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https://www.readbyqxmd.com/read/29684092/weekends-off-efavirenz-based-antiretroviral-therapy-in-hiv-infected-children-adolescents-and-young-adults-breather-extended-follow-up-results-of-a-randomised-open-label-non-inferiority-trial
#1
Anna Turkova, Cecilia L Moore, Karina Butler, Alexandra Compagnucci, Yacine Saïdi, Victor Musiime, Annet Nanduudu, Elizabeth Kaudha, Tim R Cressey, Suwalai Chalermpantmetagul, Karen Scott, Lynda Harper, Samuel Montero, Yoann Riault, Torsak Bunupuradah, Alla Volokha, Patricia M Flynn, Rosa Bologna, Jose T Ramos Amador, Steven B Welch, Eleni Nastouli, Nigel Klein, Carlo Giaquinto, Deborah Ford, Abdel Babiker, Diana M Gibb
BACKGROUND: Weekends off antiretroviral therapy (ART) may help engage HIV-1-infected young people facing lifelong treatment. BREATHER showed short cycle therapy (SCT; 5 days on, 2 days off ART) was non-inferior to continuous therapy (CT) over 48 weeks. Planned follow-up was extended to 144 weeks, maintaining original randomisation. METHODS: BREATHER was an open-label, non-inferiority trial. Participants aged 8-24yrs with virological suppression on efavirenz-based first-line ART were randomised 1:1, stratified by age and African/non-African sites, to remain on CT or change to SCT...
2018: PloS One
https://www.readbyqxmd.com/read/29683854/increased-cholesterol-absorption-rather-than-synthesis-is-involved-in-boosted-protease-inhibitor-associated-hypercholesterolaemia
#2
Pere Leyes, Montserrat Cofan, Ana González-Cordón, Elisa de Lazzari, Joan Trabal, Pere Domingo, Eugenia Negredo, Francesc Vidal, Maria T Forga, Jose M Gatell, Emili Ros, Esteban Martínez
OBJECTIVE: The aim of this study was to compare the differential effects of first-line efavirenz (EFV)-based vs. boosted lopinavir-based antiretroviral regimens on cholesterol metabolism. DESIGN: Multicentre, open-label, randomized clinical trial. METHODS: Forty-nine naïve HIV-infected patients were randomized (1 : 1) to receive either ritonavir-boosted lopinavir (LPV/r) or EFV both in combination with tenofovir and emtricitabine (ClinicalTrials...
April 19, 2018: AIDS
https://www.readbyqxmd.com/read/29682296/intensification-of-antiretroviral-treatment-with-raltegravir-for-pregnant-women-living-with-hiv-at-high-risk-of-vertical-transmission
#3
EDITORIAL
Thanyawee Puthanakit, Nattawan Thepnarong, Surasith Chaithongwongwatthana, Suvaporn Anugulruengkitt, Orawan Anunsittichai, Tuangtip Theerawit, Sasiwimol Ubolyam, Chitsanu Pancharoen, Praphan Phanuphak
Objectives:  The rate of vertical HIV transmission for women at high risk of HIV transmission stands at approximately 7.6%. In the present study we describe infant infection rates in women who had received raltegravir (RAL) intensification during pregnancy to a standard three-drug antiretroviral (ART) regimen in Thailand. Methods:  This prospective cohort study enrolled HIV-1-positive pregnant women at high risk of vertical transmission, as defined by (1) ART initiation at a gestational age (GA) ≥32 weeks or (2) HIV-1 RNA >1000 copies/mL at GA of 32-38 weeks while on ART...
April 1, 2018: Journal of Virus Eradication
https://www.readbyqxmd.com/read/29661866/reciprocal-effects-of-antiretroviral-drugs-used-to-treat-hiv-infection-on-the-fibroblast-growth-factor-21-%C3%AE-klotho-system
#4
Ricardo Moure, Pere Domingo, Joan Villarroya, Laura Gasa, José M Gallego-Escuredo, Tania Quesada-López, Samantha Morón-Ros, Alberto F Maroto, Gracia M Mateo, Joan C Domingo, Francesc Villarroya, Marta Giralt
Following antiretroviral therapy, HIV-infected patients show increased circulating levels of the antidiabetic hormone fibroblast growth factor-21 (FGF21). In contrast, expression of the FGF21-obligatory co-receptor β-Klotho (KLB) is reduced in target tissues. This situation is comparable to the FGF21 resistance status observed in obesity and type-2 diabetes. Here, we performed the first systematic study of the effects of distinct members of different antiretroviral drug classes on the FGF21/KLB system in human hepatic, adipose, and skeletal muscle cells...
