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TB and HIV – A Tale of Two Epidemics

TB and HIV – A Tale of Two Epidemics. By Mark Harrington Treatment Action Group OSI Public Health Watch /TAG TB/HIV Orientation Workshop Istanbul, Turkey 25-28 September 2006. Treatment Activist Theory & Practice (I). Policy change should be based on rigorous science;

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TB and HIV – A Tale of Two Epidemics

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  1. TB and HIV – A Tale of Two Epidemics By Mark Harrington Treatment Action Group OSI Public Health Watch /TAG TB/HIV Orientation Workshop Istanbul, Turkey 25-28 September 2006

  2. Treatment Activist Theory & Practice (I) • Policy change should be based on rigorous science; • The HIV and TB epidemics have a strong political dimension; • Human rights, public health, and social justice all demand a more comprehensive response to the HIV and TB epidemics worldwide; • Understanding that the political economy of health and research at the global and national levels is crucial to making headway…

  3. Treatment Activist Theory & Practice (II) "Engaging informed community advocates and civil society organizations at local, national, and global levels is essential to unlocking the resources needed to transform health and research systems, and to discover, develop, and disseminate life-saving health technologies such as antiretroviral therapy and better TB diagnostics and treatment combinations to all who need them." - Zackie Achmat, "Science & Social Justice," 36th IUATLD keynote, 2005

  4. Structure • Science background: TB and HIV • TB and HIV in Africa: A high-burden region • What’s new in TB control: The Global Plan to Stop TB 2006-2015 and the TB/HIV Collaborative Activities IV. Why massive investment in research is needed to stop TB

  5. I. TB – Science Background • 2 billion people are infected with M. tb • 9 million new active TB cases a year • 2 million people die a year • ~ 400,000 cases of MDR-TB a year • 12 million persons are TB/HIV co-infected • Biggest killer of women of childbearing age

  6. Epidemiology – TB & HIV – the Old & the New TB • Very old disease (>1My) in humans • 1/3 world population (2B people) have latent TB infection (LTBI) • 20M people living with TB disease • 8M new TB disease cases/y • 1.8M people died of TB in 2004 HIV • Young disease in humans (1933/1959) • 40 million living HIV+ people (27M have died of AIDS) • 6M+ people with AIDS (serious clinical HIV disease) • 4.5M new HIV infections in 2004 • 3.1M people died of AIDS in 2004

  7. TB – Transmission & Natural History • TB is caused by bacterium, Mycobacterium tuberculosis • TB spread by catching it by droplets coughed in the air from people with pulmonary TB (83% smear positive, 17% smear negative) • Primary TB disease can be disseminated (throughout the body) and kills infants and young children rapidly • In most people, TB infection becomes latent (LTBI); only 5-10% will develop TB disease over their lifetime. • But among people with HIV and LTBI, up to 5-10% may develop TB disease each year. • TB accelerates HIV disease progression and HIV accelerates TB progression.

  8. Different Kinds of TB Disease • Primary TB – disseminated (throughout the body), miliary • Pulmonary TB – in the lungs – – Sputum smear positive (detected by sputum smear microscopy) – 40-60% of cases are SS+, which is the most infectious kind of TB – Sputum smear negative (not detected by microscopy, less but still infectious, lower MTB load in lungs) – is slower and less infectious among HIV-negatives, but can be faster and more fatal among HIV+. Can be detected clinically or by sputum culture. • Extra-pulmonary TB – outside of the lungs – can be in any part of the body – TB meningitis (around the brain); pleural TB (fluid around the lungs); lymphatic TB (lymph nodes), bones, other organs.

  9. TB – Social & Historical Background • Close contact with people with infectious TB creates ideal conditions for its epidemic spread. In Europe during the Industrial Revolution in the 1800s, TB was the leading infectious killer, especially when people lived in closely crowded quarters with poor access to light, ventilation, nutrition, etc. Similar conditions now spread TB in resource poor settings around the world. • TB rates dropped in Western Europe, the US, etc., even before the discovery of TB, of BCG, or of TB treatment, because economic development, improved sanitation, and rising living standards made the population better able to contain TB. Some people who became sick with TB were able to overcome or contain the disease within their bodies.

