Recreational Drugs and HIV Antiretrovirals a Guide to Interactions for Clinicians
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<I>Efavirenz</I>, New Therapeutic Agents for AIDS
CONFERENCE REPORTS 295 CHIMIA 1999. 53. NO.6 CONFERENCE REPORTS Chimia 53 (1999) 295-304 © Neue Schweizerische Chemische Gesellschaft ISSN 0009-4293 Second Swiss/German Meeting on Medicinal Chemistry Fruhjahrsversammlung 1999 der Neuen Schweizerischen Chemischen Gesellschaft (NSCG) 22./23. Marz 1999, Basel Vier Mini-Symposia uber Virologie, Multidrug Resistance, Immunologie und Gene Therapie Organisiert von der Sektion Medizinische Ghemie der NSGG, der Fachgruppe fUr Medizinische Chemie der GDGh und der Basler Chemischen Gesellschatt mit Unterstutzung der Pharmazeutischen Industrie. Report by the Research Team of G. Folkers' 'Correspondence: Prof. Dr. G. Folkers Department of Pharmacy Winterthurerstrasse 190 CH-8057Zi.irich E-Mail: [email protected] Discovery of Indinavir and Efavirenz, New Therapeutic Agents for AIDS Terry A. Lyle, Merck Research Laboratories, West Point, PA, USA For the treatment of HIV infection, two enzymes are of major interest: The HIV-l Protease (PR) and the Reverse- Tran- scriptase (RT). The HIV -Protease, an aspartic-acid pro- tease active as a dimer, is responsible for H 0 the cleavage of polypeptides assembled at o N~' the cell membrane. The inhibition of the Y I( ; N 1\ 0 = H protease-mediated cleavage of the viral "0 o o o precursor polyproteins results in the pro- duction of noninfectious progeny viral par- ticles. The development of lndinavir start- ed with screening a collection of renin inhibitors. A seven-amino-acid analog 1 1 which contains the hydroxyethylene tran- CONFERENCE REPORTS 296 CHIMIA 1999, 53. No.6 prevents the spread of the virus. Different nucleoside inhibitors like AZT, ddI, ddC, d4T and 3TC are already known, but new QH non-nucleoside inhibitors (NNRTI) are U'O developed to decrease the cytotoxicity and N : to improve the selectivity of the viral polymerases vs. -
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]. -
United States Patent (19) 11 Patent Number: 5,993,812 Tsoukas Et Al
USOO5993812A United States Patent (19) 11 Patent Number: 5,993,812 TSOukas et al. (45) Date of Patent: Nov.30, 1999 54 METHOD OF DELAYING THE Brunkhorst et al., Infection 18:28-32, 1990. PROGRESSION OF AN INFECTION WITH Coyle et al., Changes in the Lymphocyte Count and Lym THE HUMAN IMMUNODEFICIENCY VIRUS phocyte Subsets After Splenectomy in Human Immunode ficiency Virus Infection, Letters and Correspondence, pp. 75 Inventors: Christos M. Tsoukas, Montreal; Barry 144-146. Michael Woloski, Winnipeg, both of DeSimone et al., Immunopharma. and Immunotoxic., Canada 13:447-458, 1991. Gringeri et al., British Journal of Haemotology, 80:337-340, 73 Assignee: Cangene Corporation, Winnipeg, 1992. Canada Gingör et al., Eur. J. Pediatr., 152:650–654, 1993. Mofenson and Moye, Pediatric Research, 33:80-S89, 1993. 21 Appl. No.: 08/835,400 Mofenson et al., Journal of Acquired Immune Deficiency 22 Filed: Apr. 7, 1997 Syndrome, 6:1103-1113, 1993. Schrappe-Bächer et al., Vox Sang, 59:3-14, 1990. Related U.S. Application Data Shearer et al., Ann. N.Y. Acad. Sci., pp. 35-51. Wagner et al., Arch. of Disease in Childhood., 63 Continuation-in-part of application No. 08/713,765, Sep. 13, 67:1267-1271, 1992. 1996, abandoned. Watson, et al., “Recombinant DNA”, Scientific American 60 Provisional application No. 60/003,756, Sep. 14, 1995. Books, Chapter 25. 51) Int. Cl. ............................ A61K 39/395; CO7K 1/00 Okesenhendeler, et al., “Anti-RH immunoglobulin therapy 52 U.S. Cl. ................... 424/130.1; 530/350, 530/388.7; for human immunodeficiency virus-related immune throm 424/142.1; 424/141.1; 424/153.1 bocytopenic purpura’, Blood, 71 (5) 1499-502. -
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. -
TRIZIVIR® (Abacavir Sulfate, Lamivudine, and Zidovudine) Tablets
