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appropriate comparator therapy ARV antiretroviral EVG/COBI/FTC/TDF elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (fumarate) G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HIV-1 humanimmunodeficiencyvirus type 1 IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) RCT randomized controlled trial SGB Sozialgesetzbuch (Social Code Book) Extract of dossier assessment A17-59 Version 1.0 EVG/COBI/FTC/TDF (HIV (...) was based on a dossier compiled by the pharmaceutical company (hereinafter referred to as “the company”). The dossier was sent to IQWiG on 16 November 2017. Research question The aim of the present report was to assess the added benefit of EVG/COBI/FTC/TDF in comparison with the appropriate comparator therapy (ACT) in adolescents aged 12 to < 18 years with a body weight of = 35 kg who are infected with humanimmunodeficiencyvirus type 1 (HIV-1) without known mutations involving resistances against 1
for Quality and Efficiency in Health Care (IQWiG) - vi - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy AE adverse event ATV/co cobicistat-boosted atazanavir ATV/r ritonavir-boosted atazanavir bPi boosted protease inhibitor DRV darunavir DRV/co cobicistat-boosted darunavir DRV/r ritonavir-boosted darunavir FTC emtricitabine G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HIV-1 humanimmunodeficiencyvirus type 1 IQWiG Institut für Qualität und Wirtschaftlichkeit (...) to IQWiG on 27 September 2017. Research question The aim of this report was to assess the added benefit of DRV/COBI/FTC/TAF in comparison with the appropriate comparator therapy (ACT) in adults and adolescents (12 years of age and older and with a body weight of at least 40 kg) infected with humanimmunodeficiencyvirus type 1 (HIV-1). The G-BA's specification of the ACT resulted in 4 research questions, which are presented in the following Table 2. Table 2: Research questions of the benefit assessment
Bictegravir, emtricitabine and tenofovir alafenamide (Biktarvy) - for the treatment of humanimmunodeficiencyvirus-1 (HIV-1) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located
Assessment of HIV-related mental status changes Assessment of HIV-related mental status changes - Differential diagnosis of symptoms | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search Assessment of HIV-related mental status changes Last reviewed: February 2019 Last updated: October 2018 Summary Altered mental status and allied cognitive disorders have devastating consequences for HIV-infected individuals and their carers. Neuropsychological deficits also (...) have a negative impact on the quality of life. Pandya R, Krentz HB, Gill MJ, et al. HIV-related neurological syndromes reduce health-related quality of life. Can J Neurol Sci. 2005 May;32(2):201-4. http://www.ncbi.nlm.nih.gov/pubmed/16018155?tool=bestpractice.com These may arise as a direct effect of HIV infection: for example, as part of a spectrum of HIV-associated neurocognitive disorders (HAND) or as a psychiatric comorbidity (e.g., depression or alcohol/substance abuse). While HIV-related
â€˜Why would you promote something that is less percent safer than a condom?â€™: Perspectives on partially effective HIV prevention technologies among key populations in South Africa New biomedical prevention technologies (NPTs) for HIV, including oral Pre-Exposure Prophylaxis, and vaginal and rectal microbicides and HIV vaccines in development, may contribute substantially to controlling the HIV epidemic. However, their effectiveness is contingent on product acceptability and adherence. We
â€˜They care rudely!â€™: resourcing and relational health system factors that influence retention in care for people living with HIV in Zambia Despite access to free antiretroviral therapy (ART), many HIV-positive Zambians disengage from HIV care. We sought to understand how Zambian health system 'hardware' (tangible components) and 'software' (work practices and behaviour) influenced decisions to disengage from care among 'lost-to-follow-up' patients traced by a larger study on their current (...) health status.We purposively selected 12 facilities, from 4 provinces. Indepth interviews were conducted with 69 patients across four categories: engaged in HIV care, disengaged from care, transferred to another facility and next of kin if deceased. We also conducted 24 focus group discussions with 158 lay and professional healthcare workers (HCWs). These data were triangulated against two consecutive days of observation conducted in each facility. We conducted iterative multilevel analysis using
An evaluation of the innovative potentials of a HIV pilot exploring medical pluralism in rural South Africa This article reflects on an internal evaluation undertaken to estimate the potentials of a community-university pilot project to be developed into a bonafide innovation that can be applied at scale. The focus of the community-university partnership has been to reduce the unintended consequences of medical pluralism on the HIV and AIDS epidemic in Waterberg district, Limpopo Province (...) , South Africa. Despite promising outputs from the partnership - including an increase in adherence to antiretroviral therapy and a reduction in stigma among traditionalists living with HIV - the partnership wished to establish whether further funding should be applied for to take the pilot from its current prototype status to a more established innovation. In order to evaluate the innovative potentials of the pilot, the opportunity vacuum model of innovation was adapted and applied. The findings
