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Doravirine / lamivudine / tenofovir disoproxil fumarate (Delstrigo) - for the treatment of adults infected with HIV-1 Final Appraisal Recommendation Advice No: 1020 – September 2020 Doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo ® ) 100mg/300mg/245mg film-coated tablets Submission by Merck Sharp & Dohme Ltd Additional note(s): ? Please refer to the Summary of Product Characteristics section 4.4 (special warnings and precautions for use) and 5.1 (pharmacodynamic properties (...) . This recommendation has been ratified by Welsh Government and will be considered for review every three years. Recommendation of AWMSG Doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo ® ) is recommended as an option for use within NHS Wales for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, lamivudine, or tenofovir. This recommendation applies only in circumstances where the approved
Doravirine (Pifeltro) - for the treatment of adults infected with HIV-1 Final Appraisal Recommendation Advice No: 0920 – September 2020 Doravirine (Pifeltro ® ) 100 mg film-coated tablets Submission by Merck Sharp & Dohme Ltd Additional note(s): ? Please refer to the Summary of Product Characteristics section 4.4 (special warnings and precautions for use) and 5.1 (pharmacodynamic properties) for further information, as specified in the licenced indication In reaching the above recommendation (...) three years. Recommendation of AWMSG Doravirine (Pifeltro ® ) is recommended as an option for use within NHS Wales, in combination with other antiretroviral products, for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class. This recommendation applies only in circumstances where the approved Wales Patient Access Scheme (WPAS) is utilised or where the list/contract price is equivalent or lower than the WPAS price. Statement of use: No part
on the management of opportunistic infection in people living with HIV: The clinical management of Candidiasis 2019. HIV Med 2019; 20 Suppl 8: 2–24. 5. Kadayifci A, Gulsen MT, Koruk M, Savas MC. Doxycycline-induced pill esophagitis. Dis Esophagus 2004; 17: 168–171. 6. Wilcox CM, Alexander LN, Clark WS, Thompson SE. Fluconazole compared with endoscopy for humanimmunodeficiencyvirus-infected patients with esophageal symptoms. Gastroenterology 1996; 110: 1803–1809. 7. Onishi A, Iwasaku M, Sato A, Furukawa TA (...) in HIV-infected patients in the era of highly active antiretroviral therapy and an increasing trend of fluoroquinolone resistance. Clin Infect Dis 2007; 45: e60–67. 53. Hung CC, Chang SC. Impact of highly active antiretroviral therapy on incidence and management of humanimmunodeficiencyvirus-related opportunistic infections. J Antimicrob Chemother 2004; 54: 849–853. 54. B-Lajoie MR, Drouin O, Bartlett G et al. Incidence and prevalence of opportunistic and other infections and the impact
-transmissions-by-2030 (accessed November 2019). 3. Walensky RP, Weinstein MC, Kimmel AD et al. Routine humanimmunodeficiencyvirus testing: an economic evaluation of current guidelines. Am J Med 2005; 118: 292–300. 4. Graves N, Walker DG, McDonald AM et al. Would universal antenatal screening for HIV infection be cost-effective in a setting of very low prevalence? Modelling the data for Australia. J Infect Dis 2004; 190: 166–174. 5. General Medical Council. Consent: patients and doctors making decisions (...) public health impact of non-targeted humanimmunodeficiencyvirus screening in 29 emergency departments. Arch Intern Med 2012; 172: 12–20. 64. De Coster DA, Sivalokanathan S, Sornum A, Kegg S. HIV testing of acute medical admissions – any sign of progress? HIV Med 2015; 16 Suppl 2: 12–77 (Abstract P148). 65. Cropp A. Is the acute medical unit (AMU) the right place for HIV testing? A real life look. HIV Med 2015; 16 Suppl 2: 12–77 (Abstract P147). 66. Elgalib A, Fidler S, Sabapathy K. Hospital-based
National Trends in Drug Payments for HIV Preexposure Prophylaxis in the United States, 2014 to 2018 : A Retrospective Cohort Study. Use of HIV preexposure prophylaxis (PrEP) has increased nationwide, but the magnitude and distribution of PrEP medication costs across the health care system are unknown.To estimate out-of-pocket (OOP) and third-party payments using a large pharmacy database.Retrospective cohort study.Prescriptions for tenofovir disoproxil fumarate with emtricitabine (TDF-FTC