NDA 21-205/S-011 Page 4 PRESCRIBING INFORMATION TRIZIVIR® (abacavir sulfate, lamivudine, and zidovudine) Tablets WARNINGS TRIZIVIR contains 3 nucleoside analogues (abacavir sulfate, lamivudine, and zidovudine) and is intended only for patients whose regimen would otherwise include these 3 components. Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate, a component of TRIZIVIR. Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash, (3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain), (4) constitutional (including generalized malaise, fatigue, or achiness), and (5) respiratory (including dyspnea, cough, or pharyngitis). Discontinue TRIZIVIR as soon as a hypersensitivity reaction is suspected. Permanently discontinue TRIZIVIR if hypersensitivity cannot be ruled out, even when other diagnoses are possible. Following a hypersensitivity reaction to abacavir, NEVER restart TRIZIVIR or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death. Reintroduction of TRIZIVIR or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions. Such reactions can occur within hours (see WARNINGS and PRECAUTIONS: Information -
VIDEX (Didanosine) Chewable/Dispersible Buffered Tablets
Rx only VIDEXâ (didanosine) â VIDEX (didanosine) Chewable/Dispersible Buffered Tablets â VIDEX (didanosine) Buffered Powder for Oral Solution â VIDEX (didanosine) Pediatric Powder for Oral Solution (Patient Information Leaflet Included) WARNING FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH VIDEX USED ALONE OR IN COMBINATION REGIMENS IN BOTH TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION. VIDEX SHOULD BE SUSPENDED IN PATIENTS WITH SUSPECTED PANCREATITIS AND DISCONTINUED IN PATIENTS WITH CONFIRMED PANCREATITIS (SEE WARNINGS). LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING DIDANOSINE AND OTHER ANTIRETROVIRALS. FATAL LACTIC ACIDOSIS HAS BEEN REPORTED IN PREGNANT WOMEN WHO RECEIVED THE COMBINATION OF DIDANOSINE AND STAVUDINE WITH OTHER ANTIRETROVIRAL AGENTS. THE COMBINATION OF DIDANOSINE AND STAVUDINE SHOULD BE USED WITH CAUTION DURING PREGNANCY AND IS RECOMMENDED ONLY IF THE POTENTIAL BENEFIT CLEARLY OUTWEIGHS THE POTENTIAL RISK. (SEE WARNINGS AND PRECAUTIONS: PREGNANCY.) Page 4 of 39 DESCRIPTION â VIDEX (didanosine) is a brand name for didanosine (ddI), a synthetic purine nucleoside analogue active against the Human Immunodeficiency Virus (HIV). VIDEX Chewable/Dispersible Buffered Tablets are available for oral administration in strengths of 25, 50, 100, 150, and 200 mg of didanosine. Each tablet is buffered with calcium carbonate and magnesium hydroxide. VIDEX tablets also contain aspartame, sorbitol, microcrystalline cellulose, polyplasdone, mandarin-orange flavor, and magnesium stearate. VIDEX Buffered Powder for Oral Solution is supplied for oral administration in single- dose packets containing 100, 167, or 250 mg of didanosine. Packets of each product strength also contain a citrate-phosphate buffer (composed of dibasic sodium phosphate, sodium citrate, and citric acid) and sucrose. -
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 -
PATIENT INFORMATION STRIBILD® (STRY-Bild) (Elvitegravir, Cobicistat
PATIENT INFORMATION STRIBILD® (STRY-bild) (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate) tablets Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with STRIBILD. For more information, see the section “What should I tell my healthcare provider before taking STRIBILD?” What is the most important information I should know about STRIBILD? STRIBILD can cause serious side effects, including: • Worsening of Hepatitis B infection. If you have hepatitis B virus (HBV) infection and take STRIBILD, your HBV may get worse (flare-up) if you stop taking STRIBILD. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. o Do not run out of STRIBILD. Refill your prescription or talk to your healthcare provider before your STRIBILD is all gone. o Do not stop taking STRIBILD without first talking to your healthcare provider. o If you stop taking STRIBILD, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking STRIBILD. See “What are the possible side effects of STRIBILD?” for more information about side effects. What is STRIBILD? STRIBILD is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in people 12 years of age and older: • who have not received anti-HIV-1 medicines in the past, or • to replace their current anti-HIV-1 medicines: o in people who have been on the same anti-HIV-1 medicine regimen for at least 6 months, and o who have an amount of HIV-1 in their blood (this is called “viral load”) that is less than 50 copies/mL, and o have never failed past HIV-1 treatment. -
Epzicom and Ziagen Safety Review
Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Pediatric Postmarketing Pharmacovigilance Date: July 11, 2018 Safety Evaluator: Margee P. Webster, Pharm.D., BCPS Division of Pharmacovigilance – I (DPV-I) Medical Officer: Ivone Kim, MD, FAAP DPV-I Team Leader: Kelly Cao, Pharm.D. DPV-II Deputy Division Director: Ida-Lina, Pharm.D., MS DPV-II Product Name: Abacavir (Ziagen®) and Abacavir/Lamivudine (Epzicom®) Pediatric Labeling Approval Date: Ziagen: March 23, 2015/Epzicom: September 17, 2015 Application Type/Number: NDA 020977 (Ziagen)/ NDA 021652 (Epzicom) Applicant/Sponsor: ViiV HealthCare/GlaxoSmithKline OSE RCM #: 2018-589 1 Reference ID: 4289856 TABLE OF CONTENTS Executive Summary........................................................................................................................ 1 1 Introduction............................................................................................................................. 1 1.1 Pediatric Regulatory History............................................................................................ 1 1.2 Relevant Labeled Safety Information .............................................................................. 1 1.2.1 Ziagen product labeling ........................................................................................... 1 1.2.2 Epzicom product labeling ....................................................................................... -
ZIAGEN Safely and Effectively
HIGHLIGHTS OF PRESCRIBING INFORMATION • Patients With Hepatic Impairment: Mild hepatic impairment – 200 mg These highlights do not include all the information needed to use twice daily; moderate/severe hepatic impairment – contraindicated. (2.3) ZIAGEN safely and effectively. See full prescribing information for --------------------- DOSAGE FORMS AND STRENGTHS -------------- ZIAGEN. Tablets: 300 mg; Oral Solution: 20 mg/mL (3) ZIAGEN® (abacavir sulfate) Tablets and Oral Solution -------------------------------CONTRAINDICATIONS------------------------ Initial U.S. Approval: 1998 • Previously demonstrated hypersensitivity to abacavir. (4, 5.1) • Moderate or severe hepatic impairment. (4) WARNING: HYPERSENSITIVITY REACTIONS/LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY ----------------------- WARNINGS AND PRECAUTIONS ---------------- • Hypersensitivity: Serious and sometime fatal hypersensitivity reactions See full prescribing information for complete boxed warning. have been associated with ZIAGEN and other abacavir-containing • Serious and sometimes fatal hypersensitivity reactions have been products. Read full prescribing information section 5.1 before associated with ZIAGEN (abacavir sulfate). (5.1) prescribing ZIAGEN. (5.1) • Hypersensitivity to abacavir is a multi-organ clinical syndrome. • Lactic acidosis and severe hepatomegaly with steatosis have been (5.1) reported with the use of nucleoside analogues. (5.2) • Patients who carry the HLA-B*5701 allele are at high risk for • Immune reconstitution syndrome (5.3) and redistribution/accumulation -
Fee-For-Service Preferred Drug List
Prescription Drug Program Apple Health Medicaid: Fee-for-Service Preferred Drug List What is new in this version of the preferred drug list? Effective for dates of service on and after January 1, 2018, the Health Care Authority will make the following changes: Unless otherwise indicated in the drug class information, the authorization criteria is that the client must have tried and failed, or is intolerant to, at least two or more preferred drugs within the drug class unless contraindicated, not clinically appropriate, or only one drug is preferred. Drugs may have criteria that go beyond these basic criteria. Drug classes that are subject to the Therapeutic Interchange Program (TIP), are noted in the drug class information. For more information on TIP, see Theraputic Interchange Program in the Prescription Drug Program Medicaid Billing Guide. Drug Class Drug Name Change ACE Inhibitors Univasc Removed, no longer manufactured Galantamine Removed, no longer manufactured Alzheimer’s Drugs Aricept ODT Removed, no longer manufactured Exelon solution Removed, no longer manufactured Adrenaclick Non-Preferred, PA required Anaphylaxis Agents: Adrenalin Non-Preferred, PA required Epinephrine, Self Epinephrine Non-Preferred, PA required Injectable (new drug class) Epinephrine (Mylan only) Preferred Epipen 2-Pak/ JR 2-Pak Non-Preferred, PA required (Rev. 12/28/2017)(Eff. 1/1/2018) – 1 – Apple Health Medicaid PDL Prescription Drug Program Renamed drug class “Anticoagulants: Anticoagulants Entire class Factor XA and Thrombin Inhibitors.” Anticoagulants: