Ambassador Mark Dybul
U.S. Global AIDS Coordinator
BEFORE THE SUBCOMMITTEE on AFRICA AND GLOBAL HEALTH
COMMITTEE ON FOREIGN AFFAIRS
House of Representatives
Washington, D.C.
March 21, 2007
Tuberculosis
Mr. Chairman, Ranking Member Smith, and Members of the Subcommittee:
Thank you for this opportunity to discuss the President's Emergency Plan for AIDS Relief and our efforts to combat the spread of tuberculosis (TB) globally. The partnership between PEPFAR and the Committee on Foreign Affairs over the years is one for which I am very grateful. Chairman Payne and Ranking Member Smith, thank you for your commitment to the U.S. leadership in the fight against HIV/AIDS. Bipartisan support for this historic initiative has been a key to its success.
Thanks to the commitment of President Bush, Congress and the American people, PEPFAR is on track to exceed its original commitment of $15 billion over five years. The majority of those resources are being invested directly into partnerships with host nations. By working with our host countries to build high-quality health care networks and increase capacity, we are laying the foundation for nations and communities to sustain their efforts against not just HIV/AIDS, but a wide range of other diseases, including multi-drug resistant (MDR)- and extremely drug resistant (XDR)-TB - long after the initial five years of the Emergency Plan.
Because its effect on the immune system makes HIV-infected people more susceptible to infection, HIV is the single greatest powerful risk factor for developing tuberculosis. In Africa, TB is in lock step with the increase in HIV/AIDS. In fact, TB is the number one killer of people living with HIV - which is why PEPFAR is leading a unified U.S. Government (USG) global response to fully integrate HIV and TB services at the country level. Our goal is to ensure that people who are infected with HIV receive the best treatment and care possible, in order to prevent them from contracting TB in the first place. This is critical to the long-term control of TB at the global level. Anti-retroviral treatment (ART) is a powerful deterrent to the development of TB, because it restores immune function. A strong immune system means that an HIV-positive person on ART is much less likely to contract TB; and even if he or she already has been infected with tuberculosis, the bacteria are more likely to remain dormant.
PEPFAR also supports the full range of HIV treatment and care for people who already are co-infected with HIV and active TB. Appropriate and full treatment of TB is vital, not only to prevent HIV-positive people from dying but also to alleviate the risk of them developing drug-resistant TB. In one study in South Africa, there was an 80 percent reduction in the incidence of TB among HIV-positive people who are on anti-retroviral treatment, as compared to those who are not on ART. With 50 percent of TB cases occurring in Sub-Saharan Africa, ART is a powerful too in the fight against TB.
PEPFAR recognizes the significance of these dual epidemics and the danger they pose for societies worldwide, particularly in settings of high HIV prevalence, and this is why our support for TB/HIV has increased more than six-fold in just three years - from $18.8 million in 2005, to $48.6 million in 2006, to at least $120 million in 2007. As of September 2006, PEPFAR had supported care for approximately 301,000 TB/HIV co-infected people in the focus countries. Collaboration among USG agencies, including those working domestically, has been strengthened - as have PEPFAR's ties with our multilateral partners, including the WHO and the Global Fund. Such collaborations are essential for mounting an effective response at the global level.
However, our most important work in combating TB takes place through partnerships at the country level to support national health authorities, non-governmental organizations, and community- and faith-based organizations to implement more effective TB/HIV activities. Activities include providing HIV testing for people with TB and improving TB diagnosis for people with HIV; providing isoniazid preventive therapy to HIV-infected people in order to reduce their risk of developing TB; improving TB infection control to prevent people with HIV from coming in direct contact with someone with active TB; implementing the WHO-recommended International Standards for TB Care, which build on Directly Observed Therapy-Short Course (DOTS) strategy, in PEPFAR HIV care settings, in order to ensure that patients complete their TB treatment; and improving laboratory surveillance systems in order to detect outbreaks of MDR- and XDR-TB.
