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And Ritonavir-Boosted HIV Protease Inhibitors
16 February 2012 EMA/CHMP/117973/2012 EMEA/H/C/002332/II/0004 Questions and answers on drug interactions between Victrelis (boceprevir) and ritonavir-boosted HIV protease inhibitors The European Medicines Agency has recommended changes to the prescribing information for Victrelis (boceprevir), a medicine used to treat hepatitis C, after a drug interaction study identified interactions between Victrelis and medicines used to treat HIV called ritonavir-boosted HIV protease inhibitors. These interactions could potentially reduce the effectiveness of these medicines if used together in patients being treated for both hepatitis C and HIV. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the changes to ensure doctors are informed of these interactions while further data are awaited to assess the clinical impact of these drug interaction findings on these patients. What is Victrelis? Victrelis is a medicine used to treat long-term hepatitis C genotype 1 (a disease of the liver due to infection with the hepatitis C virus) in adults with compensated liver disease who have not been treated before or whose previous treatment has failed. Compensated liver disease is when the liver is damaged but is still able to work normally. Victrelis is given in combination with two other medicines, peginterferon alfa and ribavirin. The active substance in Victrelis, boceprevir, is a protease inhibitor which blocks an enzyme called HCV NS3 protease found on the hepatitis C genotype 1 virus. Victrelis was authorised in the EU in July 2011. What is the issue with Victrelis? In January 2012, the EMA was informed of the results of a study in healthy volunteers which identified drug interactions between Victrelis and the antiviral medicines atazanavir, darunavir and lopinavir, which are used to treat HIV. -
Telaprevir (Incivek)
© Hepatitis C Online PDF created September 25, 2021, 4:19 pm Telaprevir (Incivek) Discontinued. This treatment has been discontinued. Table of Contents Telaprevir Incivek Summary Drug Summary Adverse Effects Class and Mechanism Manufacturer for United States FDA Status Indications Dosing Clinical Use Cost and Medication Access Resistance Key Drug Interactions Full Prescribing Information Figures Drug Summary Although telaprevir was a promising direct-acting antiviral agent that had impact in the hepatitis C treatment field during 2011 to 2013, it was subsequently replaced by newer direct-acting antiviral agents that were more effective, better tolerated, and more convenient. Based on the dwindling role of telaprevir after newer direct-acting antiviral agents were approved, Vertex pharmaceuticals discontinued the sales and distribution of telaprevir in the United States in October 2014. Telaprevir does have some current importance since persons who previously failed a telaprevir-based regimen may have developed resistant associated variants, which could potentially impact subsequent therapy. Adverse Effects The most significant adverse effects reported in the main registration trials and in post-marketing experience were rash, anorectal complaints, and anemia. When comparing triple therapy of telaprevir, peginterferon, and ribavirin with dual therapy of peginterferon and ribavirin alone significant differences were noted with rash (56% versus 34%), anemia (36% versus 17%), and anorectal complaints that include anorectal discomfort, anal pruritus, and hemorrhoids (29% versus 7%). In most cases, the rash that develops is eczematous or maculopapular in character and mild to moderate in severity; the rash is typically manageable with good skin care and topical emollients or corticosteroids. In some instances, however, telaprevir has caused serious skin Page 1/5 rashes, including Steven's Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN). -
Telaprevir for HIV/Hepatitis C Virus–Coinfected Patients Failing
