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https://www.readbyqxmd.com/read/29767543/efficacy-of-single-tablet-darunavir-cobicistat-emtricitabine-and-tenofovir-alafenamide-in-the-treatment-of-hiv-1
#1
Eugènia Negredo, Bonaventura Clotet
HIV eradication is not feasible and lifelong treatment is warranted to manage HIV infection. In this scenario, the advent of single-tablet, once-daily, fixed-dose co-formulations is important for reducing pill burden and maximize long-term drug adherence. Cobicistat-boosted darunavir along with emtricitabine and tenofovir alafenamide co-formulation (DRV/c/FTC/TAF or the trade name Symtuza®) is the first marketed protease inhibitor-based fixed-dose combination regimen for the treatment of HIV infection. It was approved in late 2017 by the European Medical Agency both for naïve patients and treatment-experienced patients with viral suppression...
May 16, 2018: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29746294/a-maintenance-three-day-per-week-schedule-with-the-single-tablet-regimen-efavirenz-emtricitabine-tenofovir-disoproxil-fumarate-is-effective-and-decreases-sub-clinical-toxicity-the-a-tri-week-pilot-trial
#2
Jhon Rojas, Jose L Blanco, Sonsoles Sanchez-Palomino, Maria A Marcos, Alberto C Guardo, Ana Gonzalez-Cordon, Montserrat Lonca, Amparo Tricas, Ana Rodriguez, Anabel Romero, Jose M Miro, Josep Mallolas, Jose M Gatell, Montserrat Plana, Esteban Martinez
BACKGROUND: Antiretroviral drugs contained in single tablet Atripla® have pharmacokinetic properties that could allow for longer than once-daily (OD) dosing. We hypothesized that simplifying Atripla® OD to 3-day per week would be feasible, able to maintain viral suppression and less toxic. METHODS: Virologically suppressed (≥2 years) HIV+ adults on Atripla® OD, CD4 >350/mm at inclusion, and no prior documented virological failure or evidence of resistance mutations to efavirenz, tenofovir, or emtricitabine were randomized to maintain their OD regimen or to reduce it to 3 days (Mondays, Wednesdays, and Fridays) a week (3W)...
May 9, 2018: AIDS
https://www.readbyqxmd.com/read/29740676/adverse-reactions-associated-with-first-line-regimens-in-patient-initiating-antiretroviral-therapy
#3
Jullye Campos Mendes, Palmira de Fátima Bonolo, Maria das Graças Braga Ceccato, Juliana de Oliveira Costa, Adriano Max Moreira Reis, Henrique Dos Santos, Micheline Rosa Silveira
OBJECTIVE: To evaluate the prevalence of adverse drug reactions (ADR) and associated factors during the use of Highly Active Antiretroviral Therapy (HAART) in patients initiating treatment. METHODS: This is a cross-sectional analysis of a prospective study conducted in three public referral services specialized in HIV/AIDS care in Belo Horizonte, Brazil. Self-reported ADR and explanatory variables were obtained from face-to-face interview and from Information Systems...
May 8, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29704556/antiretroviral-therapy-treatment-in-australia-comparing-the-australian-hiv-observational-database-using-a-national-representative-database-of-prescription-data
#4
Robin Huang, Kathy Petoumenos, Richard T Gray, Hamish McManus, Nila Dharan, Rebecca Guy, David A Cooper
OBJECTIVES: Cohort studies are often used as a national surveillance tool to monitor trends in HIV treatment and morbidity outcomes. However, there are limited studies validating the accuracy of using cohorts as a representation of the overall HIV-positive population. We compared data from a large Australian HIV-positive cohort study (Australian HIV Observational Database (AHOD)) and a 10% longitudinal sample from Australia's subsidized prescription medication scheme (the Pharmaceutical Benefits Scheme (PBS)) to assess the use of cohorts for providing representative data for surveillance and monitoring purposes...
April 25, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29683855/a-week-48-randomized-phase-3-trial-of-darunavir-cobicistat-emtricitabine-tenofovir-alafenamide-in-treatment-na%C3%A3-ve-hiv-1-patients
#5
Joseph J Eron, Chloe Orkin, Joel Gallant, Jean-Michel Molina, Eugenia Negredo, Andrea Antinori, Anthony Mills, Jacques Reynes, Erika Van Landuyt, Erkki Lathouwers, Veerle Hufkens, John Jezorwski, Simon Vanveggel, Magda Opsomer
OBJECTIVES: To investigate efficacy and safety of a single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg vs. darunavir/cobicistat plus emtricitabine/tenofovir disoproxyl fumarate (TDF) (control) in antiretroviral-treatment-naïve, HIV-1-infected adults. DESIGN: Phase-3, randomized, active-controlled, double-blind, international, multicenter, noninferiority study (NCT02431247). METHODS: Seven hundred and twenty-five participants were randomized (1 : 1) to D/C/F/TAF (362) or control (363)...
