Meanwhile, the Treatment Action Group (TAG), an organization of healthcare activists focused on diseases such as HIV and TB, among others, reports that while the United States continues to lead global funding efforts for TB-related research, contributing nearly 40% of the $674 million in funds raised in 2014, government allocations have “flat-lined” since 2009, at roughly $250 million annually. TAG writes that “TB R&D is woefully underfunded, with a gap of $1.3 billion to meet the funding targets set by the Global Plan to Stop TB
”—which, ironically, is a partnership between the Stop TB Partnership and WHO.
Several other NGOs—namely, Médecins Sans Frontières (MSF), Partners In Health, and Interactive Research & Development—have initiated a UNITAID-funded Phase III clinical trial designed to research novel approaches to treating Multidrug-Resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB). The so-called “endTB” clinical trial is centered in Tblisi, Georgia and will focus on the safety and efficacy of bedaquiline (Sirturo, Janssen) and delamanid (Deltyba, Otsuka) in MDR-TB. The 2 drugs are the first novel treatments developed for TB in decades.
“While both drugs have shown very promising results when added to the standard, long and badly-tolerated MDR-TB treatments, we know little about how to optimize them,” Francis Varaine, MD, co-principal investigator of the endTB clinical trial and leader of MSF’s TB working group said in a statement
released by the organization. “Without further research, we are only scratching the surface and patients continue to suffer.”
Of course, this suffering is due not only to the ravages of TB but also the side effects of many antibiotics used to treat it. The clinicians heading up the endTB trial hope to enroll 2,600 MDR-TB patients on treatment with the new TB drugs in 6 countries: Georgia, Kazakhstan, Kyrgyzstan, Lesotho, Peru, and South Africa. MSF was also involved in the launch of the TB PRACTECAL
trial in Uzbekistan in January. The Phase III trial will assess the potential role of bedaquiline and pretomanid (PA-824), the latter of which was developed by biotech firm Pathogenesis Corp. and transferred to the TB Alliance.
Brian P. Dunleavy is a medical writer and editor based in New York. His work has appeared in numerous healthcare-related publications. He is the former editor of Infectious Disease Special Edition.
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