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1 Printing Special The PARTNERS Report on MDR-TB Treatment ANNIVERSARY Half of his family died from TB but Joel has survived the disease because of an affordable new treatment. The message is hope.

2 325 Swanton Way Decatur, Georgia, USA As the coordinating body for the PARTNERS Project, The Task Force for Global Health was responsible for production of this report. It was written in , and printed by The Task Force for Global Health in October The Task Force for Global Health Contributors included: Writers: Editors: Photographers: Graphic Designer: Creative Director: Pranay Ranjan, Alan Hinman, Margaret McIntyre Katie Baer, Debbie Horvitz, Julie Rosenberg Mark Rosenberg, Margaret McIntyre, Chip Simone Cathey Oldroyd Mark Rosenberg

3 Partners National TB Control Program Ministry of Health, Lima, Peru Partners in Health and Socios en Salud Boston, Massachusetts, USA and Lima, Peru The Task Force for Global Health Decatur, Georgia, USA US Centers for Disease Control and Prevention Atlanta, Georgia, USA World Health Organization Geneva, Switzerland Acknowledgements Our deepest, heartfelt thanks go to the patients and their families who shared their stories of struggle and strength with us and whose experiences inform and shape this work. None of the work would have been possible without the devoted community health workers and the dedicated staff who delivered care on the front lines. Thank you to the Peruvian Ministry of Health for the invaluable human and material resources and for believing in and supporting a new approach to MDR-TB. Partners in Health and Socios en Salud staff, including nurses and physicians, were there supporting the project and the patients throughout. The US Centers for Disease Control and Prevention and the World Health Organization provided valuable technical and scientific support and a voice for patients in the global policy arena. The Bill & Melinda Gates Foundation trusted in this work and the goal of social justice enough to provide unprecedented levels of financial support. A special thank you to: Roberto Accinelli, Jaime Bayona, Katie Baer, Mercedes Becerra, César Bonilla, Roberto Canales, Ken Castro, Peter Cegielski, Nicholas DeLuca, Marcos Espinal, Paul Farmer, William Foege, Hamish Fraser, Jennifer Furin, Howard Hiatt, Alan Hinman, Debbie Horvitz, Keith Joseph, Salmaan Keshavjee, Kayla Laserson, Evan Lyons, Jim Kim, Edward Nardell, Margaret McIntyre, Carol Mitnick, Joia Mukherjee, Cathey Oldroyd, Pranay Ranjan, Mario Raviglione, Lee Reichman, Michael Rich, Julie Rosenberg, Rocio Sapag, KJ Seung, Sonya Shin, Chip Simone, Peter Small, Sally Stansfield, Pedro Suarez, Eduardo Ticona, Luis Zavala, Paul Zintl and countless others who helped and remained committed to this project throughout as well as those who continue to build on the work that was done. Don Berwick, Llyod Provost, Judy Provost and the staff the the Institute for Healthcare Improvement provided valuable guidance on management systems and project planning and continuous improvement. 1

4 The Report on MDR-TB Treatment Table of Contents Preface 3 Thoughts 4 Foreword 5 Introduction 7 Chapter One: The Ever-Growing Threat of MDR-TB 13 Chapter Two: Global Efforts 23 Chapter Three: Peru and The PARTNERS Project 31 Chapter Four: Controlling MDR-TB in Other Countries 53 Joel A Photodocumentary 60 Chapter Five: Research 91 Chapter Six: Challenges 99 Chapter Seven: Recommendations 111 Afterword 116 Abbreviations Used 117 References 118 2

5 Preface Preface The PARTNERS TB Control Program accomplished perhaps the most important thing we can hope to accomplish in global health: it won a victory for humanity and made the world a better place for everyone. The effort began simply enough, with a vision and the visionaries. These two things were the most critical elements, the vision treating drug-resistant TB in resource-poor areas and getting the right people, working together and independently, in locations all around the world. Then, as I ve seen so many times in such earthshaking, conventionbreaking efforts, the rest of us must just get out of the way. The PARTNERS project has seen learning continue to occur and strategy develop over time. The trick was in choosing the objective and then recognizing that you would be changing strategy as you went forward. As a result a wonderful result instead of exporting a simple model, they exported an attitude that the desired results can be achieved. The PARTNERS project also served to unite many different threads. It was serendipitous that so many things started happening in multiple locations. Usually they don t get connected. But the partners in this project were smart enough to link all these pieces together. We know we can do better together than we can do separately. We help our own peoples, our own countries by being globalists, by learning from and with others. Einstein reminded us that Nationalism is an infantile disease. He called it the measles of mankind. We have learned that strengthening our ability to solve disease problems involves the paradox involved in strengthening ourselves that is, our independence as both people and countries is achieved through consenting to interdependence. As Gandhi said, if we understand that, we will pursue interdependence with the same zeal that we show when pursuing self-reliance. Having worked on treating MDR-TB should make us a lot more humble in our approach to other diseases. The time and energy that people have wasted in arguing over the right approach could have gone into saving so many lives. There is a lesson here. In talking about TB or AIDS, you have to do treatment in order to prevent disease. But what frequently happens is that treatment absorbs all the emotional energy of both patients and healthcare personnel. This MDR-TB project helped people to stand back and look at various approaches, to use unique resources and to adapt. We have to be very careful that we are not so successful in treatment that we fall behind on prevention. One secret to successful coalitions is to make the last mile absolutely clear. For some things, this is easy. For disease eradication smallpox and polio or if you re running the International AIDS Vaccine Initiative (IAVI) program, you know the last mile has to do with developing a vaccine. For political campaigns, people see the election of a person as the last mile. But after defining the last mile, one has to figure out the first mile. How do we get started? You can t figure out that first mile until you ve identified the last mile. We seek social justice in health. It is our work foundation, our professional creed, our reason for holding the positions we hold. There will be a moment when the phrase, The world cannot be allowed to exist half healthy and half sick, goes from being a nice statement to an actual commitment. A moment when there is no turning back and the world, in the words of Toynbee, dares to think of the health of the whole human race as a practical objective. That moment could come at any time in the future, but it might just as well come today. It will require us to give new attention to accumulating data, identifying gaps, evaluating interventions, and always emphasizing outcomes. There are pioneers helping to blaze this trail. The Bill and Melinda Gates Foundation, along with Rotary International, has totally changed the paradigm for global health. We ve gone from what can we do with what we have to what will it take to do what needs to be done as partners with government, the private sector, and NGOs. When Bill Gates was asked how it matters to an American what happens to someone else in another country, he said that you do something because this is the right thing to do. There is something better than just global health. Global health is not our last mile. It is not just how do we improve global health, but how do we enhance civilization? How do we enhance the way we treat each other? We have much left to do. William H. Foege, MD, MPH The Task Force for Global Health, Founder Bill & Melinda Gates Foundation, Senior Adviser 3

