Abstract
Antimicrobial resistance is a major public health problem globally. Likewise, forms of tuberculosis (TB) resistant to first- and second-line TB medicines present a major challenge for patients, healthcare workers and healthcare services. In November 2019, the World Health Organization (WHO) convened an independent international expert panel to review new evidence on the treatment of multidrug- (MDR) and rifampicin-resistant (RR) TB, using the Grading of Recommendations Assessment, Development and Evaluation approach.Updated WHO guidelines emerging from this review, published in June 2020, recommend a shorter treatment regimen for patients with MDR/RR-TB not resistant to fluoroquinolones (of 9–11 months), with the inclusion of bedaquiline instead of an injectable agent, making the regimen all oral. For patients with MDR-TB and additional fluoroquinolone resistance, a regimen composed of bedaquiline, pretomanid and linezolid may be used under operational research conditions (6–9 months). Depending on the drug-resistance profile, extent of TB disease or disease severity, a longer (18–20 months) all-oral, individualised treatment regimen may be used. In addition, the review of new data in 2019 allowed the WHO to conclude that there are no major safety concerns on the use of bedaquiline for >6 months’ duration, the use of delamanid and bedaquiline together and the use of bedaquiline during pregnancy, although formal recommendations were not made on these topics.The 2020 revision has highlighted the ongoing need for high-quality evidence and has reiterated the need for clinical trials and other research studies to contribute to the development of evidence-based policy.
Highlights
Antimicrobial resistance is a major public health problem globally and has become a health security concern worldwide [1, 2]
For patients with Multidrug resistant (MDR)-TB and additional fluoroquinolone resistance, a regimen composed of bedaquiline, pretomanid and linezolid may be used under operational research conditions (6–9 months)
PICO question: in MDR/RR-TB patients, does an all-oral treatment regimen lasting 9–12 months and including bedaquiline safely improve outcomes when compared with other regimens conforming to World Health Organization (WHO) guidelines? The evidence reviewed on the shorter all-oral bedaquiline-containing regimen was derived from programmatic data from South Africa’s Electronic Drug-Resistant Tuberculosis Register. 10 152 records of patients with MDR/RR-TB initiating TB treatment anytime between January and June 2017 were available, of which 891 patients who received an all-oral bedaquiline-containing shorter regimen were included in the primary analyses
Summary
Antimicrobial resistance is a major public health problem globally and has become a health security concern worldwide [1, 2]. In MDR/RR-TB patients, does an all-oral treatment regimen lasting 9–12 months and including bedaquiline safely improve outcomes when compared with other regimens conforming to WHO guidelines?. A combination of exact matching and propensity score-based matching on several variables (covariates) was used to minimise bias and TABLE 2 Scoring of outcomes considered relevant by the World Health Organization convened guideline development group for the evidence review for the 2020 update on multidrug/ rifampicin-resistant tuberculosis (TB) treatment. GRADE evidence profiles were discussed by the GDG before the development of “evidence to decision (EtD)” frameworks These frameworks captured the judgements of the GDG in selected areas that relate to the PICO questions and the evidence presented, including but not limited to the desirable and undesirable effects of the intervention; the balance of these effects; the certainty of the evidence; the effect of the intervention on resource use, equity, feasibility and acceptability; and the value that people would place on the outcomes of interest. The GRADE evidence tables and EtD frameworks are available in their entirety in the guideline annexes [37]
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