GLASS Methodology for Surveillance of National Antimicrobial Consumption
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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. -
Hepatitis C Agents Therapeutic Class Review
Hepatitis C Agents Therapeutic Class Review (TCR) November 2, 2018 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2018 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Mfr FDA-Approved Indications Interferons peginterferon alfa-2a Genentech Chronic hepatitis C (CHC) 1 (Pegasys®) . -
General Items
Essential Medicines List (EML) 2019 Application for the inclusion of imipenem/cilastatin, meropenem and amoxicillin/clavulanic acid in the WHO Model List of Essential Medicines, as reserve second-line drugs for the treatment of multidrug-resistant tuberculosis (complementary lists of anti-tuberculosis drugs for use in adults and children) General items 1. Summary statement of the proposal for inclusion, change or deletion This application concerns the updating of the forthcoming WHO Model List of Essential Medicines (EML) and WHO Model List of Essential Medicines for Children (EMLc) to include the following medicines: 1) Imipenem/cilastatin (Imp-Cln) to the main list but NOT the children’s list (it is already mentioned on both lists as an option in section 6.2.1 Beta Lactam medicines) 2) Meropenem (Mpm) to both the main and the children’s lists (it is already on the list as treatment for meningitis in section 6.2.1 Beta Lactam medicines) 3) Clavulanic acid to both the main and the children’s lists (it is already listed as amoxicillin/clavulanic acid (Amx-Clv), the only commercially available preparation of clavulanic acid, in section 6.2.1 Beta Lactam medicines) This application makes reference to amendments recommended in particular to section 6.2.4 Antituberculosis medicines in the latest editions of both the main EML (20th list) and the EMLc (6th list) released in 2017 (1),(2). On the basis of the most recent Guideline Development Group advising WHO on the revision of its guidelines for the treatment of multidrug- or rifampicin-resistant (MDR/RR-TB)(3), the applicant considers that the three agents concerned be viewed as essential medicines for these forms of TB in countries. -
Jan7merck to Present New Data from Clinical Trials Evaluating ISENTRESS® HD (Raltegravir) and Investigational HIV Therapies Doravirine and MK- 8591 at IAS 2017
NEWS RELEASE Jan7Merck to Present New Data from Clinical Trials Evaluating ISENTRESS® HD (raltegravir) and Investigational HIV Therapies Doravirine and MK- 8591 at IAS 2017 7/6/2017 Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new data from the company’s HIV portfolio and pipeline are scheduled to be presented at the 9th IAS Conference on HIV Science (IAS 2017). Presentations include late-breaker abstracts from two Phase 3 pivotal clinical trials – Week 96 data from ONCEMRK, a study evaluating once-daily ISENTRESS ® HD (raltegravir) in combination with other antiretroviral agents in previously untreated adult patients with HIV-1 infection, and Week 48 data from DRIVE-AHEAD, a study evaluating doravirine (MK-1439), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) as part of a xed dose regimen containing doravirine (DOR), lamivudine (3TC), and tenofovir disoproxil fumarate (TDF) compared to a regimen containing efavirenz (EFV), emtricitabine (FTC), and TDF in previously untreated adult patients with HIV-1 infection. In addition, a late-breaker abstract will be presented of a Phase 1 study of MK-8591, Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) in adult patients with HIV-1 infection. IAS 2017 is taking place in Paris, France, from July 23-26, 2017. “Merck has never wavered in our commitment to addressing the treatment needs of people living with HIV, and the data to be presented at IAS 2017 on our portfolio and our pipeline reect that commitment,” said Dr. George Hanna, associate vice president, clinical research, Merck Research Laboratories. In the United States, once-daily ISENTRESS HD was approved by the Food and Drug Administration (FDA) on May 26, 1 2017, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults, and pediatric patients weighing at least 40 kg, who are treatment-naïve or whose virus has been suppressed on an initial regimen of ISENTRESS 400 mg given twice daily. -
Download Article PDF/Slides