PEPFAR also supports expanding the capacity of the local health workforce to deal with these dual epidemics and improving supply chain management systems for medications and other commodities. It also is essential to establish linkages between TB treatment and ART services so that people who are co-infected receive the medical attention they need. PEPFAR also supports the development of a strong, tiered public health laboratory network for diagnosing and managing drug-resistant TB and other opportunistic infections. We also work with partners to train health care providers in the DOTS strategy for treating TB and preventing the development of drug resistance.
Our in-country partnerships include leveraging PEPFAR resources to amplify the effects of other global health initiatives, especially the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) and support for the Green Light Committee for multi-drug resistant TB grants of the Global Fund. The USG remains the largest contributor to the Global Fund, which provides significant TB grants. Through PEPFAR, the USG has provided approximately one-third of the Fund's resources - and through 2007, the Global Fund will have committed $1.4 billion to TB grants. We also work with the World Bank, the World Health Organization, UNAIDS, the International Union Against TB and Lung Disease, and the private sector.
As an initial step in addressing MDR- and XDR-TB, the U.S. Government convened the U.S. Federal TB Task Force to develop a coordinated domestic response by U.S. Government agencies to the looming threat of MDR- and XDR-TB. The Administration will convene an interagency team in the near future to formulate a comprehensive response and to assign responsibilities for a unified strategic international approach. The U.S. Government also participates in the WHO Global XDR-TB Task Force, which is finalizing a global plan to respond to XDR-TB. The White House will convene an interagency meeting in the next few weeks to ensure U.S. Government activities are integrated in a unified strategic approach.
The Evolution of Drug-Resistant TB
In discussing XDR-TB, let me start by making two observations: (1) the development of drug resistant tuberculosis is of concern, but not surprising, and (2) it is not new. At the population level, particularly in high HIV prevalence countries in Africa, the combination of poverty, overcrowding, and HIV have led to dramatic increases in TB infection. Beginning in the 1990s, the number of TB cases exceeded the capacity of poorly-financed, under-staffed TB control programs to deliver effective TB management. Drug-resistant TB is the direct result of inadequate TB control. This is why there is a saying in TB circles that poor TB treatment is worse than no treatment at all.
On an individual patient level, drug resistance can develop when someone is infected with an already-resistant organism. It also can develop if a person infected with TB and the disease progresses to active TB, which can happen very quickly among people who are immuno-compromised. This is what has happened in the recent and well-publicized outbreak in South Africa. Another way to develop drug-resistant TB is through inadequate TB treatment, or by not completing a full course of TB therapy. The more this happens, the more TB drug-resistance will develop. We have seen the same problem with resistance to HIV medications when anti-retroviral treatment is improperly prescribed or taken.
The implications of MDR- and XDR-TB, particularly for people with HIV, are serious. Most cases of TB are drug-sensitive and can be cured in someone with or without HIV infection after six months of treatment and for just a few hundred dollars. However, people with MDR-TB have a much poorer prognosis, requiring as much as 18 months of treatment, and costing many thousands of dollars. When the second-line drugs for MDR-TB are misused or mismanaged and therefore also become ineffective, then XDR-TB can develop. Because XDR-TB is resistant to both first- and man second-line drugs, it is - for the time being at least - almost untreatable.
There has been growing concern recently about the incidence of drug-resistant TB, and we should be concerned. The WHO estimates that there are 425,000 cases of MDR-TB per year globally - nearly 5 percent of the world's annual TB burden. In addition, there are 27,000 cases of XDR-TB, which is of particular concern to us because it is almost universally fatal to people who are HIV-positive.
TB and HIV in Africa
Globally, more than 80 percent of the TB cases occur in Africa and East and Southeast Asia. Not surprisingly, HIV prevalence in TB patients varies widely, from between 30 percent and 80 percent in most African countries, to 7 percent in Russia, 5 percent in India, and less than 1 percent in China. These varying epidemiologic patterns have important implications for TB control and TB/HIV interventions.
