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121. Bictegravir/emtricitabine/tenofovir alafenamide (HIV infection) - Benefit assessment according to §35a Social Code Book V

. Research question The aim of this report is to assess the added benefit of BIC/FTC/TAF in comparison with the appropriate comparator therapy (ACT) in adults infected with human immunodeficiency virus type 1 (HIV-1). The HIV virus must not have shown any evidence of past or current resistance to the class of integrase inhibitors, FTC, or tenofovir. The G-BA’s specification of the ACT results in 2 research questions, which are presented in Table 2 below. Table 2 2 : Research questions of the benefit (...) ; G-BA: Federal Joint Committee; HIV-1: human immunodeficiency virus type 1; TAF: tenofovir alafenamide; ART: antiretroviral therapy The company followed the G-BA’s specification of the ACT for both research questions. The assessment was conducted by means of patient-relevant outcomes on the basis of the data provided by the company in the dossier. Randomized controlled trials (RCTs) with a minimum duration of 48 weeks were used to derive any added benefit. 2 Table numbers start with “2

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

122. Medical and surgical abortion for women living with HIV. Full Text available with Trip Pro

Medical and surgical abortion for women living with HIV. The World Health Organization (WHO) guidelines for safe abortion recommend medical abortion with mifepristone and misoprostol or surgical abortion with vacuum aspiration or dilation and evacuation as safe and effective options for women. However, no specific clinical considerations are stipulated within these guidelines for women living with HIV. Concerns have been raised that women living with HIV may be at greater risk of adverse (...) abortion outcomes compared to HIV-uninfected women due to immunosuppression, high rates of co-infection with other sexually transmitted infections, and possible contraindications between medications used for medical abortion and antiretroviral therapy regimens.Our primary objective was to assess the effectiveness and safety of medical versus surgical abortion among women living with HIV. Our secondary objectives were to: (1) compare outcomes of medical and surgical abortion between women living

2018 Cochrane

123. HIV infection in pregnancy

and specialty care provided if the test is positive. All pregnant women with HIV should receive antiretroviral therapy (ART), as early as possible in the pregnancy, regardless of CD4 count or viral load. ART should be administered during the antepartum, intrapartum, and postnatal periods, as well as postnatally to the neonate. Breastfeeding is not recommended unless replacement feeding is not possible or feasible. Definition Human immunodeficiency virus (HIV) is a retrovirus that causes HIV infection (...) by infecting CD4 T cells and can lead to acquired immunodeficiency syndrome (AIDS). Van de Perre P, Simonon A, Msellati P, et al. Postnatal transmission of human immunodeficiency virus type 1 from mother to infant. A prospective cohort study in Kigali, Rwanda. N Engl J Med. 1991 Aug 29;325(9):593-8. http://www.ncbi.nlm.nih.gov/pubmed/1812850?tool=bestpractice.com Pregnancy in women living with HIV is complicated not only by HIV infection itself but also by the medical and psychosocial comorbidities

2018 BMJ Best Practice

124. HIV self-testing at the workplace

to include HIVST. Workplaces must implement HIVST within the context of human rights principles as set forth in the ILO Recommendation concerning HIV and AIDS and the world of work, 2010 (Recommendation 200) 7 – which apply to any HIV testing. They include: Consent: HIV testing must be genuinely voluntary and free of any coercion. It is the workers’ choice to accept a test kit or not, after receiving information or offer of the test. Also, workers should be free to choose the place and time to test (...) a better price with the manufacturer due to larger procurement volumes. Resource considerations Adequate human and financial resources are essential to operationalize HIVST at the workplace. Resource needs will depend on the scale and nature of the programme and the models adopted for delivering HIVST. Human resource and infrastructure: Staffing needs should be considered: Will enough staff be available to cope with the likely increase in demand for HIV testing? In workplaces with on-site health-care

