Drug Resistant Tuberculosis (DR-TB)

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In 2018 WHO regrouped medicines into three categories (A, B and C) and ranked them based on the latest evidence about the balance of effectiveness to safety. Injectables are no longer recommended for DR-TB treatment and have been phased out in Malawi. 

Group A: levofloxacin/moxifloxacin, bedaquiline and linezolid. These are medicines that must be prioritized for the standardized DR-TB regimen

Group B: clofazimine, cycloserine/terizidone. These are the medicines to be added next for the standardized DR-TB regimen

Group C: ethambutol, delamanid, pyrazinamide, imipenem-cilastatin, meropenem, amikacin (streptomycin), ethionamide/prothionamide, p-aminosalicylic acid. These are the medicines to be included to complete the regimens and when agents from Groups A and B cannot be used.

Imipenem-cilastatin and meropenem not recommended in Malawi due to cost and complexities of administration. p-aminosalicylic acid and amikacin (streptomycin) not recommended in Malawi due to relative ineffectiveness and risk of toxicity. Ethambutol, delamanid and pyrazinamide can be used under specified conditions (see below);

For DR-TB patients without Fluoroquinolone (FQ) resistance for both adults and children;

  • All oral, longer treatment regimen (LTR) for 18-20 months, containing at least 4 active medications from Group A, B, and C
  • The regimen for Malawi comprises six months of Bedaquiline (Bdq), Levofloxacin (Lfx), Linezolid (Lzd), Clofazimine (Cfz) and Cycloserine (Cs) followed by 12-14 months of Levofloxacin, Linezolid, Clofazimine and Cycloserine
  • Standardized regimen for DR-TB patients without Fluoroquinolone (FQ) resistance for both adults and children: 6 Bdq-Lfx-Lzd-Cfz-Cs/12-14 Lfx-Lzd-Cfz-Cs. Delamanid to be used in place of Bedaquiline in children under six years.

For MDR/RR-TB patients with FQ resistance (Pre-XDR-TB) or resistance to second-line medications, the following regimen could be applied for both adults and children;

  • This is an individualized regimen that must be designed based on the resistance pattern of the TB strain, tolerance to the available medicines and treatment history
  • Examples of medicines that can be considered include Bedaquiline (Bdq), Delamanid (Dlm), Ethionamide (Eto), Moxifloxacin (Mfx) and Prazinamide (Z)
  • The regimen must be for a total duration of 18-20 months long. If Bedaquiline is considered, it must be restricted to the first 6 months .