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https://www.readbyqxmd.com/read/28627427/144-week-efficacy-and-safety-of-a-once-daily-single-tablet-regimen-of-tenofovir-lamivudine-and-efavirenz-among-arv-na%C3%A3-ve-and-arv-experienced-hiv-1-infected-thai-adults
#1
Anchalee Avihingsanon, Wirach Maek-A-Nantawat, Sivaporn Gatechompol, Vorapot Sapsirisavat, Wanida Thiansanguankul, Jiratchaya Sophonphan, Narujakorn Thammajaruk, Sasiwimol Ubolyam, David M Burger, Kiat Ruxrungtham
OBJECTIVES: 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 Thais. METHODS: This was a 144 week, prospective study among 51 treatment naïve and 49 experienced patients on separated pill of TDF, 3TC and EFV with HIV RNA<50 copies/ml. CD4, HIV RNA, liver, renal functions and lipid profiles were assessed at baseline, weeks 12, 24, 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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
https://www.readbyqxmd.com/read/28259776/switching-from-efavirenz-emtricitabine-and-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
#12
Edwin DeJesus, Moti Ramgopal, Gordon Crofoot, Peter Ruane, Anthony LaMarca, Anthony Mills, Claudia T Martorell, Joseph de Wet, Hans-Jürgen Stellbrink, Jean-Michel Molina, Frank A Post, Ignacio Pérez Valero, Danielle Porter, YaPei Liu, Andrew Cheng, Erin Quirk, Devi SenGupta, Huyen Cao
BACKGROUND: Tenofovir alafenamide is a prodrug that reduces tenofovir plasma concentrations by 90% compared with tenofovir disoproxil fumarate, thereby decreasing bone and renal risks. The coformulation of rilpivirine, emtricitabine, and tenofovir alafenamide has recently been approved, and we aimed to investigate the efficacy, safety, and tolerability of switching to this regimen compared with remaining on coformulated efavirenz, emtricitabine, and tenofovir disoproxil fumarate. METHODS: In this randomised, double-blind, placebo-controlled, non-inferiority trial, HIV-1-infected adults were enrolled at 120 hospitals and outpatient clinics in eight countries in North America and Europe...
March 1, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28182625/viability-of-primary-osteoblasts-after-treatment-with-tenofovir-alafenamide-lack-of-cytotoxicity-at-clinically-relevant-drug-concentrations
#13
Christian Callebaut, Yang Liu, Darius Babusis, Adrian Ray, Michael Miller, Kathryn Kitrinos
Tenofovir alafenamide (TAF) is a phosphonoamidate prodrug of the nucleotide HIV reverse transcriptase inhibitor tenofovir (TFV). TAF is approved for the treatment of HIV-1 infection as part of the single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and TAF. When dosed once-daily, TAF results in approximately 90% lower levels of plasma TFV and a 4-fold increase in intracellular TFV-diphosphate (TFV-DP) in PBMCs compared with the TFV prodrug tenofovir disoproxil fumarate (TDF). Several antiretrovirals, including TDF, have been associated with bone mineral density decreases in patients; the effect of clinically relevant TAF concentrations on primary osteoblast viability was therefore assessed in vitro...
2017: PloS One
https://www.readbyqxmd.com/read/28168828/relative-bioavailability-of-a-dolutegravir-dispersible-tablet-and-the-effects-of-low-and-high-mineral-content-water-on-the-tablet-in-healthy-adults
#14
Ann M Buchanan, Michael Holton, Ian Conn, Mark Davies, Mike Choukour, Brian R Wynne
Dolutegravir (DTG) is approved in the United States to treat HIV-1-infected patients weighing ≥30 kg. A dispersible DTG tablet formulation was recently developed for pediatric patients. This study compares the pharmacokinetics (PK) of the dispersible tablet with that of a previously evaluated granule formulation. In this randomized, open-label, crossover study, 15 healthy adults received single oral doses of DTG 20 mg every 7 days across 5 treatment arms: granules consumed immediately after mixture with purified water, dispersible DTG consumed immediately after reconstitution in low-mineral-content (LMC) or high-mineral-content (HMC) water, and dispersible DTG consumed 30 minutes after dispersal in LMC or HMC water...
