Start of a new era in fight against drug resistant TB

WHO released a rapid communication on the treatment of drug resistant (DR) and extensively drug resistant (XDR) tuberculosis (TB). This puts an ‘end to tears’, for painful daily injections in the treatment of the most common forms of DR TB are no longer necessary. For XDR TB patients, the WHO provides the option of shortening the duration of treatment from 20 to only 6 months, using the new TB drug pretomanid in the so called BPaL regimen.

“This marks the start of a new era. We stand ready to support countries to phase out injectable based regimens and to introduce the BPaL regimen under operational research conditions; providing rapid life-saving treatment, while contributing to the global evidence on this new treatment regimen”, says Kitty van Weezenbeek, executive director of KNCV Tuberculosis Foundation.

This latest WHO rapid communication gives a ‘preview’ of the most important recommendations and considerations from the new consolidated WHO Guidelines for the management of DR and XDR TB, ahead of finalization in 2020.

DR TB: no more injectables

In many cases, TB can be cured with 6 months of antibiotic therapy, if properly diagnosed and treated. Some people however have forms of drug resistant TB (DR TB) that do not respond to 1 or more key antibiotics. DR TB affects over half a million people worldwide every year. For most of these patients only a painful and prolonged treatment is available, in many cases at least 9 months, including the use of daily injectables for 4 months or more. Currently the only alternative is an even longer fully oral regimen of 20 months duration.

For the first time WHO now recommends a fully oral regimen of only 9-12 months duration for the treatment of the most common forms of drug resistant TB. This is a welcome improvement for both patients and health care workers, who struggle to cope with the painful daily injections. KNCV welcomes the conditions for implementing this regimen, encouraging treatment providers as well as governments to invest in patient centered care with psychological and socio-economic support and active monitoring and management of adverse events during treatment and the follow-up period.

XDR TB: cured in 6 months

Extensively drug-resistant TB is resistant to the main first- and second-line drugs, making curative treatment particularly challenging. While the current treatment of XDR TB consists of 20 months treatment with around 6-7 different drugs a day, the TB Alliance has shown that a 6 month regimen with only 3 drugs – including the novel drug pretomanid developed by the TB Alliance – can achieve excellent treatment results. In August this treatment was approved by the U.S. Food & Drug Administration (FDA). As the regimen was tested in a limited population of people with highly treatment-resistant forms of tuberculosis, WHO requires countries to apply this regimen under operational research conditions.

KNCV has been at the forefront of the introduction of new drugs and regimens in eighteen countries under the USAID funded Challenge TB project (2015 – 2019). Over the last year KNCV collaborated with TB Alliance on acceptability and costing studies for the novel BPaL regimen in Indonesia, Kyrgyzstan and Nigeria, and is planning BPaL introduction in 9 countries in collaboration with national stakeholders. Under the TB REACH W7 KNCV supports BPaL introduction in Tajikistan and Ukraine.

KNCV stands ready to support countries to ensure access for all TB patients in need of oral shorter treatment, including the 6 month BPaL regimen. KNCV will work with countries to ensure state of the art clinical management, patient support and quality data collection during early implementation, thus contributing to the global body of evidence on this new treatment.