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https://www.readbyqxmd.com/read/28729158/fixed-dose-combination-dolutegravir-abacavir-and-lamivudine-versus-ritonavir-boosted-atazanavir-plus-tenofovir-disoproxil-fumarate-and-emtricitabine-in-previously-untreated-women-with-hiv-1-infection-aria-week-48-results-from-a-randomised-open-label-non-inferiority
#1
Catherine Orrell, Debbie P Hagins, Elena Belonosova, Norma Porteiro, Sharon Walmsley, Vicenç Falcó, Choy Y Man, Alicia Aylott, Ann M Buchanan, Brian Wynne, Cindy Vavro, Michael Aboud, Kimberly Y Smith
BACKGROUND: Dolutegravir is a once-daily integrase strand transfer inhibitor with no need for pharmacokinetic boosting that is approved for the treatment of HIV-1 infection. Because women are often under-represented in HIV clinical trials, we addressed the safety and efficacy of dolutegravir in women with HIV-1. METHODS: The ARIA study is a randomised, open-label, multicentre, active-controlled, parallel-group, non-inferiority phase 3b study done in 86 hospital and university infectious disease clinics, local health clinics, and private infectious disease clinics in 12 countries and one US territory, in North America, South America, Europe, Africa, and Asia...
July 17, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28723333/enhanced-prophylaxis-plus-antiretroviral-therapy-for-advanced-hiv-infection-in-africa
#2
James Hakim, Victor Musiime, Alex J Szubert, Jane Mallewa, Abraham Siika, Clara Agutu, Simon Walker, Sarah L Pett, Mutsa Bwakura-Dangarembizi, Abbas Lugemwa, Symon Kaunda, Mercy Karoney, Godfrey Musoro, Sheila Kabahenda, Kusum Nathoo, Kathryn Maitland, Anna Griffiths, Margaret J Thomason, Cissy Kityo, Peter Mugyenyi, Andrew J Prendergast, A Sarah Walker, Diana M Gibb
BACKGROUND: In sub-Saharan Africa, among patients with advanced human immunodeficiency virus (HIV) infection, the rate of death from infection (including tuberculosis and cryptococcus) shortly after the initiation of antiretroviral therapy (ART) is approximately 10%. METHODS: In this factorial open-label trial conducted in Uganda, Zimbabwe, Malawi, and Kenya, we enrolled HIV-infected adults and children 5 years of age or older who had not received previous ART and were starting ART with a CD4+ count of fewer than 100 cells per cubic millimeter...
July 20, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28722790/switching-to-a-rilpivirine-emtricitabine-tenofovir-single-tablet-regimen-in-rna-suppressed-patients-infected-with-human-immunodeficiency-virus-1-effectiveness-safety-and-costs-at-96%C3%A2-weeks
#3
Paula Arrabal-Durán, Carmen G Rodríguez-González, Esther Chamorro-de-Vega, Paloma Gijón-Vidaurreta, Ana Herranz-Alonso, María Sanjurjo-Sáez
OBJECTIVES: This study evaluates the effectiveness, safety and costs of switching to a rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF) regimen in treatment-experienced HIV-1-infected patients with sustained virological suppression. METHODS: Observational, prospective study. Study population included all treatment-experienced patients with sustained virological suppression who switched to RPV/FTC/TDF during 2013 in a tertiary hospital. Patients were followed until they completed 96 weeks of treatment...
July 19, 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28720173/simultaneous-determination-of-first-line-4-fdc-antituberculosis-drugs-by-uhplc-uv-and-hplc-uv-a-comparative-study
#4
Pedro H C Franco, Paula R Chellini, Marcone A L Oliveira, Gerson A Pianetti
Tuberculosis is the second most deadly infectious disease, surpassed only by HIV/AIDS, and has resulted in over 1 billion deaths in the last 200 years. The World Health Organization estimates that in 2014, 9.6 million people were infected by this disease and 1.5 million had died. First-choice treatment consists of fixed-dose combination tablets containing rifampicin, isoniazid, pyrazinamide, and ethambutol hydrochloride (4-FDC). There are pharmacopeial protocols available to test 4-FDC, but they are prolonged, two-step methods...
July 1, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28705153/a-randomized-clinical-pharmacokinetic-trial-of-tenofovir-in-blood-plasma-and-urine-in-adults-with-perfect-moderate-and-low-prep-adherence-the-target-study
#5
Tim R Cressey, Oraphan Siriprakaisil, Virat Klinbuayaem, Justice Quame-Amaglo, Rachel W Kubiak, Pra-Ornsuda Sukrakanchana, Kanchana Than-In-At, Jared Baeten, Wasna Sirirungsi, Ratchada Cressey, Paul K Drain
BACKGROUND: Tenofovir disoproxil fumarate (TDF) is key component of pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) for HIV, but existing tools to monitor drug adherence are often inaccurate. Detection of tenofovir (TFV) in accessible biological samples, such as fingerprick blood, urine or oral fluid samples could be a novel objective measure of recent TDF adherence. To measure TFV concentrations associated with different levels of TDF adherence, we designed a randomized clinical trial to assess the blood, urine and oral fluid concentrations of TFV in adults with perfect, moderate and low drug adherence...