February 7, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28152047/effectiveness-and-tolerance-of-single-tablet-versus-once-daily-multiple-tablet-regimens-as-first-line-antiretroviral-therapy-results-from-a-large-french-multicenter-cohort-study
#15
Laurent Cotte, Tristan Ferry, Pascal Pugliese, Marc-Antoine Valantin, Clotilde Allavena, André Cabié, Isabelle Poizot-Martin, David Rey, Claudine Duvivier, Antoine Cheret, Pierre Dellamonica, Pierre Pradat, Jean-Jacques Parienti
OBJECTIVES: Pill burden during antiretroviral treatment (ART) is associated with worse adherence and impaired virological suppression. We compared the effectiveness, tolerance, and persistence on treatment of single tablet regimens (STRs) with non-STR once-daily regimens in patients receiving first-line ART. METHODS: Retrospective analysis of naïve HIV-1 infected patients prospectively enrolled in the French Dat'AIDS cohort and initiating first-line ART with STRs or once-daily non-STRs from 2004 to 2013...
2017: PloS One
https://www.readbyqxmd.com/read/28147708/tolerability-of-central-nervous-system-symptoms-among-hiv-1-infected-efavirenz-users-analysis-of-patient-electronic-medical-record-data
#16
Lisa Rosenblatt, Michael S Broder, Tanya G K Bentley, Eunice Chang, Sheila R Reddy, Elya Papoyan, Joel Myers
Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor indicated for treatment of HIV-1 infection. Despite concern over EFV tolerability in clinical trials and practice, particularly related to central nervous system (CNS) adverse events, some observational studies have shown high rates of EFV continuation at one year and low rates of CNS-related EFV substitution. The objective of this study was to further examine the real-world rate of CNS-related EFV discontinuation in antiretroviral therapy naïve HIV-1 patients...
February 1, 2017: AIDS Care
https://www.readbyqxmd.com/read/28143756/real-world-persistence-with-antiretroviral-therapy-for-hiv-in-the-united-kingdom-a-multicentre-retrospective-cohort-study
#17
Joseph M Lewis, Colette Smith, Adele Torkington, Craig Davies, Shazaad Ahmad, Andrew Tomkins, Jonathan Shaw, Margaret Kingston, Ghadeer Muqbill, Philip Hay, Larissa Mulka, Deborah Williams, Laura Waters, Nataliya Brima, Neal Marshall, Margaret Johnson, Mas Chaponda, Mark Nelson
OBJECTIVES: Persistence with an antiretroviral therapy (ART) regimen for HIV can be defined as the length of time a patient remains on therapy before stopping or switching. We aimed to describe ART persistence in treatment naïve patients starting therapy in the United Kingdom, and to describe differential persistence by treatment regimen. METHODS: We performed a retrospective cohort study at eight UK centres of ART-naïve adults commencing ART between 2012 and 2015...
April 2017: Journal of Infection
https://www.readbyqxmd.com/read/28135199/pre-exposure-prophylaxis-prep-as-an-additional-tool-for-hiv-prevention-among-men-who-have-sex-with-men-in-belgium-the-be-prep-ared-study-protocol
#18
Irith De Baetselier, Thijs Reyniers, Christiana Nöstlinger, Kristien Wouters, Katrien Fransen, Tania Crucitti, Chris Kenyon, Jozefien Buyze, Céline Schurmans, Marie Laga, Bea Vuylsteke
BACKGROUND: Pre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent HIV. With the approval of Truvada as daily PrEP by the European Commission in August 2016, individual European Member states prepare themselves for PrEP implementation following the examples of France and Norway. However, context-specific data to guide optimal implementation is currently lacking. OBJECTIVE: With this demonstration project we evaluate whether daily and event-driven PrEP, provided within a comprehensive prevention package, is a feasible and acceptable additional prevention tool for men who have sex with men (MSM) at high risk of acquiring HIV in Belgium...
January 30, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28117606/tenofovir-alafenamide-emtricitabine-elvitegravir-and-cobicistat-combination-therapy-for-the-treatment-of-hiv
#19
Arkaitz Imaz, Daniel Podzamczer
Tenofovir alafenamide (TAF) is a novel prodrug of the nucleotide analogue reverse-transcriptase inhibitor, tenofovir. TAF has been co-formulated with emtricitabine (FTC), elvitegravir (EVG) and the EVG metabolic enhancer, cobicistat (COBI) as a single-tablet regimen being the first TAF-containing antiretroviral combination available. Areas covered: This article summarizes the available information on the pharmacology of the novel compound TAF and overviews TAF/FTC/EVG/COBI use for HIV-1 infected patients, with specific focus on clinical efficacy and safety data...
January 24, 2017: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/28087863/hiv-update-which-single-tablet-regimens-and-when
#20
REVIEW
Jeffrey T Kirchner
With the approval of single-tablet regimens that contain 3 or 4 drugs, many patients take just one pill a day. So what are the options and what's on the horizon?
November 2016: Journal of Family Practice
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