2425.  Frequency of symptoms and treatment discontinuation during programmatic use of the 12-dose Isoniazid-Rifapentine Regimen for Treatment of Latent Tuberculosis Infection
Session: Poster Abstract Session: Tuberculosis: Epidemiology and Management
Saturday, October 7, 2017
Room: Poster Hall CD
  • IDSA 3HP poster 2017_10 FINAL.pdf (677.0 kB)
  • Background: Treating Latent Tuberculosis Infection (LTBI) is important for TB elimination. In the Prevent TB trial, the 12-dose isoniazid-rifapentine (3HP) regimen had a higher completion rate than the 9-month isoniazid regimen (9H). 3HP had less hepatotoxicity than 9H, but possible hypersensitivity reactions occurred in 4% of persons receiving 3HP. A post-marketing assessment was conducted in part to identify factors associated with treatment discontinuation during programmatic use of 3HP.

    Methods: We followed patients who received 3HP prospectively at 16 U.S. program sites between 06/2011-12/2013. All sites reported demographics, weekly symptoms (Sx) while on 3HP, and treatment outcomes. Ten sites also reported co-morbid conditions and concomitant medications. We performed descriptive analyses, and did multivariable logistic regression to identify factors independently associated with treatment discontinuation.

    Results: Among 3288 patients who received ≥1 3HP dose, 2867 (87%) completed treatment--median age 36 (5–91), 53% male, 23% Hispanic, 36% Black, 22% White and 60% U.S.-born. 1174 (36%) reported > 1 Sx. 246 (8%) patients stopped treatment after Sx began; of these, 152 reported onset of Sx < 48 hours after dosing. Frequent Sx included nausea/vomiting (15%), fatigue (12%), and myalgia (8%). No single Sx was significantly associated with treatment discontinuation. Likelihood of stopping 3HP increased with the number of Sx reported after a dose [RR 1 Sx 1.8 (1.4, 2.4) vs RR >2 Sx 7.5 (6.2, 9.1)]. 14 patients had hepatitis, 8 had hypotension (SBP<90mmHg); 3 reported hypersensitivity Sx. 26 patients were hospitalized (may be unrelated to 3HP); no permanent sequelae or deaths were reported. Of the 2389 patients with detailed medical information, 33% reported ≥1 underlying medical condition. Patients with diabetes, homelessness, incarceration, or excessive alcohol use were not more likely to report Sx. Higher rates of Sx were reported with certain concomitant medications.

    Conclusion: Programmatic use of 3HP was associated with a high rate of LTBI treatment completion. Discontinuation due to Sx while on therapy, and possible hypersensitivity reactions occurred at rates similar to those previously reported. TB programs should consider use of the 3HP regimen for LTBI treatment.

    Shu-Hua Wang, MD, MPH, PharmD1, Christine Ho, MD, MPH2, Nwabunie Nwana, MPH2, Ruth Moro, MD, MPH2, Sapna Morris, MD, MBA3, Mark Lobato, MD, MPH2, Amy Sandul, CIP, MPH, DHSc2, John A. Jereb, MD, FAAP4, Mike Holcombe, MPPA, CPM5, Lynn Sosa, MD6, Vernard Green, MSPH2, Sundari Mase, MD, MPH7, Brock Stewart, PhD2, Terence Chorba, MD, DSc, MPH, MPA, FACP, FIDSA2, Risa Webb, MD, DTMH, FIDSA8 and The 3HP Post-Marketing Assessment Group, (1)Division of Infectious Disease, The Ohio State University Wexner Medical Center, Columbus, OH, (2)Division of Tuberculosis Elimination, CDC, Atlanta, GA, (3)Division of TB Elimination, Centers for Disease Control and Prevention, Atlanta, GA, (4)Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, GA, (5)Mississippi State Department of Health, Jackson, MS, (6)Connecticut Department of Public Health, Hartford, CT, (7)Dtbe/Fseb, Centers for Disease Control and Prevention, Atlanta, GA, (8)University of Mississippi Medical Center, Jackson, MS


    S. H. Wang, None

    C. Ho, None

    N. Nwana, None

    R. Moro, None

    S. Morris, None

    M. Lobato, None

    A. Sandul, None

    J. A. Jereb, None

    M. Holcombe, None

    L. Sosa, None

    V. Green, None

    S. Mase, None

    B. Stewart, None

    T. Chorba, None

    R. Webb, None

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 4th with the exception of research findings presented at the IDWeek press conferences.