6 The Report on MDR-TB Treatment Thoughts from Project Leaders (2007) The valuable financial and technical support we received through the PARTNERS project helped us accomplish what many would have considered a mission impossible in the fight against MDR-TB. Additionally, I must acknowledge the extraordinary contributions made by the health promoters, the members of the community. Their genuine commitment and solidarity towards their neighbors affected by this terrible disease have formed a key weapon in this fight. They are pioneers, accompanying patients day to day, encouraging them to not abandon treatment, and identifying and helping satisfy their most urgent needs. Their tireless patience and cleverness, working to overcome the obstacles, has been an unforgettable lesson to me. Jaime Bayona, MD, MPP Socios En Salud (SES), Lima, Peru The PARTNERS project was truly a labor of love for all of us who were lucky enough to have participated. A commitment to treating MDR-TB is by necessity a commitment to the poorest and most marginalized people on the planet. Now, as MDR-TB emerges as a major threat to the millions living with HIV in Africa and elsewhere, the global community can take some comfort in knowing that the PARTNERS project has helped to identify the most effective treatment regimens, designed community based delivery models, helped shape policy and prepared the way for a much more aggressive assault on drug-resistant tuberculosis. We will be forever grateful to the Bill and Melinda Gates Foundation for giving us this opportunity. Jim Yong Kim, MD, PhD Brigham and Women s Hospital François-Xavier Bagnoud Center for Health and Human Rights, Department of Social Medicine, Harvard Medical School, Boston, Massachusetts, USA This was not an easy project, and we encountered strong opposition from outside forces and intense debates among ourselves, but what ultimately kept us together and provided the driving and sustaining force for our success was our common goal: to make available to even the poorest people in the poorest countries the treatment that could save their lives and cure their MDR-TB, because it was a treatment that the rich countries had and a treatment that the world could well afford. This goal of global health equity inspired us as individuals, mobilized our organizations, and helped to change the policies of the most important health bureaucracies in the world. We are grateful to all those who had faith in us and shared our goal. Mark L. Rosenberg, MD, MPP The Task Force for Child Survival and Development Decatur, Georgia, USA The MDR TB projects have provided a powerful proof of principle and thus enabled us to collectively overcome the impoverished will and resignation that plagued tuberculosis control in resource-limited settings. Both caretakers and affected persons now feel empowered to think boldly and expansively and to demand the resources necessary to benefit the individual and their communities. This win-win situation seeks optimal individual outcomes while simultaneously protecting effective tuberculosis treatment regimens for future generations. Ken Castro, MD National Center for HIV, STD and TB Prevention Centers for Disease Control and Prevention, Atlanta, Georgia, USA Never was a project more timely and with such an extraordinary historical importance. [The PARTNERS project] was timely, as it allowed a rapid transformation of a dream into reality: the Green Light Committee, just established with minimum finances by a group of friends, got the funding needed resulting in a true model in public health. It was historically important, as it proved that modern MDR-TB treatment in resource-limited settings was feasible. Today this is clear, but it was not at all five or six years ago. I truly loved this project, for it challenged the status quo: as a result, thousands of lives were, and will be, saved. Mario Raviglione, MD, FRCP The Stop TB Department, World Health Organization Geneva, Switzerland 4