April 16, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29656449/regimen-durability-in-hiv-infected-children-and-adolescents-initiating-first-line-art-in-a-large-public-sector-hiv-cohort-in-south-africa
#5
Rachael Bonawitz, Alana T Brennan, Lawrence Long, Timothy Heeren, Mhairi Maskew, Ian Sanne, Matthew P Fox
INTRODUCTION: In April 2010 tenofovir and abacavir replaced stavudine in public-sector first-line antiretroviral therapy (ART) for children under 20 years old in South Africa. The association of both abacavir and tenofovir with fewer side-effects and toxicities compared to stavudine could translate to increased durability of tenofovir or abacavir-based regimens. We evaluated changes over time in regimen durability for pediatric patients 3 to 19 years of age at 8 public sector clinics in Johannesburg, South Africa...
April 15, 2018: Tropical Medicine & International Health: TM & IH
https://www.readbyqxmd.com/read/29655904/3d-printed-controlled-release-tritherapeutic-tablet-matrix-for-advanced-anti-hiv-1-drug-delivery
#6
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/29649076/pharmacokinetics-of-tenofovir-alafenamide-when-co-administered-with-other-hiv-antiretrovirals
#7
Rebecca Begley, Moupali Das, Lijie Zhong, John Ling, Brian P Kearney, Joseph M Custodio
BACKGROUND: Tenofovir alafenamide (TAF), a prodrug of the nucleotide analogue tenofovir (TFV), is an antiretroviral (ARV) agent approved either as a complete regimen (elvitegravir/cobicistat/emtricitabine (F)/tenofovir alafenamide (TAF), rilpivirine/F/TAF, bictegravir/F/TAF), or for use with other ARVs (F/TAF), for treatment of HIV. TAF is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters. Disposition of TAF may be altered by co-medications that can inhibit or induce P-gp or BCRP transporters...
April 10, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/29629676/a-proposed-management-algorithm-for-late-onset-efavirenz-neurotoxicity
#8
H M Cross, S Chetty, M T Asukile, H S Hussey, E B Lee Pan, L M Tucker
A high proportion of HIV-positive patients in South Africa receive concomitant efavirenz (EFV) and isoniazid (INH) therapy. EFV is metabolised in the liver via CYP2B6, and genetic polymorphism of CYP2B6 is known to result in slowed metabolism of the drug. INH is also metabolised in the liver, causing inhibition of a pathway that plays an important role in slow EFV metabolisers. Concomitant INH use therefore affects plasma levels of EFV. EFV is well known to cause neuropsychiatric side-effects on initiation, and a recent adult case series described late-onset neurotoxicity in the form of subacute ataxia and encephalopathy in patients treated with EFV for a median of 2 years, in association with toxic plasma levels of the drug...
March 28, 2018: South African Medical Journal, Suid-Afrikaanse Tydskrif Vir Geneeskunde
https://www.readbyqxmd.com/read/29626533/the-repurposing-of-ivermectin-for-malaria-a-prospective-pharmacokinetics-based-virtual-clinical-trials-assessment-of-dosing-regimen-options
#9
Raj Badhan, Zaril Zakaria, Olusola Olafuyi
Ivermectin has demonstrated many successes in the treatment of a range of nematode infections. Considering the increase in malaria resistance attention has turned towards ivermectin as a candidate for repurposing for malaria. This study developed and validated an ivermectin physiologically-based pharmacokinetic model in healthy adults (20-50 years) and paediatric (3-5 years/15-25 kg) subjects and in a representative adult malaria population group (Thailand). Dosing optimisation demonstrated a twice daily for 3- or 5-day regimens would provide a time above the LC50 of more than 7 days for adult and paediatric...
April 4, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29624706/pharmacokinetics-of-efavirenz-in-patients-on-antituberculosis-treatment-in-high-hiv-and-tuberculosis-burden-countries-a-systematic-review
#10
REVIEW
Daniel Atwine, Maryline Bonnet, Anne-Marie Taburet
AIMS: Efavirenz (EFV) and Rifampicin-Isoniazid (RH) are cornerstone drugs in HIV-tuberculosis (TB) co-infection treatment but with complex drug interactions, efficacy and safety challenges. We reviewed recent data on EFV and RH interaction in TB/HIV high-burden countries. METHODS: We conducted a systematic review of studies conducted in the high TB/HIV-burden countries between 1990 and 2016 on EFV pharmacokinetics during RH co-administration in co-infected patients...