April 19, 2018: AIDS
https://www.readbyqxmd.com/read/29676935/current-and-emerging-two-drug-approaches-for-hiv-1-therapy-in-art-na%C3%A3-ve-and-art-experienced-virologically-suppressed-patients
#6
Barbara Rossetti, Francesca Montagnani, Andrea De Luca
Current guidelines recommend a 2-drug antiretroviral regimen as an alternative to triple antiretroviral therapy (ART) in selected patients to reduce long-term toxicity and costs. Areas covered: This review is intended to provide insight into the efficacy, safety and tolerability of 2-drug versus 3-drug ART in naïve and in treatment-experienced virologically-suppressed patients. Expert opinion: Dual therapy regimens are not feasible in HBV-coinfected individuals and should not be applied during pregnancy. Positive data on 2-drug ART in drug naïve patients are still limited, while, in virologically-suppressed individuals, several regimens have shown non-inferiority as compared to 3-drug regimens...
May 2018: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29672676/a-trial-of-a-single-tablet-regimen-of-elvitegravir-cobicistat-emtricitabine-and-tenofovir-disoproxil-fumarate-for-the-initial-treatment-of-hiv-2-infection-in-a-resource-limited-setting-48-week-results-from-senegal-west-africa
#7
Selly Ba, Dana N Raugi, Robert A Smith, Fatima Sall, Khadim Faye, Stephen E Hawes, Papa Salif Sow, Moussa Seydi, Geoffrey S Gottlieb
Background: There is an urgent need for safe and effective ART for HIV-2 infection. We undertook the first clinical trial of a single-tablet-regimen containing elvitegravir-cobicistat-emtricitabine-tenofovir disoproxil fumarate (E/C/F/TDF) to assess its effectiveness in HIV-2-infected individuals in Senegal, West Africa. Methods: HIV-2-infected, ART-naïve adults with WHO stage 3-4 disease or CD4 counts below 750 cells/mm3 were eligible for this 48 week, open-label trial...
April 17, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29655904/3d-printed-controlled-release-tritherapeutic-tablet-matrix-for-advanced-anti-hiv-1-drug-delivery
#8
Margaret Siyawamwaya, Lisa C du Toit, Pradeep Kumar, Yahya E Choonara, Pierre P P D Kondiah, Viness Pillay
PURPOSE: A 3D-Bioplotter® was employed to 3D print (3DP) a humic acid-polyquaternium 10 (HA-PQ10) controlled release fixed dose combination (FDC) tablet comprising of the anti-HIV-1 drugs, efavirenz (EFV), tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). METHODS: Chemical interactions, surface morphology and mechanical strength of the FDC were ascertained. In vitro drug release studies were conducted in biorelevant media followed by in vivo study in the large white pigs, in comparison with a market formulation, Atripla® ...
April 12, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29627709/rare-emergence-of-drug-resistance-in-hiv-1-treatment-na%C3%A3-ve-patients-receiving-elvitegravir-cobicistat-emtricitabine-tenofovir-alafenamide-for-144-weeks
#9
Nicolas Margot, Stephanie Cox, Moupali Das, Scott McCallister, Michael D Miller, Christian Callebaut
BACKGROUND: The single tablet regimen (STR) composed of elvitegravir (E), cobicistat (C), emtricitabine (F), and tenofovir alafenamide (TAF) (E/C/F/TAF) was compared to the STR composed of E, C, F, and tenofovir disoproxil fumarate (TDF) (E/C/F/TDF) in 2 phase 3 studies in 1733 HIV-1 infected treatment-naïve adults. Superior efficacy of E/C/F/TAF compared to E/C/F/TDF was demonstrated at Week 144 with 84% treatment success compared to 80%, respectively, along with significantly better outcomes of bone and renal safety...
April 2, 2018: Journal of Clinical Virology: the Official Publication of the Pan American Society for Clinical Virology
https://www.readbyqxmd.com/read/29607652/stable-caloric-intake-and-continued-virologic-suppression-for-hiv-positive-antiretroviral-treatment-experienced-women-after-switching-to-a-single-tablet-regimen-of-emtricitabine-rilpivirine-and-tenofovir-disoproxil-fumarate
#10
Prema Menezes, Katie Mollan, Erin Hoffman, Zimeng Xie, Jennifer Wills, Cheryl Marcus, John Rublein, Michael Hudgens, Joseph J Eron
BACKGROUND: Benefits of switching to a single-tablet regimen (STR) of FTC/RPV/TDF in virologically suppressed antiretroviral treatment experienced HIV-positive women include pregnancy category B rating and lack of clinically significant drug interactions between RPV and oral contraceptives. Unfortunately, studies involving switching to FTC/RPV/TDF enrolled fewer than 25% women. We undertook this 48 week study to assess the ability of virologically suppressed HIV-positive women switching to RPV STR to remain virologically suppressed and comply with the caloric intake requirement...