HIV/AIDS MAJOR ARTICLE Telaprevir for HIV/Hepatitis C Virus–Coinfected Patients Failing Treatment With Pegylated Interferon/Ribavirin (ANRS HC26 TelapreVIH): An Open-Label, Single-Arm, Phase 2 Trial Downloaded from https://academic.oup.com/cid/article/59/12/1768/2895305 by guest on 01 October 2021 Laurent Cotte,1 Joséphine Braun,2 Caroline Lascoux-Combe,3 Corine Vincent,2 Marc-Antoine Valantin,4 Philippe Sogni,5 Karine Lacombe,6 Didier Neau,7 Hugues Aumaitre,8 Dominique Batisse,9 Pierre de Truchis,10 Anne Gervais,11 Christian Michelet,12 Philippe Morlat,13 Daniel Vittecoq,14 Isabelle Rosa,15 Inga Bertucci,16 Stéphane Chevaliez,17 Jean-Pierre Aboulker,2 and Jean-Michel Molina3; for the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) HC26 Study Groupa 1Hospices Civils de Lyon, Croix-Rousse Hospital, and INSERM U1052, 2INSERM SC10-US019, Villejuif, 3Assistance Publique–Hôpitaux de Paris (AP-HP), Saint-Louis Hospital, University of Paris VII Denis Diderot, and Sorbonne Paris-Cité, INSERM U941, 4AP-HP, Pitié-Salpêtrière Hospital, and UMR-S 943, INSERM, 5AP-HP, Cochin Hospital and Paris Descartes University, INSERM U-1016, 6AP-HP, Saint-Antoine Hospital, Sorbonne Universités, UPMC University Paris 06, UMR-S1136, 7Pellegrin University Hospital, Bordeaux, 8Saint-Jean Hospital, Perpignan, 9AP-HP, Georges Pompidou European Hospital, Paris, 10AP-HP, Raymond Poincaré Hospital, Garches, 11AP-HP, Bichat-Claude Bernard Hospital, Paris, 12Pontchaillou University Hospital, Rennes, 13Saint-André University Hospital, Bordeaux, 14AP-HP, Bicètre Hospital, Le Kremlin-Bicètre, 15Créteil Hospital, 16French National Agency for Research on AIDS and Viral Hepatitis, Paris, and 17AP-HP, Henri Mondor Hospital, Créteil, France (See the Editorial Commentary by Rockstroh on pages 1777–8.) Background. -
Drug Repurposing for Identification of Potential Inhibitors Against SARS-Cov-2 Spike Receptor-Binding Domain: an in Silico Approach
Indian J Med Res 153, January & February 2021, pp 132-143 Quick Response Code: DOI: 10.4103/ijmr.IJMR_1132_20 Drug repurposing for identification of potential inhibitors against SARS-CoV-2 spike receptor-binding domain: An in silico approach Santosh Kumar Behera1, Namita Mahapatra1, Chandra Sekhar Tripathy1 & Sanghamitra Pati2 1Health Informatics Centre, 2ICMR-Regional Medical Research Centre, Bhubaneswar, Odisha, India Received April 10, 2020 Background & objectives: The world is currently under the threat of coronavirus disease 2019 (COVID-19) infection, caused by SARS-CoV-2. The objective of the present investigation was to repurpose the drugs with potential antiviral activity against receptor-binding domain (RBD) of SARS-CoV-2 spike (S) protein among 56 commercially available drugs. Therefore, an integrative computational approach, using molecular docking, quantum chemical calculation and molecular dynamics, was performed to unzip the effective drug-target interactions between RBD and 56 commercially available drugs. Methods: The present in silico approach was based on information of drugs and experimentally derived crystal structure of RBD of SARS-CoV-2 S protein. Molecular docking analysis was performed for RBD against all 56 reported drugs using AutoDock 4.2 tool to screen the drugs with better potential antiviral activity which were further analysed by other computational tools for repurposing potential drug or drugs for COVID-19 therapeutics. Results: Drugs such as chalcone, grazoprevir, enzaplatovir, dolutegravir, daclatasvir, tideglusib, presatovir, remdesivir and simeprevir were predicted to be potentially effective antiviral drugs against RBD and could have good COVID-19 therapeutic efficacy. Simeprevir displayed the highest binding affinity and reactivity against RBD with the values of −8.52 kcal/mol (binding energy) and 9.254 kcal/mol (band energy gap) among all the 56 drugs under investigation. -
OLYSIO (Simeprevir) Capsules, for Oral Use Ribavirin May Cause Birth Defects and Fetal Death and Animal Studies Initial U.S