July 14, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28696345/optimal-hiv-postexposure-prophylaxis-regimen-completion-with-single-tablet-daily-elvitegravir-cobicistat-tenofovir-disoproxil-fumarate-emtricitabine-compared-with-more-frequent-dosing-regimens
#6
Kenneth H Mayer, Daniel Jones, Catherine Oldenburg, Sachin Jain, Marcy Gelman, Shayne Zaslow, Chris Grasso, Matthew J Mimiaga
STRUCTURE: The study evaluated elvitegravir/cobicistat/tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) ("Quad pill") for postexposure prophylaxis (PEP). BACKGROUND: HIV-exposed individuals may benefit from PEP, but completion rates have been suboptimal because of regimen complexity and side effects. Newer antiretroviral combinations coformulated as single daily pills may optimize PEP adherence. SETTING: One hundred HIV-uninfected individuals who presented to a Boston community health center after an acute HIV sexual exposure were enrolled and initiated PEP with the daily, single-pill combination Quad pill for a 28-day course...
August 15, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28689453/switching-to-the-single-tablet-regimen-of-elvitegravir-cobicistat-emtricitabine-and-tenofovir-df-from-non-nucleoside-reverse-transcriptase-inhibitor-plus-coformulated-emtricitabine-and-tenofovir-df-regimens-week-96-results-of-strategy-nnrti
#7
Anton Pozniak, Jason Flamm, Andrea Antinori, Mark Bloch, Douglas Ward, Juan Berenguer, Pierre Cote, Kristen Andreatta, William Garner, Javier Szwarcberg, Thai Nguyen-Cleary, Damian J McColl, David Piontkowsky
BACKGROUND: HIV-1-infected, virologically suppressed adults wanting to simplify or change their non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens may benefit from switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF). OBJECTIVE: We examined differences in the proportion of participants with HIV-1 RNA < 50 copies/mL (Snapshot analysis), change in CD4 cell count, safety, and patient-reported outcomes in participants switching to E/C/F/TDF from an NNRTI + FTC/TDF (TVD) regimen...
July 9, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28687550/sofosbuvir-velpatasvir-a-single-tablet-treatment-for-hepatitis-c-infection-of-all-genotypes
#8
REVIEW
Misty M Miller
PURPOSE: The pharmacology, pharmacokinetics, interaction potential, efficacy, and safety of the newest direct-acting antiviral (DAA) medication for the treatment of chronic hepatitis C are reviewed. SUMMARY: Nonstructural proteins 5A (NS5A) and 5B (NS5B) are key drivers of hepatitis C virus (HCV) replication. Velpatasvir, an inhibitor of NS5A, was coformulated with the NS5B inhibitor sofosbuvir to provide a single-tablet combination DAA (Epclusa, Gilead Sciences)...
July 15, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28664942/darunavir-stands-up-as-preferred-hiv-protease-inhibitor
#9
Josep Mallolas
Current antiretroviral therapy reaches and maintains viral suppression over the years in more than 90% of treated HIV-infected individuals. Although integrase inhibitors are the preferred third agent in antiretroviral therapy in the current guidelines, rilpivirine, a non-nucleoside reverse transcrip- tase inhibitor, and darunavir (DRV), a second-generation protease inhibitor, are the preferred third companion to be used along with a backbone of two nucleos(t)ide reverse transcriptase inhibitors as first-line triple HIV combination treatment...
April 2017: AIDS Reviews
https://www.readbyqxmd.com/read/28627427/efficacy-and-safety-of-a-once-daily-single-tablet-regimen-of-tenofovir-lamivudine-and-efavirenz-assessed-at-144-weeks-among-antiretroviral-na%C3%A3-ve-and-experienced-hiv-1-infected-thai-adults
#10
Anchalee Avihingsanon, Wirach Maek-A-Nantawat, Sivaporn Gatechompol, Vorapot Sapsirisavat, Wanida Thiansanguankul, Jiratchaya Sophonphan, Narujakorn Thammajaruk, Sasiwimol Ubolyam, David M Burger, Kiat Ruxrungtham
OBJECTIVE: To assess the efficacy and safety of a new single-tablet regimen (STR) of tenofovir disoproxil fumarate (TDF) 300mg, lamivudine (3TC) 300mg, and efavirenz (EFV) 600mg in HIV-infected Thai patients. METHODS: This was a prospective study performed for 144 weeks among 51 treatment-naïve patients and 49 experienced patients on separate tablets of TDF, 3TC, and EFV with HIV RNA<50 copies/ml. CD4, HIV RNA, liver and renal function, and lipid profiles were assessed at baseline, weeks 12, 24, and 48, and then every 24 weeks...