Antiretroviral therapies for treating HumanImmunodeficiencyVirus type 1 (HIV-1) infection 1 Driving better decision-making in healthcare Antiretroviral therapies for treating HumanImmunodeficiencyVirus type 1 (HIV-1) infection Technology Guidance from the MOH Drug Advisory Committee Published on 1 September 2020 Guidance recommendations The Ministry of Health’s Drug Advisory Committee has recommended the following antiretroviral therapies (ARTs): ? Nucleoside and nucleotide reverse (...) solution, ritonavir 100 mg tablet; ? Integrase strand transfer inhibitors (INSTIs): dolutegravir 50 mg tablet, raltegravir 400 mg and 600 mg tablets; and ? Fixed-dose combinations: abacavir 600 mg/lamivudine 300 mg tablet, abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg tablet, emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg tablet in line with their registered indications for the treatment of HumanImmunodeficiencyVirus type 1 (HIV-1) infection. Subsidy status Raltegravir 400 mg
timely humanimmunodeficiencyvirus confirmation and care after rapid humanimmunodeficiencyvirus self-test: Data from partner services program, New York City. Sexually Transmitted Diseases. 2017;44(10):608–12. Myers JE, El-Sadr Davis OY, Weinstein ER, Remch M, Edelstein A, Khawja A, et al. Availability, accessibility, and price of rapid HIV self-tests, New York City pharmacies, summer 2013. AIDS and Behavior. 2017;21(2):515–24. Estem KS, Catania J, Klausner JD. HIV self-testing: A review of current (...) implementation and fidelity. Current HIV/AIDS Reports. 2016;13(2):107–15. Mathews A, Conserve D, Mason H, Alston L, Rennie S, Tucker J. ‘Informed and empowered’: A mixed-methods study of crowdsourcing contests to promote uptake of HIV self-testing kits among African Americans. Journal of Virus Eradication. 2020;6(2):74–80. Edelstein ZR, Hubbard SJ, Myers JE. Implementation of HIV self-testing program in New York City. JAMA Internal Medicine. 2020;180(4):616. Bjornshagen V, Moseng BU, Ugreninov E. Who do you
: The unmet need for linguistically and culturally competent care for Latinx people living with HIV in a southern region with a low density of Spanish speakers. AIDS Research and Human Retroviruses. 2020. [Epub ahead of print]. Brooks RA, Nieto O, Landrian A, Donohoe TJ. Persistent stigmatizing and negative perceptions of pre-exposure prophylaxis (PrEP) users: Implications for PrEP adoption among Latino men who have sex with men. AIDS Care. 2019;31(4):427–35. Rhodes SD, Daniel J, Alonzo J, Duck S, Garcia (...) , Bloom FR, Leichliter JS, Montaño J. Outcomes from a community-based, participatory lay health adviser HIV/STD prevention intervention for recently arrived immigrant Latino men in rural North Carolina. AIDS Education & Prevention. 2009;21(Supplement B):103–8. Adam BD, Betancourt G, Serrano Sanchez AA. Development of an HIV prevention and life skills program for Spanish speaking gay and bisexual newcomers. Canadian Journal of Human Sexuality. 2011;20(1):11–17. Zamudio-Haas S, Maiorana A, Gomez LG
Mortality in adults with multidrug-resistant tuberculosis and HIV by antiretroviral therapy and tuberculosis drug use: an individual patient data meta-analysis. HIV-infection is associated with increased mortality during multidrug-resistant tuberculosis treatment, but the extent to which the use of antiretroviral therapy (ART) and anti-tuberculosis medications modify this risk are unclear. Our objective was to evaluate how use of these treatments altered mortality risk in HIV-positive adults (...) with multidrug-resistant tuberculosis.We did an individual patient data meta-analysis of adults 18 years or older with confirmed or presumed multidrug-resistant tuberculosis initiating tuberculosis treatment between 1993 and 2016. Data included ART use and anti-tuberculosis medications grouped according to WHO effectiveness categories. The primary analysis compared HIV-positive with HIV-negative patients in terms of death during multidrug-resistant tuberculosis treatment, excluding those lost to follow up
Fostemsavir (Rukobia) - HIV Drug Approval Package: RUKOBIA U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: RUKOBIA Company: ViiV Healthcare Company Application Number: 212950 Approval Date: 07/02/2020 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 Review Files (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created: July 29
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. 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.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
