Efficacy of 4-Month Short-Course Drug-Susceptible Tuberculosis Treatment Regimens : A Systematic Review of Randomized Controlled Trials and Primary Studies
Abstract
Background: Tuberculosis (TB) remains the leading global infectious disease killer. The standard 6-month drug-susceptible tuberculosis (DS-TB) regimen—comprising rifampicin, isoniazid, pyrazinamide, and ethambutol—presents challenges in adherence, programmatic burden, and patient quality of life. Shorter treatment regimens, particularly 4-month regimens, have been investigated as potential alternatives to enhance treatment completion and reduce disease burden.1,2 Methods: The study strictly adhered to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) 2020 guidelines. Eligible studies included phase 2–3 RCTs, subgroup analyses, pooled analyses studies involving adults or children with newly diagnosed DS-PTB receiving any 4-month treatment regimen compared to standard 6-month therapy. Sixteen studies encompassing 3 landmark phase 3 RCTs, multiple subgroup analyses, pooled analyses, were included. Risk of bias was assessed using the Cochrane Risk of Bias 2.0 (RoB 2.0) tool. GRADE certainty ratings were applied to key outcomes.3,4 Results: Sixteen studies met inclusion criteria, representing data from more than 15,000 patients across multiple international settings. The landmark Study 31/A5349 (Dorman et al., 2021) demonstrated that the 4-month regimen comprising rifapentine (RPT), moxifloxacin (MOX), isoniazid (INH), and pyrazinamide (PZA) achieved non-inferiority to the standard 6-month regimen for the primary efficacy outcome (unfavorable outcome…
How strong is the evidence?
Evidence Hub reads this as a systematic review, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 15,000 participants or records.
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