April 1, 2018: AIDS Research and Human Retroviruses
https://www.readbyqxmd.com/read/29584910/week-96-efficacy-of-lopinavir-ritonavir-monotherapy-in-virologically-suppressed-patients-with-hiv-a-randomized-non-inferiority-trial-anrs-140-dream
#11
Jean-Luc Meynard, Laetitia Moinot, Roland Landman, Laurence Morand-Joubert, Amel Besseghir, Sami Kolta, Bruno Spire, Eve Todesco, Olivier Bouchaud, Catherine Fagard, Geneviève Chene, Pierre-Marie Girard
Background: Sparing of antiretroviral drug classes could reduce the toxicity and cost of maintenance treatment for HIV infection. Objectives: To evaluate the non-inferiority of efficacy and the safety of lopinavir/ritonavir (r) monotherapy versus a single-tablet regimen of efavirenz, emtricitabine and tenofovir (EFV/FTC/TDF) over 2 years. Methods: Adults on stable ART with plasma HIV-1 RNA viral load <50 copies/mL for the past 12 months and no documented treatment failure were randomized to receive either lopinavir/r or EFV/FTC/TDF for 2 years...
March 23, 2018: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29564777/bictegravir-first-global-approval
#12
Anthony Markham
Gilead Sciences has developed a single tablet anti-HIV-1 medication (Biktarvy® ) combining the novel integrase strand transfer inhibitor (INSTI) bictegravir with the nucleos(t)ide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide. This fixed dose combination has demonstrated efficacy as treatment for both anti-retroviral naïve and virologically suppressed HIV-1 infection in patients switching therapy, and was recently approved in the USA. This article summarizes the milestones in the development of bictegravir leading to this first approval of bictegravir/emtricitabine/tenofovir alafenamide as treatment for HIV-1 infection...
March 21, 2018: Drugs
https://www.readbyqxmd.com/read/29557204/next-generation-fixed-dose-combination-pharmacotherapies-for-treating-hiv
#13
Margaret R Caplan, Eric S Daar, Katya C Corado
Treatment options for patients with HIV-1 infection have grown over the past two decades to include multiple fixed-dose combination pharmacotherapies that have greatly simplified administration of antiretroviral therapy (ART) for both patients and providers. Effective virologic control can often be achieved with once-daily use of a single-tablet regimen. Over the past three years, ART drug development has focused on the next generation of fixed-dose combinations for initial and maintenance therapy with improved efficacy, safety and tolerability...
March 20, 2018: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29533918/intentional-overdose-of-dolutegravir-abacavir-lamivudine-triumeq-in-a-26-year-old-man
#14
Paul Mel van Dam, Mark Wl van Geffen, Thomas Ra Havenith, Dirk Posthouwer
Triumeq is a single-tablet regimen for patients with HIV infection comprising dolutegravir, abacavir and lamivudine. Overdoses with Triumeq have not been reported previously. We present a case of a 26-year-old man who presented to our hospital after intentionally ingesting 30 tablets of Triumeq. An intoxication with Triumeq can lead to several side effects. An overdose of abacavir and lamivudine can cause mitochondrial toxicity and lactic acidosis. An intoxication with dolutegravir appears to be relatively harmless...
March 13, 2018: Antiviral Therapy
https://www.readbyqxmd.com/read/29530239/-haemorrhagic-proctocolitis-as-primary-manifestation-of-lymphogranuloma-venereum-in-an-hiv-positive-male
#15
Andreas Brandt Gormsen, Jon Erik-Fraes Diernæs, Jørgen Skov Jensen, Uffe Koppelhus
This is a case report of lymphogranuloma venereum (LGV) manifesting as haemorrhagic proctocolitis in a homosexual HIV-positive male. The primary symptom was a rectal abscess, which was initially surgically treated and subsequently insufficiently treated with single-dose tablet azithromycin. The patient's symptoms were successfully treated after a 21-day doxycycline regime. LGV is a sexually transmitted infection with a rising incidence among persons with risk behaviour. This case report underlines the importance, that all positive rectal screenings for Chlamydia trachomatis should be routinely serotyped...