  10. TB Science Background • MTB was discovered by Robert Koch in the 1880s. He isolated the MTB organism, proved it caused TB, showed how it was transmitted, and invented the most widely used diagnostic tests for TB – sputum smear microscopy for acid-fast bacilli (AFB), and tuberculin skin testing (TST). • In the 1920s French researchers developed the Bacillus Calmette-Guérin (BCG) vaccine, an attenuated MTB organism which can help protects infants and young children from disseminated, miliary, and meningeal TB, but does not protect adolescents or adults from pulmonary or extra-pulmonary TB.

  11. TB Drug Revolution (1940-1966) • In the 1940s researchers in the US, UK, and elsewhere discovered antibiotics drugs which could treat TB and could dramatically reduce disease and mortality. • At first these drugs – Streptomycin, Isoniaizid, etc. – were used alone, but used alone, MTB rapidly develops resistance to them, and people continued to die of TB. • When 2, 3, or 4 drugs were combined, however, MTB could not become resistant, and TB could be cured. • The combination of improved public health, widespread BCG vaccination, the introduction of anti-tuberculosis treatment (ATT), and isoniazid preventive therapy (IPT) for LTBI, resulted in dramatic global reductions in TB disease between 1940-1980.

  12. TB – Treatment Shortening • The last new TB drug class – the rifamycins – was introduced in 1966. • Studies done in India, Tanzania, and elsewhere, showed that TB treatment could be dramatically shortened (from 2 years to 6 months) using: • 2 months of a 4-drug combination called HRZE: • – Isoniazid H • – Rifampicin R • – Pyrazinamide Z • – Ethambutol E • Followed by 4-6 months of 2 drugs (RH or EH)

  13. Decay of TB control, Rise of AIDS, Introduction of DOTS • Short-term success with TB control using BCG, TB drugs, isoniazid preventive therapy, with other antibiotic “success stories” led to declining interest in infectious disease research and control. • From 1980 on, US, IMF, World Bank, and others supported policies which weakened health systems in developing countries. • HIV/AIDS exploded around the world from 1981. As the pandemic spread, TB came roaring back. • In 1991, there was an outbreak of HIV-related MDR-TB in New York City, which cost >$1B to contain. • Long-term treatment proved difficult without health worker supervision, which led to the “directly observed therapy short-course” DOTS approach endorsed by WHO in 1993, and now used in most countries.

  14. DOTS is Better, but still not Good Enough (I) • The first anchor of DOTS, political commitment, is weak in many countries, especially where health systems are weak. This is a political issue related to social justice. • The second anchor of DOTS, passive case finding by sputum smear microscopy, relies on patients to actively seek care at microscopy facilities, and cases ust be smear positive. 40-60% of TB cases, and even more among PLWHA and children, have smear negative TB. • The third anchor of DOTS is directly observed chemotherapy, short-course(HRZE 2 months, then HR 4 or EH 6 months) observed daily or 3 weekly. Direct observation is labor intensive for health workers and patients and disempowers the latter.

  15. DOTS is not Enough (II) • The fourth anchor of DOTS is an uninterrupted supply of high quality TB drugs. TB drug stock-outs are frequent. In 2005 there was a 6 month stock-out of TB drugs in Uganda – one of the more successful ARV scale-up countries. Political commitment, lack of economic resources, and weak health systems are not supporting strong TB control programs. • The fifth anchor of DOTS is accurate reporting and recording systems, but these systems do not capture smear negative, extrapulmonary, TB/HIV, MDR-TB, and pediatric TB. They do not measure political commitment or show when stock-outs occur. Finally, they do not involve patients and communities affected by TB in monitoring program success.

