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Rifampin for 4 months preferred to isoniazid for 9 months for latent TB in high-risk patients
Clinical Question
For the treatment of latent tuberculosis, how does 4 months of rifampin compare with 9 months of isoniazid with respect to effectiveness, compliance, and adverse events?
Bottom line
In high-risk patients with latent tuberculosis (TB), 4 months of rifampin provides greater adherence, equivalent efficacy, and better safety than the current standard of 9 months of isoniazid. A similar study in children found the same thing: similar efficacy and safety, and better adherence (N Engl J Med 2018;379:454-63). 1b
Reference
Study design: Randomized controlled trial (single-blinded)
Funding: Government
Setting: Population-based
Synopsis
Nine months is a long time, especially to take a medication like isoniazid when you feel fine. As a result, adherence to this regimen for the treatment of latent TB is poor. This trial recruited adults from 9 countries with a positive TB skin test or interferon-gamma release assay result, who did not have active TB but were at increased risk of reactivation (eg, those who were immunocompromised, had a body mass index of less than 19 kg/m2, or had close contact with a person with active TB). A total of 6063 patients, with a mean age of 38 years, were randomized to receive standard therapy with 9 months of isoniazid (5 mg/kg, maximum dose 300 mg) once daily or rifampin (10 mg/kg, maximum dose 600 mg) once daily for 4 months. Patients were seen regularly for evaluation of signs of active TB and were followed up for up to 28 months. For patients lost to follow-up, the local TB program was contacted to determine whether they were receiving active therapy. Nearly 90% had a TB skin test reaction of 10 mm or more, and the most common risk factor for active TB was confirmed active TB in a close contact or household member. At the end of the study period, patients in the rifampin group were significantly more likely to have completed their course of therapy (78.8% vs 63.2%; P < .001; number needed to treat = 7). Among the 92% of patients for whom there was 28-month follow-up data, there was no significant difference between groups with regard to the number of cases of confirmed active TB (9 in the isoniazid group and 8 in the rifampin group). Comparing events during the first 4.5 months of treatment, serious adverse events (2.0% vs 0.9%; P < .001; number needed to treat to harm [NNTH] = 91) and hepatotoxic events (1.7% vs 0.3%; P < .002; NNTH = 71) were significantly less likely in the rifampin group.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Comments
I have been working in TB campaign for nearly four years. I always use 9 months Isoniazid regime for high risk patients . Some times I found poor complain in the patient as the course is too long. After knowing Rifampin 4 month course has more benefit I can apply it to my practice.
Excellent