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Need for New Regimens

About the TB Pandemic

Tuberculosis is a bacterial infection that is spread from person to person primarily by breathing infected air during close contact. TB kills someone approximately every 18 seconds — more than 4,000 people every day, or 1.8 million in 2015 alone, according to the latest estimates from the World Health Organization (WHO). TB is the leading infectious killer of adults worldwide, is a top five killer of women in their reproductive years, and the leading infectious cause of death among people with HIV/AIDS.

Drug-resistant TB

In recent years, the world has seen a rapidly emerging epidemic of drug-resistant TB (MDR-TB or multi drug-resistant and XDR-TB or extremely drug-resistant TB). There are an estimated 480,000 cases of MDR-TB and XDR-TB around the world each year. The long and inadequate treatment for TB means that many patients are unable to complete the course of treatment, and their disease may become drug resistant. Once a drug-resistant strain has developed, it can be transmitted directly to others.

Inadequate Treatment

The current first-line TB drug regimen of four drugs is approximately 50 years old, takes six to nine months to complete, and could have side effects, particularly when taken with antiretroviral drugs. Treatment for MDR-TB or XDR-TB can last 2 years or longer, consisting of up to 14,000 drugs including injectibles, many of which have significant side effects. MDR-TB and XDR-TB is extremely expensive and resource-intensive to deliver.

With the rapid and lethal spread of drug-resistant TB, accelerating the development of new, simpler and more effective drug regimens is no longer just an option, but a major public health imperative.

Regimen Development

Tuberculosis must be treated with combinations of drugs to prevent the development of drug-resistance. Therefore, in order to yield a major impact on TB and save more lives, TB therapies containing multiple new drugs are needed. Novel treatment regimens are the most direct path to drastically shorten and simplify the treatment of both drug-sensitive and drug-resistant tuberculosis, and enable both forms of the disease to be treated with the same multidrug treatment. Developing new drugs together in novel regimens requires multiple new drugs to be tested together early in the development cycle. This strategy represents a change from the traditional approach of adding or substituting a single drug at a time into existing regimens. CPTR has played a leading role in shifting the paradigm shift, such tha regimen development is now considered to be the gold standard for accelerating the development of new TB cures.

Today’s cutting edge TB research makes use of this paradigm, with several trials testing novel regimens now underway.

 

regimen development timeline

 

Preparing for Impact

To ensure promising new regimens are appropriately used and have maximum impact on the disease, drug-susceptibility tests must also be developed. The development of these diagnostics must be coordinated with advances in the pipeline as well as an understanding of evolving patterns of drug resistance. CPTR is bringing partners together to advance these goals, as well as fostering advances in regulatory science and the capacity and infrastructure required to support TB research and regimen development.