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Tuberculosis

Strategy Overview

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Better vaccines, drugs, and diagnostics are needed to reduce the burden of TB, which remains one of the leading causes of death worldwide.

our goal:

Accelerate the global decline in tuberculosis incidence.

The Challenge

At A Glance

TB remains a leading cause of death from infectious disease worldwide, with 10.4 million new cases reported in 2016.

We are working to better understand the basic science behind the TB epidemic and support new tools for prevention, diagnosis, and treatment, as well as the optimal delivery of TB care.

Our TB strategy is led by Gilla Kaplan and is part of our Global Health Division.

Over the past two decades, the world has made significant progress in the fight against tuberculosis (TB). Between 1990 and 2014, TB mortality fell by 47 percent, and 66 million TB patients were successfully treated between 1995 and 2014 thanks to coordinated global efforts and the use of the recommended treatment, the directly observed therapy short-course (DOTS) strategy. Of those patients, 8 million people were also treated for HIV co-infection.

While effective diagnosis and treatment has saved millions of lives, TB remains the leading cause of death from infectious disease worldwide. In 2016, an estimated 10.4 million new cases were reported, and nearly 1.7 million people died from the disease.

In recent years, drug-resistant strains of TB have created a growing sense of urgency to control the spread of the disease. Two strains have emerged: multidrug-resistant TB (MDR-TB), a form that is resistant to first-line drugs, and extensively drug-resistant TB (XDR-TB), which is also resistant to some second-line drugs. MDR-TB has appeared in nearly every country, with an estimated 490,000 new cases in 2016. These forms of the disease are difficult and costly to treat. The TB epidemic has also accelerated in concert with HIV: In 2016, about 375,000 people died from TB/HIV co-infection.

Current approaches to preventing, diagnosing, and treating TB are inadequate. The vaccine used today, Bacillius Calmette-Guerin (BCG), protects young children against severe forms of TB. However, BCG offers limited protection against pulmonary TB in adults, which is the most common form of the disease. The most commonly used diagnostic method, microscopic detection of bacteria from sputum, identifies only half of all cases. It also requires special skills and is labor-intensive. Even the standardized DOTS treatment regimen, despite significant success, has inherent challenges: With DOTS, patients must take a complex combination of pills every day for six months, with a health-care worker supervising the full treatment. The current regimen also has significant side effects. Many patients are unable to stay on treatment sufficiently to be cured.

As a result of these issues, current TB care and treatment programs identify, diagnose, and successfully treat only around 50 percent of all patients with active TB disease.

The Opportunity

Over the past decade, innovative new tools and delivery strategies have reduced deaths from TB and improved the quality of patient care. But we urgently need more investments and greater collaboration to accelerate progress in treatment delivery and expand the pipeline of safe, effective drug and vaccine candidates.

A more effective vaccine would be the single most powerful tool to reduce the incidence of TB. Even a partially effective new vaccine introduced in 2024 could, by some projections, decrease TB incidence by up to 70 percent by 2050.

While the development of a better vaccine continues, we need tools we can start using now to interrupt the TB epidemic in the short and medium term. New ways to use existing tools to identify patients early, link them to care, and facilitate faster and more effective treatment will help reduce the burden of TB. Improved diagnostic tools will reduce delays in starting treatment. A simpler, safer, shorter, and more affordable drug regimen will improve treatment success rates.

The field of TB also needs more funding. The drugs and diagnostics currently in clinical development can reach the people who need them most only if they are affordable and can be deployed efficiently. We need substantial financial resources for research and development, and investments from developed and TB-endemic countries, pharmaceutical companies, and foundations must be sustained.

Our Strategy

The Bill & Melinda Gates Foundation’s strategy aims address the key gaps on the patient pathway to care through new approaches to protect against infection, prevent progression from infection to disease, and improve TB diagnosis and treatment. Our portfolio of work is diversified based on the understanding that vaccines, diagnostics, drugs, and improved care delivery are all essential to address the epidemic.

Areas of Focus

More Effective Drug Regimens

Our efforts to develop a treatment regimen that is safer, shorter, simpler, and more affordable begin with the TB Drug Accelerator (TBDA) program, which aims to identify new drugs that work differently than existing drugs to kill bacteria. The program has developed new tools for drug discovery, and by bringing together academic and industry partners in a unique collaboration, it facilitates the sharing of best practices, methods, and data.

