Key Tuberculosis Treatment and Prevention Issues

Slides:

Advertisements

Similar presentations

HIV TB. World wide TB is the most common cause of death in people with HIV About 1/3 of HIV infected people worldwide are co-infected with TB (co-infection.

Advertisements

The Global Alliance for TB Drug Development

The TB Alliance-Bayer Moxifloxacin Deal

New approaches in TB diagnosis and treatment Prof. M.A. Tageldin.

Daniel Everitt, MD; Erica Egizi MPH Global Alliance for TB Drug Development, New York Helen Winter, PhD University of Otago, New Zealand 2012 International.

Scott Butler Infection Innovative Medicines Group AstraZeneca R&D, Boston CPTR Workshop, 2012 Arlington, VA AZD5847 Oxazolidinone for the treatment of.

New drugs and regimens for TB: 2015 update

Rifapentine Development Progress – October 4, 2012 | 1 I. CIEREN-PUISEUX – ACCES TO MEDECINE Rifapentine Development Progress CPTR 2012 Workshop.

Rationale for New Drugs for Tuberculosis 500,000 cases annually of MDR TB – Second line treatment toxic and weak 15% of TB is HIV-related – Drug-drug interactions.

TB/HIV: Impact and Opportunities Helene Gayle, MD, MPH Bill and Melinda Gates Foundation DATE, 2004.

Interim analysis of a double- blind, placebo-controlled study with TMC207 in patients with Multi-Drug Resistant (MDR) Tuberculosis Karel de Beule, CDTL.

Eight Week Randomized Trial of Treatment with Pa-824, Moxifloxacin, and Pyrazinamide in Drug Sensitive and Multi-Drug Resistant Tuberculosis July 21, 2014.

Impact evaluation Evaluate new tools Translate new knowledge into policy and implementation Knowledge gap Program implementation.

PUTTING AN END TO TB WHERE ARE THE OPPORTUNITIES AND WHAT ARE THE CHALLENGES? STRATEGY MEETING ON RESOURCE MOBILIZATION FOR THE GLOBAL FUND TO FIGHT AIDS,

T reatment A ction G roup Update on Global TB Research By Claire Wingfield Treatment Action Group Advisory Council for the Elimination of Tuberculosis.

Increasing HIV treatment for TB patients – thinking out of the box Anthony D Harries, The Union Paris, France.

Johns Hopkins Center for Tuberculosis Research

TB 101 Part II Brenda Mayes, R. N. March TREATMENT TB DISEASE MDR XDR LATENT TB INFECTION.

End TB Strategy HCW with cough since January. Seen at government clinic thrice with no sputum/CXR. Diagnosed TB in May only.

Strategic Information and the Control of Tuberculosis Brian Williams and Chris Dye TB programme, Monitoring and Evaluation, WHO.

Tuberculosis Trials Consortium (TBTC) Overview Completed, Ongoing, and Moxifloxacin Clinical Trials Kenneth G. Castro, M.D. Assistant Surgeon General,

R&D Update Carl M. Mendel, M.D. SHA Meeting October 28, 2013 Paris, France.

TOMORROW’S TB TREATMENT IN CHILDREN Anneke C. Hesseling Desmond Tutu TB Centre Stellenbosch University 31 October 2014.

Role(s) of EBA Studies – Substitute for Dose Ranging JL Johnson, MD Case Western Reserve Univ.

TB and HIV integrated services at Martin Preuss Centre in Lilongwe, Malawi : “The Lighthouse Trust initiative” Dr Sam Phiri Executive Director Lighthouse.

PanACEA Studies: Phase I Phase IIa Phase IIb Phase III Q203 BTZ043

TB Drug Development: Year-in-Review Barbara Laughon, PhD Co-Chair Working Group on New TB Drugs 4 December 2015 Working Group on New TB Drugs Cape Town,

Christo van Niekerk, M.D. IUATLD Meeting, Cape Town December 5, 2015 TB Alliance Ongoing Clinical Trials in DS-, MDR-and XDR-TB.

Treatment Regimens for Pulmonary Tuberculosis Caused by Drug- Susceptible Organisms Initial PhaseContinuation Phase RegimenDrugs Interval and Doses (Minimal.

Depart. of Pulmonology 백승숙. More than 80% of cases of tuberculosis in the United States –The result of reactivated latent infection –Nearly all these.

Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis UZ-UCSF ARD April 08, 2016 W.Samaneka MBChB, MSc Clin Epi, Dip HIV Man.

SuPAR and sICAM-1 as Immune Markers for Treatment Response in Ethiopian TB patients with and without HIV co-infection Wegene T. Mekasha ICASA, Addis Ababa.

#AIDS2016 Innovations in TB treatment : what the future holds C. Padmapriyadarsini National Institute for Research in Tuberculosis Indian.

Sarah Al-Obaydi M.B.Ch.B, MPH(c) Fulbright scholar.

TB Drug Development: Year-in-Review

New WHO algorithm to prevent TB deaths in seriously ill patients with HIV Yohhei Hamada TB/HIV and Community Engagement.

IMPAACT 2001 STUDY Mhembere T.P. (B. Pharm (Hons), MPH)

ACTG TB Transformative Science Group

Treatment for Multi-drug Resistant TB

STREAM Trials Andrew Nunn MRC Clinical Trials Unit at UCL

The story of Munya* (and us)

Community Representative Update

Tuberculosis Treatment

STAND Trial NC-006 (M-Pa-Z) Dr Suzanne Staples Principal Investigator at THINK 26 Mar 2015.

