An analysis of treatment outcomes at 12 months, a secondary endpoint, showed that there were five cases of treatment failure, including three in the control arm and one each in 15- and 20-mg/kg arms, and six cases of recurrence after cure, which occurred in three, one, and two patients, respectively,
The safety analysis by intention-to-treat showed that the incidence of grade 2 or greater rifampin-related adverse events (AEs) were 43.3%, 51.7%, and 38.3% in the 10-, 15-, and 20-mg/kg doses, differences that were not statistically significant.
In addition, there were no significant differences among the treatment arms in either time to first grade 2 or greater rifampin-related AEs, the occurrence of one or more grade 2 or greater hepatic rifampin-AEs, or time to first hepatic rifampin-related AEs of grade 2 or above.
Dr. Velásquez noted that the study was limited by the possibility that the study halts could have biased efficacy effect estimates toward null and by differences in weight distribution among the three treatment arms.