• Because ribavirin may cause birth defects and fetal death, OLYSIO in HIGHLIGHTS OF PRESCRIBING INFORMATION combination with peginterferon alfa and ribavirin is contraindicated in These highlights do not include all the information needed to use pregnant women and in men whose female partners are pregnant. (4) OLYSIOTM safely and effectively. See full prescribing information for OLYSIO. ------------------------WARNINGS AND PRECAUTIONS---------------------- • Embryofetal Toxicity (Use with Ribavirin and Peginterferon Alfa): OLYSIO (simeprevir) capsules, for oral use Ribavirin may cause birth defects and fetal death and animal studies Initial U.S. Approval – 2013 have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have ----------------------------INDICATIONS AND USAGE--------------------------- a negative pregnancy test prior to initiating therapy, use at least OLYSIO is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for two effective methods of contraception during treatment, and undergo the treatment of chronic hepatitis C (CHC) infection as a component of a monthly pregnancy tests. (5.1) combination antiviral treatment regimen. (1) • Photosensitivity: Serious photosensitivity reactions have been observed • OLYSIO efficacy has been established in combination with during combination therapy with OLYSIO, peginterferon alfa and peginterferon alfa and ribavirin in HCV genotype 1 infected subjects ribavirin. Use sun protection measures and limit sun exposure. Consider with compensated liver disease (including cirrhosis). (1, 14) discontinuation if a photosensitivity reaction occurs. (5.2) • OLYSIO must not be used as monotherapy. (1) • Rash: Rash has been observed during combination therapy with • Screening patients with HCV genotype 1a infection for the presence of OLYSIO, peginterferon alfa and ribavirin. -
Boceprevir (Victrelis™)
Boceprevir (Victrelis™) UTILIZATION MANAGEMENT CRITERIA DRUG CLASS: Protease Inhibitors BRAND (generic) NAMES: Victrelis (boceprevir); 200mg strength capsule FDA-APPROVED INDICATIONS Victrelis (boceprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age or older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders, partial responders, and relapsers. Victrelis must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin. The efficacy of Victrelis has not been studies in patients who have previously failed therapy with a treatment regimen that includes Victrelis or other HCV NS3/4A protease inhibitors. COVERAGE AUTHORIZATION CRITERIA INITIAL THERAPY Boceprevir (Victrelis) may be eligible for coverage when the following criteria are met: 1. The patient is 18 years of age or older; AND 2. The patient has a diagnosis of chronic hepatitis C (CHC) infection with confirmed genotype 1; AND 3. The patient: Has F2 or higher on the IASL, Batts-Ludwig, or Metavir fibrosis staging scales (medical record documentation required); OR Has F3 or higher on the Ishak fibrosis staging scale (medical record documentation required); OR Has cirrhosis secondary to CHC [Metavir F4, Ishak F5-6, or radiographic evidence of portal hypertension, esophageal varices, ascites (medical record documentation required)]; AND 4. The patient has contraindications to a sofosbuvir-based regimen (i.e., Sovaldi or Harvoni), in addition to Viekira Pak. -
Pharmaceutical Targeting the Envelope Protein of SARS-Cov-2: the Screening for Inhibitors in Approved Drugs
Pharmaceutical Targeting the Envelope Protein of SARS-CoV-2: the Screening for Inhibitors in Approved Drugs Anatoly Chernyshev XR Pharmaceuticals Ltd., Cambridge, New Zealand email: [email protected] Abstract An essential overview of the biological role of coronavirus viroporin (envelope protein) is given, together with the effect of its known inhibitors on the life cycle of coronavirus. A docking study is conducted using a set of known drugs approved worldwide (ca. 6000 compounds) on a structure of the SARS-CoV-2 viroporin modelled from the published NMR-resolved structures. The screening has identified 36 promising drugs currently on the market, which could be proposed for pre-clinical trials. Introduction Viral ion channels (viroporins) are known since at least 1992, when the M2 channel of influenza A virus has been discovered. These ion channels exist in a form of homotetra- (e.g. the M2 channel) or homopentamers (e.g. coronavirus E channel); each subunit is 50–120 aminoacids long and has at least one transmembrane domain (TMD). The pore formed by the transmembrane domains of the oligomer acts as an ion channel. It is speculated that viroporins initiate a leakage in host cell membranes, which alters the tans-membrane potential and serves as a marker of viral infection [1]. SARS coronaviruses were found to have at least three types of ion channels: E and 8a (both with single TMD, forming pentameric assemblies), and 3a with three TMD [2, 3]. Both proteins E and 3a possess PDZ domain- binding motif (PBM). In the protein E it is the last four aminoacids in the C-terminus (DLLV, Table 1). -