2018 World Health Organisation HIV Guidelines

125. Postpartum women living with HIV: Challenges related to retention in care, treatment adherence, and mental health

and Gynaecology Canada. 2014;36(8):721–34. Gardner EM, McLees MP, Steiner JF, Del Rio C, Burman WJ. The spectrum of engagement in HIV care and its relevance to test-and-treat strategies for prevention of HIV infection. Clinical Infectious Diseases. 2011;52(6):793–800. Skarbinski J, Rosenberg E, Paz-Bailey G, Hall HI, Rose CE, Viall AH, et al. Human immunodeficiency virus transmission at each step of the care continuum in the United States. JAMA Internal Medicine. 2015;175(4):588–96. CATIE. Your guide to HIV (...) , McGregor DV, Sutton SH, Garcia PM, et al. Is maternal disclosure of HIV serostatus associated with a reduced risk of postpartum depression? American Journal of Obstetrics & Gynecology. 2016;215(4):521.e1–e5. Aaron E, Bonacquisti A, Geller PA, Polansky M. Perinatal depression and anxiety in women with and without human immunodeficiency virus infection. Women’s Health Issues. 2015;25(5):579–85. Stephens S, Ford E, Paudyal P, Smith H. Effectiveness of psychological interventions for postnatal depression

2018 Ontario HIV Treatment Network

126. British Association for Sexual Health and HIV national guideline for the management of infection with Mycoplasma genitalium

British Association for Sexual Health and HIV national guideline for the management of infection with Mycoplasma genitalium British Association for Sexual Health and HIV national guideline for the management of infection with Mycoplasma genitalium (2018) Suneeta Soni, Paddy Horner, Michael Rayment, Nicolas Pinto-Sander, Nadia Naous, Andy Parkhouse, Darren Bancroft, Carl Patterson, Helen Fifer 2 Introduction This is the first British Association of Sexual Health and HIV (BASHH) guideline (...) recommendations were presented at the joint British HIV Association and BASHH annual conference 2018. The draft guideline was appraised by the CEG using the AGREE instrument, posted on the BASHH website for a consultation period of 2 months, and piloted in a sample of clinics. In response to the consultation, suitable amendments were made to the guideline and the final draft was submitted to the CEG. The patient information leaflet (PIL) was reviewed by the CEG, BASHH patient and public panel, and also

2018 British Association for Sexual Health and HIV

127. HIV infection

HIV infection HIV infection - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  HIV infection Last reviewed: February 2019 Last updated: March 2019 Important updates 09 Nov 2018 US guidelines now recommend doravirine for the treatment of HIV Updated guidelines published by the US Department of Health and Human Services now recommend doravirine-based antiretroviral regimens as an initial option for the treatment of HIV (...) therapy (ART) as soon as possible. Pre-exposure prophylaxis with daily ART reduces the risk of HIV infection in adults who are at high risk for HIV acquisition and is recommended in select patients. Diagnosis and management varies between resource-intensive settings and resource-limited settings. Definition HIV infection is a pandemic infectious disease whose impact on societies is without precedent. It is caused by a retrovirus that infects and replicates in human lymphocytes and macrophages, eroding

2018 BMJ Best Practice

128. External quality assessment for HIV rapid tests: challenges and opportunities in Haiti Full Text available with Trip Pro

-efficient strategies are sought to ensure the quality of HIV diagnosis in LMICs. Qualified human resources, continuous training, supervision and community-tailored PT programmes remain key components for the success of HIV RDT quality management. (...) External quality assessment for HIV rapid tests: challenges and opportunities in Haiti HIV rapid diagnostic tests (RDTs) are instrumental in scaling-up HIV testing services (HTS) in low-income and middle-income countries (LMICs). HIV misdiagnosis is a growing concern in the era of expanded and decentralised access to HTS. External quality assurance (EQA) programme including proficiency testing (PT) for HIV RDTs is a priority to guarantee the accuracy and reliability of the patients' result

2018 BMJ global health

129. The pull of soccer and the push of Xhosa boys in an HIV and drug abuse intervention in the Western Cape, South Africa Full Text available with Trip Pro

The pull of soccer and the push of Xhosa boys in an HIV and drug abuse intervention in the Western Cape, South Africa There is growing interest in engaging men and boys in health and development programmes targeting the intersection of HIV risk, substance abuse, and violence. Understanding the conceptualisations of masculinities or masculine identities that shape both behaviours and opportunities for intervention is central to advancing the global agenda to engage men in health and development (...) interventions. This paper examines an intervention using soccer and job training to engage and deliver activities for HIV prevention, substance abuse, and gender-based violence in a South African township. A literature review provides theoretical, historical and social context for the intersection of gender, masculinity, soccer, violence, and sexual relationships. Qualitative data from in-depth interviews and focus groups is analysed using theoretical and contextual frames to elucidate the negotiation

