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Access to TB Drugs and Diagnostics Gregg Gonsalves Open Society Foundations Division of the Epidemiology of Microbial Diseases, Yale School of Public Health Department of Global Health and Social Medicine, Harvard Medical School The global TB situation Estimated number of cases, 2010 All forms of TB 8.8 million (8.5–9.2 million) HIV-associated TB Multidrugresistant TB Estimated number of deaths, 2010 1.1 million* (0.9–1.2 million) 1.1 million 350,000 (1.0–1.2 million) (320,000–390,000) ~ 650,000 out of 12 million (11-14 million) prevalent TB cases * Excluding deaths attributed to HIV/TB Source: WHO Global Tuberculosis Control Report 2011 (www.who.int/tb/publications/global_report/2011/gtbr11_full.pdf) TB Incidence Rates - 2009 0–24 West Pacific 20% 25–49 Americas 3% 50–99 100–299 >300 No estimate Per 100 000 population Africa 30% SE Asia 35% East Mediterranean 7% Europe 4% •Highest burden in Asia (55% of 9.4 million cases) •Highest rates in Africa, due to high HIV infection rate ~80% of HIV+ TB cases in Africa Impact of HIV on TB in Africa •79% of all TB/HIV cases world-wide are in Africa •50% of all TB/HIV cases world-wide in 9 African countries •23% of the estimated 2 million HIV deaths due to TB Notified cases per 100,000 pop. 1980-2008 Time trends in MDR-TB Available data from 74 countries and territories with measurements for at least two years could not answer the question of whether the proportion of previously untreated TB cases with MDR was increasing, decreasing or stable over time at a global or regional level. Proportion of MDR among new TB cases Latest available data, 1994-2010 0-<3 3-<6 6-<12 12-<18 >18 No data available Subnational data only The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. WHO 2011. All rights reserved Proportion of MDR among previously treated TB cases Latest available data, 1994-2010 0-<6 6-<12 12-<30 30-<50 >50 No data available Subnational data only The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. WHO 2011. All rights reserved Countries that had reported at least one XDR-TB case by Oct 2011 Argentina Armenia Australia Austria Azerbaijan Bangladesh Belarus Belgium Benin Botswana Brazil Burkina Faso Bhutan Cambodia Canada Chile China Colombia Czech Republic Dominican Republic Ecuador Egypt Estonia Japan France Kazakhstan Georgia Kenya Germany Kyrgyzstan Greece Latvia India Lesotho Indonesia Lithuania Iran (Islamic Rep. of) Mexico Ireland Mongolia Israel Mozambique Italy Myanmar Namibia Nepal Netherlands Niger Norway Pakistan Peru Philippines Poland Portugal Qatar Republic of Korea Republic of Moldova Romania Russian Federation Slovenia South Africa Spain Swaziland Sweden Tajikistan Thailand The Former Yugoslav Republic of Macedonia Togo Tunisia Turkey Ukraine United Arab Emirates United Kingdom United Republic of Tanzania United States of America Uzbekistan Viet Nam Treatment Evolution for “Drug Sensitive” TB 1950 1960 1946 Streptomycin 1st used for TB 1952 1970 1963 Rifampin 1970 1st regimen: • Streptomycin • PAS • Isoniazid (H) (R) discovered BMRC Trials add R 1961 Ethambutol (E) discovered 1954 Pyrazinamide (Z) discovered – but liver toxicity 1980 2005 1974 1998 BMRC Trials add R & Z Rifapentine approved Standard Therapy 2 months: R, H, Z, E + 4 months: R, H Standard Regimen by 1960s based on 1952 drugs Rx shortened to 6 months Rx shortened to 9 months Rx lasts from 12-24 months 9 The Burden of Therapy for Multi-drug Resistant TB Example of a typical regimen for MDR-TB •Intensive phase of 6-9 months – aim to directly observe 6 days/week: – Six drug combination, one given by injection •Continuation phase of 18 months: – Four drugs •A patient may need longer therapy if sputum is not clear of TB at month 4 Note: If the patient has HIV, he/she may need to take 3 additional anti-retroviral drugs 1 The Burden of Therapy for Multi-drug Resistant TB • The price of four medicines in particular weigh heavily in the overall cost of a DR-TB regimen. Overall costs of the DR-TB regimen are particularly driven by capreomycin, moxifloxacin, PAS, and cycloserine. • For most DR-TB drugs, patents are not typically a factor in causing high prices, because the medicines were developed so long ago that patents on most have long run out. However, moxifloxacin is a notable exception—until now, Bayer’s monopoly has kept prices high. • Some DR-TB drug prices have increased considerably between 2001 and 2011, including for the medicines procured through the GDF for GLC-approved treatment programs. This is true of the prices of amikacin (the most affordable source in 2011 costs eight times more the most affordable source in 2001), kanamycin (six times more), cycloserine, and capreomycin (both three times more). 1 MDR-TB Drug Prices Current TB Therapy and Unmet Needs Patient Population Current Therapy Unmet Needs Drug-Susceptible TB 4 drugs; ≥6 month therapy Shorter, simpler therapy Drug-Resistant M(X)DR-TB Few drugs (including injectables); ≥18 months therapy; toxicities Totally oral, shorter, more efficacious, safer and lower cost therapy TB/HIV Co-Infection Drug-drug interactions with HIV medications Ability to co-administer TB regimens with ARVs Latent TB Infection 6-9 months of treatment Shorter, safer therapy 4 drugs; ≥6 month therapy Shorter, simpler therapy with pediatric-friendly dosing Children ► Significant improvements in therapy are needed for all patient populations 1 The Global TB Development Pipeline From the Stop TB Partnership Working Group on New Drugs 14 Tuberculosis Diagnosis: Then and Now The Future of TB Diagnostics Xpert MTP/RIF – Xpert MTB/RIF : • Level of the Health system: Peripheral laboratory, at district and sub-district level (intended for use in secure facilities with a reliable source of electricity) • For LICs and MICs FIND negotiated a 75% reduction relative to the market price: • $16.86 per cartridge • $17,000 - $17,500 per Instrument • But • Not the POC diagnostic that is needed. The TB Test We Need • Point-of-care: easy to perform in peripheral health centres • Detect active TB in adults regardless of HIV status • Improved diagnosis of TB in children • Result that allow decision on treatment initiation • Patient can receive result on the same day Intermediate level Lab Peripheral level 2007 2008 10-40% 70% 95% 2009 Abbreviations DST: Drug susceptibility test NAAT: Nucleic acid amplification test LTBI: Latent TB infection POC: Point of care MODS: Microscopic observation drug-susceptibility NRA: Nitrate reductase assay CRI: Colorimetric redox indicator assay LED: Light-emitting diode LPA: Line probe assay 2010 2011 2012 2013 2014 2015 2016 Technologies or methods endorsed by WHO Technologies at late stages of development Technologies at early stages of development % Access after 5 years Distance from Patients Reference level Tonight! From 7-8PM Meet in Hotel Lobby (with guest Salmaan Keshavjee, Harvard Medical School/Partners in Health) Let’s Start a Campaign to Drop the Price of MDR-TB Drugs!