  16. No estimate TB Today: Current TB Cases Number of cases < 1 000 1 000 - 9 999 10 000 - 99 999 100 000 - 999 999 1 000 000 or more Infected – 2 billion Prevalent– 17- 20 million Incident – 8.4 million Deaths – 1.8 million

  17. II. TB and HIV in Africa • Weak health systems, poor political commitment, poverty, and global inequality make TB and HIV a deadly combination. • Africa is home to the most HIV+ people in the world (29 of 40 million). • Due to HIV, TB rates have come roaring back in Africa (rising 800% in some countries).

  18. % of people on ART among those needing it, December 2005

  19. % in sub-Saharan Africa on ART among those in need

  20. Where HIV rages, TB control is weak: Reported DOTS coverage, 2003 (WHO)

  21. III. The Stop TB Strategy, The Global Plan to Stop TB, TB/HIV Collaborative Activities • The new WHO Stop TB Strategy • The Global Plan to Stop TB: 2006-2015 • TB/HIV Collaborative Activities

  22. The Stop TB Strategy (2006) VISION: A WORLD FREE OF TB GOAL: To reduce dramatically the global burden of TB by 2015 in line with the Millennium Development Goals and the Stop TB Partnership targets OBJECTIVES - To achieve universal access to high-quality diagnosis and patient centred treatment - To reduce the suffering & socioeconomic burden associated with TB - To protect poor vulnerable populations from TB, TB/HIV and MDR-TB - To support development of new tools and enable their timely and effective use

  23. Stop TB Strategy Targets TARGETS MDG 6, Target 8 – ...halted by 2015 and begun to reverse the incidence... Stop TB Partnership targets linked to the MDGs: – by 2005, detect at least 70% of new sputum smear-positive TB cases, and cure at least 85% of cases – by 2015, reduce TB prevalence and death rates by 50% relative to 1990 – by 2050, eliminate TB as a public health problem (<1 case per million population)

  24. Stop TB Strategy Components 1. Pursue high-quality DOTS expansion and enhancement a. Political commitment with increased and sustained financing b. Case detection through quality-assured bacteriology c. Standardized treatment, with supervision and patient support d. An effective drug supply and management system e. Monitoring and evaluation system, and impact measurement 2. Address TB/HIV, MDR-TB and other challenges a. Implement collaborative TB/HIV activities b. Prevent and control MDR-TB c. Address prisoners, refugees and other high-risk groups/situations 3. Contribute to health system strengthening 4. Engage all care providers 5. Empower people with TB, and communities 6. Enable and promote research

  25. Global Plan to Stop TB 2006-2015 Goals • Expand equitable access for all to quality TB diagnosis and treatment • Treat 50 million people; save 14 million lives • Introduce first new TB drug in 40 years by 2010 (appears unlikely at this time). • Detect active TB disease with newdiagnostic tests at point of care for rapid, sensitive, inexpensive detection by 2010 (unlikely). • A new, safe, effective, affordable vaccine by 2015 (unlikely).

  26. GP2 Priority activities in Africa • Improve quality and access of DOTS TB services • Strengthen laboratory and diagnostic services • Address problem of human resources • Implement collaborative TB/HIV activities • Enhance community-based care • Public-private collaboration esp. in urban areas • Better coordination between TB programmes, antipoverty initiatives, health system strengthening.

  27. GP2 Expected effects in Africa • Africa high HIV • 14 million people treated for TB • 2.6 million people put on antiretroviral therapy (ART) • 18,000 treated for drug resistant TB • 3.8 million deaths will be averted • Africa low HIV • 2.9 million people treated for TB • 140,000 people put on antiretroviral therapy (ART) • 11,000 treated for drug resistant TB • 600,000 deaths will be averted

  28. Funding for Global Plan • $56 billion needed over 10 years, 2006-2015 • $28 billion for DOTS expansion • $6 billion for DOTS-Plus • $7 billion for TB/HIV activities • $3 billion for Advocacy activities • $3 billion for technical cooperation • $9 billion for research and development (R&D) • $25 billion likely available; gap = $31 billion • Africa needs the most investment • Africa high HIV : $15.8 billion (36%) • Africa low HIV : $3.6 billion (8%)

  29. Impact of GP2 in Africa In African countries with high HIV incidence, the GP2 estimates that ~14 million people will be treated in DOTS programmes and 18 000 in DOTS-Plus. 2.6 million TB patients will be enrolled on antiretroviral therapy (ART). The interventions will prevent ~3.8 million deaths.

