Executive summary

Tuberculosis (TB), with an estimated incidence of 10 million people every year (range 8.9–11.0 million), is a major cause of ill health and one of the leading causes of death worldwide. Until the coronavirus disease (COVID-19) pandemic, TB was the leading cause of death from a single infectious agent, ranking above HIV, with an estimated 1.2 million TB deaths among people who are HIV-negative (range, 1.1–1.3 million), and an additional 208 000 deaths among people who are HIV-positive (range, 177 000– 242 000). Of the estimated 10 million cases, about 70% are diagnosed and treated, and reported to the World Health Organization (WHO), resulting in 7.1 million TB notifications by national TB programmes (NTPs). Of the 7.1 million people notified in 2019, 5.9 million (84%) had pulmonary TB.²

For several decades, WHO has developed and issued recommendations for the treatment of TB. WHO published recommendations for treating people suffering from drug-susceptible TB (DS-TB) in 2010,³, with updates in 2017⁴ and 2022. A focus of the 2010 and 2017 guidelines was a 6-month treatment regimen comprising four first-line TB medicines (i.e. isoniazid, rifampicin, pyrazinamide and ethambutol) recommended for treatment of DS-TB. This regimen is well known and has been widely adopted worldwide for decades; about 85% of patients on this regimen have a successful treatment outcome. The regimen is based on seminal TB treatment studies conducted by the Medical Research Council of the United Kingdom of Great Britain and Northern Ireland in the second half of the 20th century.⁵ The 2010 WHO guidelines and the 2017 update also included several recommendations on the modalities and formulations used for treatment, frequency of treatment administration, special situations and patient care during treatment. The 2022 WHO consolidated guidelines on tuberculosis Module 4: Treatmentdrug-susceptible tuberculosis treatment consolidates all valid and evidencebased recommendations from the 2010 guidelines and the 2017 guideline updates; it also includes a new section stemming from the most recent round of guidelines development – the recommendation for two 4-month regimens for the treatment of DS-TB.⁶,,

This document, the WHO operational handbook on tuberculosis Module 4: Treatment – drug-susceptible TB treatment, has been developed in the context of the End TB Strategy, which recommends treatment and care for all people with TB.⁹ It aims to use the best available evidence on the treatment of DS-TB to inform policy decisions made by NTP managers, national policy-makers and medical practitioners in all geographical, economic and social settings.

² Global tuberculosis report 2021. Geneva: World Health Organization; 2021
(https://www.who.int/publications/i/item/9789240037021.
³ Treatment of tuberculosis: guidelines – 4th ed. (WHO/HTM/TB/2009.420). Geneva: World Health Organization; 2010
(https://apps.who.int/iris/handle/10665/44165).
⁴ Guidelines for treatment of drug-susceptible tuberculosis and patient care, 2017 update. Geneva: World Health Organization; 2017
(https://apps.who.int/iris/handle/10665/255052).
⁵ Fox W, Ellard GA, Mitchison DA. Studies on the treatment of tuberculosis undertaken by the British Medical Research Council
tuberculosis units, 1946–1986, with relevant subsequent publications. Int J Tuberc Lung Dis. 1999;3(10 Suppl 2):S231–79
(https://pubmed.ncbi.nlm.nih.gov/10529902/).
⁶ WHO consolidated guidelines on tuberculosis Module 4: Treatment – drug-susceptible tuberculosis treatment, 2022 update. Geneva:
World Health Organization; 2022.
⁷ WHO consolidated guidelines on tuberculosis Module 5: Management of tuberculosis in children and adolescents. Geneva:
World Health Organization; 2022 (https://www.who.int/publications/i/item/9789240046764).
⁸ WHO operational handbook on tuberculosis Module 5: Management of tuberculosis in children and adolescents. Geneva:
World Health Organization; 2022 (https://apps.who.int/iris/bitstream/handle/10665/352523/9789240046832-eng.pdf).
⁹ The End TB Strategy (WHO/HTM/TB/2015.19). Geneva: World Health Organization; 2015
(https://www.who.int/publications/i/item/WHO-HTM-TB-2015.19).

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