June 13, 2017: International Journal of Infectious Diseases: IJID
https://www.readbyqxmd.com/read/28581645/effects-of-a-nutritional-protein-rich-drink-on-the-pharmacokinetics-of-elvitegravir-cobicistat-emtricitabine-tenofovir-alafenamide-and-tenofovir-compared-with-a-standard-meal-in-healthy-japanese-male-subjects
#11
REVIEW
Hiroyuki Yamada, Ippei Ikushima, Takanori Nemoto, Tomohiro Ishikawa, Noriko Ninomiya, Shin Irie
This study investigated the effects of ingested meal types on the pharmacokinetics of elvitegravir (EVG), cobicistat (COBI), emtricitabine (FTC), tenofovir alafenamide (TAF), and tenofovir (TFV) following a single administration of the single-tablet regimen (STR) of EVG/COBI/FTC/TAF (150/150/200/10 mg) in Japanese HIV-negative healthy subjects (n = 12). In this open-label, randomized, 3-way crossover study, the bioequivalence of the EVG/COBI/FTC/TAF STR following ingestion of a nutritional protein-rich drink with a reference treatment of taking a standard breakfast was evaluated...
June 5, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28560499/the-impact-of-substance-use-on-adherence-to-antiretroviral-therapy-among-hiv-infected-women-in-the-united-states
#12
Yuehan Zhang, Tracey E Wilson, Adebola Adedimeji, Daniel Merenstein, Joel Milam, Jennifer Cohen, Mardge Cohen, Elizabeth T Golub
Research is scant regarding differential effects of specific types of recreational drugs use on antiretroviral therapy adherence among women, particularly to single-tablet regimens (STR). This is increasingly important in the context of marijuana legalization. We examined the effects of self-reported substance use on suboptimal (<95%) adherence in the Women's Interagency HIV Study, 2003-2014. Among 1799 HIV-infected women, the most prevalent substance used was marijuana. In multivariable Poisson GEE regression, substance use overall was significantly associated with suboptimal adherence (adjusted prevalence ratio, aPR = 1...
May 30, 2017: AIDS and Behavior
https://www.readbyqxmd.com/read/28558493/a-review-of-the-efficacy-and-safety-of-genvoya-%C3%A2-elvitegravir-cobicistat-emtricitabine-and-tenofovir-alafenamide-in-the-management-of-hiv-1-infection
#13
Sara A Angione, Sibyl M Cherian, Ayşe Elif Özdener
INTRODUCTION: This review evaluates the efficacy and safety of Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide [EVG/c/TAF/FTC]), a single-tablet regimen used for the management of HIV-1 infection. Phase II and III randomized clinical trials evaluate the efficacy and safety of EVG/c/TAF/FTC and tenofovir disoproxil fumerate (TDF)-containing arms; renal impairment, bone mineral density, metabolic effects, and other adverse events are topics explored within this review...
January 1, 2017: Journal of Pharmacy Practice
https://www.readbyqxmd.com/read/28555519/simplification-to-single-tablet-regimen-of-elvitegravir-cobicistat-emtricitabine-tenofovir-df-from-multi-tablet-ritonavir-boosted-protease-inhibitor-plus-coformulated-emtricitabine-and-tenofovir-df-regimens-week-96-results-of-strategy-pi
#14
Jose R Arribas, Edwin DeJesus, Jan van Lunzen, Christine Zurawski, Manuela Doroana, William Towner, Adriano Lazzarin, Mark Nelson, Damian McColl, Kristen Andreatta, Raji Swamy, Javier Szwarcberg, Thai Nguyen
BACKGROUND: Antiretroviral therapy (ART) simplification to a single-tablet regimen can benefit HIV-1-infected, virologically suppressed, individuals on ART composed of multiple pills. OBJECTIVE: We assessed long-term efficacy and safety of switching to co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF) from multi-tablet ritonavir-boosted protease inhibitor (PI + RTV) plus F/TDF (TVD) regimens. METHODS: STRATEGY-PI was a 96-week, phase 3b, randomized (2:1), open-label, non-inferiority study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF from PI + RTV + TVD regimens in virologically suppressed individuals (HIV-1 RNA <50 copies/mL)...
