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.
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 a cure.
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.