7 Foreword Foreword The lessons learned in the fight against multidrugresistant tuberculosis (MDR-TB) are more relevant today than ever before. The emergence of a newly identified threat to tuberculosis control extensively drugresistant or XDR-TB has been reported in countries in every region of the world. Data from a rural community hospital in KwaZulu-Natal province in South Africa appears to confirm the worst fears: of 53 patients affected by XDR-TB, only one person survived, all others died within an average of 25 days. All those who were tested were HIV-infected, confirming the much feared convergence of the HIV epidemic with that of highly drug-resistant TB. The findings have prompted unprecedented media attention in Africa and globally. Journalists refer to the fear and awakening of a preantibiotic era in TB control. While most of the news reporting on XDR-TB has been accurate, some of it has been exaggerated by headline grabbing hyperbole. In spite of this, the international TB community must maintain a strategic and technically sound approach to identifying and treating this disease. Public health seeks to understand more and to explore emergency interventions that can save lives. As always in TB control, the efficacy of the approach to combat XDR-TB will be measured not by reactions to front-page headlines but by the intensity of the response and the cure rates. Our mandate at the international level is to seek to provide countries with the best recommendations and to support them in their attempts to implement complex interventions in the field. The experiences with MDR-TB of the PARTNERS TB Control Program and other DOTS-Plus projects have been invaluable and so can guide the global response to XDR-TB. The challenges around prevention, diagnosis, and treatment of drug-resistant TB are enormous, and in the case of XDR-TB even more so. Although our knowledge of the extent of XDR-TB is still limited, it is likely to be a global phenomenon with foci in many settings. Therefore, we must fight this disease globally using a combination of prevention, diagnosis, and treatment to control it, and using country-led campaigns to raise awareness, resources and responses. The main target is to strengthen TB control in general, for this is the best way to prevent the onset of drug resistance, be it multi-drug or extensive drug resistance. At the same time, case management is fundamental for those who are already infected. We believe XDR-TB can still be cured, though in most cases it will be extremely difficult. Thus, we need to put in place the best practices for treatment success. We must examine closely where there have been positive results in the management of MDR-TB, such as in Latvia, Estonia, the Philippines, and Peru, countries whose experiences are profiled in this report. We also need to address the risks associated with poor infection control to prevent XDR-TB gaining ground in congregate settings. Good practices of infection control are ignored in most settings around the world. We need to guarantee protection through prevention to those most vulnerable, especially people living with HIV/ AIDS. This must be done without delay, everywhere. Further, we must fight not only the disease, but also the stigma associated with it. As pointed out in this report, we will not combat MDR-TB and XDR-TB (and tuberculosis in general, for that matter) successfully unless we also tackle stigma, ignorance, and fear. This must be done through information-sharing, public education, and effective communication strategies that have the right outcomes at all levels. We must also intensify resource mobilization, as MDR-TB and XDR-TB require additional resources often not foreseen in the modest national TB control budgets. We have then to revise (where necessary) the compelling argument for Stop TB stakeholders to implement and fund the Global Plan to Stop TB This is an absolute necessity if we are to prevent and cure drugresistant TB. The Global Plan is ambitious, with a target to treat more than 50 million TB patients and save millions of lives, but achievable. And the revised MDR-TB section of the Plan must be fully implemented to manage 1.6 million patients by 2015, given the additional, urgent threat of XDR-TB. Finally, we need to take a hard look at the agenda of TB research and development. We cannot afford failure and slow progress in this area. The emergence of XDR-TB has exposed us to the limits of current tools. We must have new rapid diagnostics, new drugs and new vaccines, and we must have them as soon as possible. When available they must quickly be made accessible to all, no matter who TB patients are or where they live. 5

8 The Report on MDR-TB Treatment All of these challenges are summarized in this report and also prominently featured in a document that has become the cornerstone of our work the new Stop TB Strategy, which calls for integration of activities relating to MDR-TB (and XDR-TB) and TB/HIV into all TB control programs. The Stop TB Strategy was launched with The Lancet in its World TB Day 2006 edition. The Strategy was developed over a two-year period alongside other key initiatives in public health such as universal access to HIV care and prevention. One approach cannot be complete without the other. Through the strengthening of TB control everywhere, through the full and high quality expansion and enhancement of DOTS as outlined in the 2006 Stop TB Strategy, we can strike a serious blow against one of the world s leading infectious killers and we can prevent further misery caused by the manmade failures that unleash TB drug resistance. This is the responsibility of everyone working in TB control today. Mario Raviglione, MD Director, Stop TB Department World Health Organization Geneva, Switzerland November

9 Introduction Introduction A New Twist on an Old Disease Tuberculosis (TB) had killed millions of people for thousands of years until treatments finally became available in the middle of the 20th century. (See Box 1 for an overview of TB.) No treatment had been accepted as the universal standard of care until the World Health Organization (WHO) endorsed the Directly Observed Treatment Shortcourse (DOTS) strategy in (See Box 2 for components of DOTS.) DOTS, a strategy in which healthcare workers supervise patients while they undergo a standard six-month treatment, brought hope to caretakers and patients alike. Patricia received DOTS treatment in Peru the same year that WHO endorsed the DOTS strategy. Two years later, at the time WHO recognized Peru for having one of the best national tuberculosis programs in the world, Patricia gave birth to her third child and relapsed with TB. Returning to her local health center, she received DOTS again but reacted differently to the medicines and suffered debilitating side effects. So that she could physically care for her three small children, Patricia temporarily stopped her treatment. Growing sicker by the day, she later returned to the health center and resumed her treatment. She stopped only when told that she had exhausted all of her treatment options and could not be cured. Patricia s strain of tuberculosis was resistant to the two primary drugs used in DOTS treatment, isoniazid and rifampicin, and so was identified as multi-drug resistant tuberculosis (MDR-TB). Although cases of MDR-TB were recorded around the globe, it was considered rare in the early 1990s. (Box 3 gives an overview of MDR-TB.) Healthcare professionals continued to recommend the standard DOTS treatment short-course chemotherapy with first-line drugs for all TB patients. The treatment failed for some patients, but treating these failures on a programmatic level would have required an enormous investment of money and supplies, as well as the development of a treatment protocol far more complex than DOTS. Realizing that DOTS was not a magic bullet for all patients was extremely difficult; its broad success had been an enormous victory in public Box 1 What is TB? Tuberculosis (TB) is a bacterial infection caused by the organism, Mycobacterium tuberculosis. Globally, 2 million people die from TB every year. Most commonly this bacterium infects the lung, giving rise to pulmonary tuberculosis (PTB). Infection with the organism does not always progress to disease. In the vast majority of cases, the infection is successfully countered by the body s immune response and does not progress to disease. In some cases however, the infection can lie dormant for several years before causing illness. Usually such a dormant infection surfaces when the immune system is weakened, either due to illness or old age. Infection with HIV is a common reason for activation of dormant TB infection. What are first-line drugs (FLDs)? The 5 main drugs used to treat drug susceptible tuberculosis are called first-line drugs (FLDs): Rifampicin Isoniazid Ethambutol Pyrazinamide Streptomycin health. Furthermore, many in the healthcare community believed that failed patients who developed MDR-TB did so because they did not adhere to their prescribed regimen. Treating a small number of patients who may have brought the disease upon themselves, they argued, was worth neither the resources nor the difficulties inherent in such a complex treatment. At this point, the science behind the development of the disease was not fully understood and, hence, it was determined that MDR-TB would not be treated in resource-poor countries. Patricia watched friends and neighbors die. When the doctors at the National Tuberculosis Program suggested 7

