Preliminary results of a quasi-experimental study of treatment of rifampin-resistant tuberculosis with an all-oral regimen containing new drugs in Zhytomyr oblast, Ukraine

Objective — to study preliminary effectiveness among patients with RR-TB in Zhytomyr Oblast, who were prescribed treatment with an all-oral 9 to 12-month regimen containing bedaquiline (and delamanid).Materials and methods. The design is a quasi-experimental prospective operational research in Zhytomyr Oblast implemented in partnership with and with the technical assistance from MSF (Charitable Fund «Medecins Sans Frontieres-Belgium») and is a part of scientific and research work of the SI «National Institute of Phthisiologyand Pulmonology named after F.G. Yanovsky of the NAMS of Ukraine». Preliminary results were obtained from 74 RR-TB patients who consented to participate in the study and initiated treatment since March 2019 and have results at the 6th month after its start. The following treatment algorithm was used: patients with no signs of resistance to fluoroquinoloneswere prescribed bedaquiline, levofloxacin, clofazimine, cycloserine, and linezolid; if fluoroquinolones resistance wasdisco-vered, levofloxacin was changed to delamanid.Results and discussion. The following results were obtained during first 6 months: 65 patients comple-ted 6 months of treatment; 1 patient switched to an individualized treatment regimen due to linezolid and fluoroquinolones resistance; 8 patients died due to progressive TB. It was found that during this period, culture of all patients who completed the first 6 months of treatment converted to negative (or culture was negative from the start and during following months of treatment). 54 patients with a positive baseline culture converted after an average of 2.0 (IQR: 1.0—2.9) months. 14 (19.0 %) patients had severe adverse events, including 9 patients who died or early completed treatment with short regimens under study. Neither severe adverse event is linked to direct effect of new drugs.Conclusions. The threshold for continuation of the operational research study has been met; 100 % (> 60 %) of patients with a positive baseline culture converted by six months, and 19 % (< 25 %) had severe adverse events.