The bacteria that causes TB can rapidly develop resistance to a single drug, so treatment always requires a combination of drugs. Because of conventional drug development requirements, however, developing more effective TB regimens can take decades. Currently, new TB drugs must be evaluated separately in clinical trials, and new drugs can be tested in combination only after individual approval.

To address this obstacle, we have joined with partners to create the Critical Path to TB Drug Regimens (CPTR) initiative, which brings together leading international pharmaceutical companies, public health experts, NGOs, and U.S. and other regulatory authorities. CPTR aims to identify new pathways to regulatory approval and expedite testing of promising TB drug candidates in combination.

We are currently co-funding multiple drug trials, with the goal of achieving an effective, short, and simple treatment regimen for all forms of TB, including drug-resistant TB. In the near term, the new regimens will benefit those with XDR-TB and MDR-TB, while providing important safety data and insights that will ultimately help us expand our efforts to patients with drug-sensitive TB. This will help us achieve our goal of a universal drug regimen.

New Diagnostic Tools


A technician explains how the GeneXpert machine diagnoses TB using DNA in Jakarta, Indonesia.

Of the estimated 10.4 million new cases of TB worldwide each year, more than 4 million people are undiagnosed and/or unreported. We are developing less expensive, more effective diagnostic tools that can reach more people with TB. We also support the development of communications systems that help more people access appropriate treatment and care.

One new technology we helped fund, the GeneXpert diagnostic test, has led to an increase in overall TB case finding and has the potential to more effectively guide proper treatment. It better detects drug-resistant cases of TB from  sputum samples, helping providers select the most appropriate treatment.

We are currently working on next-generation TB diagnostic tests based on samples that are easier to obtain than sputum, including blood, urine, and potentially even breath or sweat. While these techniques are in the early stages of development, we remain committed and optimistic that they will markedly improve TB detection, facilitate faster treatment, and reduce transmission.

Improved Vaccines

BCG, the only available TB vaccine, was developed almost 100 years ago and has limited efficacy after childhood. We need a more effective option to accelerate TB prevention.

We work with multiple partners to better understand how to protect people against TB with a vaccine, with a focus on how the immune system responds to new vaccines. This requires lengthy, costly trials because mechanisms of TB protection are poorly understood and there are no known biomarkers that can predict how well a vaccine candidate will work.

We established the Collaboration for TB Vaccine Discovery to facilitate the exchange of ideas among TB scientists. The group develops guidelines for safely and effectively progressing vaccine candidates through clinical trials, even as questions remain about early signs of efficacy. Among vaccine candidates currently supported in preclinical development, a cytomegalovirus (CMV)-based vaccine has shown the best protection in animal models.

Innovative Delivery Approaches

In India and China, we partner with governments to pilot innovative approaches to modernize TB control. With the government of India, the World Health Organization (WHO), USAID, and the World Bank, we are expanding TB-control efforts into the private health care sector, where most patients seek care. This includes an information and communications technology system to track patients throughout their course of treatment. In China, we have supported the government’s shift to hospital-led TB care, which increases referrals while maintaining a high standard of treatment. This model is being scaled up by national health authorities in cities and provinces across the country.


Employees at a call center in Patna, India remind TB patients to take their medication, answer any questions and monitor treatment progress through the Universal Access to TB Care program.

We have recently begun to expand our efforts in South Africa, where the new TB Think Tank provides evidence-based policy recommendations to the National Department of Health. We are also supporting an initiative to link health system databases to improve the monitoring of patients and programs.

We are expanding all of our efforts through partnerships such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria; WHO; and UNITAID that maximize the impact of resources and investments. We support the use of data and analytics to drive policy and funding decisions globally and at the national level. We are also supporting the use of adherence technologies that will help patients complete treatment and increase their probability of being cured.

Advocacy

We advocate for greater political commitment and funding to fight TB, particularly for research and development of new tools. We believe that strengthening partnerships with donor governments and multinational institutions, the pharmaceutical and biotechnology industries, and governments of TB-endemic countries is critical to fighting the disease. These partnerships can lead to greater investments in research and development as well as in the delivery of existing and new tools.

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