Update of the Global Plan to Stop TB TB/HIV Working Group Meeting Geneva, November 2009 Christian Lienhardt

Objectives of the Global Plan Overall Goal: –To achieve both MDGs (“to have halted by 2015 and begun to reverse, the incidence of TB") and Stop TB Partnership’s 2015 targets (to halve prevalence and death rates of TB compared with 1990 levels). Objectives: –To promote wider and wiser use of existing strategies to interrupt TB transmission by: accelerating DOTS implementation to achieve the global targets for TB control; and increasing the availability, affordability and quality of anti-TB drugs. –To prevent and manage multidrug-resistant TB, and to reduce the impact of HIV related TB –To accelerate the elimination of TB by: promoting research and development for new TB diagnostic tests, drugs and vaccines; and promoting adoption of new and improved tools by ensuring appropriate use, access and affordability.

The Global Plan proposed achievements 1.MDGs for TB and the Partnership ’ s 2015 targets to halve prevalence and death rates globally 2.Treatment of 50 million people with TB, 3 million TB/HIV co-infected patients on ARV, and 1.6 million with MDR 3.Saving of 14 million lives from The first new TB drug introduced by The "point of care" diagnostics introduced by Develop a new vaccine by 2015

Total needs by Working Group area of responsibility,

Global Plan targets – Research and Development By 2006By 2010By 2015 Vaccines3 vaccines in phase I trials 9 candidates in phase II trials; at least 2 vaccines in "proof of concept" trials; beginning phase III trials 4 phase III trials carried out; one safe, effective vaccine available Drugs27 new compounds in the pipeline 1-2 new drugs registered; treatment shortened to 3-4 months 7 new drugs; treatment shortened to 1-2 months Diagnosticsrapid culture for case detection and DST in demonstration phase point of care, rapid culture, improved microscopy, phage detection, simplified NAAT predictive test for LTBI

Global Plan – Research and Development: Limitations The R & D component of the GP was solely relying on the works to be carried out to develop new tools, i.e. new Diagnostics, Drugs and Vaccines Basic research considered as part of the new tools research Operation research imbedded in the implementation part of the GP, with costs calculated at 0.1% But what's about the specific aspects related to MDR-TB, TB/HIV and childhood TB ?

The Update The purpose of the Global Plan Update is to look critically at the objectives set at start and, on the basis of the developments so far, to revise the objectives, ensuring feasibility and achievement; to outline clearly the main activities to reach these objectives; to define appropriate indicators to evaluate progress; to define appropriate targets to measure effectiveness; to identify the costs of these activities, ensuring comparability between tools and over time. The update will take into account the specific aspects of research to be carried out in the field of TB/HIV, MDR-TB, and childhood TB, with reference to basic research, development of new tools, and operation research The endpoint is to ensure that achievable objectives are set, and that a process of constant evaluation of progress and funding is possible, through the comparison with the Annual R&D Funding Assessment Report produced by TAG in collaboration with STP

The process Development of a logical framework based on goal, objectives and proposed activities set in GP for new tools; Critical review of the goal, objectives and activities based on progress , current status, major areas of work and related targets for ; Identification of appropriate indicators to measure activities and estimate costs; Development of revised agenda with appropriate budget to implement activities

The process (contd) For New Tools (drugs, vaccines and diagnostics): –Work going on through communications within WGs – led by chairs and core groups –Advice/input from health economists –2 workshops to advance (Sept '09) and finalise (Jan '10) revised frameworks For Basic Research and OR: –Workshops to define the suitable research agenda and develop appropriate cost estimates Writing-up (March – May '10)

Defining a prioritized Research Agenda for TB/HIV The WG defined TB/HIV research priorities first in 2005 Research priorities currently being revised with a clearly defined prioritization process Grading scale to assess the importance of the question based on defined criteria of effectiveness, deliverability, answerability and equity; Questions with the highest scores will be rated of high priority and will be subject for wide web based consultation

Integration in the GP update These research priorities need to be incorporated in the updated Global Plan with appropriate costing: –addressing the special needs of PLWHIV is a minimum standard of care for any innovation in TB diagnostics, drugs and vaccines –within the present process, TB/HIV priorities in terms of diagnostics, drugs and vaccines are being addressed with the ad-hoc WGs –priorities in terms of OR to be indetified and integrated in a larger OR agenda Get feedback from the WG on this and possibility to achieve this process by May 2010

The GP update The development of the Global Plan has relied on contributions from the Stop TB Partnership’s seven working groups (DEWG, MDR-TB WG; TB/HIV; new TB diagnostics; new TB drugs; new TB vaccines; ACSM) – coordinated by the Partnership Secretariat. Contribution from all the WGs is essential for an update that will present all characteristics of feasibility and credibility and represent a major tool for advocacy Thank you very much !