2018 SAHARA J : journal of Social Aspects of HIV/AIDS Research Alliance

130. Antiretroviral resistance testing in HIV-positive people. Full Text available with Trip Pro

Antiretroviral resistance testing in HIV-positive people. Resistance to antiretroviral therapy (ART) among people living with human immunodeficiency virus (HIV) compromises treatment effectiveness, often leading to virological failure and mortality. Antiretroviral drug resistance tests may be used at the time of initiation of therapy, or when treatment failure occurs, to inform the choice of ART regimen. Resistance tests (genotypic or phenotypic) are widely used in high-income countries (...) , but not in resource-limited settings. This systematic review summarizes the relative merits of resistance testing in treatment-naive and treatment-exposed people living with HIV.To evaluate the effectiveness of antiretroviral resistance testing (genotypic or phenotypic) in reducing mortality and morbidity in HIV-positive people.We attempted to identify all relevant studies, regardless of language or publication status, through searches of electronic databases and conference proceedings up to 26 January 2018. We

2018 Cochrane

131. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferior (Abstract)

Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferior Effective two-drug regimens could decrease long-term drug exposure and toxicity with HIV-1 antiretroviral therapy (ART). We therefore aimed to evaluate the efficacy and safety of a two-drug regimen compared with a three-drug regimen (...) for the treatment of HIV-1 infection in ART-naive adults.We conducted two identically designed, multicentre, double-blind, randomised, non-inferiority, phase 3 trials: GEMINI-1 and GEMINI-2. Both studies were done at 192 centres in 21 countries. We included participants (≥18 years) with HIV-1 infection and a screening HIV-1 RNA of 500 000 copies per mL or less, and who were naive to ART. We randomly assigned participants (1:1) to receive a once-daily two-drug regimen of dolutegravir (50 mg) plus lamivudine (300

2018 Lancet Controlled trial quality: predicted high

132. HIV-related opportunistic infections

HIV-related opportunistic infections HIV-related opportunistic infections - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  HIV-related opportunistic infections Last reviewed: February 2019 Last updated: November 2018 Summary The risk of HIV-related opportunistic infections (OIs) in HIV-infected people increases as the CD4+ count declines. Risk also increases in patients who are not receiving, or are not responding (...) to, antiretroviral treatment (ART). For most HIV-infected patients with an acute OI, ART should be considered within the first 2 weeks of initiation of treatment for the acute OI. However, in tuberculosis (TB) it might be appropriate to wait for a therapeutic response before ART is started. The use of ART among patients treated for OIs is complicated by drug interactions, drug toxicity profiles, and immune reconstitution inflammatory syndrome (IRIS). IRIS has been observed most commonly with mycobacterial

2018 BMJ Best Practice

133. Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV-1 infection 2015: optimizing health in preparation for adult life

. • A negative serological test in children who have had a positive HIV RNA PCR test does not exclude ongoing HIV infection. • A detailed history of any possible previous ART given to the child and/or mother (or other likely source of infec- tion) should be documented. • The genotypic HIV resistance pro?le should be docu- mented at baseline. • The human leucocyte antigen (HLA) B*5701 genotype shouldbecon?rmednegativebeforeusingabacavir(ABC). • Clinical assessment should be carried out 3-4-monthly in children (...) infants at low risk of HIV transmission (maternal VL 100000 copies/ml); • in asymptomatic children aged 1–3 years irrespective of immune status and VL; • in sexually active adolescents, to minimize the risk of onward transmission; • in the presence of any signi?cant HIV-related clinical symptoms; • in hepatitis B virus (HBV) coinfection irrespective of immune status. 6. Which ART regimen to start as ?rst-line therapy • Children should start effective (at least three drugs) ART, usually a dual

