Abstract
The introduction of the nine-month short-treatment regimen (STR) has drastically improved outcomes of rifampicin-resistant tuberculosis (RR-TB) treatment. Adverse events (AE) commonly occur, including injectable-induced hearing loss. In Burundi we retrospectively assessed the frequency of adverse events and treatment modifications in all patients who initiated the STR between 2013–2017. Among 225 included patients, 93% were successfully treated without relapse, 5% died, 1% was lost-to-follow-up, 0.4% had treatment failure and 0.4% relapsed after completion. AE were reported in 53%, with grade 3 or 4 AE in 4% of patients. AE occurred after a median of two months. Hepatotoxicity (31%), gastro-intestinal toxicity (22%) and ototoxicity (10%) were most commonly reported. One patient suffered severe hearing loss. Following AE, 7% of patients had a dose reduction and 1% a drug interruption. Kanamycin-induced ototoxicity led to 94% of modifications. All 18 patients with a modified regimen were cured relapse-free. In this exhaustive national RR-TB cohort, RR-TB was treated successfully with the STR. Adverse events were infrequent. To replace the present STR, all-oral regimens should be at least as effective and also less toxic. During and after transition, monitoring, management, and documentation of AE will remain essential.
Highlights
Tuberculosis (TB) is among the lead causes of deaths caused by antimicrobial resistance
Among drugs used in short-treatment regimen (STR), second-line injectables have the highest risk of severe Adverse events (AE) leading to treatment discontinuation (capreomycin (Cm) 8.2%, kanamycin (Km) 7.5%), while others have a lower risk (moxifloxacin (Mfx) 2.9%, clofazimine (Cfz) 1.6%, levofloxacin 1.3%) [7]
We aimed to describe the time course of AE, regimen modifications and resulting changes in AE grading in patients who started the rifampicin-resistant tuberculosis (RR-TB) STR between May 2013 and December 2017 in Burundi
Summary
Tuberculosis (TB) is among the lead causes of deaths caused by antimicrobial resistance. While 484,000 people developed drug rifampicin-resistant tuberculosis (RR-TB) in 2018, only 187,000 were detected and notified, and 156,000 started treatment. Short treatment regimens (STR), based on the so-called “Bangladesh regimen”, showed over 80% treatment success [2,3], compared to 75% of patients treated with longer individualised regimens [4]. Among drugs used in STR, second-line injectables have the highest risk of severe AE leading to treatment discontinuation (capreomycin (Cm) 8.2%, kanamycin (Km) 7.5%), while others have a lower risk (moxifloxacin (Mfx) 2.9%, clofazimine (Cfz) 1.6%, levofloxacin 1.3%) [7]. The WHO recommended phasing out injectable drugs in favor of all-oral short or long individualised regimens containing bedaquiline, depending on baseline resistance [9].
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