COMMENTARY

This Novel, 1-Month Regimen to Prevent TB Is Practice-Changing

Paul E. Sax, MD

Disclosures

March 26, 2018

Hi. This is Dr Paul Sax from Brigham and Women's Hospital and Harvard Medical School. The Conference on Retroviruses and Opportunistic Infections (CROI) took place in March in Boston. I think the most important study[1] presented at this conference is interesting not just for those who provide care for those with HIV, but for all clinicians. It's a study about tuberculosis (TB) prevention.

This study (called BRIEF-TB) looked at an experimental way of preventing TB that didn't consist of the 9-month isoniazid course that we all know is rarely completed by patients. Instead, BRIEF-TB looked at a novel, 1-month approach of daily isoniazid and rifapentine. The study was conducted in 3000 people with HIV in multiple countries around the world, mostly in high-prevalence TB areas. The patients were randomized to receive either the standard 9-month isoniazid course or daily isoniazid plus weight-based rifapentine. At baseline, about half of the patients were receiving antiretroviral therapy. Patients were eligible for the study if they had either a reactive tuberculin skin test or a positive interferon gamma release assay, or if they lived in one of the very-high-prevalence-TB nations.

The good news is that after 3 years of follow-up, the likelihood of TB, TB-related death, or death from any cause was similar in both the experimental 1-month arm and the standard 9-month arm. There was a bit more hematologic toxicity with the 1-month treatment course and more hepatic toxicity with the 9-month isoniazid course; and not surprising, more people finished the 1-month course than the 9-month course. Another observation in the study was that people who had a reactive tuberculin skin test or positive gamma interferon release assay were more likely to develop TB, as were those who had a CD4 cell count of < 250 cells/mm3.

The results of this study are really practice-changing. It wouldn't surprise me at all if this 1-month isoniazid/rifapentine regimen becomes the standard of care for preventing TB in people with HIV, with the caveat that rifapentine, like rifampin, interacts with many antiretroviral agents. The big question for the field of infectious disease and TB prevention more globally is whether this short-course regimen is actually applicable to people who are HIV uninfected. There is no reason to think biologically that it wouldn't work as well, if not better, in people without HIV. But some people I spoke to were not quite willing to extrapolate the results of the study to people without HIV.

That's a summary of the BRIEF-TB study, presented for the first time at CROI. I hope you found the study as interesting as I did. We'll hear much more about it when it is published. Thanks very much for listening.

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