New TB Medications. National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
|
|
- Tobias O’Brien’
- 6 years ago
- Views:
Transcription
1 National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention New TB Medications Neha Shah MD MPH Field Medical Officer Tuberculosis Control Branch California Department of Public Health Centers for Disease Control and Prevention PITCA September 2017
2 Outline New drugs Repurposed drugs Clinical trials underway
3 Goals of TB treatment trials From endtb.org
4
5 5 Part 1: New Drugs?
6 New Drugs Pipeline
7 New Drugs in Clinical Development Drug Class Comp any Status Bedaquiline diarylquinolone Janssen Phase 3 Delamanid nitroimidazole Otsuka Phase 3 Pretomanid nitroimidazole TB Alliance Phase 3 OPC carbostyril Otsuka Phase 2
8 Bedaquiline (BDQ) Mode of action: inhibits proton pump for ATP synthase Half life: 165 days Approved by US FDA for use in MDR TB
9 BDQ Optimized background treatment Number 79 patients 81 patients Median time to culture conversion 83 days 125 days Cure at week % 32% Serious adverse event 23% 19% Deaths 10 2
10
11 Bedaquiline By 2017, close to 10,000 patients have gotten BDQ Appears to be very safe Currently being used in several trials Nix-TB trial STREAM trial Expensive
12 Delamanid (DLM) Mode of action: mycolic acid synthesis inhibitor Half life: hours Currently only approved in Europe
13 D 100 D200 Optimizing background regimen Dose 100 BID 200 BID Number mo sputum culture conversion 64 (45.4%) 57 (41.9%) 38 (29.6%) QT prolongation 16 (9.9%) 21 (13.1%) 6 (3.8%)
14 Delamanid Only 1 patient in the US Limited international experience Clinical trials STREAM MDR-END Prevention trials Pediatric data
15 Pretomanid (Pa) Mode of action: mycolic acid synthesis inhibitor Half life: hours Seems promising
16 Phase 2 OPC Mode of action: inhibition of cell wall biosynthesis Bactericidal against growing and intracellular bacilli In co-development with delamanid Unclear if will be tested with other drugs not owned by the company FDA granted fast-track status Can be used for MDR and DS TB Adapted from Dr Jeffrey Hafkin
17 Sutezolid Similar to linezolid Thought to be more effective and less toxic than linezolid Initial company stalled and intellectual property transferred Need to restart trials from beginning
18 Part 3: Repurposed Drugs
19 INH and Rifamycins High-dose INH 5, 10, 15 mg/kg for individuals with inha mutations ACTG in South Africa 2018 Rifampin Dosing escalation trials: 35, 20, and 10 mg/kg 30 mg/kg: reduced time to culture conversion and was safe Rifapentine 4 months replacing RIF with RPT or replacing EMB and RIF with MFX and RPT 2019 looking at relapse
20 FQN Opti-Q: optimal dose of levofloxacin: 11, 14, 17, 20 mg/kg Outcome: culture conversion 100 patients in Peru and South Africa Expected 2017
21 Linezolid (LZD) Optimal dosing ZeNix: 1200 daily, 600 daily, 1200 daily for 2 months, 600 daily for 2 months Six dosing schedules for DS TB: 300 daily, 300 BID, 600 daily, 600 BID, 1200 daily for 2 weeks, 1200 TIW for 2 weeks ACTG 5356: optimal dosing with DLM (300, 600, 1200) DS trials: Replacing EMB with LZD
22 Clofazimine (Cfz) Novartis applying for TB indication Renewed interest after short course regimen
23
24 Nitazoxanide and Carbapenems Nitazoxanide: antiparasitic and antivrial in phase 2; 14-day EBA studies for DS TB Carbapenems Imipenem and meropenem increasing being used Have to be given IV several times a day Faropenem oral under clinical trials
25 Part 2: New Regimens Drug Susceptible 26
26 DS Clinical Trials Goal: Shorten treatment Trial Regimen Duration Expected Outcome TBTC 31 Rifapentine daily instead of RIF Moxifloxacin instead of EMB 4 months 2019 Rifashort Dosing of RIF: 600, 1200, 1800mg 4 months 2018 TRUNCATE TB 5 arms: LZD, BDQ, FQN, CFZ, DLM, RPT 2-3 months?
