Feedback
High treatment success rates shown for the BPaLM and BPaL regimens in the Nix-TB study and in the ZeNix and TB-PRACTECAL trials, and favourable comparison with the current SoC regimens led to thorough discussions during the GDG meeting of an overall recommendation for implementation under routine programmatic conditions and of the implementation considerations for this regimen.
Based on the decisions taken during the review and the combination of assessments described above, the new recommendation is to use the BPaLM regimen as the first choice in the defined patient group with MDR/RR-TB, with the regimen to be used under routine programmatic conditions. Patients with MDR/RR-TB who are not eligible for this regimen can be treated using one of the 9-month regimens (see Section 2).
This section provides the PICO questions posed, the data and studies considered to answer the questions, the methods used for analysis and data synthesis, a summary of evidence on desirable and undesirable effects and certainty of evidence, and a summary of other evidence considered during development of the recommendation.
Drug-resistant tuberculosis (DR-TB) continues to be a public health problem, taking a heavy toll on patients, communities and health care systems. Recent global estimates indicate that there were about half a million new cases of multidrug- or rifampicin-resistant TB (MDR/RR-TB) in 2018, with less than 40% of the estimated burden being notified and 32% reported to have started second-line treatment (1). Current treatment regimens for MDR/RR-TB patients are far from satisfactory.
Tuberculosis (TB) strains that are resistant to TB medicines are more difficult to treat than drug-susceptible ones, and present a major challenge for patients, health care workers and health care services. In addition, the increase of drug-resistant TB (DR-TB) threatens global progress towards the targets set by the End TB Strategy4 of the World Health Organization (WHO).
Bacteriologically confirmed: when a biological specimen is positive by smear microscopy, culture or a rapid diagnostic test for tuberculosis (TB) recommended by the World Health Organization (WHO).
Clinically diagnosed: when a person who does not fulfil the criteria for bacteriological confirmation has been diagnosed with TB disease by a medical practitioner who has decided to give the person a full course of TB treatment.
The recommendations and remarks in the current module on the treatment of drug-resistant tuberculosis (DR-TB) are the result of collaborative efforts of professionals from a range of specialties who have extensive expertise and experience in public health policy, tuberculosis (TB) programme management, and the care and management of patients with DR-TB and multidrug-resistant TB (MDR-TB). The recommendations herein have been developed through several meetings of the Guideline Development Group (GDG) and have then been consolidated in the present module.