State of HIV Cure Research

TB- HIV Collaborative activities in Romania- may 2006 status

Latent Infection In the nonimmune (susceptible) host, the bacilli initially multiply unopposed by normal host defense mechanisms. The organisms are then.

Safe and effective bedaquiline treatment of drug-resistant tuberculosis (DR-TB) within the National Bedaquiline Clinical Access Programme in South Africa.

William Burman Denver Public Health Tuberculosis Trials Consortium

Drug Resistant (DR) TB (Back to Basics)

Community Advisory Boards on Repeat:

Tuberculosis Treatment

PRIORITIZING TB in 2018 PEPFAR COPS

World Tuberculosis Day 2015

Monitoring the implementation of the TB Action Plan for the WHO European Region, 2016–2020 EU/EEA situation in 2016 ECDC Tuberculosis Programme European.

Pre-conference Meeting Report

The results are in: now what?

Drug Development Coalition

Is it Time for a Paradigm Change in HIV Management?

24 July 2018 Treatment outcomes with bedaquiline use when substituted for second-line injectables in multidrug resistant tuberculosis: a retrospective.

Comments on design and sequence of biomarker studies

Issues in TB Drug Development: A Regulatory Perspective

ANTIRETROVIRAL TREATMENT IN RESOURCE-LIMITED SETTINGS: PROGRESS & CHALLENGES IN SOUTH AFRICA YOGAN PILLAY DEPARTMENT OF HEALTH, SOUTH AFRICA IAS, 2014.

Anthony D Harries Ministry of Health, Malawi

MDR-TB Clinical Trials Landscape Overview: Current and Future Trials

Testing Novel Combination Regimens

Strategic framework for TB/HIV

Management of NTM Lung Disease

The IAS TB/HIV Research Prizes are awarded to:

Presentation transcript:

Key Tuberculosis Treatment and Prevention Issues Prof JG Hakim, Parirenyatwa CRS Leader Annual Research Day; 8th April 2016

TB- A Global Problem

TB Transformative Science Group (TB TSG) Agenda Treatment & prevention of TB with or without HIV co-infection Anti-TB new drugs & combinations Develop shorter Rx regimens Rx for MDR/XDR TB Optimal Rx of latent TB Optimal Rx for TB in patients on ART Evaluation of drug-drug interactions (anti-TB & ART) Improved TB diagnostic assays & biomarkers to predict & detect disease

Recent accomplishments of TB TSG A5295-Xpert TB/RIF trial in US, RSA, Brazil A5306-PK/DDI study of Pa824 (Pretomanid), EFV and LPV/r A5311-High dose rifapentine PK study A5274-REMEMBER trial, enrolment complete A5279-Rifapentine-EFV sub-study completed A5221-STRIDE study, 2Y analysis of CD4 and risk of death

TB Treatment Shortening Studies Study Description Status A5289 Phase 2 trial of Sutezolid for improving sputum conversion at 8 weeks Protocol in development pending drug availability A5344/STAND Phase 3 trial of Pa824/Moxi/PZA to shorten TB therapy to 4 months (with TB Alliance) Started 2015 PR686/TBTC31 Phase 3 trial of rifpentine + moxi to shorten TB therapy to 4 months (with TBTC) PR698 Phase 2 trial of clofazamine in drug susceptible TB Protocol in development

MDR TB Sub-studies in Progress or Development Study Description Status A5312 Early bactericidal activity of high-dose INH in patients with MDR TB and inha mutations A5343 PK safety study of bedaquiline and delamanid in patients with MDR TB in South Africa (with Janssen and Otsuka) A5319 (Marvel) Phase 2 trial of bedaquiline, linezolid (sutezolid) and Pa824 in MDR TB Deregistered

Novel drugs for MDR TB treatment Class Agents Comments Availability to ACTG Flouroquinolones Moxifloxacin Levofloxacin QT issues Available Nitroimidazoles Delamanid Pa824 (Pretominid) ATP Synthetase Inhibitor Bedaquiline Drug-drug interactions limitations, QT, deaths Oxazolidinones Linezolid Sutezolid AZD Tedizolid Licenced, toxicity Toxicity/efficacy Licenced Phenazine dyes Clofazamine Skin toxicity, QT Access global market

TB Preventive Therapy Studies Study Description Status A5279 Daily Rifapentine/INH for 1 month vs INH for 9 months to prevent TB in HIV+ve patients Enrolling ~2300/3000 (with IMPAACT) A5300 Phoenix Phase 3 trial of levofloxacin vs INH for high-risk contacts M/XDR TB patients

Host-Directed Therapies for TB TB TSG Working Group since March/2013 Collaboration with Bill & Melinda Gates Foundation Others Statins to prevent IRIS in TB/HIV Doxycycline to reduce immunopathology Imatinib dose selection for TB Adalibumab for TB Recombinant IL-7 as adjuvant TB therapy

Laboratory and Biomarkers Laboratory Strengthening in the ACTG International reference Lab-Stellenbosch Regional Labs, BARC (Jo’burg, JCRC (Kampala) and TRC (Chennai) Xpert TB/RIF at all sites Lab standardization protocol Biomarker Research A5302 (with Alliance, TBTC); B-SMART Four funded discovery Projects Sputum markers with flow cytometry Serum markers-proteomic and exosomes Urine metabolomics fingerprinting Cellular immune signals

Thank You