Informatorium of COVID-19 Drugs in Indonesia" Has Been Compiled and Can Be Published Amidst the COVID-19 Outbreak in Indonesia
THE INDONESIAN FOOD AND DRUG AUTHORITY INFORMATORIUM OF COVID-19 DRUGS IN INDONESIA THE INDONESIAN FOOD AND DRUG AUTHORITY MARCH 2020 1 INFORMATORIUM OF COVID-19 DRUGS IN INDONESIA THE INDONESIAN FOOD AND DRUG AUTHORITY ISBN 978-602-415-009-9 First Edition March 2020 COPYRIGHT PROTECTED BY LAW Reproduction of this book in part or whole, in any form and by any means, mechanically or electronically, including photocopies, records, and others without written permission from the publisher. This informatorium is based on information up to the time of publication and is subject to change if there is the latest data/information 2 3 FOREWORD Our praise and gratitude for the presence of God Almighty for His blessings and gifts, "The Informatorium of COVID-19 Drugs in Indonesia" has been compiled and can be published amidst the COVID-19 outbreak in Indonesia. As we know, the infections due to Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) began to plague in December 2019 in Wuhan City, Hubei Province, People's Republic of China. The disease was caused by SARS-CoV-2 infection which was later known as Coronavirus Disease 2019 (COVID-19) which in early 2020 began to spread to several countries and eventually spread to almost all countries in the world. On March 11, 2020, WHO announced COVID-19 as a global pandemic. In Indonesia, the first case was officially announced on March 2, 2020. Considering that the spread of COVID-19 has been widespread and has an impact on social, economic, defense, and public welfare aspects in Indonesia, the President of the Republic of Indonesia established the Task Force for the Acceleration of COVID- 19 Handling aiming to increase readiness and ability to prevent, detect and respond to COVID-19. -
The Legally Binding Text Is the Original French Version TRANSPARENCY
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 14 December 2011 INCIVO 375 mg, film-coated tablet B/4 bottles of 42 tablets (CIP code: 217 378-5) B/1 bottle of 42 tablets (CIP code: 219 249-8) Applicant: JANSSEN-CILAG telaprevir ATC Code: J05AE11 (protease inhibitor) List I Hospital prescription restricted to gastroenterology, hepatology, internal medicine or infectiology specialists. Date of Marketing Authorisation (centralised European procedure): Box of 4 bottles: 19/09/2011 Box of 1 bottle: 13/10/2011 Reason for request: Inclusion on the list of medicines refundable by National Health Insurance and on the list of medicines approved for hospital use. Medical, Economic and Public Health Assessment Division 1/22 1. CHARACTERISTICS OF THE MEDICINAL PRODUCT 1.1. Active ingredient telaprevir 1.2. Background This is an NS3/4A protease inhibitor of the genotype 1 hepatitis C virus. 1.3. Indication “INCIVO, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis): - who are treatment-naive; - who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders (see sections 4.4 and 5.1 of the SPC).” 1.4. Dosage “Treatment with INCIVO must be initiated and monitored by a physician experienced in the management of chronic hepatitis C. INCIVO, 750 mg dose of INCIVO (two 375 mg film-coated tablets) should be taken orally every 8 hours with food (the total daily dose is 6 tablets (2,250 mg)). -
Caracterización Molecular Del Perfil De Resistencias Del Virus De La
ADVERTIMENT. Lʼaccés als continguts dʼaquesta tesi queda condicionat a lʼacceptació de les condicions dʼús establertes per la següent llicència Creative Commons: http://cat.creativecommons.org/?page_id=184 ADVERTENCIA. El acceso a los contenidos de esta tesis queda condicionado a la aceptación de las condiciones de uso establecidas por la siguiente licencia Creative Commons: http://es.creativecommons.org/blog/licencias/ WARNING. The access to the contents of this doctoral thesis it is limited to the acceptance of the use conditions set by the following Creative Commons license: https://creativecommons.org/licenses/?lang=en Programa de doctorado en Medicina Departamento de Medicina Facultad de Medicina Universidad Autónoma de Barcelona TESIS DOCTORAL Caracterización