intervention designed to promote condom use among young black men who have sex with men (YBMSM).Six hundred YBMSM were enrolled in a randomized controlled trial, using a 12-month observation period. An intent-to-treat analysis was performed (...) , with multiple imputation for missing data.Compared with the reference group, human immunodeficiency virus (HIV)-infected men in the intervention group had 64% greater odds of reporting consistent condom use for anal receptive sex over 12 months (estimated odds ratio, 1.64; 95% confidence interval, 1.23-2.17, P = 0.001). Also, compared with the reference group, HIV-uninfected men in the intervention group had more than twice the odds of reporting consistent condom use for anal receptive sex over 12 months

2019 Sexually transmitted diseases Controlled trial quality: uncertain

11. Labor and Delivery Management of Women With Human Immunodeficiency Virus Infection

Labor and Delivery Management of Women With Human Immunodeficiency Virus Infection Labor and Delivery Management of Women With Human Immunodeficiency Virus Infection - ACOG Menu ▼ Labor and Delivery Management of Women With Human Immunodeficiency Virus Infection Page Navigation ▼ Number 751 (Replaces Committee Opinion No. 234, May 2000) Committee on Obstetric Practice HIV Expert Work Group The Society for Maternal–Fetal Medicine endorses this document. This Committee Opinion was developed (...) of pregnant women during pregnancy and delivery to prevent mother-to-child transmission of the human immunodeficiency virus (HIV). Prevention of transmission of HIV from the woman to her fetus or newborn is a major goal in the care of pregnant women infected with HIV. Continuing research into mother-to-child transmission of HIV has suggested that a substantial number of cases of perinatal HIV transmission occur as the result of fetal exposure to the virus during labor and delivery. The precise mechanisms

2018 American College of Obstetricians and Gynecologists

12. Emtricitabine/Tenofovir disoproxil Zentiva - human immunodeficiency virus type 1 (HIV-1)

Emtricitabine/Tenofovir disoproxil Zentiva - human immunodeficiency virus type 1 (HIV-1) 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 15 September 2016 EMA/650230/2016 Committee for Medicinal Products for Human Use (CHMP (...) efavirenz Assessment report EMA/650230/2016 Page 4/28 eGFR estimated glomerular filtration rate EMA European Medicines Agency ESRD end-stage renal disease FDA U.S. Food and Drug Administration FTC emtricitabine GC gas chromatography GCP good clinical practise GFR glomerular filtration rate h hour HAART highly active antiretroviral therapy HBeAg hepatitis B e antigen HBV hepatitis B virus HDL high-density lipoprotein HDPE high density polyethylene HIV human immunodeficiency virus HPLC high performance

2016 European Medicines Agency - EPARs

13. The Brazilian experience of nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus infections in blood donors. Full Text available with Trip Pro

The Brazilian experience of nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus infections in blood donors. The history of the development and implementation of the Brazilian nucleic acid testing (NAT) platform to detect and discriminate among human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) infections in blood donors is described here. The results for the sensitivity, reproducibility, and NAT yield (...) of the platform since program implementation are provided.The Brazilian NAT HIV, HCV, and HBV kit was developed and evaluated with regard to analytical sensitivity, specificity, intralot and interlot reproducibility, interfering substances, and genotype and diagnostic sensitivity. Additionally, a sample of identified NAT-yield cases was characterized with regard to viral load.The 95% limits of detection for HIV, HCV, and HBV were 68.02, 102.35, and 9.08 IU/mL, respectively. All replicates were detected

2018 Transfusion

14. Human Immunodeficiency Virus Serodiscordance and Dual Contraceptive Method Use Among Human Immunodeficiency Virus-infected Men and Women in Lilongwe, Malawi Full Text available with Trip Pro

