US Food and Drug Administration (US FDA) has approved bedaquiline, the first new drug active against tuberculosis (TB) to be registered since 1963. Welcoming the approval, Dr Manica Balasegaram, Executive Director, MSF Access Campaign said, “The first new drug to treat TB in 50 years is an immense milestone. The fact that the drug is active against drug-resistant forms of the disease makes it a potential game changer.”
In addition to bedaquiline, developed by Janssen (brand name:Sirturo), a second new drug that is active against MDR-TB called delamanid, developed by Otsuka, is undergoing registration by the European Medicines Agency and is expected to be approved for use in 2013. An MSF release stresses that together, the two new drugs represent an unprecedented opportunity to improve treatment for MDR-TB, and ensuring the drugs are combined and introduced in the most effective manner is extremely urgent.
Balasegaram added, “Ministries of health and drug regulators need to work together to make sure people with MDR-TB benefit from this important medical advance as soon as possible. The onus is on all of us to use bedaquiline to devise new treatment regimens for drug-resistant TB that are shorter, more tolerable for patients, and are more effective. With better treatment on the way, there should be all the more incentive to scale up our efforts to treat MDR-TB today.”
“Scale-up of global DR-TB treatment has remained shockingly low, to a large degree because the current treatment regimen is so complex and costly for health programmes and difficult to tolerate for patients. With simpler, shorter and more effective treatment regimens, we will be able to scale-up treatment and cure more people with DR-TB,” said Dr Francis Varaine, Leader of MSF’s TB Working Group.
Today’s treatment for multi-drug-resistant TB (MDR-TB) is a two-year course of up to 20 different pills per day and around eight months of daily injections. Patients are subjected to excruciating side effects, ranging from permanent deafness and persistent nausea to psychosis. Globally, only 48 per cent of people who start treatment for DR-TB are cured. In MSF programmes, the cure rate is slightly better – 53 per cent – but still unacceptably low.
MSF have called on the manufacturers to make the drugs available for research in order to develop shorter, more effective regimens, to register them in high-burden countries as quickly as possible once they have been approved, and to ensure they are affordable in countries where they are needed most.
India scenario
According to the MSF release, India has the second highest multi-drug-resistant (MDR) TB burden in the world with nearly 66,000 new cases every year. More recently an increasing number of cases of not only multidrug-resistant TB (MDR-TB) but also extensively drug-resistant tuberculosis (XDR-TB), an even more severe form of drug resistant (DR) TB are being documented in India. This new drug comes at a time when patients diagnosed with extreme forms of drug-resistant tuberculosis (XDR-TB) desperately need more options.
The current treatment of DR-TB relies on old antibiotics-many of which have severe side effects, ranging from constant nausea, deafness and psychosis. Patients must receive 6 months of painful injections and take up to 17 pills every day for up to two years.
According to Leena Menghaney, India Campaign Manager, MSF Access Campaign, “The challenge for governments like India and treatment providers like us is to use bedaquiline in combination with other drugs to devise new treatment regimens for drug-resistant TB that are shorter, more tolerable for patients, and are more effective.
She opines that the Indian Ministry of Health, RNTCP and the Drug Controller General of India (DCGI) have several challenges before them. They need to put in the necessary regulatory framework for compassionate use to ensure that XDR TB patients left with few treatment options can access new TB drugs like bedaquiline free of charge while the formalities for local registration in India are completed in the coming years.
MSF is equally worried about the indiscriminate use of TB drugs in the private sector and the inconsistent and poor management of TB treatment which in the past have fuelled drug resistance in the country, with DR TB acquiring the shape of a serious public health challenge in India. Patients who reach MSF’s clinic in Mumbai often arrive in very bad condition and some even die before they can start their treatment. A lot of them have already been treated in the private sector with inappropriate TB drug regimens. Often, there is a lack of monitoring among treatment providers to ensure that patients are able to take their drugs continuously.
With such a ground reality, she feels that the Indian health ministry and DCGI should take measures in advance to prevent indiscriminate prescription and sale of new TB drugs by the private sector to preserve their efficacy and avoid fuelling resistance.
EP News Bureau – Mumbai
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