Tea Polyphenols As Natural Products for Potential Future Management of HIV Infection
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Eparate Formulations According to the Prescribed Dosing Recommendations for These Products
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Lamivudine/Zidovudine Teva 150 mg/300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg lamivudine and 300 mg zidovudine. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, capsule shaped, biconvex, film-coated scored tablet – engraved with “L/Z” on one side and “150/300” on the other side. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection (see section 4.2). 4.2 Posology and method of administration Therapy should be initiated by a physician experienced in the management of HIV infection. Lamivudine/Zidovudine Teva may be administered with or without food. To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. For patients who are unable to swallow tablets, tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2). Adults and adolescents weighing at least 30 kg: the recommended oral dose of Lamivudine/Zidovudine Teva is one tablet twice daily. Children weighing between 21 kg and 30 kg: the recommended oral dose of Lamivudine/Zidovudine Teva is one-half tablet taken in the morning and one whole tablet taken in the evening. Children weighing from 14 kg to 21 kg: the recommended oral dose of Lamivudine/Zidovudine Teva is one-half tablet taken twice daily. -
HIV Tropism Testing for Maraviroc Response
Lab Management Guidelines V1.0.2021 HIV Tropism Testing for Maraviroc Response MOL.TS.185.A v1.0.2021 Introduction HIV tropism testing for maraviroc response is addressed by this guideline. Procedures addressed The inclusion of any procedure code in this table does not imply that the code is under management or requires prior authorization. Refer to the specific Health Plan's procedure code list for management requirements. Procedures addressed by this Procedure codes guideline HIV-1 Tropism Phenotyping 87999 HIV-1 Tropism Genotyping, Common 87901 HIV-1 Tropism Genotyping, Other 87906 What is HIV tropism testing for Maraviroc response Definition HIV tropism testing is used to help determine an individual's response to maraviroc (Selzentry®). Maraviroc is only effective against CCR5-tropic HIV-1. Human immunodeficiency virus (HIV) HIV replicates itself in humans by infecting T-cells with CD4 receptors (often called CD4 cells). HIV-1 enters the CD4 cell by binding one of two cell surface co-receptors: CCR5 or CXCR4.1,2 Tropism classifications Tropism is the ability of HIV-1 virus to use one or both of these co-receptors. There are three main tropism classifications:3 o CCR5 tropism (R5-tropic) — HIV-1 virus that only infects cells with the CCR5 co-receptor. o CXCR4 tropism (X4-tropic) — HIV-1 virus that only infects cells with the CXCR4 co-receptor. © 2020 eviCore healthcare. All Rights Reserved. 1 of 5 400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924 www.eviCore.com Lab Management Guidelines V1.0.2021 o Dual or mixed tropism (D/M-tropic) — HIV-1 virus populations that can use either co-receptor to infect cells. -
Revised 4/1/2021 GEORGIA MEDICAID FEE-FOR-SERVICE HIV
GEORGIA MEDICAID FEE-FOR-SERVICE HIV-AIDS PA SUMMARY Preferred (may not be all inclusive) Non-Preferred Abacavir generic Abacavir/lamivudine/zidovudine generic Abacavir/lamivudine generic Aptivus (tipranavir) Complera (emtricitabine/rilpivirine/tenofovir disoproxil Atazanavir capsules generic fumarate) Atripla (efavirenz/emtricitabine/tenofovir disoproxil Crixivan (indinavir) fumarate) Biktarvy (bictegravir/emtricitabine/tenofovir Delstrigo (doravirine/lamivudine/tenofovir disoproxil alafenamide) fumarate) Cimduo (lamivudine/tenofovir disoproxil fumarate) Fuzeon (enfuvirtide) Descovy (emtricitabine/tenofovir alafenamide) Intelence (etravirine) Dovato Invirase (saquinavir) Edurant (rilpivirine)* Lexiva (fosamprenavir) Efavirenz tablets generic Nevirapine extended-release generic Emtriva (emtricitabine) Norvir Powder (ritonavir) Epivir solution (lamivudine) Pifeltro (doravirine) Evotaz (atazanavir/cobicistat)* Reyataz Powder (atazanavir) Genvoya (elvitegravir/cobicistat/emtricitabine/ Ritonavir tablets generic tenofovir alafenamide) Isentress and Isentress HD (raltegravir)* Rukobia (fostemsavir) Juluca (dolutegravir/rilpivirine) Selzentry (maraviroc) Kaletra (lopinavir/ritonavir) Stavudine generic^ Stribild (elvitegravir/cobicistat/emtricitabine/ tenofovir Lamivudine generic disoproxil fumarate) Symfi (efavirenz 600 mg/lamivudine/tenofovir Lamivudine/zidovudine generic disoproxil fumarate) Symfi Lo (efavirenz 400 mg/lamivudine/tenofovir Nevirapine immediate-release tablets generic disoproxil fumarate) Norvir (ritonavir) Temixys (lamivudine/tenofovir -