Human Immunodeficiency Virus Serodiscordance and Dual Contraceptive Method Use Among Human Immunodeficiency Virus-infected Men and Women in Lilongwe, Malawi Some human immunodeficiency virus (HIV) serodiscordant couples are faced with the dual challenge of preventing HIV transmission to the uninfected partner and avoiding unintended pregnancy. Therefore, we hypothesized that serodiscordance is associated with dual method use at last sex.We analyzed data from a cross-sectional survey of HIV (...) -infected men and women attending 2 ante-retroviral therapy clinics in Lilongwe, Malawi. We used Fisher exact test and Wilcoxon rank sum to assess for associations between serodiscordance, covariates, and dual method use. Multivariable logistic regression was used to estimate the adjusted odds ratio (aOR) and 95% confidence intervals (CI) of dual method use at last sex, comparing serodiscordant to seroconcordant relationships. Separate analyses were conducted for men and women.We surveyed 253 HIV

2018 Sexually transmitted diseases

15. National scale-up of tuberculosis-human immunodeficiency virus collaborative activities in Myanmar from 2005 to 2016 and tuberculosis treatment outcomes for patients with human immunodeficiency virus-positive tuberculosis in the Mandalay Region in 2015. Full Text available with Trip Pro

National scale-up of tuberculosis-human immunodeficiency virus collaborative activities in Myanmar from 2005 to 2016 and tuberculosis treatment outcomes for patients with human immunodeficiency virus-positive tuberculosis in the Mandalay Region in 2015. HIV-associated TB is a serious public health problem in Myanmar. Study objectives were to describe national scale-up of collaborative activities to reduce the double burden of TB and HIV from 2005 to 2016 and to describe TB treatment outcomes (...) of individuals registered with HIV-associated TB in 2015 in the Mandalay Region.Secondary analysis of national aggregate data and, for treatment outcomes, a cohort study of patients with HIV-associated TB in the Mandalay Region.The number of townships implementing collaborative activities increased from 7 to 330 by 2016. The number of registered TB patients increased from 1577 to 139 625 in 2016, with the number of individuals tested for HIV increasing from 432 to 114 180 (82%) in 2016: 10 971 (10%) were

2018 Transactions of the Royal Society of Tropical Medicine & Hygiene

16. Emtricitabine/rilpivirine/tenofovir disoproxil (as fumarate) (Eviplera) - antiretroviral treatmentexperienced adults infected with human immunodeficiency virus type 1 (HIV-1)

as an option for use within NHS Wales for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load = 100,000 HIV-1 RNA copies/mL. Genotypic resistance testing and/or historical resistance data should guide the use of emtricitabine/rilpivirine/tenofovir disoproxil (Eviplera ® ). 2 of 2 Statement of use: No part (...) Emtricitabine/rilpivirine/tenofovir disoproxil (as fumarate) (Eviplera) - antiretroviral treatmentexperienced adults infected with human immunodeficiency virus type 1 (HIV-1) Final Appraisal Recommendation Advice No: 1514 – June 2014 Emtricitabine/rilpivirine/tenofovir disoproxil (as fumarate) (Eviplera ® ) 200 mg/25 mg/245 mg film-coated tablet Limited submission by Gilead Sciences Ltd Additional note: ? This advice incorporates and replaces the existing AWMSG recommendation on emtricitabine

2014 All Wales Medicines Strategy Group

17. TAILoR (TelmisArtan and InsuLin Resistance in Human Immunodeficiency Virus [HIV]): An Adaptive-design, Dose-ranging Phase IIb Randomized Trial of Telmisartan for the Reduction of Insulin Resistance in HIV-positive Individuals on Combination Antiretroviral Full Text available with Trip Pro