BHIVA guidance for the management of adults with HIV on antiretroviral treatment (ART) during the coronavirus pandemic BHIVA COVID-19 ART guidelines 1 st May 2020 BHIVA guidance for the management of adults with HIV on antiretroviral treatment (ART) during the coronavirus pandemic HIV services have a key role to play in the NHS response to coronavirus and this must be planned. In response to pressures on the NHS, the elective component of our work may be altered. However patients will continue (...) regarding social distancing and shielding should be followed (https://www.gov.uk/government/publications/covid-19-guidance-on- social-distancing-and-for-vulnerable-people/guidance-on-social-distancing-for- everyone-in-the-uk-and-protecting-older-people-and-vulnerable-adults). There is no evidence to date that people with HIV but without other risks are at increased risk of acquiring or developing complications from COVID-19. The latest evidence is available in the regularly updated joint British HIV
Cabotegravir and rilpivirine (Vocabria/Cabenuva) - 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 below. Recent Activity for SBDs written for approved after September 1
therapy CDC Centers for Disease Control and Prevention CD4 + Cluster-of-Differentiation-4-positive DAIDS Division of AIDS DTG dolutegravir EQ-5D European Quality of Life Questionnaire 5 Dimensions FTC emtricitabine G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HIVhumanimmunodeficiencyvirusHIV-1 humanimmunodeficiencyvirus type 1 INI integrase inhibitor IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) NNRTI (...) was to assess the added benefit of DTG/3TC 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 HI virus was not to have any known or suspected resistances to the class of integrase inhibitors (INI) or 3TC. Four research questions resulted from the ACT specified by the G-BA. Extract of dossier assessment A19-55 Version 1.0 Dolutegravir
Incidence and Severity of COVID-19 in HIV-Positive Persons Receiving Antiretroviral Therapy: A Cohort Study. The incidence and severity of coronavirus disease 2019 (COVID-19) among HIV-positive persons receiving antiretroviral therapy (ART) have not been characterized in large populations.To describe the incidence and severity of COVID-19 by nucleos(t)ide reverse transcriptase inhibitor (NRTI) use among HIV-positive persons receiving ART.Cohort study.HIV clinics in 60 Spanish hospitals between (...) 1 February and 15 April 2020.77 590 HIV-positive persons receiving ART.Estimated risks (cumulative incidences) per 10 000 persons and 95% CIs for polymerase chain reaction-confirmed COVID-19 diagnosis, hospitalization, intensive care unit (ICU) admission, and death. Risk and 95% CIs for COVID-19 diagnosis and hospital admission by use of the NRTIs tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC), tenofovir alafenamide (TAF)/FTC, abacavir (ABC)/lamivudine (3TC), and others were estimated
Systematic or Test-Guided Treatment for Tuberculosis in HIV-Infected Adults. In regions with high burdens of tuberculosis and humanimmunodeficiencyvirus (HIV), many HIV-infected adults begin antiretroviral therapy (ART) when they are already severely immunocompromised. Mortality after ART initiation is high in these patients, and tuberculosis and invasive bacterial diseases are common causes of death.We conducted a 48-week trial of empirical treatment for tuberculosis as compared (...) with treatment guided by testing in HIV-infected adults who had not previously received ART and had CD4+ T-cell counts below 100 cells per cubic millimeter. Patients recruited in Ivory Coast, Uganda, Cambodia, and Vietnam were randomly assigned in a 1:1 ratio to undergo screening (Xpert MTB/RIF test, urinary lipoarabinomannan test, and chest radiography) to determine whether treatment for tuberculosis should be started or to receive systematic empirical treatment with rifampin, isoniazid, ethambutol
Assessment, Development and Evaluation HPV Human papilloma virus ICER Incremental cost-effectiveness ratio ICO Istituto Catala' d'Oncologia (Spain) LY Life years 9vHPV Nine-valent HPV vaccine PeIN Penile intraepithelial neoplasia PICO Population Intervention Comparison Outcome POTS Postural orthostatic tachycardia syndrome QALY Quality-adjusted life years 6MPI Six-month persistent infection VaIN Vaginal intraepithelial neoplasia VLP Virus-like particle VIN Vulvar intraepithelial neoplasia Glossary Cost (...) the most favorable conditions, e.g. experimental setting. Vaccine hesitancy Delay in acceptance or refusal of vaccines despite availability of vaccination services. Viroprevalence Prevalence of virus in population. SCIENTIFIC ADVICE Guidance on HPV vaccination in EU countries: focus on boys, PLHIV and 9-valent HPV vaccine introduction 1 Executive summary Scope This guidance on human papilloma virus (HPV) vaccination in EU countries covers the following areas: efficacy/effectiveness of the 9-valent HPV