With the enrollment of its first patients in Eastern Europe, the largest trial yet to test a four-drug, four-month treatment regimen against tuberculosis will set out to demonstrate whether fewer medicines, over a shorter length of time can cure nearly all TB patients.
The trial, which will launch in Tbilisi, the capital of the country of Georgia, will put the BPaMZ regimen, a treatment comprised of bedaquiline — one of the two newest approved drugs — an investigational drug, a repurposed drug and an existing tuberculosis drug, to its most widespread test yet. Over the next year the trial will enroll about 450 patients — across at least 26 study sites in 10 countries, among patients whose tuberculosis responds to existing first-line treatments, and then, in a six-month regimen among patients whose tuberculosis is resistant to multiple current treatments. Results announced in 2016 of the earlier NC-005 eight-week trial of BPaMZ among 250 patients testing the regimen across 10 sites in southern Africa, showed patients on the regimen clearing the bacteria at the fastest rate ever seen — up to three times faster than the standard first line regimen.
Similar findings in the new trial, which researchers have dubbed SimpliciTB, could have significant ramifications for treatment of tuberculosis, odds of surviving the illness, and advances against the disease. While current standard treatment regimens for tuberculosis responsive to first-line drugs takes six months, treatment for tuberculosis that is resistant to first line medicines can stretch from nine months to two years or longer, with permanent, life-altering side-effects challenging treatment completion. With a cure rate of about 50 percent among those accessing treatment for drug-resistant tuberculosis, rates of the disease continue to rise.
The launch of the trial was announced today by the TB Alliance, a partnership of nonprofit organizations, pharmaceutical companies, governments, philanthropic donors, academic and research institutions, and patients, seeking new treatments for tuberculosis. While tuberculosis was considered effectively addressed with the development of antibiotics in the middle of the last century, stalled research toward new treatments contributed to the resurgence of the disease, and the development of increasingly drug-resistant strains, around the world. Bedaquiline, one of the drugs in the regimen, was the first new drug to receive regulatory approval in nearly half a century, when in 2012 the U.S. Food and Drug Administration approved its use for patients with drug-resistant tuberculosis. The BPaMZ regimen also includes pretomanid — an investigational drug developed by TB Alliance, moxifloxacin — a repurposed antibacterial medicine, and pyrazinamide, an established drug used in standard treatment. Over the months to come, the trial will enroll patients at sites in South Africa, Tanzania, Malaysia, Russia, the Philippines, Uganda, Thailand, Ethiopia and Brazil.