TAILoR (TelmisArtan and InsuLin Resistance in Human Immunodeficiency Virus [HIV]): An Adaptive-design, Dose-ranging Phase IIb Randomized Trial of Telmisartan for the Reduction of Insulin Resistance in HIV-positive Individuals on Combination Antiretroviral Combination antiretroviral therapy results in metabolic abnormalities which increase cardiovascular disease risk. We evaluated whether telmisartan reduces insulin resistance in human immunodeficiency virus (HIV)-positive individuals (...) on antiretrovirals.We conducted a multicenter, randomized, open-label, dose-ranging controlled trial of telmisartan. Participants with HIV infection receiving combination antiretroviral therapy were randomized equally to either no intervention (control) or 20, 40, or 80 mg telmisartan once daily. The adaptive design allowed testing of all dose(s) of telmisartan in stage I, with the promising dose(s) being taken into stage II. The primary outcome measure was reduction in homeostasis model assessment of insulin

2019 Clinical Infectious Diseases Controlled trial quality: uncertain

18. Drug resistance mutations and viral load in human immunodeficiency virus type 2 and dual HIV-1/HIV-2 infected patients in Ghana. Full Text available with Trip Pro

Drug resistance mutations and viral load in human immunodeficiency virus type 2 and dual HIV-1/HIV-2 infected patients in Ghana. Antiretroviral therapy (ART) and drug resistance studies worldwide have focused almost exclusively on human immunodeficiency virus type 1 (HIV-1). As a result, there is limited information on ART and drug resistance in HIV-2 patients. In Ghana, the HIV epidemic is characterized by the domination of HIV-1, with cocirculating HIV-2. We, therefore, sought to determine (...) viral load and drug resistance mutations in HIV-2 patients to inform the clinical management of such individuals in Ghana.We used purposive sampling to collect blood from 16 consented patients, confirmed as HIV-2 or HIV-1/2 dual infections by serology. A 2-step real-time RT-PCR assay was used to determine plasma HIV-2 RNA viral loads. For drug resistance testing, nucleic acids were extracted from plasma and peripheral blood mononuclear cells. The reverse transcriptase and protease genes of HIV-2

2019 Medicine

19. Estimating Initial Viral Levels during Simian Immunodeficiency Virus/Human Immunodeficiency Virus Reactivation from Latency Full Text available with Trip Pro

Estimating Initial Viral Levels during Simian Immunodeficiency Virus/Human Immunodeficiency Virus Reactivation from Latency Human immunodeficiency virus (HIV) viremia rebounds rapidly after treatment interruption, and a variety of strategies are being explored to reduce or control viral reactivation posttreatment. This viral rebound arises from reactivation of individual latently infected cells, which spread during ongoing rounds of productive infection. The level of virus produced (...) of approaches being tested aimed at either eradicating latently infected cells or controlling the virus if it returns. Studying both the small pool of latently infected cells and the early events during viral reactivation is difficult, because these involve very small levels of virus that are difficult to measure directly. Here, we combine experimental data and mathematical modeling to understand the very early events during viral reactivation from latency in both HIV infection of humans and SIV infection

2018 Journal of virology

20. Performance of Two-Stage Cervical Cancer Screening With Primary High-Risk Human Papillomavirus Testing in Women Living With Human Immunodeficiency Virus. (Abstract)

Performance of Two-Stage Cervical Cancer Screening With Primary High-Risk Human Papillomavirus Testing in Women Living With Human Immunodeficiency Virus. To evaluate the performance of cervical cancer screening algorithms for women living with human immunodeficiency virus (HIV), using primary high-risk human papillomavirus (HPV) testing followed by cytology, visual inspection with acetic acid, or colposcopy.We conducted a prospective cohort study of women living with HIV in Botswana. All (...) + of +1.2, and LR- of -0.8. High-risk HPV testing followed by cytology also resulted in a reduced sensitivity of 62%, specificity of 77%, PPV of 60%, LR+ of +2.7, and LR- of -0.5. Stratification by HPV 16/18/45 did not improve performance of the algorithms.In a high-risk population with HIV, high-risk HPV testing followed by colposcopy demonstrated the highest sensitivity and PPV in detecting high-grade cervical dysplasia. Allocating resources to colposcopy in resource-limited settings may be more

2019 Obstetrics and Gynecology

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