May 30, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28520610/candidates-for-inclusion-in-a-universal-antiretroviral-regimen-dolutegravir
#15
Pedro Cahn
PURPOSE OF REVIEW: The review addresses the role of dolutegravir (DTG) in first-line therapy. In the era of test and treat, where United Nations AIDS Program and WHO have set the ambitious targets of 90/90/90, new efficacious, well tolerated, and simple therapeutic options are needed. RECENT FINDINGS: DTG has been tested in large clinical trials in treatment-naïve patients, showing noninferiority to raltegravir and superiority compared with efavirenz and ritonavir-boosted darunavir, respectively...
July 2017: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/28489729/trends-in-art-prescription-and-viral-suppression-among-hiv-positive-young-adults-in-care-in-the-united-states-2009-2013
#16
Linda Beer, Christine L Mattson, Heather Bradley, R Luke Shouse
BACKGROUND: Only 13% of HIV-positive young adults are estimated to be virally suppressed and, even among those receiving medical care, HIV-positive young adults are less likely than older adults to take antiretroviral therapy (ART), be adherent, and be virally suppressed. We sought to examine trends in treatment and health outcomes from 2009 to 2013 among HIV-positive young adults (ages 18-24) in care. SETTING: The Medical Monitoring Project (MMP) is a complex sample survey of HIV-infected adults receiving medical care in the United States...
April 25, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28447075/sofosbuvir-velpatasvir-fixed-dose-combination-for-the-treatment-of-chronic-hepatitis-c-virus-infection
#17
REVIEW
V Nehra, S A Rizza, Z Temesgen
The fixed-dose combination of sofosbuvir, a nucleotide analogue NS5B polymerase inhibitor, and velpatasvir, a second-generation NS5A inhibitor, has been approved by the United States Food and Drug Administration and the European Medicines Agency for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection. This combination, administered over 12 weeks as a single-tablet regimen, has resulted in high cure rates in all 6 HCV genotypes and in a variety of patient populations, including patients without cirrhosis, patients with compensated cirrhosis and patients with HIV coinfection...
March 2017: Drugs of Today
https://www.readbyqxmd.com/read/28393587/addressing-discriminatory-benefit-design-for-people-living-with-hiv-a-california-case-study
#18
Sara B McMenamin, Riti Shimkhada, Sarah P Hiller, Garen Corbett, Ninez Ponce
Concern is growing in the United States regarding the potential for health insurance benefit designs to discriminate against persons living with HIV as research demonstrates that such practices are occurring. A recent complaint filed against health insurers in seven states alleges that some health insurance companies have been using benefit designs that discourage enrollment of people living with HIV either by not covering essential HIV medications or by requiring cost-sharing for these prohibitively expensive medications...
April 9, 2017: AIDS Care
https://www.readbyqxmd.com/read/28383402/comparative-effectiveness-of-single-versus-multiple-tablet-antiretroviral-therapy-regimens-in-clinical-hiv-practice
#19
COMPARATIVE STUDY
Daniel R Drozd, Michael S Saag, Andrew O Westfall, William Chris Mathews, Richard Haubrich, Stephen L Boswell, Stephen R Cole, Donna Porter, Mari M Kitahata, Timothy Juday, Lisa Rosenblatt
We determined risk of virologic failure (VF) in individuals initiating tenofovir/emtricitabine/efavirenz as single versus multiple tablet regimens (MTR). We found no significant difference in the risk of VF, though did observe a trend toward more VF and M184 V mutations among persons initiating MTR. Temporal trends in care may have confounded results.
April 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28259777/switching-from-tenofovir-disoproxil-fumarate-to-tenofovir-alafenamide-coformulated-with-rilpivirine-and-emtricitabine-in-virally-suppressed-adults-with-hiv-1-infection-a-randomised-double-blind-multicentre-phase-3b-non-inferiority-study
#20
Chloe Orkin, Edwin DeJesus, Moti Ramgopal, Gordon Crofoot, Peter Ruane, Anthony LaMarca, Anthony Mills, Bernard Vandercam, Joseph de Wet, Jürgen Rockstroh, Adriano Lazzarin, Bart Rijnders, Daniel Podzamczer, Anders Thalme, Marcel Stoeckle, Danielle Porter, Hui C Liu, Andrew Cheng, Erin Quirk, Devi SenGupta, Huyen Cao
BACKGROUND: Tenofovir alafenamide, a tenofovir prodrug, results in 90% lower tenofovir plasma concentrations than does tenofovir disproxil fumarate, thereby minimising bone and renal risks. We investigated the efficacy, safety, and tolerability of switching to a single-tablet regimen containing rilpivirine, emtricitabine, and tenofovir alafenamide compared with remaining on rilpivirine, emtricitabine, and tenofovir disoproxil fumarate. METHODS: In this randomised, double-blind, multicentre, placebo-controlled, non-inferiority trial, HIV-1-infected adults were screened and enrolled at 119 hospitals in 11 countries in North America and Europe...
March 1, 2017: Lancet HIV
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