Safety and Efficacy of Rifampin or Isoniazid among People with Mycobacterium tuberculosis Infection and Living with Human Immunodeficiency Virus or Other Health Conditions: Post Hoc Analysis of 2 Randomized Trials

Abstract

Background: The safety and efficacy of rifampin among people living with human immunodeficiency virus (PLHIV) or other health conditions is uncertain. We assessed completion, safety, and efficacy of 4 months of rifampin vs 9 months of isoniazid among PLHIV or other health conditions. Methods: We conducted post hoc analysis of 2 randomized trials that included 6859 adult participants with Mycobacterium tuberculosis infection. Participants were randomized 1:1 to 10 mg/kg/d rifampin or 5 mg/kg/d isoniazid. We report completion, drug-related adverse events (AE), and active tuberculosis incidence among people living with HIV; with renal failure or receiving immunosuppressants; using drugs or with hepatitis; with diabetes mellitus; consuming >1 alcoholic drink per week or current/former smokers; and with no health condition. Results: Overall, 270 (3.9%) people were living with HIV (135 receiving antiretroviral therapy), 2012 (29.3%) had another health condition, and 4577 (66.8%) had no condition. Rifampin was more often or similarly completed to isoniazid in all populations. AEs were less common with rifampin than isoniazid among PLHIV (risk difference,-2.1%; 95% confidence interval [CI],-5.9 to 1.6). This was consistent for others except people with renal failure or on immunosuppressants (2.1%; 95% CI,-7.2 to 11.3). Tuberculosis incidence was similar among people receiving rifampin or isoniazid. Among participants receiving rifampin living with HIV, incidence was comparable to those with no health condition (rate difference, 4.1 per 1000 person-years; 95% CI,-6.4 to 14.7). Conclusions: Rifampin appears to be safe and as effective as isoniazid across many populations with health conditions, including HIV. Clinical Trials Registration: NCT00170209; NCT00931736.