Recent findings from a WHO and CDC survey (with support from USAID) of data from 2000 to 2004 found that XDR-TB has been identified in all regions of the world, including the U.S. It is most commonly found in the countries of the former Soviet Union and in Asia, where it seems to be stable. Improved TB control and surveillance will be important to monitor trends in XDR-TB in this part of the world.
However, an immediate concern about MDR-TB and XDR-TB is its explosive potential in settings of high HIV prevalence, such as sub-Saharan Africa. In the U.S. during the early 1990s, we saw numerous outbreaks of MDR-TB in people with HIV/AIDS, but drug-resistant TB has not been seen among HIV-positive people in sub-Saharan Africa until recently. To date, little surveillance data has been available from sub-Saharan Africa on MDR- and XDR-TB, but it appears that new cases may be rapidly increasing. The recently-reported outbreak of XDR-TB in South Africa is especially troubling. It appears that people with MDR-TB had received inadequate treatment and developed XDR-TB. They then subsequently spread their XDR-TB to people with HIV/AIDS in the community or in the local hospital. Because their immune systems were so weak, the people with HIV/AIDS rapidly developed XDR-TB and the consequences have been devastating -- 52 out of 53 XDR-TB patients in the original report have died. Of these, 44 patients had been tested for HIV, and all were positive. USG agencies, including HHS/CDC and USAID, along with the WHO and local authorities, took the lead in alerting the world to this potential threat.
Guidance on TB/HIV activities supported by PEPFAR has been included in our technical guidance since 2004, but in response to the XDR-TB outbreak in South Africa, PEPFAR has alerted all focus countries to the problem, and we have advised them to take it into account during the development of their FY07 Country Operational Plans, in partnership with national TB and HIV control programs. Teams of epidemiologists, laboratory scientists, and environmental engineers have been dispatched to a range of countries to develop response plans, conduct local assessments and training, and support implementation. Six teams of USG staff along with local staff from TB and HIV control programs in focus countries (Kenya, Rwanda, Ethiopia, Zambia, Namibia, and South Africa) were recently brought to Washington, in collaboration with the WHO and the Bill and Melinda Gates Foundation, to develop accelerated TB/HIV plans. According to the WHO, 10 countries in the region have started or plan to start rapid surveillance studies to determine the extent of MDR- or XDR-TB in their population.
Addressing HIV and drug-resistant TB
Addressing HIV/TB and drug-resistant TB is particularly challenging-especially in impoverished settings that are heavily impacted by HIV/AIDS. In sub-Saharan Africa and elsewhere, TB control programs are already overburdened and unable to deal with the emerging threat of drug-resistant TB.
In tackling the problem of emergent drug-resistant TB, PEPFAR's primary goal is to increase cross-testing of TB and HIV patients. Estimates are that more than half of the people infected with TB in sub-Saharan Africa are co-infected with HIV. For example, in South Africa, 60 percent of all TB patients are HIV-positive - and in Botswana and Swaziland, 80 percent of all TB cases are co-infections. Unfortunately, by the end of 2005, only 10 percent of all TB patients throughout the African region had been tested for HIV, and only 13 percent of the estimated HIV-infected TB patients had been detected. Therefore, one of PEPFAR's top priorities is to increase consistent cross-testing for TB and HIV.
Another goal is to ensure that eligible TB/HIV patients are put on ART. Studies have shown[1] an 80 percent reduction in the incidence of TB among HIV-positive people who are on anti-retroviral treatment, as compared to those who are not on ART. Thus, in a country where 60 percent of all TB patients also have HIV, if all co-infected people were put on ART, we could reasonably expect allover TB rates to drop by close to 50 percent.
The first step in accelerating TB/HIV collaborative activities and preventing the emergence of drug-resistant TB is to strengthen weak and struggling TB programs. For years, TB programs have been under-resourced and they now face incredible challenges in delivering care to thousands of TB patients, many of whom also have HIV. There are a number of essential components for a strong TB program. Through our focus on supporting and building host country capacity, PEPFAR is focusing on a few of the most important elements.
