Mel Spigelman

In this guest post, Dr. Mel Spigelman—president and CEO of the TB Alliance—writes about advancing the first-ever drug regimen designed to treat both drug-sensitive and some forms of multi-drug resistant tuberculosis (TB) to a global Phase III clinical trial. Receiving treatment for multi-drug resistant TB (MDR-TB), which afflicts nearly half a million people around the world, is one of the harshest experiences modern medicine has to offer. Treatment lasts up to two years, with more than 14,000 pills and daily injections for the first six month of treatment. Side effects range from nausea to permanent hearing loss and worse. Compounding matters is that this treatment only works about half the time, and is even more challenging to administer in patients also receiving therapy for HIV and AIDS. While this sounds extremely bleak, those who experience this care are fortunate. The above situation represents the best MDR-TB care available. Many TB and MDR-TB patients are unable to receive an accurate diagnosis. These patients have an even harder time with drug-resistant TB, and many ultimately die. Based on positive results from earlier clinical studies, TB Alliance is advancing the first-ever drug regimen designed to treat both drug-sensitive and some forms of multi-drug resistant tuberculosis (TB) to a global Phase III clinical trial. Photo: PATH/Gabe Bienczycki Today, however, there is hope. Better yet, those infected with drug-sensitive (or “normal”) TB—eight million people around the world—can also enjoy this hope. By the end of 2014, a new global clinical trial will begin testing the first ever drug regimen designed to treat both versions of TB in 50 sites on four continents. The trial, known as STAND (Shortening Treatments by Advancing Novel Drugs), will test a novel drug combination, or regimen. Traditionally, individual drugs were developed, then added or substituted into the existing treatment, enabling incremental progress. But the STAND trial, which tests a regimen called PaMZ, represents an opportunity to transform treatment. PaMZ promises to shrink the length of time patients are treated by more than a year for some forms of MDR-TB. As a completely oral regimen, it would eliminate injections and reduce the extraordinary demands that a TB diagnosis places on both patients and healthcare providers. Additionally, this regimen was developed for compatibility with commonly used antiretroviral drugs, which would improve patient care for the millions infected with both TB and HIV. With such a vastly reduced amount of medicine, PaMZ is expected to reduce the cost of MDR-TB treatment by over 90 percent in some countries. In the case of drug-sensitive TB, the regimen projects to be competitive with current treatment. Such cheaper, faster, simpler cures would provide amazing benefits not just to patients but for communities and national health care systems overly stressed from such an intractable disease. This regimen has been advanced to date thanks to the commitment of a series of partners including the Bill & Melinda Gates Foundation, the UK Department for International Development the Australian Department for Foreign Affairs and Trade, the US Agency for International Development, Irish Aid, and the Directorate-General for International Cooperation in the Netherlands. Now, as preparations for the STAND trial begin, we call for continuing as well as new support to bring this promising treatment through its final hurdle before it can be made available to the millions in need. TB has afflicted mankind since the time of the Pharaohs. The current first-line treatment for TB was assembled almost half a century ago; while the disease has continued to evolve, new medicines have been few and far between. TB is second only to HIV as the leading infectious killer of adults worldwide, and is also the leading infectious cause of death among people with HIV and AIDS. Hope has been a scarce commodity for TB patients today, especially those who have MDR-TB. We owe it to the millions of these patients—and the millions more to come—to move the STAND trial to the finish line. In this day and age, taking medicine and getting cured should be an easy sprint, not a gruesome marathon. To learn more about the STAND trial, click here.