10 The Report on MDR-TB Treatment Box 2 What is DOTS? In 1995, WHO officially named Directly Observed Therapy Short-Course (DOTS) as the strategy for global TB elimination. Initially applied in 1991, DOTS was based on the short course chemotherapy that had long been used in various settings around the world. DOTS involves 5 components: Sustained political commitment to increase human and financial resources and make TB control a nation-wide activity and an integral part of the national health system. Access to quality-assured TB sputum microscopy for case detection among persons presenting with symptoms of TB, screening of individuals with prolonged cough by sputum microscopy and special attention to case detection among HIV-infected people and other high-risk groups, e.g. people in institutions. Standardized short-course chemotherapy to all cases of TB including direct observation of treatment; and proper case management conditions with technically sound and socially supportive treatment. Uninterrupted supply of quality-assured drugs with reliable drug procurement and distribution systems. Recording and reporting system enabling outcome assessment of each patient and assessment of the overall program performance. she invest in a coffin rather than in further health interventions, she worried that the end was in sight for her too. A Cure to Treat All Individuals Among those refusing to dismiss MDR-TB as untreatable in resource-poor countries were Paul Farmer and Jim Kim, two doctors from Harvard Medical School in Boston who were committed to making the highest quality of medical care available to the poor around the globe through the work of their non-profit organization, Partners in Health (PIH), established in Recognizing that WHO s DOTS solution was not the ultimate in TB control and disagreeing with a decision that, in essence, decreed that the poor did not merit expensive and difficult medical treatments, Farmer and Kim expanded their vision of a preferential option for the poor. Noting that people in the poor shantytown of Carabayllo, Peru, were not responding to TB treatment and dying from a treatable disease, the two PIH physicians joined with a doctor from Lima, Jaime Bayona, to establish Socios en Salud (SES), a community-based health clinic located in Carabayllo. They found that most of the patients who did not respond to DOTS treatment were infected with resistant strains of the disease, sometimes resistant to as many as 9 or more drugs. While some patients had strains that developed resistance over time as a result of multiple treatments, others had been directly infected with resistant strains. SES developed a system for treating Carabayllo s MDR-TB patients. Sputum samples from patients considered treatment failures were shipped to the Massachusetts State Laboratory Institute (MSLI), where experts identified which drugs would work on the microorganisms infecting each patient. SES then procured the drugs from Harvard Medical School (HMS) and established individualized treatment plans. Since many of the very powerful medications used to treat MDR-TB caused severe side effects, patients often felt worse once they began their new, individualized treatment. Furthermore, because they had been told by their local doctors that there was no cure for their disease, some patients did not believe in the new treatments that the foreign organization was offering. Aware of these concerns, the trained community health workers who were administering the medication, patient by patient, also provided psychological support. SES made financial and nutritional support available to patients to ensure that they were equipped with at least the minimal resources necessary for recovery and health. By 1998, only three years after SES was established, several patients were cured. SES had proven that this individualized treatment for MDR-TB was, indeed, feasible in a resource-poor setting. WHO named this treatment DOTS-Plus and organized a DOTS-Plus working group. (Box 4 explains the basics of the DOTS-Plus strategy.) The movement for change envisioned by Farmer and Kim was in motion. Beginning in 2000, several DOTS-Plus projects were established around the world. That same year, the still-small SES opened a clinic in Patricia s district of Lima. She was living in her parents home with her husband, three children, four siblings, and extremely damaged lungs after six years of TB. Hopeful that her illness would come to an end, she began the new treatment targeted specifically at her strain of TB. However treatment had come too late and, at 28 years 8

11 Introduction old, Patricia died. She had fought the disease, the drug side effects, the heavy stigma of carrying a deadly infectious disease, and the burden of poverty. By the time she died, the infection had spread to four of her siblings. Their awareness of DOTS-Plus and timely search for individualized treatment saved their lives. Reconsidering the Paradigm Joel s siblings were not as lucky as Patricia s. In 2000, the year Patricia began and ended individualized treatment, Joel s 17-year-old sister, Jonni, died suddenly from MDR-TB. His brothers, Moses and Marcos, were ill by the next year. At the time of their deaths, Moses was 27 and Marco, 32. Each had received DOTS, but none was cured. They did not know about drug-resistant strains and their disease advanced quickly. Living too far from SES or arriving for help too late, people in shantytowns like Carabayllo were continuing to die. As PIH and SES doctors shared their experiences, proving that poverty did not prevent MDR-TB from being cured, the global burden of the disease came to be recognized. Several groups joined together to advocate for immediate action against MDR-TB and to combat the threat it posed to future generations. In August 2000, the Partnership Against Resistant Tuberculosis: A Network for Equity and Resource Strengthening (PARTNERS) was established. PARTNERS members were the Peruvian National TB Control Program (PNCT), SES, PIH, WHO, the Centers for Disease Control and Prevention (CDC), and The Task Force for Child Survival and Development (Task Force). Funded by the Bill and Melinda Gates Foundation (Gates Foundation), PARTNERS aimed to develop a model for treating MDR-TB in a resource-poor country (Peru) and in an MDR-TB hot-spot (Tomsk, Russia). A further goal was to create global policies for MDR-TB based on research and programmatic findings. The project was funded for five years. WHO shifted its TB control strategies and became part of a team with a powerful philosophy about MDR-TB treatment to share and spread. Other alliances and committees formed as well. The Green Light Committee (GLC), for example, negotiated significant discounts in the prices of second-line drugs. The GLC also provided expertise for DOTS-Plus projects seeking technical assistance. Some drugs were reduced in cost by up to 99%, thanks to the GLC. Not only had MDR-TB treatment become feasible, it could be affordable. Box 3 What is MDR-TB? Multi drug-resistant tuberculosis (MDR-TB) is a form of tuberculosis in which the TB bacteria are resistant to the two main first-line drugs used to treat TB, Rifampicin and Isoniazid. It typically arises as a result of incomplete or inadequate treatment of drug sensitive TB (acquired resistance) but a person can also be infected with multiplyresistant bacteria (primary resistance). What are second-line drugs? Because of resistance to FLDs, MDR-TB requires a second set of drugs also known as secondline drugs (SLDs). The TB bacteria are much less likely to have resistance against these drugs. Amikacin Capreomycin Ciprofloxcacin Cycloserine Ethionamide Kanamycin Levofloxacin Ofloxacin Para-aminosalycylic acid Prothionamide Joel and his sister, Marlene, were among the estimated 273,000 MDR-TB cases in 2002; the number of cases was growing quickly. They started DOTS-Plus treatment with SES. Unfortunately, Marlene started too late and she died soon after. Having watched Marlene as well as three other siblings die within two years, Joel was depressed. Taking every dose of his medication, he tried to believe in a cure, but it was hard. The drugs exacerbated his depression and caused psychosis, nausea, and skin discoloration. His relationship with his girlfriend fell apart, as did his health. Despite his new college degree, Joel had to stop working, as did his father who became mentally ill after losing four children. Joel s mother supported the household, including her orphaned grandchildren, working every day in the market. The health promoters reassured Joel that the treatment would work if he stayed with his drug regimen, and he attended an SES patient support group. With lots of help, Joel pulled through. 9

