WHO updates treatment guidelines for multidrug-resistant TB

Adrian Thomas MD Johnson & Johnson
Adrian Thomas

WHO announced changes to treatment guidelines for multidrug-resistant tuberculosis.

“The treatment landscape for patients with multidrug-resistant tuberculosis (MDR-TB) will be dramatically transformed for the better,” Soumya Swaminathan, MD, WHO Deputy Director-General for Programs, said in a news release.

A new priority ranking of available medicines for MDR-TB was “based on a careful balance between expected benefits and harms,” WHO said. The preferred options for treatment now include a fully oral regimen.

To prepare countries to implement the changes, WHO released a rapid communication to explain the new priority ranking of available drugs for MDR-TB.

Longer MDR-TB regimens were broken down into three groups. Group A medicines levofloxacin/moxifloxacin, bedaquiline and linezolid, are prioritized. Medicines in Group B include clofazimine and cycloserine/terizidone. Finally, when agents from Group A and Group B cannot be used, drugs from Group C — including ethambutol, delamanid, pyrazinamide, imipenem-cilastatin, meropenem, amikacin (streptomycin), ethionamide/prothionamide and p-aminosalicylic acid — can also be included to complete the regimen.

WHO no longer recommends kanamycin and capreomycin because, when used in longer MDR-TB regimens, they have an increased risk of treatment failure and relapse.

The new guidelines prioritize oral drugs, such as bedaquiline, and minimize injectables, which can cause patients pain and distress and serious adverse events that lead to interruption of treatment, WHO said.

WHO also based the rankings on the results of drug-susceptibility testing (DST), the reliability of existing DST methods, population drug resistance levels, history of previous use of medicines in a patient, drug tolerability and potential drug-drug interactions.

In a statement, Doctors Without Borders praised WHO’s revamped treatment regimen and called upon Johnson & Johnson to lower the price of bedaquiline, the first drug specifically developed to treat MDR-TB. The drug is made by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

“At Johnson & Johnson, ensuring access to bedaquiline for eligible patients is our top priority and a responsibility we take very seriously,” Adrian Thomas, MD, vice president of global public health and access at Johnson & Johnson, told Infectious Disease News.

“That’s why in July 2018 — inspired by South Africa’s leadership and commitment to replace less effective and toxic injectable drugs with bedaquiline for all patients with MDR-TB — we announced that we will reduce the price of bedaquiline to $400 for South Africa. In anticipation of other countries following their lead and to catalyze further action against MDR-TB, we will also offer the same special effort price to eligible national treatment programs and [nongovernment organizations] procuring through the Stop TB Partnership’s Global Drug Facility.”

Later this year, WHO said the “consolidated, updated and more detailed” MDR-TB treatment policy guidelines will be released. On September 26, 2018, world leaders will meet in New York for the first-ever United Nations General Assembly high-level meeting on tuberculosis.

“Building on the available new data, and with the involvement of a large number of stakeholders, WHO has moved forward in rapidly reviewing the evidence and communicating the key changes needed to improve the chances of survival of MDR-TB patients worldwide,” Swaminathan. “Political momentum now needs to urgently accelerate if the global crisis of MDR-TB is to be contained.” – by Marley Ghizzone

Reference:

WHO. Rapid communication: Key changes to treatment of multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB). http://www.who.int/tb/publications/2018/rapid_communications_MDR/en/. Accessed Aug. 21, 2018.

Disclosures: Swaminathan works for WHO. Thomas works for Johnson & Johnson.

Adrian Thomas MD Johnson & Johnson
Adrian Thomas

WHO announced changes to treatment guidelines for multidrug-resistant tuberculosis.

“The treatment landscape for patients with multidrug-resistant tuberculosis (MDR-TB) will be dramatically transformed for the better,” Soumya Swaminathan, MD, WHO Deputy Director-General for Programs, said in a news release.

A new priority ranking of available medicines for MDR-TB was “based on a careful balance between expected benefits and harms,” WHO said. The preferred options for treatment now include a fully oral regimen.

To prepare countries to implement the changes, WHO released a rapid communication to explain the new priority ranking of available drugs for MDR-TB.

Longer MDR-TB regimens were broken down into three groups. Group A medicines levofloxacin/moxifloxacin, bedaquiline and linezolid, are prioritized. Medicines in Group B include clofazimine and cycloserine/terizidone. Finally, when agents from Group A and Group B cannot be used, drugs from Group C — including ethambutol, delamanid, pyrazinamide, imipenem-cilastatin, meropenem, amikacin (streptomycin), ethionamide/prothionamide and p-aminosalicylic acid — can also be included to complete the regimen.

WHO no longer recommends kanamycin and capreomycin because, when used in longer MDR-TB regimens, they have an increased risk of treatment failure and relapse.

The new guidelines prioritize oral drugs, such as bedaquiline, and minimize injectables, which can cause patients pain and distress and serious adverse events that lead to interruption of treatment, WHO said.

WHO also based the rankings on the results of drug-susceptibility testing (DST), the reliability of existing DST methods, population drug resistance levels, history of previous use of medicines in a patient, drug tolerability and potential drug-drug interactions.

In a statement, Doctors Without Borders praised WHO’s revamped treatment regimen and called upon Johnson & Johnson to lower the price of bedaquiline, the first drug specifically developed to treat MDR-TB. The drug is made by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

“At Johnson & Johnson, ensuring access to bedaquiline for eligible patients is our top priority and a responsibility we take very seriously,” Adrian Thomas, MD, vice president of global public health and access at Johnson & Johnson, told Infectious Disease News.

“That’s why in July 2018 — inspired by South Africa’s leadership and commitment to replace less effective and toxic injectable drugs with bedaquiline for all patients with MDR-TB — we announced that we will reduce the price of bedaquiline to $400 for South Africa. In anticipation of other countries following their lead and to catalyze further action against MDR-TB, we will also offer the same special effort price to eligible national treatment programs and [nongovernment organizations] procuring through the Stop TB Partnership’s Global Drug Facility.”

Later this year, WHO said the “consolidated, updated and more detailed” MDR-TB treatment policy guidelines will be released. On September 26, 2018, world leaders will meet in New York for the first-ever United Nations General Assembly high-level meeting on tuberculosis.

“Building on the available new data, and with the involvement of a large number of stakeholders, WHO has moved forward in rapidly reviewing the evidence and communicating the key changes needed to improve the chances of survival of MDR-TB patients worldwide,” Swaminathan. “Political momentum now needs to urgently accelerate if the global crisis of MDR-TB is to be contained.” – by Marley Ghizzone

Reference:

WHO. Rapid communication: Key changes to treatment of multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB). http://www.who.int/tb/publications/2018/rapid_communications_MDR/en/. Accessed Aug. 21, 2018.

Disclosures: Swaminathan works for WHO. Thomas works for Johnson & Johnson.