One-Month Regimen Noninferior for Preventing HIV-Related TB
THURSDAY, March 14, 2019 -- For HIV-infected patients, a one-month regimen of rifapentine and isoniazid is noninferior to nine months of isoniazid alone for preventing tuberculosis, according to a study published in the March 14 issue of the New England Journal of Medicine.
Susan Swindells, M.B., B.S., from the University of Nebraska Medical Center in Omaha, and colleagues conducted a randomized, open-label, phase 3 noninferiority trial involving 3,000 HIV-infected patients to compare the efficacy and safety of a one-month regimen of daily rifapentin plus isoniazid to that of nine months of isoniazid alone.
The researchers found that the primary end point (first diagnosis of tuberculosis or death from tuberculosis or unknown cause) was reported in 2 percent of patients in both the one-month group and the nine-month group, with incidence rates of 0.65 and 0.67 per 100 person-years, respectively (rate difference in one-month group, −0.02 per 100 person-years; upper limit of 95 percent confidence interval, 0.3). These findings met noninferiority criteria. Serious adverse events occurred in 6 and 7 percent of patients in the one-month and nine-month groups, respectively (P = 0.07). Significantly more patients completed treatment in the one-month versus the nine-month group (97 versus 90 percent; P < 0.001).
"Given the abundant evidence for the efficacy of rifapentine-containing regimens, advocacy to reduce the cost of this medicine should be supported and scaled up to improve access for patients who are most likely to benefit," write the authors of an accompanying editorial.
Sanofi provided rifapentine and financial support for the procurement of isoniazid.
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Posted: March 2019