27 Part 2: New Regimens MDR TB 29
28 STREAM Modified short course regimen ( Bangladesh ) Regimen Moxi instead of gatifloxacin BDQ and LFX instead of PRO and KM BDQ and LFX instead EMB Duration: 6 or 9 months Treatment outcome endpoint Expected results 2018 and 2021
29 NeXT-TB Linezolid, bedaquiline, levofloxacin, pyrazinamide and ethionamide/high dose isoniazid 6 9 months Endpoint: Treatment outcome at 24 months Expected results 2020
30 endtb 5 arms all with PZA for 9 months BDQ, LZD, MFX BDQ, CFZ, LZD, LFX BDQ, DLM, LZD, LFX DLM, CFZ, LZD, LFX DLM, CFZ MFX Endpoint: Treatment success Outcomes 2021
31 MDR-END Injectable-free DLM-based regimen DLM, LZD, LFX, PZA for 9 12 months Endpoint: Treatment success Outcomes 2019
32 TB-PRACTECAL 3 arms for 6 months BDQ, Pa, LZD, MFX BDQ, Pa, LZD, CFZ BDQ, PA, LZD Endpoint: Treatment success Unsure
33 Nix-TB 6 months of Pretomanid with BDQ and LZD Endpoint: Relapse-free cure Outcomes 2017 ZeNix: LZD dosing
34 Trials for MDR TB Trial Regimen Duration Outcome NEXT TB LZD, BDQ, LFX, PZA, ETA, INH (H) 6-9 months 2020 endtb 5 arms with PZA BDQ, LZD, MFX, CFZ, DLM 9 months 2023 Nix TB Pa, BDQ, LZD 6 months 2017 MDR END DLM, LZD, LFX, PZA 9-12 months 2019 PRACTECAL 3 arms: BDQ, Pz, LZD, MFX, CFZ 6 months? STREAM Bangladesh regimen modified (BDQ, LFX, MFX) 6-9 months 2018 and 2021
35 Summary
36 Summary Many new drugs and regimens in the pipeline Hopefully shorter treatments and regimens without an injectable are on the horizon Need to ensure availability in the US Pipeline is slow and need for new methods and quicker development process
37 Acknowledgements DO NOT try to remember all of this. Information is available online from Treatment Action Group Bob Horsburgh Family
38 Questions
Current Status in the Development of the New Anti-Tuberculosis Drugs
National Scientific Meeting TB UPDATE IX 2017 WORKSHOP AND SYMPOSIUM Novel Management to End TB Hotel Bumi Surabaya 29-30 April 2017 Current Status in the Development of the New Anti-Tuberculosis Drugs
More informationMultiple Drug-resistant Tuberculosis: a Threat to Global - and Local - Public Health
Multiple Drug-resistant Tuberculosis: a Threat to Global - and Local - Public Health C. Robert Horsburgh, Jr. Boston University School of Public Health Background Outline Why does drug resistance threaten
More informationHA Convention 2016 : Special Topic Session 3 May 2016
HA Convention 2016 : Special Topic Session 3 May 2016 Diagnosis and Management of TB in Adults Dr. Thomas Mok COS(RMD), KH Tuberculosis An airborne infectious disease caused by Mycobacterium tuberculosis
More informationMultidrug-resistant tuberculosis in children
Multidrug-resistant tuberculosis in children James Seddon Clinical Lecturer Imperial College London UCL-TB and LSHTM TB Centre World TB Day 2015 24th March 2015 Outline Burden Recent studies Preventive
More informationShorter TB regimens What is in de pipeline? Martin Boeree, Associate Professor Radboudumc, Nijmegen, the Netherlands Tuesday, 23 September, 2014
Shorter TB regimens What is in de pipeline? Martin Boeree, Associate Professor Radboudumc, Nijmegen, the Netherlands Tuesday, 23 September, 2014 Disclosures Clinical trials and studies funded by EDCTP,
More informationNEW DRUGS FOR TUBERCULOSIS: THE NEED, THE HOPE AND THE REALITY
NEW DRUGS FOR TUBERCULOSIS: THE NEED, THE HOPE AND THE REALITY Neil W. Schluger, M.D. Professor of Medicine, Epidemiology and Environmental Health Sciences Columbia University Global tuberculosis incidence
More informationBDQ/DLM COMBINATION: FRENCH-LATVIAN EXPERIENCE AND FUTURE PERSPECTIVES LORENZO GUGLIELMETTI RESIST-TB WEBINAR, 5 APRIL 2018
BDQ/DLM COMBINATION: FRENCH-LATVIAN EXPERIENCE AND FUTURE PERSPECTIVES LORENZO GUGLIELMETTI RESIST-TB WEBINAR, 5 APRIL 2018 OUTLINE New TB drugs in France and Latvia Bdq/Dlm: the French-Latvian experience
More informationHot Issues in Tuberculosis: Treatment of Latent TB Infection and New TB Drugs
Slide 1 Hot Issues in Tuberculosis: Treatment of Latent TB Infection and New TB Drugs Constance A. Benson, M.D. Professor of Medicine Division of Infectious Diseases University of California, San Diego
More informationPAEDIATRIC TB TRIAL UPDATE
PAEDIATRIC TB TRIAL UPDATE ANNEKE C. HESSELING PROFESSOR IN PAEDIATRICS AND CHILD HEALTH DIRECTOR: DESMOND TUTU TB CENTRE DEPARTMENT OF PAEDIATRICS AND CHILD HEALTH STELLENBOSCH UNIVERSITY, SOUTH AFRICA
More informationUpcoming TB Alliance Studies. CPRT DST Review September, 2014
Upcoming TB Alliance Studies CPRT DST Review September, 2014 STAND PaMZ Ph 3 STAND: Phase 3 Trial of the Pa-M-Z Regimen Participants with newly diagnosed smear positive DS- and MDR-TB DS Pa(100mg)-M-Z
More informationBedaquiline and delamanid combination as part of a MDR-TB treatment regimen: Current evidence and practices
Bedaquiline and delamanid combination as part of a MDR-TB treatment regimen: Current evidence and practices Cathy Hewison, Médecins Sans Frontières RESIST-TB 5 th April 2018 Outline Current recommendations
More informationNew Drugs, New Treatments, Shorter Regimens
New Drugs, New Treatments, Shorter Regimens Sarah K. Brode, MD MPH FRCP(C) West Park Healthcare Centre, University Health Network, University of Toronto TB Elimination: Back to Basics November 16, 2016
More informationShort Course Treatment for MDR TB
Objectives Short Course Treatment for MDR TB Barbara J Seaworth M.D. Medical Director Heartland National TB Center Professor of Medicine, University of Texas Health Northeast Participants will utilize
More informationSupplementary Appendix
Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Zumla A, Raviglione M, Hafner R, von Reyn CF. Tuberculosis.