KALETRA (Lopinavir/Ritonavir)
HIGHLIGHTS OF PRESCRIBING INFORMATION CONTRAINDICATIONS These highlights do not include all the information needed to use • Hypersensitivity to KALETRA (e.g., toxic epidermal necrolysis, Stevens- KALETRA safely and effectively. See full prescribing information for Johnson syndrome, erythema multiforme, urticaria, angioedema) or any of KALETRA. its ingredients, including ritonavir. (4) • Co-administration with drugs highly dependent on CYP3A for clearance KALETRA (lopinavir and ritonavir) tablet, for oral use and for which elevated plasma levels may result in serious and/or life- KALETRA (lopinavir and ritonavir) oral solution threatening events. (4) Initial U.S. Approval: 2000 • Co-administration with potent CYP3A inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for RECENT MAJOR CHANGES loss of virologic response and possible resistance and cross resistance. (4) Contraindications (4) 12/2019 WARNINGS AND PRECAUTIONS The following have been observed in patients receiving KALETRA: INDICATIONS AND USAGE • The concomitant use of KALETRA and certain other drugs may result in KALETRA is an HIV-1 protease inhibitor indicated in combination with other known or potentially significant drug interactions. Consult the full antiretroviral agents for the treatment of HIV-1 infection in adults and prescribing information prior to and during treatment for potential drug pediatric patients (14 days and older). (1) interactions. (5.1, 7.3) • Toxicity in preterm neonates: KALETRA oral solution should not be used DOSAGE AND ADMINISTRATION in preterm neonates in the immediate postnatal period because of possible Tablets: May be taken with or without food, swallowed whole and not toxicities. A safe and effective dose of KALETRA oral solution in this chewed, broken, or crushed. -
Truvada (Emtricitabine / Tenofovir Disoproxil)
Pre-exposure Prophylaxis (2.3) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Recommended dose in HIV-1 uninfected adults: One tablet TRUVADA safely and effectively. See full prescribing information (containing 200 mg/300 mg of emtricitabine and tenofovir for TRUVADA. disoproxil fumarate) once daily taken orally with or without food. (2.3) TRUVADA® (emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use Recommended dose in renally impaired HIV-uninfected Initial U.S. Approval: 2004 individuals: Do not use TRUVADA in HIV-uninfected individuals if CrCl is below 60 mL/min. If a decrease in CrCl is observed in WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH uninfected individuals while using TRUVADA for PrEP, evaluate STEATOSIS, POST-TREATMENT ACUTE EXACERBATION OF potential causes and re-assess potential risks and benefits of HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF continued use. (2.4) TRUVADA FOR PrEP IN UNDIAGNOSED HIV-1 INFECTION -----------------------DOSAGE FORMS AND STRENGTHS------------------- See full prescribing information for complete boxed warning. Tablets: 200 mg/300 mg, 167 mg/250 mg, 133 mg/200 mg, and 100 Lactic acidosis and severe hepatomegaly with steatosis, mg/150 mg of emtricitabine and tenofovir disoproxil fumarate . (3) including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA. (5.1) --------------------------------CONTRAINDICATIONS----------------------------- TRUVADA is not approved for the treatment of chronic Do not use TRUVADA for pre-exposure prophylaxis in individuals with hepatitis B virus (HBV) infection. Severe acute unknown or positive HIV-1 status. TRUVADA should be used in exacerbations of hepatitis B have been reported in patients HIV-infected patients only in combination with other antiretroviral coinfected with HIV-1 and HBV who have discontinued agents. -