12 The Report on MDR-TB Treatment Box 4 What is DOTS-Plus? The term DOTS-Plus was adopted by WHO in 1998 at a conference in Cambridge, Massachusetts, as a case management approach for MDR-TB. Since then DOTS-Plus pilot projects have been initiated in several countries and DOTS-Plus has come to encompass the following five principles slightly adapted from the principle of DOTS. Sustained political commitment that assures: long term investment of staff and resources; coordination of efforts between community, local governments, and international agencies; a wellfunctioning DOTS program; and prevention of the emergence of MDR-TB Diagnosis of MDR-TB through quality-assured culture and drug susceptibility testing; proper triage of patients into DST testing and the DOTS-Plus program; and relationship with Supra-National Laboratory Appropriate treatment strategies that utilize SLDs under proper management conditions; rational treatment design (evidence-based); directly observed therapy (DOT); monitoring and management of side effects; and adequate human resources Uninterrupted supply of quality-assured secondline anti-tuberculosis drugs Recording and reporting system designed for DOTS-Plus programs that enables program performance monitoring and evaluation of treatment outcome. As Joel began to recover, his mother fell ill, revealing the unyielding resilience of the TB bacilli. He risked reinfection in order to help her, even as he completed his own treatment. They survived together no longer infectious and able to move ahead with life and work. As people gain access to treatment earlier, the outcome improves. Over time the disease becomes more familiar to doctors and the stigma lessens. Esperanza and her husband represent two additional MDR-TB cases. When Esperanza s husband relapsed after completing DOTS treatment in 2001, doctors knew to prescribe DOTS-Plus treatment for him. Esperanza took a second job to provide food for the family while her husband was treated. A 29-year-old mother of four, Esperanza lived in a small, two-room house with a dirt floor, but she trusted the treatment and believed her husband would recover. Before long, however, she became ill with TB. After three months of first-line treatment with no improvement, Esperanza began DOTS-Plus. She stopped working while she was contagious and received some financial help from SES. Her primary worry was her children. Esperanza and her husband gained strength and grew closer by sharing their experiences. They believed in the treatment and the SES health workers who visited daily as the couple struggled through the disease that exacerbated the hardships of poverty. After two years of treatment, both were cured and able to raise their children in a stronger, happier family. The Paradigm Change in TB Control Until the late 1990s, virtually nothing was known about MDR-TB. No initiatives or guide-lines for its prevention and treatment in resource-poor countries were in sight; there were no public health programs or policies; only a few parts of the world had been surveyed; scarcely any research existed. In fact, experts doubted the transmissibility and resiliency of MDR-TB and questioned whether it was a threat at all. The research and clinical work performed by the PARTNERS TB Control Program and other DOTS-Plus projects have erased that doubt. Over 100 DOTS-Plus programs around the world are now treating families and saving lives in small shantytowns like Esperanza s that a few years ago would have left children, like Patricia s, orphaned. In 2002, the year after WHO first published guidelines on the programmatic management of MDR-TB, the disease s global incidence was estimated to be 273,000. Four years later, that estimate was revised upwards to 423,000, showing that the disease was a bigger problem than previously acknowledged. The exploding HIV epidemic also has brought attention to MDR-TB because concurrent infection increases its spread. Publicity also surrounds recent information about the potentially lethal co-existence of HIV/AIDS and extensively drug-resistant TB (XDR-TB). WHO revised its MDR-TB management guidelines in 2006 and now recommends that programs to control MDR-TB be integrated within all TB programs around the world. WHO set specific objectives in the second Global Plan to Stop TB and brought this enormous public health 10

