In a “rapid communication”, WHO has informed all member States to take “immediate steps” to ensure that all injectables are replaced with a fully-oral regimen that includes bedaquiline to treat all MDR-TB patients. The guidelines, to be published later this year, are based on assessment of new evidence on the safety and efficacy of bedaquiline drug.
The “treatment landscape” for patients with multidrug-resistant TB (MDR-TB) is all set to be “dramatically transformed” following the recent communication by the World Health Organisation’s (WHO). Based on assessment of new evidence, the WHO has made an important change in the regimen to treat patients with MDR-TB (resistant to at least two of the first-line drugs — isoniazid and rifampicin). All injectables are to be replaced with a fully oral regimen to treat MDR-TB patients. And the powerful alternative drug bedaquiline, which was specifically developed for treating MDR-TB patients after more than 40 years, has been included in the fully oral regimen.
Injectables (kanamycin and capreomycin) to treat MDR-TB can cause serious adverse effects such as deafness leading to many patients discontinuing treatment midway. As per the 2017 WHO Global TB report, the current treatment success rate for MDR-TB is only 54% globally. Replacing these injectables with bedaquiline will therefore lead to major improvement in treatment outcomes and quality of life of patients.
While the new guidelines for MDR-TB treatment will be released later this year, the “rapid communication” issued by the WHO is to inform member States to take “immediate steps” to ensure MDR-TB patients receive treatment in accordance to the latest evidence on drug effectiveness and safety.
The formal review of the 2016 WHO guidelines was prompted by evidence of effectiveness and safety of drugs from several clinical trials, observational studies and programmatic implementation of new regimens to treat MDR-TB patients.
WHO’s interim guidelines recommended that the drug be given to MDR-TB patients only as a last resort as large-scale clinical trials (Phase III) using bedaquiline have not been carried out. In Phase IIb trials, the drug was found to have cardio-toxicity. There was also increased number of deaths during the trials.
South Africa is already on track to meet the WHO guidelines to be published later this year. It was the first country to scale up access to bedaquiline to make MDR-TB treatment more tolerable and reduce the devastating adverse effects of injectables. In June, South Africa said bedaquiline would replace injectables for treating all MDR-TB patients. In July, South Africa struck a deal with the drug manufacturer Johnson & Johnson to halve the price of the drug — from about $750 to $400 — for a six-month course of treatment. The company has committed to offer the drug at $400 to India, over 50% cheaper than the earlier price of $900 negotiated with the government two years ago.
As per WHO Global TB Report 2017, India had an estimated 84,000 MDR/rifampicin-resistant-TB new cases in 2016 among those notified. And based on the first-ever drug susceptibility testing on nearly 5,000 TB patients (new and previously treated) carried out in India between 2014 and 2016, 6.19% were found to be multidrug-resistant.
India has been getting bedaquiline drug courses for free under conditional access programme the USAID programme, which will end next year. India has got nearly 11,000 drug courses free from the company under this programme.