Page: Treatment-Drugs
© National HIV Curriculum PDF created September 29, 2021, 5:12 am Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine (Symtuza) Table of Contents Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine Symtuza Summary Drug Summary Key Clinical Trials Key Drug Interactions Drug Summary The fixed-dose combination tablet darunavir-cobicistat-tenofovir alafenamide-emtricitabine is a single-tablet regimen that can be considered for treatment-naïve or certain treatment-experienced adults living with HIV. This single-tablet regimen offers a one pill daily regimen with high barrier to resistance (due to the darunavir- cobicistat), with potentially less renal and bone toxicity as compared to regimens that include tenofovir DF; however, it has potential gastrointestinal adverse effects and drug-drug interactions, primarily due to the cobicistat component. In clinical trials, darunavir-cobicistat-tenofovir alafenamide-emtricitabine was compared to darunavir-cobicistat plus tenofovir DF-emtricitabine as initial therapy for treatment-naïve individuals and found to be equally effective in terms of viral suppression. A switch to the fixed-dose combination tablet was also compared to continuing a boosted protease inhibitor plus tenofovir DF- emtricitabine and again determined to have equivalent efficacy. The FDA has approved darunavir-cobicistat- tenofovir alafenamide-emtricitabine as a complete regimen for treatment-naïve individuals or treatment- experienced individuals who have a suppressed HIV RNA level on a stable regimen for at least 6 months and no resistance to darunavir or tenofovir. Key Clinical Trials A phase 3 trial in treatment-naïve individuals compared the fixed-dose single-tablet regimen darunavir- cobicistat-tenofovir alafenamide-emtricitabine with the regimen darunavir-cobicistat plus tenofovir DF- emtricitabine emtricitabine [AMBER]. -
Pureweigh®-FM
Manufacturers of Hypo-al ler gen ic Nutritional Sup ple ments PureWeigh®-FM INTRODUCED 2000 What Is It? than DHEA in stimulating the thermogenic enzymes of the liver, helping to support a leaner BMI (Body Mass PureWeigh®-FM is an encapsulated supplement companion Index) and healthy weight control. In a double blind to PureWeigh® PREMEAL Beverage containing banaba study involving 30 overweight adults, 7-KETO supported (Lagerstroemia speciosa L.) extract, green tea extract, healthy body composition and BMI when combined with taurine, 7-KETO™ DHEA, biotin, magnesium citrate and exercise.* chromium polynicotinate. PureWeigh®-FM may also be used independently of PureWeigh® PREMEAL Beverage to support • Biotin, facilitating protein, fat and carbohydrate healthy glucose metabolism and promote weight loss.* metabolism by acting as a coenzyme for numerous metabolic reactions. A clinical study reported that high Features Include dose administration of biotin helped promote healthy glucose metabolism. A number of animal studies support • Banaba extract, containing a triterpenoid compound this claim. Biotin may also act to promote transcription called corosolic acid, reported in studies to support and translation of glucokinase, an enzyme found in the healthy glucose function and absorption. A recent liver and pancreas that participates in the metabolism phase II, double-blind, placebo-controlled multi-center of glucose to form glycogen. In addition, a double-blind trial in Japan suggested that banaba extract maintained study reported that biotin supplementation may promote healthy glucose function and was well tolerated by healthy lipid metabolism, citing an inverse relationship volunteers. Furthermore, an independent U.S. between plasma biotin and total lipids.* preliminary clinical study reported statistically significant weight loss in human volunteers • Magnesium citrate, providing a highly bioavailable supplementing with a 1% corosolic acid banaba extract. -
Targeting Fibrosis in the Duchenne Muscular Dystrophy Mice Model: an Uphill Battle