13 Introduction problem into the world s consciousness. This sea change regarding drug-resistant strains of TB is a result of the dedication of so many people who, in addition to saving lives, have helped bring attention to the disease, which, in turn has enhanced funding to control and prevent it. PARTNERS TB Control Program s Role in the Change While numerous people around the world deserve credit for the successes achieved thus far in controlling MDR-TB in resource-poor countries, this report focuses on the work of the PARTNERS TB Control Program. This report documents the stages and phases of the major paradigm change in TB control over the last decade and especially between 2000 and 2005, when the PARTNERS group was active. It is the story of the group that galvanized efforts and helped prove to the world that MDR-TB is curable, even in resource-poor nations. Its members commitment to bringing first rate medical care to impoverished patients has inspired the initially reluctant public health world to change its view and save lives everywhere. Challenges remain for future leaders, and we hope that this report also helps policy and healthcare funding leaders understand the threat that MDR-TB poses to the world and can build upon these past successes. Furthermore, this report can be a tool for those with visions like Farmer and Kim; we hope it serves as a road map for those who are inspired to organize their own project or to take action with people locally to bring about a higher quality of life. Above all, the report aims to show that we can bring to poor places and poor people the same opportunities for good health that we bring to people in richer countries. Demonstrating the feasibility of global health equity was as central to this project as demonstrating the effectiveness of DOTS-Plus as a treatment for MDR-TB. This report records the evolution of the struggle that motivated WHO, among other organizations, to reverse its strategic position on MDR-TB and agree to treat the disease in resource-poor countries. The Task Force, as a member of the PARTNERS Project, has accepted the responsibility and challenge of documenting this powerful story that summarizes what was accomplished with the support of the Gates Foundation. While this report addresses global policy makers on TB control, funding organizations, leaders of national tuberculosis programs, and other institutions directly concerned with TB, it will, we hope, be instructional and inspirational to those unfamiliar with tuberculosis who will, we think, be interested in its broader aspects, such as working within a coalition that is forging a new path, establishing effective programs, contending with adversity, and accommodating to enormous cultural differences. If this report engages anyone in the movement for social change and universal MDR-TB treatment, it will have proven successful. The PARTNERS Report The chapters that follow will explain what the global community needs to do to meet the goals of the second Global Plan for TB control. Chapter 2 discusses how the threat of MDR-TB has increased over the past few years and Chapter 3 traces the global efforts to tackle it. Chapter 4 describes how DOTS-Plus has been implemented in several countries and how each pilot project has influenced global policy. Since Peru was the initial site for DOTS-Plus, as well as a primary focus for the PARTNERS Project, Chapter 5 is dedicated to the experience there. Chapter 6 discusses what has been gleaned from targeted research, including the tremendous advances in science resulting from investigations and studies conducted in Peru and elsewhere. And, the report closes with a compilation of the challenges we face along with recommendations for immediate and long-term action. Throughout the report, we have included photographs and quotations from three Peruvian patients Patricia, Esperanza, and Joel, already introduced. We got to know them well over the years as they shared their stories with us. They volunteered to participate in this photo documentary to give voice to all patients affected by MDR-TB those who are undergoing treatment now, feeling sick from the medication every day, and those who continue to suffer without access to care. The patient s family members speak for families that can no longer speak for themselves, some still struggling with the disease and others that have been cut in half. The photos of the children represent our hope that future generations will know about this disease only as a piece of past history if we all continue to do our parts to bring about change. 11

14 My biggest fear is that my children will come down with TB. We have to take care of them, lots of care. Esparanza, MDR-TB patient

15 The Ever-Growing Threat of MDR-TB Chapter One The Ever-Growing Threat of MDR-TB Through the efforts of many organizations and dedicated individuals over the past seven years, we have learned much about the origin, distribution, diagnosis, treatment, and prevention of MDR-TB. The most significant finding is that it is a far more serious and pervasive threat than previously realized. Already wide-spread and increasingly recognized are even more highly resistant strains, called Extensively Drug Resistant TB (MDR-TB), resistant not only to the two most important first-line anti-tb drugs but also to any fluoroquinolone and at least one of three injectable second-line drugs (capreomycin, kanamycin, and amikacin). Furthermore, MDR-TB poses a grave threat when it occurs in persons with HIV/AIDS. Our research affirms that controlling MDR-TB demands a still greater investment of time, resources, and dedicated effort. Today we are treating less than 2% a of the cases that occur each year. The Global Plan to Stop TB calls for immediate and considerable expansion of programs over the 10-year period. However it is likely that at the end of the period too few new incident cases will have been treated. MDR-TB Is More Widespread than Previously Thought Latest Estimates of Incidence Are Significantly Larger than Previous Estimates In 1994, the World Health Organization (WHO), the International Union Against Tuberculosis and Lung Diseases (IUATLD), and other partners began the Global Project on Anti-Tuberculosis Drug Resistance Surveillance, which has published three reports over the last 10 years, including one in March Based on the collected data, estimates of the global burden of MDR-TB have regularly been revised upwards. In 2002, the estimate of new cases was 273,000, while in 2006 the total estimated number grew to 424, One explanation for the increase is the fact that the 2006 estimate is the first to include patients with MDR-TB patients who had been previously treated at least once in addition to those who had received no prior treatment. Before this, all reports counted only patients in the latter group. a Annual incidence was 489,000. One percent was 4,890. We treated 30,000 in the years or approximately 6,000 per year. 13

16 Figure 1: MDR-TB prevalence among new (never treated before) cases has been estimated for several countries between 1994 and (Source: World Health Organization) Prevalence 0.9% 1.0%-2.9% 3.0%-6.4% 6.5% Figure 2: MDR-TB prevalence among previously treated cases has been estimated for several countries between 1994 and (Source: World Health Organization) Prevalence 9.9% 10.0%-19.9% 20.0%-29.9% 30.0% Highest MDR-TB rates >10% among new cases >50% among previously treated cases New cases Figure 3: Highest MDR-TB rates were found in the Eastern European Region and the Russian Federation. (Source: World Health Organization) 14 Previously treated cases 14.2 Estonia 13.2 Uzbekistan 58.1 Russia (Ivabovo) 14.2 Kazakhstan 12.3 Russia (Ivabovo) 66.4 Kazakhstan 13.7 Russia (Tomsk) 63.3 Lithuania