More informationCertainty assessment of patients Effect Certainty Importance. a standardised 9 month shorter MDR-TB regimen. e f
Author(s): STREAM Stage 1 Trial investigators reported for the Guideline Development Group for the WHO treatment guidelines on MDR/RR-TB, 2018 update (6 July 2018) - FINAL RESULTS Question: PICO 1. In
More informationBedaquiline and delamanid Experience of use in children. Bobojon Sharipov Deputy Director of the Republican Tuberculosis Control Centre
Tuberculosis in 2017: Searching for new solutions in the face of new challenges 6th TB Symposium Ministry of Health of the Republic of Belarus, Republican Scientific and Practical Center for Pulmonology
More informationTRAITEMENT DE MYCOBACTERIUM TUBERCULOSIS MULTIRÉSISTANT
TRAITEMENT DE MYCOBACTERIUM TUBERCULOSIS MULTIRÉSISTANT LORENZO GUGLIELMETTI RICAI, 18 DÉCEMBRE 2017 CNR des Mycobactéries OUTLINE Introduction New regimens and new drugs New drugs in France Future perspectives
More informationThe Evaluation of Effectiveness and Safety of Novel Shorter. Treatment Regimens for Multidrug-Resistant Tuberculosis
The Evaluation of Effectiveness and Safety of Novel Shorter Treatment Regimens for Multidrug-Resistant Tuberculosis Operational Research Protocol Template May 2018 A publication of the Global Drug-resistant
More informationManagement of MDR TB. Dr Priscilla Rupali MD; DTM&H Professor and Head Department of Infectious Diseases Christian Medical College Vellore
Management of MDR TB Dr Priscilla Rupali MD; DTM&H Professor and Head Department of Infectious Diseases Christian Medical College Vellore Outline Global epidemiology of Tuberculosis Epidemiology of Tuberculosis
More informationDevelopment of New Regimens for Tuberculosis Zhenkun Ma, Ph.D.
Development of New Regimens for Tuberculosis Chief Scientific Officer Global Alliance for TB Drug Development 40 Wall Street, 24th Floor New York, NY 10005 USA 1 Outline What are the unmet needs in TB
More informationTreatment of XDR-TB. Focus on the Nix-TB and ZeNix Trials. RESIST-TB Webinar 11 January 2018 Daniel Everitt, MD
Treatment of XDR-TB Focus on the Nix-TB and ZeNix Trials RESIST-TB Webinar 11 January 2018 Daniel Everitt, MD Global Alliance for TB Drug Development Outline of Discussion TB Alliance Approach to Treatment
More informationOverview: TB Alliance Drug Development Pipeline
Overview: TB Alliance Drug Development Pipeline Mengchun Li, MD Head of Pharmacovigilance, TB Alliance Mar 26, 2018 TB Alliance is a not for profit organization dedicated to the discovery and development
More informationAPSR RESPIRATORY UPDATES
Volume 11 Issue 1 Newsletter Date: January 2019 APSR EDUCATION PUBLICATION Inside this issue: Updates on Treatment in Drug Resistant Tuberculosis World TB Day 2018: the challenge of drug resistant tuberculosis
More informationPresented by Leigh Snyman April 2017
Presented by Leigh Snyman April 2017 Overview Definition of Palliative Care Case based discussion Take home messages What is Palliative Care? WHO Definition of Palliative Care: Palliative care is an approach
More informationSupplementary Appendix
Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Mitnick CD, Shin SS, Seung KJ, et al. Comprehensive treatment
More informationPharmacology and Pharmacokinetics of TB Drugs Part I
Pharmacology and Pharmacokinetics of TB Drugs Part I Charles A. Peloquin, Pharm. D. Professor, and Director Infectious Disease Pharmacokinetics Laboratory College of Pharmacy and The Emerging Pathogens
More informationNew Frontiers: Innovation and Access
8 th Regional TB Symposium - Tashkent, Uzbekistan New Frontiers: Innovation and Access New Guidelines: An Opportunity for National Programmes and Patients: Evidence for new WHO recommendations on MDR-TB
More informationElizabeth A. Talbot MD Assoc Professor, ID and Int l Health Deputy State Epidemiologist, NH GEISELMED.DARTMOUTH.EDU GEISELMED.DARTMOUTH.
