The international medical humanitarian organisation Médecins Sans Frontières (MSF) has welcomed the World Health Organisation (WHO)'s interim policy guidance on the use of bedaquiline, a new TB drug in 50 years, which was granted accelerated approval by the United States Food and Drug Administration (FDA) in December 2012.
“The new WHO guidelines on bedaquiline use are welcomed, and are very timely given the drug’s recent approval by the US FDA and the urgent need to scale-up treatment of drug-resistant TB. Regulated, controlled use of bedaquiline is essential in ensuring we don’t burn one of the very few drugs available that could effectively treat drug-resistant TB,” Dr Jennifer Cohn, medical co-ordinator, MSF Access Campaign, said.
The WHO in its 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). It lists five conditions that must be in place if bedaquiline is used to treat adults with MDR-TB.
The treatment must be closely monitored for effectiveness and safety, using sound treatment and management protocols approved by relevant national authorities; special caution is required when bedaquiline is used in people aged 65 and over, and in adults living with HIV; use in pregnant women and children is not advised; patients must be fully aware of the potential benefits and harms of the new drug, and give documented informed consent before embarking on treatment; all principles on which WHO-recommended MDR-TB treatment regimens are based, must be followed, particularly the inclusion of four effective second-line drugs. In line with general principles of TB therapeutics, bedaquiline alone should not be introduced into a regimen in which the companion drugs are failing to show effectiveness; and active pharmacovigilance measures must be in place to ensure early detection and proper management of adverse drug reactions and potential interactions with other drugs.
Commenting further on the WHO guidance, the MSF said that as one of the biggest NGO providers of DR-TB treatment, it sees people with increasingly drug-resistant forms of the disease, and without the development of new drugs that could, in combination with other drugs, result in shorter, more effective and less toxic regimens, DR-TB will continue to grow as a global emergency.
Acknowledging the growing crisis of multi-drug-resistant TB (MDR-TB) and the urgent need for improved drugs with better efficacy and safety profiles, WHO has taken an unprecedented step to make interim recommendations about a drug based on phase IIb clinical trial data. Given the risk-benefit considerations for many people living with MDR-TB, MSF applauds this strong move to accelerate improved treatment to those who need it most, the MSF said.