March 12, 2018: Ugeskrift for Laeger
https://www.readbyqxmd.com/read/29521670/a-longitudinal-analysis-of-daily-pill-burden-and-likelihood-of-optimal-adherence-to-antiretroviral-therapy-among-people-living-with-hiv-who-use-drugs
#16
Nur Afiqah Mohd Salleh, Lindsey Richardson, Thomas Kerr, Jean Shoveller, Julio Montaner, Adeeba Kamarulzaman, M-J Milloy
OBJECTIVES: Among people living with HIV (PLWH), high levels of adherence to prescribed antiretroviral therapy (ART) is required to achieve optimal treatment outcomes. However, little is known about the effects of daily pill burden on adherence amongst PLWH who use drugs. We sought to investigate the association between daily pill burden and adherence to ART among members of this key population in Vancouver, Canada. METHODS: We used data from the AIDS Care Cohort to Evaluate Exposure to Survival Services study, a long-running community-recruited cohort of PLWH who use illicit drugs linked to comprehensive HIV clinical records...
March 7, 2018: Journal of Addiction Medicine
https://www.readbyqxmd.com/read/29505661/comparison-of-adherence-to-generic-multi-tablet-regimens-vs-brand-multi-tablet-and-brand-single-tablet-regimens-likely-to-incorporate-generic-antiretroviral-drugs-by-breaking-or-not-fixed-dose-combinations-in-hiv-infected-patients
#17
Joseph Rwagitinywa, Maryse Lapeyre-Mestre, Robert Bourrel, Jean-Louis Montastruc, Agnès Sommet
Adherence to antiretroviral (ARV) is crucial to achieve viral load suppression in HIV-infected patients. This study aimed to compare adherence to generic multi-tablet regimens (MTR) vs. brand MTR likely to incorporate ARV drugs without breaking fixed-dose combinations (FDC) and brand single-tablet regimens (STR) likely to incorporate generics by breaking the FDC. Patients aged of 18 years or over exposed to one of the generic or the brand of lamivudine (3TC), zidovudine/lamivudine (AZT/TC), nevirapine (NVP), or efavirenz (EFV), or the brand STR of efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF)...
March 5, 2018: Fundamental & Clinical Pharmacology
https://www.readbyqxmd.com/read/29481486/efficacy-and-safety-of-switching-to-coformulated-elvitegravir-cobicistat-emtricitabine-and-tenofovir-alafenamide-e-c-f-taf-in-virologically-suppressed-women
#18
Sally Hodder, Kathleen Squires, Cissy Kityo, Debbie Hagins, Anchalee Avihingsanon, Anna Kido, Shuping Jiang, Rima Kulkarni, Andrew Cheng, Huyen Cao
BACKGROUND: The integrase inhibitor regimen (elvitegravir [EVG]/cobicistat [COBI]/emtricitabine [FTC]/tenofovir disoproxil fumarate [TDF]) demonstrated superior efficacy when compared to a protease inhibitor regimen (ritonavir-boosted atazanavir [ATV+RTV] plus FTC/TDF) in 575 treatment-naïve women at week 48. We investigated the efficacy, safety, and tolerability of switching to a TAF-based, single-tablet regimen containing EVG, COBI, FTC, and tenofovir alafenamide TAF (E/C/F/TAF) versus remaining on ATV+RTV and FTC/TDF...
February 21, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/29478329/single-tablet-hiv-regimens-facilitate-virologic-suppression-and-retention-in-care-among-treatment-na%C3%A3-ve-patients
#19
Vagish Hemmige, Charlene A Flash, Josephinel Carter, Thomas P Giordano, Teddy Zerai
Newer HIV regimens are typically taken once daily but vary in the number of pills required. Whether the number of pills in a once-daily HIV regimen affects clinical outcomes is unknown. We retrospectively compared adherence, retention in care, and virologic outcomes between patients starting a once daily single-tablet regimen (STR) to patients starting a once-daily multi-tablet regimen (MTR) in a publicly funded clinic in the United States. Outcomes were measured in the year after starting ART and included retention in care, virologic suppression, and medication possession ratio of at least 80%...
February 25, 2018: AIDS Care
https://www.readbyqxmd.com/read/29474268/twenty-five-years-of-lamivudine-current-and-future-use-for-the-treatment-of-hiv-1-infection
#20
Romina Quercia, Carlo-Federico Perno, Justin Koteff, Katy Moore, Cynthia McCoig, Marty St Clair, Daniel Kuritzkes
Innovation in medicine is a dynamic, complex, and continuous process that cannot be isolated to a single moment in time. Anniversaries offer opportunities to commemorate crucial discoveries of modern medicine, such as penicillin (1928), polio vaccination (inactivated, 1955; oral, 1961), the surface antigen of the hepatitis B virus (1967), monoclonal antibodies (1975), and the first HIV antiretroviral drugs (zidovudine, 1987). The advent of antiretroviral drugs has had a profound effect on the progress of the epidemiology of HIV infection, transforming a terminal, irreversible disease that caused a global health crisis into a treatable but chronic disease...
February 22, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
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