The image part with relationship ID rid2 was not found in the file. MDR TB Management Review of the Evolution (or Revolution?) Elizabeth A. Talbot MD Assoc Professor, ID and Int l Health Deputy State Epidemiologist,
More informationProgrammatic introduction of newer drugs for drug-resistant tuberculosis
Programmatic introduction of newer drugs for drug-resistant tuberculosis Overview, clinical considerations, ethical issues, and informed consent Dr. Vivian Cox and Dr. Sein Sein Thi USAID StopTB Partnership
More informationPerspectives for new treatments for MDR-TB
Perspectives for new treatments for MDR-TB Life cycle of M. tuberculosis Active TB in 2015 10.4 million cases >1.4 million deaths Latent TB >2 billion cases Switzerland 564 cases (18 MDR) 2 Koul et al.
More informationMULTIDRUG- RESISTANT TUBERCULOSIS. Dean Tsukayama Hennepin County Medical Center Hennepin County Public Health Clinic
MULTIDRUG- RESISTANT TUBERCULOSIS Dean Tsukayama Hennepin County Medical Center Hennepin County Public Health Clinic I have no relevant financial relationships. Discussion includes off label use of: amikacin
More informationDrug Interactions with ART and New TB drugs: What Do We Know?
Drug Interactions with ART and New TB drugs: What Do We Know? HIV/TB Research Frontiers Meeting 20 th Conference on Retroviruses and Opportunistic Infections 3 March 2013 Presented by: Kelly Dooley MD,
More informationProgrammatic Uptake of Novel Treatments for Multidrug- Resistant TB: A Failure of Innovation?
Programmatic Uptake of Novel Treatments for Multidrug- Resistant TB: A Failure of Innovation? Jennifer Furin, MD., PhD. Harvard Medical School Department of Global Health and Social Medicine To review
More informationChapter 5 Treatment. 5.1 First-Line Antituberculous Treatment
Chapter 5 Treatment Abstract In this chapter the treatment of drug sensitive and drug resistant TB and timing of antiretroviral treatment for HIV infected patients will be reviewed. Emphasis is placed
More informationSoedarsono Department of Pulmonology and Respiratory Medicine Faculty of Medicine, Universitas Airlangga Dr. Soetomo General Hospital
Soedarsono Department of Pulmonology and Respiratory Medicine Faculty of Medicine, Universitas Airlangga Dr. Soetomo General Hospital MDR-TB is a public health crisis 480 000 people developed MDR-TB in
More informationUsing delamanid in MDR-TB Francis Varaine MSF
Using delamanid in MDR-TB Francis Varaine MSF Symposium on new treatment and approaches to Tuberculosis Yerevan TB February 2015 A new anti-tb drug Nitro-dihydro-imidazo-oxazole derivative Mechanism of
More informationTerapia delle forme multi-resistenti
Ferrara, 31 Maggio 2018 Terapia delle forme multi-resistenti Dr. Marina Tadolini U.O. Malattie Infettive Dipartimento di Scienze Mediche e Chirurgiche Alma Mater Studiorum Università di Bologna Outline
More informationTuberculosis 1 Tuberculosis: progress and advances in development of new drugs, treatment regimens, and host-directed therapies
Tuberculosis 1 Tuberculosis: progress and advances in development of new drugs, treatment regimens, and host-directed therapies Simon Tiberi, Nelita du Plessis, Gerhard Walzl, Michael J Vjecha, Martin
More informationThe clinical pharmacology and drug interactions of bedaquiline
7 TH FIDSSA 2017 The clinical pharmacology and drug interactions of bedaquiline Helen McIlleron Division of Clinical Pharmacology University of Cape Town 20 years 2 drugs conditional approval based on
More informationTreatment of Active Tuberculosis
Treatment of Active Tuberculosis Jeremy Clain, MD Pulmonary & Critical Care Medicine Mayo Clinic October 16, 2017 2014 MFMER slide-1 Disclosures No relevant financial relationships No conflicts of interest
More informationUpdate on Tuberculosis Botswana, March 2017
Update on Tuberculosis Botswana, March 2017 Zelalem Temesgen, MD FIDSA AAHIVS Professor of Medicine Executive Director, Mayo Clinic Center for Tuberculosis Director, HIV Program Regional Training and
More informationThe shorter regimen for MDR-TB: evidence and pitfalls
The shorter regimen for MDR-TB: evidence and pitfalls Helen Cox 10 November 2017 What is the shortened regimen? Current conventional regimen (SA): Intensive Phase (at least 6 months): PZA / (EMB) / Kana
More informationNewer anti-tb drugs and regimens. DM Seminar
