Research priorities

The GDGs discussed future research and highlighted a number of priorities.

1. The effectiveness of fixed-dose combination TB treatment when compared to separate drug formulations in patients with DS-TB disease

  • Additional research on the reasons why FDC formulations did not show a clear benefit over separate drug formulations.
  • Pharmacokinetic studies of the bioavailability of FDCs versus separate drug formulations and better development of weight band categories for drug dosing.
  • The optimal dose of rifampicin, including the use of different drug formulations in all age groups.
  • Additional qualitative studies detailing adherence to medication.
  • Additional work on FDC formulations to further decrease the pill burden, especially among patients with comorbidities.

2. The use of steroids in the treatment regimen of extrapulmonary TB disease

  • The optimal steroid dose for TB meningitis (including different drug formulations).
  • The optimal steroid duration for TB meningitis and if this duration differs between different grades of meningitis.
  • The different effects of steroids on people who are HIV-positive or HIV-negative, or who are being treated (or not) with ART.
  • The relationship between steroid treatment and cancer risk, with reference to the Mayosi et al. study on pericarditis [50].

3. 4-month regimen of isoniazid, rifapentine, moxifloxacin and pyrazinamide for drug-susceptible pulmonary TB

  • Acquisition of drug resistance for Mycobacterium tuberculosis and for other bacteria while on treatment with a 4-month regimen.
  • The efficacy of the regimen for patients with extra-pulmonary TB.
  • Pharmacokinetic, safety and tolerability studies in younger adolescents and children. A pharmacokinetic sub-study in adults was initiated alongside the trial, and the results were expected within months of the GDG meeting.
  • The cost-effectiveness of the shorter regimen.
  • Considerations regarding the impact of the 4-month regimen on equity.
  • The acceptability of the shorter 4-month regimen, particularly for patients.
  • The use of this regimen in specific subgroups - including pregnant and lactating women, children aged less than 12 years, HIV-positive individuals with a CD4 count lower than 100 cells/mm³, people with diabetes mellitus and people with a body weight less than 40 kg.
  • Dosing considerations for people weighing less than 40 kg.
  • The use and acceptability of FDC formulations for the shorter 4-month regimen.
  • Operational research on directly observed treatment versus self-administered therapy.
  • Treatment adherence and completion in operational settings.

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