First Drug Approved Specifically for Multi-Drug Resistant Tuberculosis

By Sobieraj, Diana M. | Drug Topics, March 2013 | Go to article overview

First Drug Approved Specifically for Multi-Drug Resistant Tuberculosis


Sobieraj, Diana M., Drug Topics


NEW DRUG REVIEW

Late last year FDA approved bedaquiline (Suturo, Janssen Therapeutics) tablets for the treatment of pulmonary multi-drug-resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The accelerated approval was based on the end point of time to sputum culture conversion compared with placebo. Bedaquiline, a diaiylquinoline antimycobacterial drug, is recommended when other alternative treatments cannot be provided. It is not indicated for the treatment of latent, extra -pulmonary, or drug-sensitive TB.

In 201 1 TB affected more than 10,000 patients in the United States and almost 9 million woridwide, according to the Centers for Disease Control and Prevention. TB is caused by Mycobaderium tuberculosis and commonly infects one's lungs, but also may infect the brain, kidneys, and spine. MDR-TB is TB -resistant to isoniazid and rifampin. Although only 98 cases occurred in 201 1 in the United States, the World Health Organization estimates that MDR-TB will affect 2 million people from 2011-2015.

Bedaquiline is the first drug approved specifically for MDRTB and is used in combination with other antimycobacterial agents. Bedaquiline carries a boxed warning about the risk of QT prolongation and an increased risk of death as seen in one placebo-controlled trial. It should only be used when an effective drug regimen is not available or cannot be provided.

Efficacy

FDA approval of bedaquiline was based on data from TMC207C208 studies 1 and 2, with the primary end point being the time to sputum culture conversion. In study 1, a placebo-controlled, double-blind, randomized trial of newly diagnosed patients with MDR-TB, 79 patients received bedaquiline in combination with other drugs to treat MDR-TB and 81 received placebo and the combination of other drugs for MDR-TB, which included ethionamide, kanamycin, pyrazinamide, ofloxacin, and cycloserine/ terizidone or an available alternative. Bedaquiline was given at a dose of 400 mg once daily for the first 2 weeks of treatment and at a dose of 200 mg three times per week for another 22 weeks. After the 24- week treatment with bedaquiline, patients were continued on their other MDR-TB drugs for 18 to 24 months, or for another 12 months following the first confirmed negative culture. At 24 weeks, culture conversion success was demonstrated in 77.6% of patients who received bedaquiline combination treatment versus 57.6% of patients in the placebo group (P=0.014). At 72 weeks, culture conversion success was seen in 70. 1 % of the bedaquiline treatment group versus 56. …

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