bioRxiv preprint doi: https://doi.org/10.1101/2021.01.20.427485; this version posted January 21, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. 1 Title: Targeting fibrosis in the Duchenne Muscular Dystrophy mice model: an uphill battle 2 Marine Theret1#, Marcela Low1#, Lucas Rempel1, Fang Fang Li1, Lin Wei Tung1, Osvaldo 3 Contreras3,4, Chih-Kai Chang1, Andrew Wu1, Hesham Soliman1,2, Fabio M.V. Rossi1 4 1School of Biomedical Engineering and the Biomedical Research Centre, Department of Medical 5 Genetics, 2222 Health Sciences Mall, Vancouver, BC, V6T 1Z3, Canada 6 2Department of Pharmacology and Toxicology, Faculty of Pharmaceutical Sciences, Minia 7 University, Minia, Egypt 8 3Developmental and Stem Cell Biology Division, Victor Chang Cardiac Research Institute, 9 Darlinghurst, NSW, 2010, Australia 10 4Departamento de Biología Celular y Molecular and Center for Aging and Regeneration (CARE- 11 ChileUC), Facultad de Ciencias Biológicas, Pontificia Universidad Católica de Chile, 8331150 12 Santiago, Chile 13 # Denotes Co-first authorship 14 15 Keywords: drug screening, fibro/adipogenic progenitors, fibrosis, repair, skeletal muscle. 16 Correspondence to: 17 Marine Theret 18 School of Biomedical Engineering and the Biomedical Research Centre 19 University of British Columbia 20 2222 Health Sciences Mall, Vancouver, British Columbia 21 Tel: +1(604) 822 0441 fax: +1(604) 822 7815 22 Email: [email protected] 1 bioRxiv preprint doi: https://doi.org/10.1101/2021.01.20.427485; this version posted January 21, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. -
Viiv Healthcare Drug Class1,4: Antiretroviral Agent, Integrase
Brand Name: Tivicay Generic Name: dolutegravir Manufacturer1: ViiV Healthcare Drug Class1,4: Antiretroviral Agent, Integrase Inhibitor Labeled Uses4,5: Labeled1,4: In combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children aged 12 years and older and weighing at least 40 kg. Mechanism of Action1,2: Dolutegravir inhibits the catalytic activity of HIV integrase, which is an HIV encoded enzyme required for viral replication. Integrase is one of the three HIV-1 enzymes required for viral replication. Integration of HIV into cellular DNA is a multi-step process. First, the assembly of integrase in a stable complex with the viral DNA occurs. Second, the terminal dinucleotides from each end of the viral DNA are removed by endonucleolytic processing. Lastly, the viral DNA 3' ends are covalently linked to the cellular (target) DNA by strand transfer. The last two processes, which are catalytic, require integrase to be appropriately assembled on a specific viral DNA substrate. Inhibition of integrase by dolutegravir prevents the covalent insertion, or integration, of unintegrated linear HIV DNA into the host cell genome preventing the formation of the HIV provirus. The provirus is required to direct the production of progeny virus, so inhibiting integration prevents propagation of the viral infection. Pharmacokinetics1: Absorption: Tmax 2-3 hours Vd 17.4L T1/2 14 hours Clearance 1.0 L/h Protein Binding >98.9% Bioavailability Not established Metabolism1,2: Dolutegravir is primarily metabolized via UGT1A1 with some contribution from CYP3A. Metabolism occurs via UDP-glucuronosyltransferase (UGT)1A1 (major) and by the hepatic isoenzyme CYP3A (minor). -
Review CCR5 Antagonists: Host-Targeted Antivirals for the Treatment of HIV Infection
Antiviral Chemistry & Chemotherapy 16:339–354 Review CCR5 antagonists: host-targeted antivirals for the treatment of HIV infection Mike Westby* and Elna van der Ryst Pfizer Global R&D, Kent, UK *Corresponding author: Tel: +44 1304 649876; Fax: +44 1304 651819; E-mail: [email protected] The human chemokine receptors, CCR5 and suggest that these compounds have a long plasma CXCR4, are potential host targets for exogenous, half-life and/or prolonged CCR5 occupancy, which small-molecule antagonists for the inhibition of may explain the delay in viral rebound observed HIV-1 infection. HIV-1 strains can be categorised by following compound withdrawal in short-term co-receptor tropism – their ability to utilise CCR5 monotherapy studies. A switch from CCR5 to (CCR5-tropic), CXCR4 (CXCR4-tropic) or both (dual- CXCR4 tropism occurs spontaneously in approxi- tropic) as a co-receptor for entry into susceptible mately 50% of HIV-infected patients and has been cells. CCR5 may be the more suitable co-receptor associated with, but