Bedaquiline, new pill to treat MDR-TB, to arrive in India soon
CHENNAI, February 7, 2016: Bedaquiline, a new drug to treat extensively drug-resistant tuberculosis (XDR-TB), will soon be introduced in government facilities at selected centres across the country, according to the Indian Council of Medical Research (ICMR).
Arrival of the drug, on the WHO’s list of Essential Medicines, is the first new tuberculosis drug to be approved by the United States’ Federal Drug Administration in over 40 years. It is set to bring hope to thousands affected by the drug-resistant disease. Tuberculosis, with nine million new infected cases reported every year globally, is a disease particularly widespread in the Indian sub-continent. Official figures put the numbers in India alone at nearly 25% of the total population, with a large percentage of multidrug-resistant tuberculosis (MDR-TB) and XDR-TB cases. “The drug will be introduced on a pilot project in Chennai, Bombay, Delhi, Guhawati and in hospitals in Gujarat soon. In Chennai, the drug will be introduced in Government Hospital for Thoracic Medicine, Tambaram,” said Dr Sowmya Swaminathan, director general, ICMR. The WHO has granted a conditional recommendation for the inclusion of Bedaquiline in the adult treatment regiment of MDR-TB.
“Since the burden of MDR-TB is huge in India, we have waived clinical trial of the drug. It is not tested on the Indian population. But we will adhere to WHO recommendations or guidelines. Each and every patient will be followed up throughout the regimen period for two years and we will monitor them closely. Since the drug will be introduced in the Revised National Tuberculosis Control Programme. There will not be any problem,” Sowmya added.
The drug however does not come without its share of controversy. While widely touted as a miracle drug for patients for whom no other drugs work, its approval by the US’ FDA in 2012 brought along with it reports that the drug could lead to a higher risk of mortality. The drug consequently comes with a black-box warning of the risks involved (QT prolongation and increased mortality) and has been recommended only for use when other treatment regimens are ineffective. The ICMR Chief, however, maintained that the pilot project would be expanded only after a proper study of the results. MDR-TB is a form of TB caused by the mycobacterium tuberculosis strain, resistant to rifampicin and isoniazid – more common tuberculosis drugs.
Dr Sowmya was speaking at a three-day International seminar on “Prevention and Control of Non Communicable Diseases”, organised by Madras Diabetes Research Foundation. She was also conferred the ‘Eleventh MDRF-UAB-FIU Gold Medal Oration Award’.
KNOW YOUR DRUG
Bedaquiline is the first new tuberculosis drug to be approved by the US Federal Drug Administration in over 40 years.
It is an antimycobacterial drug that operates by a new mechanism of action: it inhibits mycobacterial ATP synthetase and depletes cellular energy stores.
Has the capacity to retain activity against some M tuberculosis isolates, which are resistant to other drugs.
It provides treatment option for patients with multidrug-resistant pulmonary tuberculosis when an effective multidrug treatment regimen cannot otherwise be constructed.
Drug’s adverse effects include nausea, joint and chest pain, and headache. It also has a black-box warning for death and arrhythmias.
Source: The New Indian Express
