WHO issues interim guidance on tuberculosis drug
The interim guidance provides advice on the inclusion of bedaquiline in the combination therapy of MDR-TB in accordance with the existing WHO Guidelines for the Programmatic Management of Drug-resistant TB (2011 Update).
The WHO guidance, which was made available to the Ghana News Agency on Thursday estimates that up to half a million new cases of occur worldwide, each year.
It said current treatment regimens for MDR-TB present many challenges such as treatment lasting for 20 months or more, requiring daily administration of drugs that are more toxic, less effective, and far more expensive than those used to treat drug-susceptible TB.
It said globally, less than half of all patients who start MDR-TB therapy are treated successfully.
“For the first time in over 40 years, a new TB drug with a novel mechanism of action – bedaquiline- is available, and was granted accelerated approval by the United States Food and Drug Administration in December 2012.
“There is considerable interest in the potential of this drug to treat MDR-TB. However, information about this new drug remains limited.
“It has only been through two Phase IIb trials for safety and efficacy,” the guidance stated.
The interim guidance lists five conditions that must be in place if bedaquiline is used to treat adults with MDR-TB: Effective treatment and monitoring, proper patient inclusion and informing patients of the potential benefits and harms of the new drug and their consent taken before embarking on treatment.
Others are adherence to WHO recommendations and active pharmacovigilance and management of adverse events.
WHO strongly recommends the acceleration of Phase III trials to generate a more comprehensive evidence base to inform future policy on bedaquiline.
The Organisation will review, revise, or update the interim guidance as additional information on efficacy and safety become available.
WHO is also developing an operational document to facilitate bedaquiline implementation and is working with partners to help ensure rational introduction.