is not required for, disease target for small-molecule antagonists because a progression. The possibility of a co-receptor natural deletion in the CCR5 gene preventing its tropism switch occurring under selection pressure expression on the cell surface is not associated by CCR5 antagonists is discussed. The completion with any obvious phenotype, but can confer of ongoing Phase IIb/III studies of maraviroc, resistance to infection by CCR5-tropic strains – the aplaviroc and vicriviroc will provide further insight most frequently sexually-transmitted strains. into co-receptor tropism, HIV pathogenesis and The current leading CCR5 antagonists in clinical the suitability of CCR5 antagonists as a potent development include maraviroc (UK-427,857, new class of antivirals for the treatment of HIV Pfizer), aplaviroc (873140, GlaxoSmithKline) and infection. -
Applications of in Silico Methods to Analyze the Toxicity and Estrogen T Receptor-Mediated Properties of Plant-Derived Phytochemicals ∗ K
Food and Chemical Toxicology 125 (2019) 361–369 Contents lists available at ScienceDirect Food and Chemical Toxicology journal homepage: www.elsevier.com/locate/foodchemtox Applications of in silico methods to analyze the toxicity and estrogen T receptor-mediated properties of plant-derived phytochemicals ∗ K. Kranthi Kumara, P. Yugandharb, B. Uma Devia, T. Siva Kumara, N. Savithrammab, P. Neerajaa, a Department of Zoology, Sri Venkateswara University, Tirupati, 517502, India b Department of Botany, Sri Venkateswara University, Tirupati, 517502, India ARTICLE INFO ABSTRACT Keywords: A myriad of phytochemicals may have potential to lead toxicity and endocrine disruption effects by interfering Phytochemicals with nuclear hormone receptors. In this examination, the toxicity and estrogen receptor−binding abilities of a QSAR modeling set of 2826 phytochemicals were evaluated. The endpoints mutagenicity, carcinogenicity (both CAESAR and ISS Toxicity models), developmental toxicity, skin sensitization and estrogen receptor relative binding affinity (ER_RBA) Nuclear hormone receptor binding were studied using the VEGA QSAR modeling package. Alongside the predictions, models were providing pos- Self−Organizing maps sible information for applicability domains and most similar compounds as similarity sets from their training Clustering and classification schemes sets. This information was subjected to perform the clustering and classification of chemicals using Self−Organizing Maps. The identified clusters and their respective indicators were considered as potential hotspot structures for the specified data set analysis. Molecular screening interpretations of models wereex- hibited accurate predictions. Moreover, the indication sets were defined significant clusters and cluster in- dicators with probable prediction labels (precision). Accordingly, developed QSAR models showed good pre- dictive abilities and robustness, which observed from applicability domains, representation spaces, clustering and classification schemes. -
Product Monograph for CELSENTRI
PRODUCT MONOGRAPH PrCELSENTRI maraviroc Tablets 150 and 300 mg CCR5 antagonist ViiV Healthcare ULC 245, boulevard Armand-Frappier Laval, Quebec H7V 4A7 Date of Revision: July 05, 2019 Submission Control No: 226222 © 2019 ViiV Healthcare group of companies or its licensor. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. Page 1 of 60 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS..................................................................................4 ADVERSE REACTIONS....................................................................................................9 DRUG INTERACTIONS ..................................................................................................19 DOSAGE AND ADMINISTRATION..............................................................................28 OVERDOSAGE ................................................................................................................31 ACTION AND CLINICAL PHARMACOLOGY ............................................................31 STORAGE AND STABILITY..........................................................................................36