Determinants of disclosure and non-disclosure of HIV-positive status, byÂ pregnant women in rural South Africa Disclosure of HIV status remains one of the major challenges to the effectiveness of the prevention of mother to child transmission of HIV in rural areas in South Africa. This study aimed at assessing the determinants of HIV status disclosure among HIV infected pregnant women who have disclosed their HIV status to someone, as well as among those who have disclosed to their partners (...) . Cross-sectional data was collected from 673 HIV sero-positive pregnant women receiving antenatal care services at 12 Community Health Centers in Mpumalanga province. Results indicated that over two-thirds (72.1%) disclosed their status to someone, while just over half (58.4%) disclosed to their partners. Multivariate analysis showed that both disclosure of ones HIV status to someone and to their male partners was significantly associated with increase in antiretroviral therapy (ART) adherence
-HSCT.Nested case series within the IciStem observational cohort.Multicenter European study.6 HIV-infected, antiretroviral-treated participants who survived more than 2 years after allo-HSCT with CCR5 wild-type donor cells.HIV DNA analysis, HIV RNA analysis, and quantitative viral outgrowth assay were performed in blood, and HIV DNA was also measured in lymph nodes, ilea, bone marrow, and cerebrospinal fluid. A humanized mouse model was used for in vivo detection of the replication-competent blood cell (...) reservoir. HIV-specific antibodies were measured in plasma.Analysis of the viral reservoir showed that 5 of 6 participants had full donor chimera in T cells within the first year after transplant, undetectable proviral HIV DNA in blood and tissue, and undetectable replication-competent virus (<0.006 infectious unit per million cells). The only participant with detectable virus received cord blood stem cells with an antithymocyte globulin-containing conditioning regimen, did not develop graft-versus-host
Effects of adolescent exposure to behaviour change interventions on their HIV risk reduction in Northern Malawi: a situation analysis Understanding adolescents' translation of HIV and AIDS-related behaviour change interventions (BCI) knowledge and skills into expected behavioural outcomes helps us appreciate behaviour change dynamics among young people and informs evidence-based programming. We explored the effects of adolescents' exposure to BCI on their HIV risk reduction in selected schools (...) model isolated sexual experience ([Beta = .727, p = .0001, p < .05]) as having the strongest correlation with the dependent variable - risk reduction. BCI exposure was stepwise excluded ([Beta = -.082, p = .053, p > .05]). There was therefore no evidence against the null hypothesis of no relationship between adolescent exposure to BCI and their HIV risk reduction. Overall there was limited BCI knowledge and skills translation to behavioural risk reduction. The study points to the need to evaluate
Prenatal and Perinatal HumanImmunodeficiencyVirus Testing - Expanded Recommendations Prenatal and Perinatal HumanImmunodeficiencyVirus Testing - Expanded Recommendations - ACOG Menu ▼ Prenatal and Perinatal HumanImmunodeficiencyVirus 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 (...) advances in the prevention of perinatal transmission of humanimmunodeficiencyvirus (HIV), it is clear that early identification and treatment of all pregnant women with HIV is the best way to prevent neonatal infection and also improve women’s health. Furthermore, new evidence suggests that early initiation of antiretroviral therapy in the course of infection is beneficial for individuals infected with HIV and reduces the rate of sexual transmission to partners who are not infected. Screening should
Labor and Delivery Management of Women With HumanImmunodeficiencyVirus Infection Labor and Delivery Management of Women With HumanImmunodeficiencyVirus Infection - ACOG Menu ▼ Labor and Delivery Management of Women With HumanImmunodeficiencyVirus 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 humanimmunodeficiencyvirus (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
Doravirine (Pifeltro) - To treat HIV-1 infection in adult patients Drug Approval Package: PIFELTRO (doravirine) U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: PIFELTRO (doravirine) Company: Merck Sharp & Dohme Corp. Application Number: 210806 & 210807 Approval Date: 08/30/2018 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA Application
Using strategic information for action: lessons from the HIV/AIDS response in Vietnam 30294455 2018 11 14 2059-7908 3 5 2018 BMJ global health BMJ Glob Health Using strategic information for action: lessons from the HIV/AIDS response in Vietnam. e000793 10.1136/bmjgh-2018-000793 Son Vo Hai VH Vietnam Administration on HIV/AIDS Control, Vietnam Ministry of Health, Hanoi, Vietnam. Abdul-Quader Abu A Center for Global Health, Centers for Disease Control and Prevention, Hanoi, Viet Nam. Suthar (...) Amitabh Bipin AB 0000-0001-9756-6593 Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. eng Journal Article 2018 09 26 England BMJ Glob Health 101685275 2059-7908 Hiv epidemiology geographic information systems health systems Competing interests: None declared. 2018 02 21 2018 05 07 2018 07 13 2018 10 9 6 0 2018 10 9 6 0 2018 10 9 6 1 epublish 30294455 10.1136/bmjgh-2018-000793 bmjgh-2018-000793 PMC6169661 Bull World Health Organ. 2010 Jan;88(1):58-65 20428354