  30. GP2 Funding for implementation

  31. Collaborative TB/HIV Activities A. Establish mechanisms for collaboration B. Reduce the burden of TB in PLWHA C. Reduce the burden of HIV in people with TB These should be included in TB control programs.

  32. GP2 TBHIV targets for Africa 2006 2010 2016 No. PWHA screened for TB (millions) 9.9 18 21 % PWHA screened for TB 63% 100%100% No. newly diagnosed eligible PWHA offered IPT (millions) 1.0 2.1 2.4 % PWHA offered IPT* 4% 8% 8% % TB patients in DOTS programmes HIV tested/counseled51% 85% 85% % HIV+ TB patients enrolled on ART45% 55% 59% * assumes IPT given pre-ART

  33. 12 Collaborative Activities A. Establish mechanisms for collaboration A1.Establish a joint national TB and HIV coordinating body including TB and HIV patient support groups; A2.Develop and implement a joint national plan; A3.Conduct HIV surveillance among TB patients, A4.Establish a system of monitoring and evaluation (M&E). B. Reduce the burden of TB in PLWHA B1.Intensified TB case-finding and joint referral systems; B2.Provide isoniazid preventive therapy (IPT) for PLWHA. B3.Ensure TB infection control in health care and congregate settings. C. Reduce the burden of HIV in TB patients C1.HIV testing for all TB patients when HIV prevalence exceeds 5%; C2.Provide HIV prevention services including harm reduction measures. C3.Provide cotrimoxazole preventive therapy (CPT) to HIV+ TB patients; C4.Provide antiretroviral therapy (ART) to TB patients with HIV; and C5.Provide care and support services to TB patients with HIV.

  34. TB/HIV targets in Africa's common position for Universal Access iv. At least 80% access of those in need, particularly children, have access to HIV/AIDS treatment, especially antiretroviral, as well as care and support. v. Enable at least 80% of HIV patients to benefit from care and assistance, including treatment of opportunistic diseases as well as accompanying psychosocial care. xiv.100% of all clients accessing HIV care and support services are screened for TB to ensure early detection and treatment xv. 100% of TB patients have access to HIV testing and counseling services xvi. 100% of HIV-positive TB patients access antiretroviral treatment” – Africa’s Common Position to the High Level Meeting of the UN General Assembly Special Session on AIDS (June 2006), Abuja AU Summit on ATM, Abuja, Nigeria, 2-4 May 2006, www.africa-union.org

  35. TB in Africa: Opportunities,challenges, & change in the era of ART • "TB control in Africa has yet to adapt to the new climate of ARV availability." • "A commitment must be made to prioritise smear-negative disease and lower the threshold for starting ATT." • "Culture outperforms other investigations for early HIV-related TB and could be used to screen at HIV diagnosis & before starting TB preventive tx." "Consider 2-line px for TB among HIV+ individuals on ART." • "The most frequently used ATT in Africa is an 8m regimen [with 6m EH] is INFERIOR to a 6m R-containing regimen. The 8m regimen should be phased out as soon as possible." • "[Despite 60-80% efficacy],IPT is little used." • Consider "fully integrated TB and HIV services." -- EL Corbett, B Marston, G Churchyard, K deCock, Tuberculosis in sub-Saharan Africa: opportunities, challenges, and change in the era of antiretroviral treatment, Lancet, 2006; 367: 926–37