Laboratories are the most important but weakest link in the fight against TB/HIV. The diagnosis and the provision of high-quality care depend on an efficient public health lab network. International recommendations for diagnosing TB have changed and now include sophisticated investigations such as culture, and effective high-quality microscopy, including fluorescent microscopy. All this requires an effective and efficient laboratory system. The emergence of XDR-TB has further highlighted the need for strong lab systems. Finally, lab support is essential for the delivery of high-quality HIV testing and treatment services. PEPFAR is working closely with host country partners to ensure the establishment of well-functioning public health laboratory networks to diagnose and manage TB among people living with HIV/AIDS.
Despite being one of the 12 WHO-recommended collaborative TB/HIV activities, TB infection control has been heretofore neglected. Given the recent emergence of XDR-TB and increasing evidence of infection risk among not only HIV-infected people but also among health care workers, it is becoming clear that countries must develop the capacity to provide appropriate care and treatment for large numbers of co-infected people. Whether it is drug-resistant or not, TB is an airborne, potentially deadly disease. PEPFAR is mobilizing our resources to meet this challenge head-on, so that health care facilities do not become "amplifiers" of the TB epidemic.
An old public health axiom is "what is measured is done." A strong HIV/TB program relies on a well-functioning monitoring and evaluation (M and E) system. M and E are critical activities, and building an effective M and E system is essential if we hope to capture what is going on in countries and use that information to inform and accelerate implementation of HIV/TB activities. PEPFAR is working closely with host countries and international partners to ensure that an effective M and E system for collaborative TB/HIV activities is central in program implementation.
In higher HIV prevalence areas, people who have symptoms of TB should be offered counseling and testing for HIV. HIV testing is a gateway for effective delivery of collaborative TB/HIV activities, including prevention, care and treatment. Although there is an increasing recognition that this is a critical HIV/TB activity, it is a very challenging endeavor. The WHO estimates that globally only 7 percent of TB patients are tested for HIV and only 13 percent of the estimated HIV infected TB patients were detected. PEPFAR recognizes that, although there have been some success stories in this area, there is an urgent need to expand counseling and testing to places where people with TB come for diagnosis and treatment.
We still have a long way to go, but our efforts are starting to have a positive impact. Recent data from Botswana's national TB program suggest that 68 percent of all registered TB patients now undergo HIV testing. Rwanda has doubled its percentage of TB patients tested for HIV and now around 90 percent receive an HIV test. In some districts of Tanzania with provider-initiated HIV counseling and testing, more than 80 percent of all TB patients opt for HIV testing and learn their status.
We know that the percentage of TB patients who are tested for HIV continues to vary widely. In An Giang province in Vietnam, 100 percent of all TB patients undergo HIV testing -- but in the Western province of Zambia, it is only about 50 percent. Often, this is a matter of logistics: even when referred, a TB patient may not go for HIV testing if the HIV counseling and testing center is not in close proximity to the TB clinic. Because of this, PEPFAR is working with partners in many countries - including Botswana, Ethiopia, Kenya, Rwanda, and Tanzania - to expand provider-initiated HIV counseling and testing services, either right in the TB clinics or nearby. We are also supporting efforts to integrate services for people living with HIV/AIDS (PLWHA). For instance, in Côte d'Ivoire, where ART programs are being decentralized, efforts are underway to co-locate TB and HIV care in the same facilities.
Diagnosing and managing TB in patients with HIV can be a challenge-but it is vital to prevent the high morbidity and mortality associated with TB. Recently released international recommendations include revised case definitions and the use of available investigations (e.g. culture, CXR [?], biopsy) to expedite the diagnosis and treatment of TB among people living with HIV. Managing extrapulmonary TB in HIV-prevalent settings is now emphasized as part of routine national TB control activity.
However, there are several significant barriers to ensuring the provision of ART for HIV infected TB patients, such as the risk of drug interactions between ART and Rifampicin, which complicates the provision of ART for TB patients. Appropriate care also is essential for TB patients, including treatment with Cotrimoxazole - but very few TB patients with HIV are provided with this life-saving therapy. PEPFAR is working with partners to expedite the diagnosis and treatment of TB (including smear negative pulmonary and extrapulmonary TB) and to ensure ART for eligible TB patients.
