BPaL treatment remains effective against tuberculosis, according to Zenix trial by TB Alliance

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The results of the study were presented ahead of the oral presentation of the abstract at the 11th IASHIV Scientific Conference next week.

The TB Alliance’s ZeNix trial in South Africa and Eastern Europe aimed to reduce linezolid exposure and optimize a 6-month treatment plan.

ZeNix, a Phase III clinical trial conducted at 11 sites in Georgia, Moldova, Russia and South Africa, found BPaL treatment to be at low dose or duration of the linezolid component of the regimen. At the same time, along with maintaining the efficacy, side effects related to linezolid were reduced.

He added that the results of the tuberculosis alliance trial were announced ahead of the summary’s oral presentation at the 11th HIV Scientific Conference next week.

The statement also received the first regulatory approval in August 2019 for the BPaL regimen, which is a combination of the antibiotics bedaquiline (B), pretomanide (Pa) and linezolid (L), for use against highly drug resistant M. tuberculosis. He says it was. Historically, treatment lasted for more than 18 months, with an average overall success rate of 43%.

“Currently, there is evidence that the BPaL diet can be optimized to make it even easier to use,” said Mel Spigelman, MD, president and CEO of TB Alliance, who developed the pretomanide for use in the drug. diet.

“Until recently, patients with drug-resistant TB were one of the most difficult infections to identify and treat, and had to undergo up to eight combinations of antibiotics for over 18 months, some of them daily. Some included injections of, ”added Spigelman.

The press release also specifies that this phase III clinical trial shows how a new 6-month tri-drug treatment for tuberculosis can be implemented by reducing the dose of linezolid. This regimen reduces the duration of treatment for drug-resistant tuberculosis from more than 18 months to 6 months.

The ZeNix trial was a randomized, double-blind, 4-arm dose and duration study of linezolid in 181 highly drug-resistant tuberculosis patients in South Africa, Russia, Georgia and Moldova. Of these participants, 36 (20%) were HIV positive. Patients have been treated with bedaquiline, pretomanide and linezolid at various doses and durations for 6 months, and so far follow-up studies have been reported up to the primary endpoint 6 months after completion. processing. The aim of this study was to assess whether the efficacy of the BPaL regimen could be maintained while reducing patient exposure to linezolid and its associated side effects.

In addition, the study reported that participants with extensive drug-resistant tuberculosis (XDR), pre-XDR-TB, or failed or refractory multidrug-resistant tuberculosis were recruited. Participants who received the highest dose of linezolid (1200 mg for 6 months) had a 93% success rate. Efficacy levels were equally high in the other groups, with 89% of participants receiving 1200 mg linezolid for 2 months, 91% of participants receiving 600 mg linezolid for 6 months, and 600 mg linezolid. It was reported that 84% of participants who received the drug. Linezolid for 2 months. The administration of bedaquiline and pretomanide was consistent in all four groups.

Adverse reactions reported in at least 10% of study participants included peripheral neuropathy (38% of patients receiving 1200 mg linezolid for 6 months and 1200 mg linezolid for 2 months). 24% of patients receiving 600 mg linezolid for 6 months; 13% of patients receiving 600 mg linezolid for 2 months). An assessment of myelosuppression manifested by anemia showed that patients had reduced hemoglobin levels associated with linezolid exposure (22% of patients who received 1200 mg linezolid for 6 months; 2 or 2100 mg linezolid linezolid. 17% of patients receiving linezolid monthly; 2% of patients receiving 600 mg linezolid for 6 months, 7% of patients receiving 600 mg linezolid for 2 months, according to a statement).

“The results of this study are encouraging. Reducing the dose and duration of linezolid can offer patients high healing potential in just six months, ”said the ZeNix clinical trial and the South African Clinical Access Program. Principal investigator Dr Francesca Conradier said. For the diet.

The statement says the TB Alliance will submit ZeNix data to peer-reviewed publications.