Dr. S. M. Egwaga NTLP - Tanzania

1. NEED FOR NEW TB DRUG REGIMEN – PERSPECTIVE FROM TANZANIA A presentation for the TB drug ForumArlington, Virginia: 6-7 Dec. 2005 Dr. S. M. Egwaga NTLP - Tanzania

2. Burden of Tuberculosis • WHO estimated 8.8 million new cases and 1.7 million deaths in 2003 –98% of these in the developing world • 80% of all cases in 22 high-burden countries in Africa, South East Asia and Western Pacific regions • 12 out of the 15 countries with the highest estimated TB incidence rates per capita are in Africa • Underlying cause of the increase is the HIV/AIDS pandemic • WHO reports indicates that 102 of 109 countries surveyed from 1994-2003 have Multi-drug resistance (MDRTB)

3. Policy Environment for TB control • Most countries have responded to the TB epidemic by scaling up the WHO recommended DOTS strategy in an environment of Health Sector Reforms and decentralization • There is often little dialogue between those responsible for health systems policy and those responsible for delivering specific programmes like TB control to ensure ownership and informed decision making • There is an acute shortage of human resource – both in quantity and quality to adequately supervise TB control • TB control may be higher on the political agenda after emergency declaration by African Health Ministers in August 2005 • The lost productivity due to prolonged TB treatment may affect the whole family and the country at large

4. Health system challenges • TB diagnosis among suspects is often subjected to user-fees charges even after declaring it free of charge • TB treatment is provided free of charge but the cost to patient to access treatment sometimes is equal or more than the cost of the drugs • TB drug logistics demand detailed planning to ensure uninterrupted supply • Pharmacy storage facilities are generally small and often without air conditioning • Adherence to treatment regimens especially after the intensive phase is problematic and requires special support • Follow-up of patients who are out of control is often expensive and often not done

5. TB regimen challenges • TB treatment is complicated - depends on a multi-drug treatment regimen not easily understood by the average health worker and majority of patients • TB treatment requires daily monitoring by health workers or treatment supporters • The treatment duration is long: 6-8 months • The number of tablets swallowed a day is big especially if accompanied with ARVs too.

6. Meeting the challenges • The Stop TB partnership has established the Global Drug Facility (GDF) to support countries access high quality drugs at an affordable price • WHO with partners has revised TB treatment guidelines to accommodate the HIV/AIDS pandemic to minimize failure and relapses after treatment • New 4-fixed dose combination drugs are now available to patients through GDF grant • The new STOP TB strategy recognises and empowers patients and communities to take active role in supervising treatment and fostering adherence • The Global Alliance for TB drug development is spearheading the development of new treatment regimens which could be shorter and simpler for the patients and service providers.

7. Desired characteristics of new TB drugs regimens -1 • New TB regimens should have the following characteristics: • More effective – reducing treatment duration to a couple of months or weeks • Ideally should be provided once a day • Ideally effective even for MDR-TB • The number of pills to be swallowed – not more two • They should be compatible with ARVs currently used or to be used in future • Well tolerated even on an empty stomach • Few serious side effects

8. Desired characteristics new TB regimen -2 • The drugs should not require air-conditioning or a cold chain system • They should have a long shelf life (not less than two years) under room temperature and high humidity • They should be affordable by the government of the country – ideally equal to or below the price of current products (about $10 per patient) • The packaging should be robust, waterproof, light but not bulky • The drugs should also be safe for children use

9. Proposed steps to adopt new TB regimens at country level -1 • Advocacy at all levels by NTP • Orienting key decision makers at national, regional and district levels on new regimens • Advocacy to include the new regimen into the essential drug list • Ensure new regimen is reflected in government budget • Sensitise key private providers and other stakeholders on the need to change drug regimen

10. Proposed steps to adopt new TB regimens at country level - 2 • Strengthening public – private mix to improve coverage • Involve faith-based providers and private for profit • Ensure same regimens in private sector as in public to minimise resistance by providing them with drugs • Same TB drug management policy guidelines in public and private sectors • Training health care workers – in public and private sectors • Reinforce prescription of anti-TB regimen by trained personnel

11. Proposed steps to adopt new TB regimens at country level - 3 • Logistics and drug management issues • Strengthen NTP capacity to estimate drug requirements: running and buffer stocks • Availability of a modern drug procurement, storage and distribution system from national to district levels • Effective clearance and forwarding system to avoid unnecessary delays at port of entry • Decentralised and appropriate storage at district level • Monitoring and accountability at all levels – stocks, ledgers, security

12. Proposed steps to adopt new TB regimens at country level - 4 • Quality of new regimen • All new drugs have to be registered with the National Drug Regulatory Authority to ensure that the source of drugs is GMP compliant • Checking quality of drugs after entering into the country • Having a mechanism for continuous market surveillance of the circulating products • Having capacity to track information relating to the products - batch number, expiry dates, manufacturer and place of issue • Establish mechanism for surveillance of side effects

13. Proposed steps to adopt new TB regimens at country level - 5 • Orienting health care providers and patients: • There should be appropriate national policy manuals, guidelines and training manuals for health providers • Updated tools for recording: registers and forms • Training health care workers on new regimens • Establish mechanism for supportive supervision and on-job training on new regimens • Provide opportunity for health workers to share experiences • Document best practices

14. Proposed steps to adopt new TB regimens at country level - 6 • Patient education and community awareness • Raise community awareness on new regimen through mass media, world TB day, local theatres • Educate patients on change of regimen and advantages – mass media, IEC materials for patients and treatment supporters • Establish peer support groups at community level

15. In conclusion • New TB treatment regimens are overdue • The Global Alliance for TB drug development provides a unique opportunity to usher in newer drugs and regimens through public private mix • Resource-limited countries especially in Africa should start creating conducive environment for the proper use of the new TB regimens • Encourage production of generic drugs to reduce prices • There should be mechanism to support local production of new regimens as part of technology transfer

16. Thank you all for your attention