Source/Disclosures
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Disclosures:
Haley reports receiving honoraria from IDSA for an IDWeek 2022 presentation, travel support from the University of Employer, and having Pfizer stock ownership. Please see the study for all other authors’ relevant financial disclosures.
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Key takeaways:
- BPaL — bedaquiline, pretomanid and linezolid — is the first novel tuberculosis regimen in decades.
- BPaL shortens treatment times significantly and has “exceptional” cure rates.
BPaL shortens treatment times significantly and shows few adverse effects in patients with drug-resistant tuberculosis, according to data published in Clinical Infectious Diseases.
“Drug-resistant TB (DR-TB) is a deadly infectious disease that has been extremely difficult to cure. BPaL (bedaquiline, pretomanid and linezolid) is the first novel TB regimen in decades, and the US was the first country to approve it,” Connie Haley, MD, MPH, a medical consultant at the Southeastern National Tuberculosis Center at the University of Florida, told Healio.
Researchers determined that BPaL is a safe and effective treatment for patients with drug-resistant tuberculosis and can also shorten patient treatment times significantly. Image: Adobe Stock.
According to Haley, when BPaL was approved by the FDA in 2019, there were no other treatments for highly drug-resistant TB proven in clinical trials. She added that treatment for DR-TB at that time typically lasted 15 months to 2 years, caused significant side effects, and cured only about 60% of those treated, while the treatment time with BPaL is 6 months, and has “exceptional cure rates .”
“US TB experts recognized the value of this regimen immediately,” she said, adding that within a few months after FDA approval, they began to cautiously use BPaL.
The BPaL Implementation Group, “BIG,” which included DR-TB experts from around the United States, was formed to evaluate implementation of this regimen in a real-world setting.
Haley and members of BIG gathered data from US patients treated with BPaL between Oct. 14, 2019, and April 30, 2022, and analyzed their baseline examination and laboratory, electrocardiographic and clinical monitoring throughout treatment and follow-up data.
In total, 70 patients who started BPaL were assessed. Of these 70, 68 (97.1%) completed BPaL, though two patients relapsed after completion.
Researchers found that the average time from first dose to last dose was 26.9 weeks, although 10 patients had their BPaL duration extended to more than 39 weeks for bone involvement, extensive TB disease/delayed culture conversion, or non-adherence.
Of the patients in the cohort, four with baseline anemia required a blood transfusion during linezolid treatment and one patient discontinued linezolid at week 23 of BPaL.
One of these patients with a high linezolid trough reported blurry vision that resolved with transfusion and change to linezolid three times weekly. Two patients also discontinued linezolid prematurely for worsening peripheral neuropathy despite and another developed neurologic symptoms. According to the study, symptoms in the patient who developed neurologic symptoms resolved with a change from linezolid 600 mg daily to TIW and the patient completed a full course of BPaL.
Numbness and tingling of extremities were also reported in five patients but did not require linezolid dose or frequency adjustment.
The researchers noted that other side effects included gastrointestinal symptoms (n=14), rashes (n=8) and anxiety (n=4).
“BPaL has become the US standard of care for people with drug-resistant TB. This is a game changer for a neglected disease,” Haley said. “It has taken us 5 decades to bring about new drugs and regimens that can be effective against TB and drug-resistant TB. We really cannot afford to settle for the typical delay of almost 2 decades from discovery to implementation into practice. Millions of individuals living with TB and their families have been waiting too long.”
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