2018 The Children's HIV Association

134. Preparing HIV-infected children and adolescents for travel

, Grabar S, Gordien E, et al. Immunological efficacy of a three-dose schedule of hepatitis A vaccine in HIV-infected adults: HEPAVAC study. J Acquir Immune Defic Syndr. 2008;49(3):272-5. 7. Crisinel PA, Posfay-Barbe KM, Aebi C, et al. Determinants of hepatitis A vaccine immunity in a cohort of human immunodeficiency virus-infected children living in Switzerland. Clin Vaccine Immunol. 2012;19(11):1751-7. 8. Crane HM, Dhanireddy S, Kim HN, et al. Hepatitis A vaccination among human immuno- deficiency (...) . Safety and immunogenicity of preexposure rabies vaccination in children infected with human immunodeficiency virus type 1. Clin Infect Dis. 2000;30(1):218. 15. WHO. Vaccines and vaccination against yellow fever: WHO Position Paper. June 2013. http://www.who.int/wer/2013/wer8827.pdf?ua=1. 16. Veit O, Niedrig M, Chapuis-Taillard C, et al. Immunogenicity and safety of yellow fever vaccination for 102 HIV-infected patients. Clin Infect Dis. 2009;48(5):659-66. 20 17. Staples JE, Bocchini JA, Jr., Rubin L

2018 The Children's HIV Association

135. Antiretroviral / HIV Drug Dosing for Paediatrics

Antiretroviral / HIV Drug Dosing for Paediatrics Antiretroviral / HIV Drug Dosing for Paediatrics 2018-19(v2) - Imperial College Healthcare NHS Trust (NOT for neonatal vertical transmission post exposure prophylaxis – see local / BHIVA guidelines) Agent Recommended dosage, class side effects and contraindications & warnings Formulation Comment Intake Advice Nucleoside Reverse Transcriptase Inhibitors (NRTI): lactic acidosis, steatosis, Lipoatrophy (effects of mitochondrial toxicity) Lamivudine (...) is intended to be used by practitioners experienced in paediatric HIV care. Please do not use this outside these recommendations. The table will be reviewed in June 2019 Tel: Family clinic: 020-3312-6349, Paed HIV Pharmacist: 020-3312-7617 Authors: Caroline Foster, Hermione Lyall, Gareth Tudor-Williams and Neil Tickner Please email feedback to: ntickner@nhs.net Version 4.1

2018 The Children's HIV Association

136. Effectiveness of oral pre-exposure prophylaxis (PrEP) for HIV

. Knox DC, Anderson PL, Harrigan PR, Tan DH. Multidrug-resistant HIV-1 Infection despite preexposure prophylaxis. New England Journal of Medicine. 2017;376(5):501–2. Montgomery MC, Oldenburg CE, Nunn AS, Mena L, Anderson P, Liegler T, et al. Adherence to pre-exposure prophylaxis for HIV prevention in a clinical setting. PLoS ONE [Electronic Resource]. 2016;11(6):e0157742. Colby DJ, Kroon E, Sacdalan C, Gandhi M, Grant RM, Phanuphak P, et al. Acquisition of multidrug-resistant human immunodeficiency (...) drug-resistant mutations; the underlying cause for this infection remains unclear (15). Authors hypothesise infection with a “wild-type” HIV virus, and that frequent condomless anal sex, potential repeated exposure to HIV, repeated diagnosis of sexually transmitted infections, and the pharmacokinetics of TDF/FTC in rectal mucosa may have contributed to seroconversion (15). Practical considerations While daily oral TDF (with or without FTC) is protective against HIV infection, this is highly

2018 Ontario HIV Treatment Network

137. Elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil (HIV-1 in adolescents) ? Benefit assessment according to §35a Social Code Book (SGB) V

appropriate comparator therapy ARV antiretroviral EVG/COBI/FTC/TDF elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (fumarate) G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HIV-1 human immunodeficiency virus 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 human immunodeficiency virus type 1 (HIV-1) without known mutations involving resistances against 1

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

138. Darunavir-cobicistat-emtricitabine-tenofovir alafenamide (HIV infection) - Benefit assessment according to §35a Social Code Book V

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 human immunodeficiency virus 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 human immunodeficiency virus 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

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

139. Bictegravir, emtricitabine and tenofovir alafenamide (Biktarvy) - for the treatment of human immunodeficiency virus-1 (HIV-1)

Bictegravir, emtricitabine and tenofovir alafenamide (Biktarvy) - for the treatment of human immunodeficiency virus-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

2018 Health Canada - Drug and Health Product Register

140. Assessment of HIV-related mental status changes

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

2018 BMJ Best Practice