Bill & Melinda Gates Foundation

New Hope for TB: A Regimen Advances to a Phase 3 Trial

April 23, 2014
More than 14,000 pills. Six months of daily injections. Up to two years of treatment. A price tag of thousands (if not hundreds of thousands) of dollars. Extremely toxic side-effects.…And nearly half the time, the drugs don’t work. This is the treatment experience of people with multi-drug resistant TB (MDR-TB) today – and that is provided a patient is lucky enough to receive an accurate diagnosis and is able to access the best care available. This can’t be reality – or at least, it shouldn’t be. Unfortunately, for nearly half a million people each year with MDR-TB, it is.

Add onto that the more than 8 million people who suffer from drug-sensitive TB, who still must endure a long and difficult treatment administered over six months, and those co-infected with TB/HIV, whose medicines could interact and cause side effects, and it’s clear that there is an urgent need for shorter, simpler, and safer TB cures.

However, at least today, there is new hope.

The first-ever drug regimen designed to treat both drug-sensitive TB and MDR-TB has reached a critical milestone and will advance to a global Phase 3 clinical trial – the last, but most important stage of testing before it can be made available. This trial, known as STAND (Shortening Treatments by Advancing Novel Drugs), is a global initiative that will span some 50 research sites around the world.

The STAND trial will test a novel drug combination, or regimen. This is important because active TB must always be treated with a combination of drugs, and new regimens are the key to bringing about the type of rapid improvement needed in TB treatment. 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.

The novel regimen is the first to tackle both drug-sensitive and MDR-TB with the same combination of drugs, realizing a new path forward for treatment of the disease. PaMZ promises to shorten treatment, reducing treatment time by more than a year for some MDR-TB patients. As a simple, completely oral regimen, it would eliminate injectable drugs and reduce the burden treatment places on both patients and care providers. Additionally, this regimen is being developed to be compatible with commonly used ARVs, which would improve patient care for the millions of TB-HIV co-infected patients.

Often progress does not come cheap, but in this case PaMZ is expected to reduce the cost of MDR-TB treatment by over 90% in some countries while being comparable to the current treatment for drug-sensitive TB. Such cheaper, faster, simpler cures could realize massive efficiencies for countries, communities, and patients.
This regimen has been advanced to date thanks to the commitment of a series of partners including the Bill & Melinda Gates Foundation (BMGF), Department for International Development (DFID), Department for Foreign Affairs and Trade (DFAT), US Agency for International Development (USAID), Irish Aid, and the Directorate-General for International Cooperation (DGIS).

Now, on the precipice of the STAND trial, 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.

A successful result in the STAND trial could change today’s reality for patients and health systems, as well as for researchers. Scientifically, it would fully validate a new approach to develop TB treatments, one that would reduce the time it takes to develop novel regimens from decades to years. Economically, it would shatter the existing cost-based burdens to expanding MDR-TB care. And, from a human perspective, it would transform TB treatment, improving health and productivity around the world.
 
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