WHO Recommends Worldwide Adoption Of All Oral-Regimen For MDR/RR-TB

The World Health Organization issued new guidelines for the treatment of multi drug-resistant (MDR) tuberculosis on Wednesday, prioritizing for the first time an all-oral treatment regimen. The new treatment recommends replacing the painful injectable drugs that patients had to endure under previous treatment guidelines with a shorter course of oral bedaquiline – one of only three new drugs approved for treatment of TB within the last half century.

A healthcare worker counsels a patient with MDR-TB

The update was announced in a rapid communication released by WHO after an independent panel reviewed new evidence on treating multi-drug resistant (MDR) and rifampicin-resistant (RR) TB in November. Compelling data from the South African TB programme, collected in collaboration with research and technical partners such as The Union, showed that replacing injectable drugs with oral bedaquiline resulted in significantly better treatment outcomes for patients with MDR/RR-TB. Not only that, but more patients also completed the full 9-month treatment when provided all-oral regimen.

“The Union supports the move towards shorter all oral treatment regimens with better outcomes, lower toxicity and reduced side effects for people with drug-resistant TB,” said Grania Bridge, director of the Department of TB at The Union said in a press release. “As new all-oral regimens are developed, there is a clear need for more and better evidence to support their implementation around the world.”

Much of the new recommendations were based on evidence coming out of traditional clinical trials and operational research – which tests the regimens that pass through clinical trials under real-life conditions, where barriers to health care, stigma, and other factors can contribute to the likelihood of patients successfully completing a full course of treatment. This is especially important to observe for the long 9 to 11-month treatment regimens recommended for MDR/RR-TB.

“The WHO rapid communication emphasizes the importance of operational research in generating high quality programmatic data,” said Bridge, highlighting the need for countries and funders to “prioritise operational research to guide future treatment guidelines, as well as complement the data expected from clinical trials currently underway.”

In the update, WHO also issued guidance for the BPAL regimen – a breakthrough regimen for treating XDR TB that just received regulatory approval from the US Food and Drug Administration this August. In the rapid communication, WHO recognized that the BPAL regimen showed high treatment success when used in 108 XDR-TB patients in South Africa, but has refrained from recommending programmatic implementation of the regimen worldwide until more evidence has been generated. For the time being, WHO recommends collecting more evidence for the BPAL regimen under operational research conditions conforming to WHO standards.

WHO is set to release the next full update of consolidated guidelines on the treatment of all forms of drug-resistant TB in March 2020. The rapid communication was preemptively issued in order to prepare national TB programmes and other key stakeholders for what changes they can expect, in order to roll out the new guidelines as quickly as possible.

Image Credits: WHO PAHO.