TB is the leading opportunistic illness and contributor to significant early mortality of people on ART. Therefore, early detection of TB among people living with HIV is crucial. For those without active TB, the provision of isoniazid preventive therapy can prevent the development of TB. Unfortunately, the WHO estimates that less than 5 percent of estimated HIV-positive children and adults in the African region were screened for TB symptoms and signs in 2005, and approximately 0.1 percent of those eligible were started on isoniazid preventive therapy. By the end of fiscal year 2006, PEPFAR had supported antiretroviral treatment for 822,100 HIV-positive people, and supported care for 4.5 million people in the focus countries. PEPFAR, through its support of care and treatment programs, is focusing on improving the screening of TB in HIV/AIDS care settings and supporting isoniazid preventive therapy and TB management using DOTS principles.
In addition to providing TB-HIV diagnostic services, some countries - including Kenya and Mozambique - are exploring ways to provide DOTS treatment to TB patients in HIV clinics such as cotrimoxazole[2] at TB sites, to facilitate simultaneous care for TB/HIV co-infected patients. Some countries, such as Tanzania, are initiating provision of ARVs in TB clinics for patients who are also HIV-positive; this requires a strong national TB program.
In many places, TB screening is taking place as part of the PEPFAR-supported preventive care package for HIV-infected people, and we are working closely with our partners to expand these efforts. With USG support, host country programs have developed simple symptom-screening tools, as well as recording-and-reporting forms to document TB screening. When appropriate, health care facilities are responsible for ensuring the proper diagnosis and management of TB according to the DOTS strategy and national TB program guidelines.
In all these efforts, PEPFAR works closely with national health authorities and local organizations, to build sustainability by expanding and strengthening indigenous healthcare capacity. Of all the adults and children who have received TB treatment with PEPFAR support, just over one-third received it at USG-supported delivery sites; the remainder received care through our support of national, regional, and local programs.
Next Steps: the Road Ahead
In partnership with host nations and the international community, PEPFAR has taken substantial steps toward combating global TB, and we will continue to do so. Just two weeks ago, we co-sponsored a meeting of the WHO's Stop TB partnership, local Ministers of Health, and other key USG and international partners to accelerate the implementation of HIV/TB activities in Ethiopia, Kenya, Namibia, Rwanda, South Africa, and Zambia. One of our first tasks following the meeting will be to work with PEPFAR missions to use additional HIV/TB resources to support host country HIV/AIDS and TB program managers to implement collaborative HIV and TB services.
Another exciting development with enormous potential for fighting TB is PEPFAR's newest public-private partnership, the Phones for Health program. It joins African entrepreneurs with local NGOs and multi-national corporations to use cell phone technology to connect health systems in 10 PEPFAR-supported countries by 2010. Working closely with national Ministries of Health and global health organizations, the Phones for Health partnership will develop an integrated set of standard information solutions that support the scale-up of HIV/AIDS, TB, malaria, and other infectious disease initiatives in a cost-effective manner that builds local capacity.
These are just some of the ways in which PEPFAR is proactively engaged in the coordination of TB and HIV programs. Moreover, PEPFAR will continue to maximize its resources with our international and country partners to support the global response in combating and ultimately conquering both HIV/AIDS and tuberculosis around the world.
PEPFAR takes the issue of XDR-TB very serious, and in response, have increased the Fiscal Year 2007 commitment for TB/HIV efforts by providing an additional $50 million more than was originally planned. In partnership with Congress and strong coordination within the Executive Branch, the U.S. Government and the American people are doing their part. Mr. Chairman and Ranking Member Smith, thank you again for your interest in this important issue. I look forward to your questions.
[1] Badri, Lancet 2002.
[2] Cotrimoxazole is recommended by the World Health Organization (WHO) for HIV-associated tuberculosis.
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