Clinical Trial for Drug-Sensitive and Drug-Resistant TB Regimen Evaluated Shorter Regimens 

SEATTLE (February 20, 2023)—Results of TB Alliance’s SimpliciTB clinical trial were presented today at the 30th annual CROI 2023 conference. SimpliciTB was conducted to evaluate the BPaMZ regimen, consisting of bedaquiline (B), pretomanid (Pa), moxifloxacin (M), and pyrazinamide (Z). This combination previously showed high efficacy and treatment shortening potential in both preclinical evaluations and an early-stage clinical study in drug-resistant patients.

SimpliciTB enrolled 455 patients with drug-susceptible (DS) or drug-resistant (DR) tuberculosis (TB) at 26 sites across eight countries: South Africa, Tanzania, Georgia, Brazil, Russia, the Philippines, Uganda, and Malaysia.¹ The clinical trial was designed to evaluate the safety and efficacy of BPaMZ in patients with either DS-TB or DR-TB. As presented at CROI, the results of the trial showed that the BPaMZ regimen was highly potent against the TB bacteria, meeting its primary endpoint with DS-TB participants 2.93 times more likely to culture convert by week 8. However, the 4-month experimental BPaMZ regimen did not meet the secondary endpoint of noninferiority in percent favorable outcomes compared to 6 months of HRZE in DS-TB. This was due to adherence challenges, with approximately 10% of patients on the BPaMZ arms discontinuing treatment due to side effects.¹

“Innovative clinical trials like SimpliciTB help us better understand how novel drug regimens work against both drug-sensitive and drug-resistant TB, lighting the way to better treatment options for all people with TB,” said Dr. Muge Cevik, infectious diseases clinician and researcher at the University of St. Andrews and presenter of the SimpliciTB trial results at CROI 2023.

In 2021, 10 million people were infected with TB and about 1.6 million people died. It is estimated that about 500,000 people every year are infected by a drug-resistant form of the disease, and in some regions as many as 40% of all cases are drug-resistant.² Novel drug regimens are urgently needed to help bring the TB pandemic under control.

TB Alliance plans to submit data from SimpliciTB to a peer-reviewed publication – https://www.tballiance.org.za/news/tballiance-simplicitb-results-croi-2023