New Antiretrovirals in Development: Reprinted from The PRN Notebook,™ june 2002. Dr. James F. Braun, Editor-in-Chief. Tim Horn, Executive Editor. Published in New York City by the Physicians’ Research Network, Inc.,® John Graham Brown, Executive Director. For further information and other articles The View in 2002 available online, visit http://www.PRN.org All rights reserved. © june 2002. Roy “Trip” Gulick, md, mph Associate Professor of Medicine, Weill Medical College of Cornell University Director, Cornell Clinical Trials Unit, New York, New York Summary by Tim Horn Edited by Scott Hammer, md espite the fact that 16 antiretro- tiviral activity of emtricitabine was estab- Preliminary results from two random- virals are approved for use in the lished, with total daily doses of 200 mg or ized studies—FTC-302 and FTC-303—were United States, there is an indis- more producing the greatest median viral reported by Dr. Charles van der Horst and putable need for new anti-hiv com- load suppression: 1.72-1.92 log. Based on his colleagues at the 8th croi, held in Feb- pounds that have potent and these data, a once-daily dose of 200 mg ruary 2001 in Chicago (van der Horst, durable efficacy profiles, unique re- was selected for further long-term clinical 2001). FTC-302 was a blinded comparison sistance patterns, patient-friendly dosing study. “This is what we’re looking forward of emtricitabine and lamivudine, both in schedules, and minimal toxicities. To pro- to with emtricitabine,” commented Dr. combination with stavudine (Zerit) and vide prn with a glimpse of drugs current- Gulick. -
Sofosbuvir-Based and Elbasvir/Grazoprevir Treatment Fai
Sofosbuvir-Based and Elbasvir/Grazoprevir Treatment Fai... From www.HCVGuidance.org on September 27, 2021 Sofosbuvir-Based and Elbasvir/Grazoprevir Treatment Failures In general, persons who have experienced treatment failure with a sofosbuvir-based regimen should be retreated with 12 weeks of sofosbuvir/velpatasvir/voxilaprevir. The main exception is persons with genotype 3 and cirrhosis, in whom addition of ribavirin to sofosbuvir/velpatasvir/voxilaprevir for 12 weeks is recommended. Sixteen weeks of glecaprevir/pibrentasvir is an alternative regimen. Elbasvir/grazoprevir treatment failure patients should also be retreated with 12 weeks of sofosbuvir/velpatasvir/voxilaprevir. However, glecaprevir/pibrentasvir for 16 weeks is not recommended as an alternative for this group of patients. Recommended and alternative regimens listed by evidence level and alphabetically for: Sofosbuvir-Based Treatment Failures, With or Without Compensated Cirrhosisa RECOMMENDED DURATION RATING Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 12 weeks I, A mg)/voxilaprevir (100 mg)b ALTERNATIVE DURATION RATING Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) 16 weeks I, A except for NS3/4 protease inhibitor inclusive combination DAA regimen failuresc Not recommended for genotype 3 infection with sofosbuvir/NS5A inhibitor experience. a For decompensated cirrhosis, please refer to the appropriate section. b Genotype 3: Add weight-based ribavirin if cirrhosis is present and there are no contraindications. c This regimen is not recommended for patients with prior exposure to an NS5A inhibitor plus NS3/4 PI regimens (eg. Elbasvir/grazoprevir). Recommended Regimen Sofosbuvir/Velpatasvir/Voxilaprevir The placebo-controlled, phase 3 POLARIS-1 trial evaluated a 12-week course of the daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg)/voxilaprevir (100mg) in 263 persons with a prior NS5A inhibitor-containing DAA regimen failure. -
Tetracycline and Sulfonamide Antibiotics in Soils: Presence, Fate and Environmental Risks
processes Review Tetracycline and Sulfonamide Antibiotics in Soils: Presence, Fate and Environmental Risks Manuel Conde-Cid 1, Avelino Núñez-Delgado 2 , María José Fernández-Sanjurjo 2 , Esperanza Álvarez-Rodríguez 2, David Fernández-Calviño 1,* and Manuel Arias-Estévez 1 1 Soil Science and Agricultural Chemistry, Faculty Sciences, University Vigo, 32004 Ourense, Spain; [email protected] (M.C.-C.); [email protected] (M.A.-E.) 2 Department Soil Science and Agricultural Chemistry, Engineering Polytechnic School, University Santiago de Compostela, 27002 Lugo, Spain; [email protected] (A.N.-D.); [email protected] (M.J.F.-S.); [email protected] (E.Á.-R.) * Correspondence: [email protected] Received: 30 October 2020; Accepted: 13 November 2020; Published: 17 November 2020 Abstract: Veterinary antibiotics are widely used worldwide to treat and prevent infectious diseases, as well as (in countries where allowed) to promote growth and improve feeding efficiency of food-producing animals in livestock activities. Among the different antibiotic classes, tetracyclines and sulfonamides are two of the most used for veterinary proposals. Due to the fact that these compounds are poorly absorbed in the gut of animals, a significant proportion (up to ~90%) of them are excreted unchanged, thus reaching the environment mainly through the application of manures and slurries as fertilizers in agricultural fields. Once in the soil, antibiotics are subjected to a series of physicochemical and biological processes, which depend both on the antibiotic nature and soil characteristics. Adsorption/desorption to soil particles and degradation are the main processes that will affect the persistence, bioavailability, and environmental fate of these pollutants, thus determining their potential impacts and risks on human and ecological health. -
Hepatitis C Treatment
