Safety & Benefits of Directly Observed Therapy with Rifapentine and Isoniazid for Latent Tuberculosis Infection – Less is More?

Abstract

BackgroundLatent tuberculosis infection (LTBI) treatment is essential in preventing the reactivation of tuberculosis. We compared the clinical and demographic characteristics of patients that have completed traditional therapy with 9 months of isoniazid (9H) with those that have completed 3 months of rifapentine plus isoniazid using directly observed therapy (3HP), focusing on adverse effects, a barrier to completion that may contribute to discontinuation of therapy.MethodsWe conducted a retrospective chart review (July 2013-March 2017) to compare the 9H group and 3HP group. Demographic and clinical variables were described by therapy type and groups were compared using Fisher’s exact test or t-test, as appropriate.ResultsPatients in the study sample (n = 124) had a mean age of 49.8 (SD=14.8) years old. Approximately half received 3HP (n = 64, 51.6%). Demographics in the 3HP and 9H groups were similar. Significantly more patients in the 3HP group completed treatment (81.3% vs. 61.7%, P < 0.0001). No patients were lost to follow-up in the 3HP group, 14 (23.33%) were lost in the 9H group. Gastrointestinal (GI) upset (n = 16), elevated liver function tests (LFTs) (n = 11), and headaches (n = 9) were the most frequent side effects. Except for neuropathy and pancreatitis, all other adverse side effects had higher incidence in the 3HP group. Specifically, the incidence of GI symptoms (23.4% vs. 1.7%, P = 0.0003), weakness (9.4% vs. 0%, P = 0.028), and headache (14.1% vs. 0%, P = 0.003) were significantly higher in the 3HP group. Of the observed patients with adverse reactions that received 3HP, 88.24% (n = 30) had them resolved within the first two weeks.ConclusionThe 3HP group had a higher completion rate and no loss to follow-up compared with 23% loss to follow-up in the 9H group, however, adverse reactions were significantly higher in the 3HP group. Closer weekly monitoring of the 3HP group could lend itself to capturing more adverse reactions, however, 88% of those adverse reactions resolved within the first two weeks of therapy. Liver function tests were not significantly different (P = 0.2079) between the two groups, and were mildly elevated. We conclude that three months of rifapentine plus isoniazid for the treatment of LTBI may be a favorable option over the traditional 9 months of isoniazid in certain populations.Disclosures All authors: No reported disclosures.