Drug-resistant tuberculosis treatment

Table 3.3. Serious adverse events in patients on longer MDR-TB regimens
a
Medicine
Absolute risk of serious adverse event
Median (%)
95% credible interval
Bedaquiline
2.4
[0.7, 7.6]
Moxifloxacin
2.9
[1.4, 5.6]
Amoxicillin–clavulanic acid
3.0
[1.5, 5.8]
Clofazimine
3.6
[1.3, 8.6]
Ethambutol
4.0
[2.4, 6.8]
Levofloxacin
4.1
[1.9, 8.8]
Streptomycin
4.5
[2.3, 8.8]
Cycloserine or terizidone
7.8
[5.8, 10.9]
Capreomycin
8.4
[5.7, 12.2]
Pyrazinamide
8.8
[5.6, 13.2]
Ethionamide or prothionamide
9.5
[6.5, 14.5]
Amikacin
10.3
[6.6, 17.0]
Kanamycin
10.8
[7.2, 16.1]
P-aminosalicylic acid
14.3
[10.1, 20.7]
Thioacetazone
14.6
[4.9, 37.6]
Linezolid
17.2
[10.1, 27.0]
GDG: Guideline Development Group; IPD: individual patient data: MDR-TB: multidrug-resistant tuberculosis; TB: tuberculosis.
a
From an “arm-based network” meta-analysis of a patient subset from the 2016 IPD for which adverse events resulting in permanent 
discontinuation of a TB medicine (27 studies) or classified as Grade 3–5 (three studies) were reported. There are slight differences between 
the final estimates cited in the resultant publication (72) and the values derived at the time of the GDG and shown in this table, because 
an expanded dataset was used in the publication; however, the slight differences have no impact on the conclusions drawn on the use 
of these medicines. There were insufficient records on delamanid, imipenem–cilastatin and meropenem to estimate risks. Agents that 
are not in Groups A, B or C are
italicized.

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Recommendations 
32
In 2018, the GDG recommended that, where possible, regimens be composed of all three Group A 
agents and at least one Group B agent, so that treatment starts with at least four medicines likely to 
be effective, and that at least three agents are continued for the remaining duration of treatment if 
bedaquiline is stopped after 6 months. New evidence on the safety profile of bedaquiline use beyond 
6 months was available to the GDG in 2019. This evidence supports the safety of using bedaquiline 
beyond 6 months in patients who receive appropriate schedules of baseline and follow-up monitoring. 
If only one or two Group A agents can be used, both Group B agents are included. If the regimen 
cannot be composed with agents from Groups A and B alone, Group C agents are added to complete 
it. For patients in whom two agents from Group A are more likely to be stopped before the