Hepatitis C Treatment The goal of treatment for hepatitis C virus (HCV) is to cure the virus, which can be done with a combination of drugs. The specific meds used and the duration of treatment depend on a number of factors, including HCV genotype (genetic structure of the virus), viral load, past treatment experience, degree of liver damage, ability to tolerate the prescribed treatment, and whether the person is waiting for a liver transplant or is a transplant recipient. In some cases, HCV treatment may be limited by your health insurance plan or drug formulary. Here’s information about each type, or class, of approved HCV treatment along with drugs in the late stages of development: Multi-Class Combination Drugs Brand Name Generic Name Status Pharmaceutical Company Epclusa* sofosbuvir + velpatasvir Approved Gilead Sciences Harvoni* ledipasvir + sofosbuvir Approved Gilead Sciences Mavyret glecaprevir + pibrentasvir Approved AbbVie Vosevi sofosbuvir/velpatasvir/ Approved Gilead Sciences voxilaprevir Zepatier elbasvir + grazoprevir Approved Merck n/a daclatasvir + asunaprevir + Phase III Bristol-Myers Squibb beclabuvir *generic available What are they? Multi-class combination drugs are a combination of drugs formulated into a single pill or package of pills. For instance, the drug Harvoni combines two drugs, ledipasvir and sofosbuvir. Ledipasvir is an NS5A inhibitor and is only sold as part of Harvoni; sofosbuvir may be prescribed separately under the brand name of Sovaldi. Pegylated Interferon Alfa Brand Name Generic Name Status Pharmaceutical Company Pegasys peginterferon alfa-2a Approved Genentech What are they? Interferon is a protein made by the immune system, named because it interferes with viral reproduction. In addition, interferon signals the immune system to recognize and respond to microorganisms, including viral and bacterial infections. -
Recommendations on First and Second Line Antiretroviral Regimens
POLICY BRIEF UPDATE OF RECOMMENDATIONS ON FIRST- AND SECOND-LINE ANTIRETROVIRAL REGIMENS JULY 2019 HIV TREATMENT WHO/CDS/HIV/19.15 © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution- NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/ licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Update of recommendations on first- and second-line antiretroviral regimens. Geneva, Switzerland: World Health Organization; 2019 (WHO/CDS/HIV/19.15). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. -
Topical Antibiotics for Impetigo: a Review of the Clinical Effectiveness and Guidelines
CADTH RAPID RESPONSE REPORT: SUMMARY WITH CRITICAL APPRAISAL Topical Antibiotics for Impetigo: A Review of the Clinical Effectiveness and Guidelines Service Line: Rapid Response Service Version: 1.0 Publication Date: February 21, 2017 Report Length: 23 Pages Authors: Rob Edge, Charlene Argáez Cite As: Topical antibiotics for impetigo: a review of the clinical effectiveness and guidelines. Ottawa: CADTH; 2017 Feb. (CADTH rapid response report: summary with critical appraisal). ISSN: 1922-8147 (online) Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. -
The Future of HIV Prevention and Treatment for Youth #Strive2optimize
THE AMERICAN ACADEMY OF HIV MEDICINE www.aahivm.org DECEMBER 2019 Patient Care, Practice Management & Professional Development Information for HIV Care Providers HIVSpecialist Integrating Transgender Healthcare for 24 The Future of Adolescents Not Your Parents’ HIV Prevention and Sex Talks 30 Treatment for Youth Adapting the Clinical Response 34 Fear of Addressing Substance Use and 36 Addiction DURABLE POWER AT PRESCRIBED REGIMEN FOR HIV-1 TREATMENT WEEK 144 Source: Ipsos Healthcare US HIV Therapy Monitor & Scope Study May-July 2019. BIKTARVY® (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg) combines the FTC/TAF* backbone with bictegravir, a novel and unboosted INSTI—for a powerful STR1,2 Learn more about the BIKTARVY 144 week data at BIKTARVY144.com Long-term e cacy in treatment-naïve adults at Week 1442-7 Results noninferior to comparators No treatment-emergent resistance associated with BIKTARVY through Week 1442-7 Study 1489: Virologic Response Study 1490: Virologic Response Week 48 Week 144 Week 48 Week 144 -0.6% (-4.8% to -2.6% (-8.5% to -3.5% (-7.9% to -1.9% (-7.8% to 1.0%; p=0.12)† 3.9%; p=0.52)† 100 3.6%; p=0.78)† 3.4%; p=0.39)† 100 HIV-1 RNA HIV-1 RNA <50 copies/mL <50 copies/mL % % % 92 93 % 93 80 % 80 89 % CASES 82% 84 82% 84 OF RESISTANCE WITH 60 60 BIKTARVY ve Adults, % Adults, ve ve Adults, % Adults, ve ï ï 0 40 40 In two large phase 3 clinical trials in treatment-naïve adults 20 20 • Among 634 treatment-naïve adults in Studies 1489 and 1490, 8 treatment-failure subjects were Treatment-Na Treatment-Na 0 0 tested and no amino acid substitutions emerged that were associated with BIKTARVY resistance Virologic failure Virologic failure HIV-1 RNA 1% 3% 1% 3% HIV-1 RNA 4% 1% 5% 3% ≥50 copies/mL ≥50 copies/mL BIKTARVY ABC/DTG/3TC BIKTARVY FTC/TAF+DTG urine glucose, and urine protein in all patients (n=314) (n=315) (n=320) (n=325) IMPORTANT SAFETY INFORMATION (cont’d) Contraindications as clinically appropriate.