LIFT-TB PHILIPPINES SHARES CLINICAL EXPERIENCE IN
BPAL OPERATIONAL RESEARCH IN THE 53rd UNION WORLD
CONFERENCE ON LUNG HEALTH
Dr Irene Flores, Principal Investigator of the BPaL OR, presented the preliminary clinical experience from the implementation of the Bedaquiline-Pretomanid-Linezolid (BPaL) Operational Research (OR) in the Philippines, along with researchers from South Africa, Kyrgyzstan, Ghana and Ecuador. This was during one session at the 2022 Union World Conference on Lung Health held virtually on 8 November 2022 chaired by TB Alliance Medical Officer Dr. Salah Foraida.
Philippines is one of the 7 countries which uses BPaL, a 6-month novel short all-oral regimen, under OR following the successful findings of the Nix-TB trial showing BPaL’s high treatment success rate for highly drug-resistant TB and following WHO guidelines to implement BPaL under OR conditions released in June 2020.
Dr Flores presented early results of the 77 enrolled patients as of August 2022. Most of the patients belonged to the economically productive age group, most of whom were males. Forty-eight percent (n=37) were intolerant to previous MDR-TB treatment and 47 % (36) were fluoroquinolone-resistant (Fq-R). The three commonly observed adverse events of special interest (AESIs) among patients who had completed treatment were peripheral neuropathy (21, 68%), myelosuppression (16, 52%) and hepatotoxicity (15, 48%), majority of which were mild and did not need any clinical intervention. Treatment outcomes in 20 patients revealed 45% cured, and 55% treatment completed with no loss-to follow-up, failures nor deaths. Dr Flores highlighted that clinical dilemmas are among the most important challenges in the OR, mostly from adverse events owing to Linezolid being given at a high dose of 1200 mg. However, with a reduced Linezolid dose to 600 mg, AEs are expected to be lesser. Nonetheless, close monitoring of AESIs especially peripheral neuropathy and myelosuppression, need to be in place.
Meantime, the BPaL OR in the Philippines has enrolled close to a hundred patients in 10 DR-TB treatment facilities across the country, the country’s enrolment target. The Department of Health is now planning on the transition to programmatic use of BPaL in line with the WHO Rapid Communication released in May 2022. Before the end of the year, WHO is expected to release its updated Consolidated Guidelines and Operational Handbook for Drug-resistant TB.