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BPaL treatment remains effective against tuberculosis, shows TB Alliance’s Zenix trial


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The results of the study were presented prior to the oral summary presentation at the 11th IASHIV Scientific Conference next week.

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

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

He added that the results of the tuberculosis alliance-led trial were announced prior to the oral summary presentation at the 11th HIV Science Conference next week.

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

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

“Until recently, patients with drug-resistant tuberculosis have been one of the most difficult infections to identify and treat, and have to suffer from as many as eight antibiotic combinations for over 18 months, some of which are daily. Some included injections of, “Spigelman added.

The statement also states that this Phase III clinical trial shows how a new 6-month triple-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 4-group randomized, double-blind study of linezolid dose and duration enrolling 181 highly drug-resistant tuberculosis patients in South Africa, Russia, Georgia, and Moldova. Of these participants, 36 (20 percent) were HIV positive. Patients have been treated with bedaquiline, pretomanid, 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 of treatment. The purpose of this study was to evaluate 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 (XDR) TB, pre-XDR-TB, or failed or refractory multidrug-resistant tuberculosis were enrolled. Participants who received the highest dose of linezolid (1200 mg for 6 months) had a success rate of 93%. Efficacy levels were similarly high in the remaining 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 the participants who received the drug. Linezolid for 2 months. Bedaquiline and pretomanid administration was consistent in the 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 as anemia showed that patients had reduced levels of hemoglobin associated with linezolid exposure (22% of patients who received 1200 mg linezolid for 6 months; 2 or 2 1200 mg linezolid. 17% of patients receiving 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 provide patients with high healing potential in just six months,” said the ZeNix clinical trial and South African clinical access program. Dr. Francesca Conradier, Principal Investigator, said. For the regimen.

The statement states that the TB Alliance will submit data from ZeNix to peer-reviewed publications.

BPaL treatment remains effective against tuberculosis, shows TB Alliance’s Zenix trial Source link BPaL treatment remains effective against tuberculosis, shows TB Alliance’s Zenix trial

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