Newer anti-tb drugs and regimens DM Seminar 31-10-14 Why are newer drugs/regimens needed? Problems with current drugs/regimens Drug resistance Drug interaction of anti-tubercular drugs with ART Long duration
More informationDR-TB Patient Treatment Log Book
REPUBLIC OF KENYA MINISTRY OF HEALTH DR-TB Patient Treatment Log Book Patient Name: Patient Reg. No.: VERSION 2016 DR-TB treatment outcome summary Outcome Mark one Date Cured Died Failed Defaulted Transferred
More informationShah: Discordant Growth- Molecular Rifampin Resistance 2/27/16 RELAPSED FAILED
/7/6 Discordant Growth- Molecular Diagnos7c Challenges and Treatment Outcomes Neha Shah, MD MPH Centers for Disease Control and Preven7on California Department of Health Tuberculosis Control NAR February
More informationManaging Complex TB Cases Diana M. Nilsen, MD, RN
Managing Complex TB Cases Diana M. Nilsen, MD, RN Director of Medical Affairs NYC Department of Health & Mental Hygiene Bureau of TB Control Case #1 You are managing a patient who was seen at a private
More informationManagement of Multidrug- Resistant TB in Children. Jennifer Furin, MD., PhD. Sentinel Project, Director of Capacity Building
Management of Multidrug- Resistant TB in Children Jennifer Furin, MD., PhD. Sentinel Project, Director of Capacity Building Objectives To review data on best practices for diagnosis, treatment and prevention
More informationTB Updates for the Physician Rochester, Minnesota June 19, 2009
TB Updates for the Physician Rochester, Minnesota June 19, 2009 Recent Findings & Activities of the Tuberculosis Trials Consortium (TBTC) Bill Burman Denver TBTC Unit & Denver Public Health Recent findings
More informationSirturo: a new treatment against multidrug resistant tuberculosis
Sirturo: a new treatment against multidrug resistant tuberculosis TB is an on-going problem WHO estimated incidence of new TB cases 2009 Global Tuberculosis Control: WHO report 2010. Available at: http://www.who.int/tb/publications/global_report/2010/en/index.html
More informationCompassionate use of bedaquiline in highly drug-resistant tuberculosis patients in Mumbai, India
AGORA RESEARCH LETTER Compassionate use of bedaquiline in highly drug-resistant tuberculosis patients in Mumbai, India To the Editor: Bedaquiline, a mycobacterial ATP synthase inhibitor [1], is the first
More informationTreatment of Tuberculosis
Treatment of Tuberculosis Marcos Burgos, MD April 5, 2016 TB Intensive April 5 8, 2016 San Antonio, TX EXCELLENCE EXPERTISE INNOVATION Marcos Burgos, MD has the following disclosures to make: No conflict
More informationActivity of PNU and its major metabolite in whole blood and broth culture models of TB
Activity of PNU 100480 and its major metabolite in whole blood and broth culture models of TB Paul Converse 1, Jin Lee 1, Kathy Williams 1, Opokua Amoabeng 1, Kim Dionne 1, Nicole Parish 1, Robert Wallis
More informationOUT OF TIME: ACCESS TO TREATMENT FOR DR- TB
MSF Briefing Document DECEMBER 2015 OUT OF TIME: ACCESS TO TREATMENT FOR DR- TB An update on the latest developments in DR- TB medicines In 2014, 1.5 million people died from tuberculosis (TB), displacing
More informationResearch gaps for eliminating TB deaths among people living with HIV. GJ Churchyard 25 th July 2017
Research gaps for eliminating TB deaths among people living with HIV GJ Churchyard 25 th July 2017 Overview Research gaps for preventing TB deaths among PLWHIV Programmatic management of LTBI Tests of
More informationNIAID TB Therapeutic Clinical Research Priorities. Prognostic biomarkers for disease progression, treatment response/relapse
NIAID TB Therapeutic Clinical Research Priorities New drugs and combinations for DS and DR TB: Efficient Phase I and II evaluations Phase III Killing Persisters Sterilizing activity is crucial Prognostic
More informationMarcos Burgos, MD has the following disclosures to make:
Guidelines for the Treatment of Tuberculosis Marcos Burgos, MD May 13, 2015 TB for Pulmonologist March 13, 2015 Phoenix, AZ EXCELLENCE EXPERTISE INNOVATION Marcos Burgos, MD has the following disclosures
More informationTherapeutic Drug Monitoring for Improving TB Treatment Outcomes: A Concept for a Randomized Clinical Trial before Clinical Implementation
