The short treatment regimen (STR) achieves a >80% cure in
rifampicin-resistant
tuberculosis (RR-TB) patients. However,
ototoxicity induced by the
injectable is a concern. This is the first study to evaluate the replacement of
injectables by
linezolid in patients with audiometry abnormalities at baseline or during the treatment.We conducted a retrospective cohort study of all RR-TB patients started on the STR between 2016 and June, 2019, in Niger. Patients underwent audiometry every 2 months in 2016 and every month since 2017.Of 195 patients, 16.9% (33 out of 195) received
linezolid from the start (n=17), or switched from
injectables to
linezolid during treatment (n=16), based on audiometry abnormalities. In 2016, two patients developed severe
ototoxicity despite switching to
linezolid. Since 2017, no patient developed severe
hearing loss or complete
deafness. Severe haematological toxicity was observed in 18.1% (six out of 33) of patients on
linezolid, none of which was life threatening. The use of
linezolid was associated with severe but manageable adverse events (hazard ratio 8.9, 95% CI 2.5-31.5; p=0.001). A total of 90.9% (30 out of 33) of patients on a
linezolid-containing STR were cured, and none experienced treatment failure. Three died, but not due to adverse events.Baseline and monthly audiometry monitoring and using
linezolid after detection of hearing abnormalities appears effective to prevent severe
ototoxicity, while keeping high treatment success and manageable adverse events.