Stick To It: pilot study results of an intervention using gamification to increase HIV screening among young men who have sex with men in California In the United States, young men who have sex with men (YMSM) experience a disproportionate burden of HIV and sexually transmitted infections (STIs). Mobile health (mHealth) interventions, including those that incorporate elements of games ("gamification"), have the potential to improve YMSM engagement in desirable sexual health services (...) and behaviors. Gamification leverages theory and tools from behavioral science to motivate people to engage in a behavior in a context of fun. The objective of the study was to determine whether an intervention using gamification is acceptable to YMSM in California and potentially increases repeat HIV screening.Eligible YMSM were: (I) 18-26 years, (II) born as and/or self-identified as male, (III) reported male sexual partners, and (IV) lived in a zip code adjacent to one of the two study clinics in Oakland
Exploring the acceptability of Option B plus among HIV-positive Nigerian women engaged and not engaged in the prevention of mother-to-child transmission of HIV cascade: a qualitative study The acceptability of lifelong antiretroviral therapy (ART) among HIV-positive women in high-burden Nigeria, is not well-known. We explored readiness of users and providers of prevention of mother-to-child transmission of HIV (PMTCT) services to accept lifelong ART -before Option B plus was implemented (...) in Nigeria. We conducted 142 key informant interviews among 100 PMTCT users (25 pregnant-newly-diagnosed, 26 pregnant-in-care, 28 lost-to-follow-up (LTFU) and 21 postpartum women living with HIV) and 42 PMTCT providers in rural North-Central Nigeria. Qualitative data were manually analyzed via Grounded Theory. PMTCT users had mixed views about lifelong ART, strongly influenced by motivation to prevent infant HIV and by presence or absence of maternal illness. Newly-diagnosed women were most enthusiastic
Factors associated with knowledge and awareness of HIV/AIDS among married women in Bangladesh: evidence from a nationally representative survey Women in Bangladesh share a greater risk of HumanImmunodeficiencyVirus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) infection compared to men. Levels of knowledge and awareness largely contribute to the prevalence of the HIV epidemic and its consequences. So, it is required to conduct studies based on most recent data to explore the determinants (...) of HIV awareness. Therefore, we aimed to find the awareness level and factors influencing HIV related awareness among the married women in Bangladesh. We used data from 2014 Bangladesh Demographic and Health Survey (BDHS). About two-third of total respondents who heard about the HIV/AIDS were selected and interviewed successfully (n = 12,593) about 11 basic questions related to individual's awareness. A score of the respondent's knowledge and awareness was determined based on these questions. We used
Integration of HIV and reproductive health services in public sector facilities: analysis of client flow data over time in Kenya Integration of HIV/AIDS with reproductive health (RH) services can increase the uptake and efficiency of services, but gaps in knowledge remain about the practice of integration, particularly how provision can be expanded and performance enhanced. We assessed the extent and nature of service integration in public sector facilities in four districts in Kenya.Between (...) 2009 and 2012, client flow assessments were conducted at six time points in 24 government facilities, purposively selected as intervention or comparison sites. A total of 25 539 visits were tracked: 15 270 in districts where 6 of 12 facilities received an intervention to strengthen HIV service integration with family planning (FP); and 10 266 visits in districts where half the facilities received an HIV-postnatal care intervention in 2009-2010. We tracked the proportion of all visits in which: (1
Validation of a Swahili version of the World Health Organization 5-item well-being index among adults living with HIV and epilepsy in rural coastal Kenya The purpose of this study was to evaluate the psychometric properties of the World Health Organization's five item well-being index (WHO-5) when administered to adults living with HIV or epilepsy in a rural setting at the coast of Kenya.A case control study design was conducted among 230 adults aged 18-50 years, who comprised 147 cases (63 (...) living with epilepsy and 84 living with HIV) and 83 healthy controls. The participants were administered to a face-to-face interview during which they completed the Swahili version of WHO-5 well-being index, the Major Depression Inventory (MDI) and responded to some items on their socio-demographic characteristics. Analysis to assess internal consistency, construct validity, discriminant validity, and convergent validity of the Swahili version of WHO-5 well-being index was conducted. A multivariate
Health-related quality of life and associated factors in adults living with HIV in Rwanda In Rwanda, as in other sub-Saharan African (SSA) countries, life expectancy of people living with HIV (PLWH) has increased dramatically as a result of combined antiretroviral therapy (cART). People living with HIV can now live longer but with increasing rates of non-communicable diseases (NCDs). Thus, prevention of NCD comorbidities in PWLHI is crucial to maintain and gain health-related benefits (...) and to maximise the health-related quality of life (HRQOL) in the long-term management of PLWH. This study determines the association between physical and mental health-related dimensions of quality of life (QOL) with behavioural and biological risk factors, after controlling socio-demographic and HIV-related factors in adults living with HIV in Rwanda. A cross-sectional study using the WHO STEPwise approach and Kinyarwanda version of the MOS-HIV Health Survey, risk factors for NCDs and HRQOL were analysed