  36. Managing HIV + TB in SSA • Embed HIV parameters in TB cohort reporting (e.g., in register and patient master cards); add columns for "N HIV tested, N HIV+, N on CTX, N on ART, [N on INH]"; • Rather than registering TB pts, giving ATT, and then referring pts for HIV T+C, see pt, complete master card, refer for T+C, review results, enter TB/HIV parameters into register, then administer ATT. • Enable pts to get ATT and ART from same clinic. Have an assistant TB officer join ARV clinic on clinic days and give ATT after ART. • Wherever an ARV clinic is set up there should be a TB registration or treatment facility, and vice versa. -- AD Harries, M Boxshall, S Phiri, J Kwanjana,Managing HIV and tuberculosis in sub-Saharan Africa, Lancet 367, 3 June 2006

  37. ART unmasks MDR-TB as cause of death among HIV+ TB patients in rural South Africa • Characteristics of 50 HDR Cases: • Pulmonary TB – 62% • Previous hosp – 56% • Previous Hx of TB – 36% • HIV+ – 98% • CD4 – 71/mm3 • On ART – 30% • HDR deaths 42/50 (84%) • Median survival 25 days (IQR 11-136d) • 197/559 (35%) patients Culture-Positive for M.tb • 118/197(60%) MDR • 50/197 (25%) HDR • 16/18 (89%) HDR genetically identical by spoligotyping • IMPLICATIONS: • MDR & HDR TB are under recognized causes of death among HIV/TB + patients in KZN • Both nosocomial and community recent transmission likely • Urgent need to improve laboratory capacity • Improve infection control strategies requid • -- A Moll, N Gandhi, R Pawinski, et al., Identification of a Multi-drug-resistant Tuberculosis Cluster as a Cause of Death among HIV-co-infected Patients in Rural South Africa abs. 795, 13th CROI, Denver, 2006

  38. TB/HIV in UNGASS review targets 33. Emphasize the need for accelerated scale-up of collaborative activities on tuberculosis and HIV in line with the Global Plan to stop TB 2006-2015 and investment in new drugs, diagnostics and vaccines appropriate for people with TBHIV co-infection; 38. Pledge to provide the highest level commitment to ensure that costed, inclusive, sustainable, credible and evidence-based national HIV/AIDS plans are funded and implemented with transparency, accountability and effectiveness, in line with national priorities; 49. Commit to set in 2006, through inclusive, transparent processes, ambitious national targets, including interim targets for 2008 … that reflect the commitment of this Declaration and the urgent need to scale up significantly towards the goal of universal access to comprehensive prevention programmes, treatment, care and support by 2010… -- UNGASS Political Declaration, 2 June 2006

  39. IV. Without New Tools We Cannot Stop TB • BCG prevents primary TB in infants and children, but not pulmonary TB in adolescents or adults. • BCG may be unsafe for HIV+ children. • Smear microscopy fails to diagnose TB disease in 2/3 of PLWHA, most children, and many other people with TB. • Even “rapid” culture is too slow (14 days) and too expensive (>$30K/machine) for use in resource poor and rural primary care settings. • 6 month DOTS takes too long. • Rifampicin (rifampin) has drug interactions with nevirapine or with protease inhibitors (PIs). NVP is the most common first-line ARV anchor drug; PIs will be the essential anchor drugs for 2nd line ARV therapy.

  40. Global Plan 2 Goal: 50% reduction in incidence, prevalence and death by 2015 vs. 1990 • Activities • 50M patients treated with DOTS • 800,000 treated for MDR TB • 140M people with HIV screened for TB • Outcomes • 14M lives saved • Halve global incidence, prevalence, deaths by 2015 • Cost • Control: $46 billion/10 years ($29B gap) • Research: $9 billion/10 years ($6.1B gap)

  41. But – In the Long Run, Stop TB’s Global Plan is Unrealistic 1600 • Because of obstacles: • Impact of TB/HIV (and MDR TB) • Ineffective vaccine • Use of insensitive diagnostic test • Patient adherence with protracted therapy 1400 1200 1000 Incidence/million/yr 800 600 400 200 0 1990 2000 2010 2020 2030 2040 2050

  42. Limited Antiquated Interventions… Vaccination 1929 Diagnostics 1882 Drugs 1960’s Isoniazid Preventive Treatment for TB/HIV co-infected

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