17 The Ever-Growing Threat of MDR-TB Chapter One Figure 1 shows the estimated prevalence of MDR-TB among patients around the globe who were not previously treated for TB. It is believed that a substantial proportion of these patients have primary MDR-TB; that is, their initial infection was with multidrug-resistant organisms. Figure 2 plots the prevalence of MDR-TB among patients who have been treated previously. These patients may have acquired MDR-TB as a result of inappropriate treatment or they may have primary MDR-TB. MDR-TB rates in the areas studied in the Russian Federation and the Eastern European region are among the highest in the world (Figure 3), where inadequate treatment of TB underlies the vast majority of cases. Confinement in close quarters combined with inappropriate treatment of drug-resistant cases led to high rates of MDR-TB among prisoners in Russia and Eastern Europe. Many infections that originated in prison are believed to have spread into the civilian sector as prisoners were released, often with incomplete follow-up. Figure 3 reflects the highest MDR-TB rates from the sites that have reported incidence; it is possible that there are sites with higher rates that have neither measured nor reported them. Current Surveillance Incomplete Despite considerable progress in the number of countries it has covered since 1994, the Global Project s most recent report acknowledges enormous gaps in surveillance. No data are available for more than 100 countries. And, in China, India, and the Russian Federation three countries that combined are estimated to account for twothirds of the global burden of MDR-TB we still do not have countrywide data. Figure 4 shows the parameters of our data procurement efforts around the world. The rates of MDR-TB for these countries have been extrapolated from subnational surveys surveys that cover only portions of the country. Because estimates have been made on the basis of incomplete data, it is possible that MDR-TB is even more extensive than the current surveys predict. One reason why surveillance is incomplete at this time is because early surveys were designed to assess MDR-TB incidence in new, untreated patients. More recent studies, however, include the previously treated cases as well. Another reason we lack data for so many regions is the difficulty of diagnosing MDR-TB, which involves complex and expensive procedures. (See Box 5, p 16 for more on MDR-TB diagnosis.) While in the long term, surveillance data can reveal trends in the disease as well as its prevalence, MDR-TB has not been monitored long enough to establish the necessary data points. Unaccounted Patients Treated in the Private Sector Persons with TB who are diagnosed and treated in the public sector (National TB Programs) are reported and treated with standardized regimens. By contrast, those who are diagnosed and treated in the private sector may not be reported and may be treated with regimens that do not follow guidelines. Thus far, no adequate strategy has been implemented for monitoring the vast number of MDR-TB patients who are treated by private practitioners. In India, for example, Figure 4: China, India, and the Russian Federation, responsible for two-thirds of the global cases of MDR-TB, have had only sub-national surveys. (Source: World Health Organization) Data source no data estimates sub-national surveys countrywide surveys 15

18 The Report on MDR-TB Treatment Box 5 Diagnosing MDR-TB The difficulty of diagnosing MDR-TB is a major obstacle to conducting good surveillance on the disease. This is not the case when diagnosing TB in general. That diagnosis is made by confirming whether or not the TB bacteria are present in a patient s sputum, which is determined with a simple microscopic examination by preparing and staining specimens, then detecting bacteria appearing in red (i.e. acid fast bacilli) on the slide. But diagnosing MDR-TB is a far more intricate procedure. First, the organisms must be cultured in appropriate media followed by complex and quantitatively precise measurement of how the cultured mycobacteria grow when exposed to the antibiotics used to treat TB. Using traditional techniques, this can take weeks to perform and many factors can interfere with accurate results, such as the culture becoming contaminated by cross-infection with other mycobacteria. Spurious results can also occur if good quality control is not maintained, which is much more likely if personnel are insufficiently trained in the handling of specimens and laboratory equipment. Furthermore, susceptibility testing for second-line drugs is more complex and less standardized than that for first-line drugs. In the field, numerous other factors can affect an accurate diagnosis. For example, in order for a laboratory to function properly, it must be well equipped, with appropriate equipment, reagents, and a continuous supply of electricity and water. Scrupulous attention must be paid to several operational aspects including specimen labeling, recordkeeping, and reporting. Good management and sustained funding by the health ministry of each country are mandatory to maintain the equipment, supplies, and the building itself. And, importantly, personnel must be specifically trained and supervised in the correct testing technique for MDR- TB. When laboratories that do not regularly perform these tests are asked to do so for a survey, the results are less likely to be accurate. Countries that lack the laboratory capacity to diagnose MDR-TB also lack the capacity to count cases, both new and existing and thereby contribute significantly to the uncertainties of global estimates. This is why the parameters of this global epidemic remain uncertain. as many as half of the approximately 2 million newly diagnosed TB patients per year visit private physicians, alternative healers, or pharmacies for their care. 2 And since, in general, the private sector remains insufficiently informed about TB, the likelihood that these patients will develop MDR-TB is higher, as a result of inadequate or improper treatment. Poor reporting combined with poor treatment means that an enormous number of MDR-TB cases are probably being missed. Given that India s private sector treats one-sixth of TB cases worldwide, 3 it is imperative that accurate methods of surveying privately-treated patients are developed. The lack of information from the private sector is certainly not a problem restricted to India; many other countries with large populations of TB patients treated outside of national government programs have similar difficulties estimating MDR-TB s true danger. If knowing the adversary is crucial to defeating it, we are duty-bound to learn the full extent of MDR-TB s global burden. Only then can we extinguish its threat to the world s health. MDR-TB Cases Continue to Be Generated in Many Ways Current estimates suggest that around the world, approximately 489,000 cases of MDR-TB are generated annually, creating a global pool (or prevalence) of 1.0 to 1.5 million. 4 Among the flowing spigots adding to this global pool of infection 5 are unavoidable treatment failures, inadequate treatment, amplification of resistance, transmission of drug-resistant strains, and the activation of latent infection. 16