Therapeutic Drug Monitoring for Improving TB Treatment Outcomes: A Concept for a Randomized Clinical Trial before Clinical Implementation Randall Reves, MD, MSc TB Consultant Professor of Medicine and
More informationMEDICINES CATALOG NOVEMBER 2018 GLOBAL DRUG FACILITY (GDF)
NOVEMBER 2018 MEDICINES CATALOG GLOBAL DRUG FACILITY (GDF) Ensuring an uninterrupted supply of quality-assured, affordable tuberculosis (TB) medicines and diagnostics to the world. stoptb.org/gdf Stop
More informationNon-rifampin rifamycins in TB/HIV
Non-rifampin rifamycins in TB/HIV Richard E. Chaisson, MD Johns Hopkins University Center for TB Research Consortium to Respond Effectively to the AIDS-TB Epidemic Rifamycins for TB Inhibit bacterial DNA-dependent
More informationClinical Trials Lecture 4: Data analysis
Clinical Trials Lecture 4: Data analysis Dick Menzies, MD Respiratory Epidemiology and Clinical Research Unit Montreal Chest Institute TB Research methods course July 17, 2014 Lecture 4: Data analysis
More informationTBTC research update: are we ready for 3 month treatment? 2009 TBTC Recompetition. NTCA presentation outline
TBTC research update: are we ready for 3 month treatment? Stefan Goldberg, MD Project officer, TBTC Studies 27, 28, 29 Tuberculosis Trials Consortium (TBTC) CDC Division of TB Elimination NTCA breakout
More informationIqbal Master Clinical Manager King Dinuzulu Hospital complex MDR TB UPDATE AWACC 2018
Iqbal Master Clinical Manager King Dinuzulu Hospital complex MDR TB UPDATE AWACC 2018 Challenges MDR faced & what was achieved The current program Key drugs The New Regimens Stats Limited facilities/ MDR
More informationPhase III Clinical Trial Results at the 48 th Union World Conference on Lung Health: Implications for the Field 1
Phase III Clinical Trial Results at the 48 th Union World Conference on Lung Health: Implications for the Field 1 Preliminary results from two phase III drug-resistant TB (DR-TB) clinical trials were presented
More informationTB-CHAMP A PHASE 3 CLUSTER RANDOMIZED TRIAL FOR PREVENTION OF TB IN CHILD HOUSEHOLD CONTACTS
TB-CHAMP A PHASE 3 CLUSTER RANDOMIZED TRIAL FOR PREVENTION OF TB IN CHILD HOUSEHOLD CONTACTS ANNEKE C. HESSELING RESIST TB WEBINAR 20 APRIL 2017 DESMOND TUTU TB CENTRE PROFESSOR IN PAEDIATRICS AND CHILD
More informationExperience with Pyrazinamide and Rifampin Regimens for Latent TB Infection
Experience with Pyrazinamide and Rifampin Regimens for Latent TB Infection Krista Powell, MD, MPH Co-Project Officer, National Surveillance for Severe Adverse Events Associated with LTBI Treatment Lead,
More informationTherapeutic TB vaccines Shortening Treatment for (DS- and) DR-TB?
Therapeutic TB vaccines Shortening Treatment for (DS- and) DR-TB? Mark Hatherill South African Tuberculosis Vaccine Initiative (SATVI) University of Cape Town, South Africa 1 1. The need for a therapeutic
More informationImproving Translation in TB Drug Development Through Quantitative Modeling. CPTR Workshop 2016, Washington DC
Improving Translation in TB Drug Development Through Quantitative Modeling Lessons from Recent Phase III TB Trials CPTR Workshop 2016, Washington DC Christian Lienhardt Global TB Programme WHO, Geneva,
More informationAccess update, registration & procurement strategies Barbara ROTH Pharmacist, TB supply - MSF
Treating Patient, Not Disease: People-Centered Approach 1-2 March, 2018, BISHKEK, KYRGYZSTAN Access update, registration & procurement strategies Barbara ROTH Pharmacist, TB supply - MSF EML Guidelines
More informationLaboratory Diagnosis for MDR TB
Laboratory Diagnosis for MDR TB Neha Shah MD MPH Centers for Disease Control and Prevention Division of Tuberculosis Elimination California Department of Public Health Guam March 07 Objectives Describe
More informationPharmacokinetics and doses of antituberculosis drugs in children
Pharmacokinetics and doses of antituberculosis drugs in children HS Schaaf Desmond Tutu TB Centre Department of Paediatrics and Child Health Stellenbosch University Declarations I have no conflict of interest
More informationTreatment of Tuberculosis, 2017
Treatment of Tuberculosis, 2017 Charles L. Daley, MD National Jewish Health University of Colorado Health Sciences Center Treatment of Tuberculosis Disclosures Advisory Board Horizon, Johnson and Johnson,
More informationACCESS TO MEDICINES. Update on tuberculosis field activities