molecular del perfil de resistencias del virus de la hepatitis C después del fallo terapéutico a antivirales de acción directa mediante secuenciación masiva Tesis para optar al grado de doctor de Qian Chen Directores de la Tesis Dr. Josep Quer Sivila Dra. Celia Perales Viejo Dr. Josep Gregori i Font Laboratorio de Enfermedades Hepáticas - Hepatitis Víricas Vall d’Hebron Institut de Recerca (VHIR) Barcelona, 2018 ABREVIACIONES Abreviaciones ADN: Ácido desoxirribonucleico AK: Adenosina quinasa ALT: Alanina aminotransferasa ARN: Ácido ribonucleico ASV: Asunaprevir BOC: Boceprevir CCD: Charge Coupled Device CLDN1: Claudina-1 CHC: Carcinoma hepatocelular DAA: Antiviral de acción directa DC-SIGN: Dendritic cell-specific ICAM-3 grabbing non-integrin DCV: Daclatasvir DSV: Dasabuvir -
PASS Information
PASS Information Title Cilostazol drug utilisation study Protocol version Version 2.3 identifier Date of last version of 5 November 2015 protocol EU PAS register number ENCEPP/SDPP/3596 http://www.encepp.eu/encepp/viewResource.htm?id=10426 Accessed 5 November 2015 Active substance Cilostazol, ATC code B01AC23, Platelet aggregation inhibitors excluding heparin Medicinal product Pletal, Ekistol Product reference UK/H/0291/001 and 002 Procedure number EMEA/H/A-31/1306 Marketing authorisation Otsuka Pharmaceutical Europe Ltd. holder(s) (MAH) Lacer S.A. Joint PASS No Research question and This study protocol was developed in the context of the European objectives Medicines Agency (EMA) referral (article 31 of Council Directive 2001/83/EC) on the risks and benefits of the use of cilostazol. The study objectives are to characterise patients using cilostazol according to demographics, comorbidity, comedications, and duration of treatment. In addition, the study will describe the dosing of cilostazol, the prescribing physician specialties, and the potential off-label prescribing. Country(-ies) of study Spain, United Kingdom, Germany, Sweden Author Jordi Castellsague, MD, MPH; Cristina Varas-Lorenzo, MD, MPH, PhD; Susana Perez-Gutthann, MD, MPH, PhD RTI Health Solutions Trav. Gracia 56 Atico 1 08006 Barcelona, Spain Telephone: +34.93.241.7766 Fax: +34.93.414.2610 E-mail: [email protected] CONFIDENTIAL 1 of 65 Marketing Authorisation Holder(s) Marketing authorisation Otsuka Pharmaceutical Europe Ltd. holder(s) Gallions Wexham Springs Framewood Road Wexham SL3 6PJ, UK Lacer S.A. Sardenya 350 08025 Barcelona Spain MAH contact person Dr Marco Avila Regional Vice President, Medical Europe Otsuka Pharmaceutical Europe Ltd EU QPPV Dr Achint Kumar Otsuka Europe Development and Commercialisation Limited (OEDC) Head of Medical Dr Sanjay Kapoor Compliance-Europe Otsuka Pharmaceutical Europe Ltd. -
Estonian Statistics on Medicines 2016 1/41
Estonian Statistics on Medicines 2016 ATC code ATC group / Active substance (rout of admin.) Quantity sold Unit DDD Unit DDD/1000/ day A ALIMENTARY TRACT AND METABOLISM 167,8985 A01 STOMATOLOGICAL PREPARATIONS 0,0738 A01A STOMATOLOGICAL PREPARATIONS 0,0738 A01AB Antiinfectives and antiseptics for local oral treatment 0,0738 A01AB09 Miconazole (O) 7088 g 0,2 g 0,0738 A01AB12 Hexetidine (O) 1951200 ml A01AB81 Neomycin+ Benzocaine (dental) 30200 pieces A01AB82 Demeclocycline+ Triamcinolone (dental) 680 g A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+ Thymol (dental) 3094 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+ Cetylpyridinium chloride (gingival) 227150 g A01AD81 Lidocaine+ Cetrimide (O) 30900 g A01AD82 Choline salicylate (O) 864720 pieces A01AD83 Lidocaine+ Chamomille extract (O) 370080 g A01AD90 Lidocaine+ Paraformaldehyde (dental) 405 g A02 DRUGS FOR ACID RELATED DISORDERS 47,1312 A02A ANTACIDS 1,0133 Combinations and complexes of aluminium, calcium and A02AD 1,0133 magnesium compounds A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 811120 pieces 10 pieces 0,1689 A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 3101974 ml 50 ml 0,1292 A02AD83 Calcium carbonate+ Magnesium carbonate (O) 3434232 pieces 10 pieces 0,7152 DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 46,1179 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 2,3855 A02BA02 Ranitidine (O) 340327,5 g 0,3 g 2,3624 A02BA02 Ranitidine (P) 3318,25 g 0,3 g 0,0230 A02BC Proton pump inhibitors 43,7324 A02BC01 Omeprazole