April 6, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29623447/decreased-bone-turnover-in-hiv-infected-children-on-antiretroviral-therapy
#11
Stephanie Shiau, Michael T Yin, Renate Strehlau, Faeezah Patel, Ndileka Mbete, Louise Kuhn, Ashraf Coovadia, Stephen M Arpadi
In this study, we evaluated the relationships between immune activation, bone turnover, and bone mass in virally suppressed HIV-infected children and HIV-uninfected children in South Africa. We found that decreased bone mass may occur or persist independent of immune activation and altered bone turnover. PURPOSE: HIV-infected children and adolescents have deficits in skeletal growth which include decreases in bone mass and alterations in bone microarchitecture. However, the mechanism by which HIV infection compromises bone accrual in children and adolescents is unclear...
April 5, 2018: Archives of Osteoporosis
https://www.readbyqxmd.com/read/29623097/renal-effects-of-non-tenofovir-antiretroviral-therapy-in-patients-living-with-hiv
#12
REVIEW
Milena M McLaughlin, Aimee J Guerrero, Andrew Merker
A review of literature published regarding non-tenofovir antiretroviral agents causing renal adverse effects was conducted. The literature involving renal adverse effects and antiretroviral therapy is most robust with protease inhibitors, specifically atazanavir and indinavir, and includes reports of crystalluria, leukocyturia, nephritis, nephrolithiasis, nephropathy and urolithiasis. Several case reports describe potential nephropathy (including Fanconi syndrome) secondary to administration of abacavir, didanosine, lamivudine and stavudine...
2018: Drugs in Context
https://www.readbyqxmd.com/read/29607651/lower-concentrations-of-circulating-medium-and-long-chain-acylcarnitines-characterize-insulin-resistance-in-persons-with-hiv
#13
Samuel Bailin, Cathy Jenkins, Christopher Petucci, Jeffrey A Culver, Bryan E Shepherd, Joshua P Fessel, Todd Hulgan, John Robert Koethe
In HIV-negative individuals, a plasma metabolite profile characterized by higher levels of branched-chain amino acids (BCAA), aromatic amino acids, and C3/C5 acylcarnitines is associated with insulin resistance and increased risk of diabetes. We sought to characterize the metabolite profile accompanying insulin resistance in HIV-positive persons to assess whether the same or different bioenergetics pathways might be implicated. We performed an observational cohort study of 70 non-diabetic, HIV-positive individuals (50% with body mass index ≥ 30 kg/m2) on efavirenz, tenofovir, and emtricitabine with suppressed HIV-1 RNA levels (< 50 copies/mL) for at least 2 years and a CD4+ count over 350 cells/µL...
April 1, 2018: AIDS Research and Human Retroviruses
https://www.readbyqxmd.com/read/29603882/the-cost-effectiveness-and-budgetary-impact-of-a-dolutegravir-based-regimen-as-first-line-treatment-of-hiv-infection-in-india
#14
Amy Zheng, Nagalingeswaran Kumarasamy, Mingshu Huang, A David Paltiel, Kenneth H Mayer, Bharat B Rewari, Rochelle P Walensky, Kenneth A Freedberg
INTRODUCTION: Dolutegravir (DTG)-based antiretroviral therapy (ART) is recommended for first-line HIV treatment in the US and Europe. Efavirenz (EFV)-based regimens remain the standard of care (SOC) in India. We examined the clinical and economic impact of DTG-based first-line ART in the setting of India's recent guidelines change to treating all patients with HIV infection regardless of CD4 count. METHODS: We used a microsimulation of HIV disease, the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-International model, to project outcomes in ART-naive patients under two strategies: (1) SOC: EFV/tenofovir disoproxil fumarate (TDF)/lamivudine (3TC); and (2) DTG: DTG + TDF/3TC...