ACCESS TO MEDICINES Update on tuberculosis field activities Update on clinical activities 1/3 Latent TB Prevent study (S26) main study (8053 patients) PK substudy construction of a POPPK model Paediatric
More informationMaha R Farhat, MD MSc Massachusetts General Hospital Harvard Medical School. I have no financial or other potential conflicts of interest to disclose
Maha R Farhat, MD MSc Massachusetts General Hospital Harvard Medical School I have no financial or other potential conflicts of interest to disclose Update on the epidemiology of TB drug resistance Success
More informationREPORT ON GREEN LIGHT COMMITTEE MONITORING MISSION INDONESIA. January Michael Rich, M.D., M.P.H. Date of mission: January 2017
REPORT ON GREEN LIGHT COMMITTEE MONITORING MISSION INDONESIA Michael Rich, M.D., M.P.H. Date of mission: 15-27 January 2017 January 2017 Acknowledgments The monitoring team would like to express gratitude
More informationAnti-Infective Drugs Advisory Committee Meeting. Briefing Document. TMC207 (bedaquiline) Treatment of Patients with MDR-TB NDA
ADVISORY COMMITTEE BRIEFING MATERIALS: AVAILABLE FOR PUBLIC RELEASE 1 Anti-Infective Drugs Advisory Committee Meeting Briefing Document TMC207 (bedaquiline) Treatment of Patients with MDR-TB NDA 204-384
More informationFirst Edition: August, 2015 This handbook was developed and written by The SWIFT Response Project (
Treatment of Drug-Resistant TB with New and Repurposed Medications: A Field Guide for Optimal Use First Edition: August, 2015 This handbook was developed and written by The SWIFT Response Project (www.swiftresponseproject.org)
More informationACTG TB Transformative Science Group Protocol updates, Union NAR Meeting February 23, 2019
ACTG TB Transformative Science Group Protocol updates, Union NAR Meeting February 23, 2019 Gavin J. Churchyard, Chair Kelly Dooley, Vice Chair Overview TB TSG scientific agenda Protocol overview New Directions
More informationTreatment of Tuberculosis
TB Clinical i l Intensive Seattle Treatment of Tuberculosis June 16, 2016 Masa Narita, MD Public Health Seattle & King County; Firland Northwest TB Center, University of Washington Outline Unique features
More informationPediatric TB Intensive San Antonio, Texas October 14, 2013
Pediatric TB Intensive San Antonio, Texas October 14, 2013 Treatment of Tuberculosis in Children Jeffrey R. Starke, M.D. Professor of Pediatrics October 14, 2013 Jeffrey R. Starke, M.D. has the following
More informationPRIORITIZATION OF HIV, HEPATITIS C AND TUBERCULOSIS MEDICINES FOR IN- LICENSING BY THE MEDICINES PATENT POOL
PRIORITIZATION OF HIV, HEPATITIS C AND TUBERCULOSIS MEDICINES FOR IN- LICENSING BY THE MEDICINES PATENT POOL - 2018 Prioritization of HIV, Hepatitis C and Tuberculosis Medicines for In-Licensing by the
More informationDisclosures. Public Health Motivation 6/6/2012. The 12-Dose INH-Rifapentine Once-Weekly DOT Regimen: What Next?
The 12-Dose INH-Rifapentine Once-Weekly DOT Regimen: What Next? NTCA Conference June 14, 2012 John Jereb, FSEB, DTBE, CDC Special thanks to Christine Ho, Elsa Villarino, and Andrey Borisov The findings
More informationRECENT ADVANCES OF TUBERCULOSIS MANAGEMENT. Qais Abdulmajeed Haddad Consultant ID & IC Security Forces Hospital Program Riyadh - Saudi Arabia
RECENT ADVANCES OF TUBERCULOSIS MANAGEMENT Qais Abdulmajeed Haddad Consultant ID & IC Security Forces Hospital Program Riyadh - Saudi Arabia RECENT ADVANCES OF TUBERCULOSIS MANAGEMENT History Epidemiology
More informationCDC's Tuberculosis Trials Consortium
CDC's Tuberculosis Trials Consortium Kayla Laserson, Andrew Vernon, Erin Bliven, Neil Schluger, William Burman, Fred Gordin, Tim Sterling, Carol Dukes Hamilton, Debra Benator, Donna Conwell, Nancy Dianis,
More informationSterilizing Activity of Novel TMC207- and PA-824-Containing Regimens in a Murine Model of Tuberculosis
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, Dec. 2011, p. 5485 5492 Vol. 55, No. 12 0066-4804/11/$12.00 doi:10.1128/aac.05293-11 Copyright 2011, American Society for Microbiology. All Rights Reserved. Sterilizing
More informationSurgery for MDR/XDR Tuberculosis
Surgery for MDR/XDR Tuberculosis John D. Mitchell, M.D. Davis Endowed Chair in Thoracic Surgery Professor and Chief, General Thoracic Surgery Department of Surgery University of Colorado School of Medicine