19 The Ever-Growing Threat of MDR-TB Chapter One Even Good DOTS Programs Cannot Completely Prevent MDR-TB Cases Even in countries with excellent DOTS programs, some patients treatments are unsuccessful. A country with a cure rate as high as 90% still has a 10% failure rate. It s likely that these patients diseases may progress to a stage where the bacteria become resistant to first-line drugs. It s not know what fraction of unsuccessful treatments will be cured by repeating DOTS treatment. Peter Small and colleagues did a study 6 in Mexico and found that repeating DOS treatment and doing it better cured a large portion of previous failures, even those thought to have MDR-TB. However retreatment may lead to the development of further resistance and lower cure rates; the issue requires additional consideration. Inadequate Treatment Causes Drug Resistance Patients who are not prescribed the right drugs or dosages, those who receive poor-quality drugs, and those who either don t take all their drugs or don t complete tuberculosis or the operational problems suffered by many facilities, including drug shortages and/or too few workers to assure patient follow-up. As a result of poor compliance, resistant strains of TB may emerge. Moreover, as we mentioned earlier, many TB patients seek care from the private sector or from alternative health providers where inadequate treatment is much more likely. Varying greatly in the type, dosage, and duration of treatment they prescribe for TB, these providers seldom supervise or educate their patients adequately, which explains a great deal of patient non-compliance and, in turn, leads to acquired resistance to the TB drugs. When a person with active TB is treated more than once with the same regimen to which the TB bacilli have already developed resistance to one or more of the drugs, a progressive increase in the number of drugs to which the TB bacteria become resistant often occurs. This phenomenon, called amplification of resistance, has been well documented in many countries, including Peru and the countries of the former Soviet Union. Several settings have reported a disturbing trend: patients with strains that are resistant to many first-line drugs in addition to isoniazid and rifampicin, the two most important firstline drugs. Some are even resistant to all five first-line drugs. When these patients are treated with first-line drugs repeatedly and repeatedly fail to be cured, they may be labeled chronic cases. The problem, however, is not that they are incurable; rather it is that they are being treated over and again with drugs that are ineffective against their resistant strains of bacteria, treatment which only exacerbates the problem of resistance. In addition, repeated treatment regimens that add only a single new drug to a failing combination can amplify resistance, which can develop to both first- and second-line drugs. Unfortunately, some patients have strains resistant to as many as 7 or 8 second-line drugs. Infectious Cases Spread Disease through Primary Transmission the regimen often develop mutant strains of TB bacilli that are resistant to the medicines most commonly used to treat TB. While inadequate treatment may occur more often in the private sector, even committed DOTS campaigns cannot always guarantee success. While trying to assure that every patient is adequately supervised and completes his or her treatment, DOTS cannot eliminate development of resistance in individual strains of M. Whether or not MDR-TB is as infectious as drug-susceptible TB continues to be debated. While some believe that the MDR-TB bacteria are neither as robust nor as easily transmitted as drug-susceptible TB bacteria, epidemics of MDR-TB suggest otherwise. The outbreaks in New York in the late 1980s and early 1990s, those in Russian prisons, and nosocomial infections in other places 5 have shown that the bacteria can be readily transmitted. 17

20 The Report on MDR-TB Treatment Previously, epidemiologists thought that one person with drug-susceptible TB would infect 7 additional people each year, 7 but more recent estimates lower this figure to between 4 and 5. 8 That MDR-TB may have similar transmission dynamics bodes poorly for the health of the world, especially in the context of ever-increasing globalization. With growing trade and tourism, this is potentially a worldwide epidemic. In hospitals where MDR-TB patients are being treated, the disease may spread readily when proper steps to prevent airborne transmission have not been taken. Poor ventilation designs and not separating MDR-TB patients from others are just two examples. In some facilities, inadequate understanding of the dynamics of airborne transmission contributes to the disease s escalation. Studies in Tomsk have shown that patients who began treatment for non-resistant TB in hospitals were 12.7 times more likely to develop MDR-TB as compared with those who were treated as outpatients only; those who were later hospitalized were 9.6 times more likely to develop MDR-TB than the outpatients. 9 A study in South Africa designed to measure airborne infection of MDR-TB has shown that 82% of guinea pigs exposed to air from MDR-TB patients rooms developed positive skin tests. 10 Certainly these figures highlight the need to implement stricter measures of infection control in hospitals, clinics, labs, and other settings where MDR-TB can be transmitted easily. Personnel in many facilities still need to be educated to the fact that sub-standard measures for controlling infection can lead directly to airborne spread. And, among those who are aware of this and are trying to promote higher standards of infection control, procuring necessary training and expertise is happening too slowly. Latent Infection with MDR-TB May Progress to Active Disease Persons who are infected with TB bacilli but are not clinically ill are considered to have latent infections. While these individuals are not contagious, their infections may manifest clinically at a later stage through endogenous reactivation. In a life-time, the risk for an infected individual to develop TB is on the order of 10%. If he or she has already been infected with HIV, the risk jumps to 8-10% per year. 11 Although latent infection with TB can be identified in many settings, it is not currently possible to differentiate latent infection with susceptible strains from latent infection with MDR strains. And, if we could, there are as yet no chemoprophylactic regimens shown to be effective in preventing future manifestation of MDR disease. Even a properly run DOTS program would be unable to cure latent MDR-TB infections. Programmatic Control of MDR-TB is Difficult In the last few years, projects around the world have demonstrated that MDR-TB can be controlled within existing national tuberculosis programs. Yet, programmatic issues diagnostic, clinical, and logistical interfere with the successful management of MDR-TB more so than they do with drug-susceptible TB: Diagnosing MDR-TB requires expensive, technologically advanced equipment, and well-trained personnel. Treatment has to be tailored according to the specific resistance pattern of the microbes. Treatment requires between months, during which patients need to be closely monitored the entire time for side effects, which in themselves can be difficult to manage. Medicines are expensive and may not be easily available. Recordkeeping is complicated considering the long treatment with numerous drugs, and the variety of possible side effects. 18

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