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New Guideline Emphasizes Treatment of Drug-Resistant Tuberculosis with All-Oral Regimens for MDR-TB Patients
The American Thoracic Society, Centers for Disease Control and Prevention, European Respiratory Society and the Infectious Diseases Society of America have published an official clinical guideline on the treatment of drug-resistant tuberculosis (DR-TB) in the Nov. 15 American Journal of Respiratory and Critical Care Medicine. The guideline makes new recommendations for the choice and number of drugs, as well as the duration of treatment for DR-TB. These recommendations prioritize the use of medications that can be administered orally.
The guideline makes clear that treatment should be tailored based on drug-susceptibility testing, and that individuals should not receive medicines to which the Mycobacterium tuberculosis strain is resistant.
The guideline includes additional key recommendations. It recommends treatment of all infected contacts of multidrug-resistant tuberculosis (MDR-TB) patients, rather than watchful observation, and it provides initial evidence-based guidance for the treatment of pregnant women with MDR-TB for the first time.
Treatment for MDR- and extensively drug-resistant (XDR)-TB is long and difficult. The availability of potent new and repurposed medicines allows practitioners, for the first time, to choose alternatives to injectable drugs, which have long been considered an essential component of treatment regimens for DR-TB. These injectable drugs have well-known toxicities, including irreversible hearing loss. By prioritizing the use of orally administered medicines, the guideline writing committee believes clinicians can spare patients some of the most debilitating effects of TB treatment, make treatment more tolerable and improve outcomes.
The guideline committee included specialists in pulmonary medicine, infectious diseases, pediatrics, primary care, public health, epidemiology, economics, pharmacokinetics, microbiology, systematic review methodology and advocacy. This guideline is generally consistent with the World Health Organization’s recommendations but includes some different recommendations that are specifically tailored to low-incidence, higher-resource countries of North America and Europe.
In making its recommendations, the committee reviewed findings from 50 studies, conducted in 25 countries involving more than 12,000 patients with DR-TB. The committee grouped questions to be answered by the guideline into six topics:
1) number of effective drugs in a regimen for DR-TB, duration of intensive and continuation phases of treatment for DR-TB;
2) review of drug and drug classes for the treatment of DR-TB;
3) the use of a standardized, shorter-course regimen of < 12 months for the treatment of MDR-TB;
4) treatment of isoniazid-resistant, rifampin-susceptible TB;
5) surgery as adjunctive therapy for MDR-TB; and
6) treatment of contacts of persons with MDR-TB.
The committee used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework to indicate the strength of the evidence supporting the 25 recommendations included in the clinical guidance. An executive summary of the guideline, as well as the full text of the guideline, can be found online.