More informationendtb Clinical and Programmatic Guide for Patient Management with New TB Drugs Version 3.3
endtb Clinical and Programmatic Guide for Patient Management with New TB Drugs Version 3.3 Notice This guide is a draft version designed to give guidance to the endtb Project site on the use of new TB
More informationNew and repurposed anti-tb drug introduction and active TB drug-safety monitoring and management
New and repurposed anti-tb drug introduction and active TB drug-safety monitoring and management Alena Skrahina, NTP Belarus WOLFHEZE WORKSHOPS 2017 REACHING OUT To find, treat and cure more TB patients
More informationDiagnosis and Management. of Tuberculosis
Chapter 6 Tuberculosis: New Laboratory Diagnostic Methods and Treatment Hongfei Duan 1 ; Zihui Li 2 ; Xiaojing Zheng 2 ; Zongde Zhang 2 ; Naihui Chu 1 1 Beijing Chest Hospital, Capital Medical University,
More informationTreatment of Tuberculosis
Treatment of Tuberculosis, 1940 s Treatment of Tuberculosis ATS/CDC/IDSA Joint Statement 2003 Saskatchewan Lung Association Outline, 2012 Treatment of Tuberculosis Principles of treatment of tuberculosis
More informationFIND and NDWG symposium Panel Discussion. Martina Casenghi, NDWG Core Group
FIND and NDWG symposium Panel Discussion Martina Casenghi, NDWG Core Group 48 Union World Conference, Guadalajara October 11th 2017 Molecular tests for diagnosis of TB and drug resistance 2008 Dec 2010
More informationendtb Clinical and Programmatic Guide for Patient Management with New TB Drugs Version 3.3
endtb Clinical and Programmatic Guide for Patient Management with New TB Drugs Version 3.3 Notice This guide is designed to give guidance to the endtb Project site on the use of new TB drugs bedaquiline
More informationOfficial ATS/CDC/IDSA Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis (Nahid et al, CID 2016)
Official ATS/CDC/IDSA Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis (Nahid et al, CID 2016) APPENDIX C: DRUGS IN CURRENT USE The U.S. Food and Drug Administration (FDA) has approved
More informationTuberculosis: What's new in diagnos6cs and management?
Tuberculosis: What's new in diagnos6cs and management? Colin Menezes, Department of Internal Medicine, Chris Hani Baragwanath Academic Hospital, University of the Witwatersrand. Objec6ves of this talk:
More informationStandard TB Treatment
Standard TB Treatment Chris Keh, MD TB Controller, TB Prevention and Control Program, San Francisco Department of Public Health Assistant Clinical Professor, Division of Infectious Diseases, University
More informationResearch Excellence to Stop TB Resistance. Plan for MDR-TB Clinical Trials: An Overview March 9, 2010
RESIST-TB: Summary Research Excellence to Stop TB Resistance Plan for MDR-TB Clinical Trials: An Overview March 9, 2010 The current epidemic of Multidrug-Resistant Tuberculosis (MDR-TB) is a major threat
More informationLusine Yeghiazaryan, Head of MDR Unit, RTBD NTC Armenia/MSF France
Feb 17 th -18 th 2015 Armenia Experience on Treatment of XDR and pre-xdr Patients with New drugs under Compassionate Use program Lusine Yeghiazaryan, Head of MDR Unit, RTBD NTC Armenia/MSF France Challenges
More informationCLINICAL EXPERIENCE OF TREATING XDR- TB AT JOSE PEARSON TB HOSPITAL
CLINICAL EXPERIENCE OF TREATING XDR- TB AT JOSE PEARSON TB HOSPITAL BY DR LIMPHO RAMANGOAELA B.Sc.Ed(NUL),MBCHB(UKZN) 20 TH OCTOBER 2017 Livingstone Resource Centre. JOSE PEARSON TB HOSPITAL Out Line Overview
More informationDelamanid Central Nervous System Pharmacokinetics in Tuberculous Meningitis
Delamanid Central Nervous System Pharmacokinetics in Tuberculous Meningitis Liz Tucker, Assistant Professor of Pediatric Critical Care Medicine On behalf of Lisa Pieterse, Matthew D. Zimmerman, Zarir F.
More informationTuberculosis medications: adverse drug reactions
Tuberculosis medications: adverse drug reactions Rajesh M. Prabhu, M.D. Infectious Diseases Essentia Health, Duluth, MN July 25, 2017 2014 MFMER slide-1 No Finanial Disclosures Learning Objectives 1. Describe
More informationUpdate on the Global Use of Bedaquiline and Delamanid for Programmatic Management of Drug- Resistant Tuberculosis
Update on the Global Use of Bedaquiline and Delamanid for Programmatic Management of Drug- Resistant Tuberculosis DR-TB Scale-Up Treatment Action Team (DR-TB STAT) October 2017 Content What is DR-TB STAT?
More information