New Three-Drug Regimen Provides Cure for Drug-Resistant Tuberculosisadmin
Tuberculosis has surpassed AIDS as the world’s leading infectious cause of death, and the XDR strain is even more deadly. While only a tiny fraction of people infected by TB are infected by this strain, very few of them survive it, according to The New York Times. Traditionally, treatment regimens are exceptionally difficult to administer, with some including taking up to 40 pills a day for two years or daily injections of antibiotics that can lead to devastating side effects.
But now, the Food and Drug Administration has endorsed a three drug regimen that consists of five pills taken every day for six months and has shown a 90 percent success rate against this deadly and drug-resistant strain of tuberculosis.
“The threat of antimicrobial-resistant infections is a key challenge we face as a public health agency,” FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. said in a statement. “The bacterium that causes tuberculosis can develop resistance to the antibiotics used to treat it. Multidrug-resistant TB and extensively drug-resistant TB are public health threats due to limited treatment options. New treatments are important to meet patient national and global health needs. That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections.”
Dubbed the Nix-TB regimen, this treatment consists of three different drugs – bedaquiline, a drug approved in several high-TB disease burden countries; pretomanid, an antibacterial compound which is currently undergoing multiple clinical trials for TB treatment; and linezolid, an oxazolidinone that has been used off-label to treat TB, according to the TB Alliance.
While this regimen does show promise, some advocacy groups argue the FDA should insist on more rigorous testing, since the initial study including a little over 100 patients. “Pretomanid looks like a promising drug, but it’s being rushed forward, and we don’t want to see the FDA lower the bar for approval,” Linday McKenna, co-director of the tuberculosis project at the Treatment Action Group, said in July, according to the Times. Others are concerned about prolonged exposure to linezolid, which has been known to kill nerves in the feet and suppress the development of bone marrow.
Read a full report on the Nix-TB trial in the New York Times.