March 2018: Journal of the International AIDS Society
https://www.readbyqxmd.com/read/29596329/crystal-structure-of-cyp2b6-in-complex-with-an-efavirenz-analog
#15
Manish B Shah, Qinghai Zhang, James R Halpert
The over two dozen CYP2B structures of human, rabbit, and woodrat enzymes solved in the last decade have significantly enhanced our understanding of the structure-function relationships of drug metabolizing enzymes. More recently, an important role has emerged for halogen-π interactions in the CYP2B6 active site in substrate selectivity, explaining in part the preference for halogenated ligands as substrates. The mechanism by which such ligands interact with CYP2B enzymes involves conserved phenylalanine side chains, in particular F108, F115, or F297, in the active site, which form π bonds with halogens...
March 29, 2018: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/29592839/high-resolution-mass-spectrometry-based-methodologies-for-identification-of-etravirine-bioactivation-to-reactive-metabolites-in-vitro-and-in-vivo-approaches
#16
Ana L A Godinho, Inês L Martins, João Nunes, Catarina Charneira, Jorge Grilo, Diogo M Silva, Sofia A Pereira, Karina Soto, M Conceição Oliveira, M Matilde Marques, Cristina C Jacob, Alexandra M M Antunes
Drug bioactivation to reactive metabolites capable of covalent adduct formation with bionucleophiles is a major cause of drug-induced adverse reactions. Therefore, elucidation of reactive metabolites is essential to unravel the toxicity mechanisms induced by drugs and thereby identify patient subgroups at higher risk. Etravirine (ETR) was the first second-generation Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) to be approved, as a therapeutic option for HIV-infected patients who developed resistance to the first-generation NNRTIs...
March 25, 2018: European Journal of Pharmaceutical Sciences
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
#17
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/29579732/development-validation-and-utilization-of-a-highly-sensitive-lc-ms-ms-method-for-quantification-of-levonorgestrel-released-from-a-subdermal-implant-in-human-plasma
#18
Lauren R Cirrincione, Sujan Dilly Penchala, Kimberly K Scarsi, Anthony T Podany, Lee C Winchester, David J Back, Saye H Khoo, Courtney V Fletcher, Marco Siccardi, Laura J Else
Levonorgestrel (LNG) is a synthetic progestin that is available in oral contraceptive tablets, a subdermal implant, and an intrauterine system for contraception. LNG pharmacokinetics are a pivotal determinant of contraceptive efficacy and essential in assessing drug-drug interactions influencing LNG exposure following different routes of LNG administration. A highly sensitive LC-MS/MS method was developed and validated to quantify levonorgestrel in human plasma. Liquid-liquid extraction was utilized with a sample volume of 500 μL to extract levonorgestrel from plasma...
March 12, 2018: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/29568549/markers-of-subclinical-atherosclerotic-disease-in-hiv-infected-individuals
#19
EDITORIAL
Pulin K Gupta, Manu Gupta, Ashok K Lal, Anil Taneja, Rajesh S Taneja, Bharat B Rewari
Background: Wider access to antiretroviral treatment (ART) has resulted in a decline in the number of people dying due to AIDS-related causes. However, with this increased longevity, accelerated rates of cardiovascular and atherosclerotic diseases are on the rise. We hypothesised that the prevalence of atherosclerotic cardiovascular diseases is greater in HIV/AIDS patients as compared to the normal population. Thus, we aimed to study the predictors of subclinical atherosclerotic disease in HIV-infected individuals...
January 1, 2018: Journal of Virus Eradication
https://www.readbyqxmd.com/read/29566538/frequent-cross-resistance-to-rilpivirine-among-subtype-c-hiv-1-from-first-line-antiretroviral-therapy-failures-in-south-africa
#20
Kerri J Penrose, Chanson J Brumme, Maritsa Scoulos-Hanson, Kristen Hamanishi, Kelley Gordon, Raquel V Viana, Carole L Wallis, P Richard Harrigan, John W Mellors, Urvi M Parikh
Background Rilpivirine (TMC278LA) is a promising drug for pre-exposure prophylaxis of HIV-1 because of its sub-nanomolar potency and long-acting formulation; however, increasing transmission of non-nucleoside reverse transcriptase inhibitor-resistant HIV-1 with potential cross-resistance to rilpivirine could reduce its preventive efficacy. This study investigated rilpivirine cross-resistance among recombinant subtype C HIV-1 derived from 100 individuals failing on first-line non-nucleoside reverse transcriptase inhibitor-containing antiretroviral therapy in South Africa whose samples were sent for routine HIV-1 drug resistance testing to Lancet Laboratories (Johannesburg, South Africa)...
January 2018: Antiviral Chemistry & Chemotherapy
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