1636. Implemenation of the 12-dose Weeekly Isoniazid plus Rifapentine Regimen for Treatment of Latent Tuberculosis Infection in Arkansas: A Preliminary Report on Adverse Effects
Session: Poster Abstract Session: Mycobacterial Infections
Saturday, October 5, 2013
Room: The Moscone Center: Poster Hall C
Posters
  • Implementation of the 12 dose poster.png (334.3 kB)
  • Background:

    Arkansas is one of several sites in the U.S. that are collaborating under CDC guidance, to assess adverse events (AEs) associated with the 3-month isoniazid/rifapentine (3HP) regimen for treating latent tuberculosis infection (LTBI). We are reporting our preliminary findings for the period July 1, 2012 to March 31, 2013.

    Methods:

    All cases of LTBI are reportable to the TB Control Program. Directly observed therapy (DOT) is used for 3HP. The CDC developed a form to capture AEs data that is completed by a nurse at each weekly visit. We downloaded LTBI data from the TB Registry and the AEs data from the CDC designed Access database. The AEs were grouped by clinical syndromes as used in Study 26.

    Results:

    Since July 2012, a total of 796 cases of LTBI have been reported; the majority with a positive IGRA test.  Of these, 465 (58.4%) cases were offered 3HP, and 331 (41.6%) received the 9-month isoniazid regimen. For the 147 cases on 3HP with complete outcome information, 125 (85.0%) completed the regimen. Among the 22 who did not complete treatment, 9 stopped due to AEs (3 of 9 had more than 1 type AE), 4 stopped on their own, 6 were lost to follow-up, 2 were changed to isoniazid or rifampin, and 1 became pregnant. The frequencies of AEs were:  flu-like illness 24.0% (30 of 37 completed), gastrointestinal 24.0% (25 of 27 completed), and cutaneous 14.0% (14 of 18 completed). There have been no deaths or hospitalizations directly associated with 3HP. The 147 cases on 3HP with complete outcome information are similar to the 308 pending cases in terms of median age, but different by gender, and race/ethnicity.

    Conclusion:

    The completion rate of 85.0% for 3HP in this study is comparable to the completion rate of 82.1% for 3HP in Study 26, and is significantly higher than the average 55.0% completion rate for the 9-month isoniazid regimen that we have reported in Arkansas for the past 5 years. The frequencies of AE in Study 26 (abstract 2013) were much lower than what we have reported here; that is, 2.2% with flu-like illness, 0.2% gastrointestinal, and 0.6% with cutaneous manifestations. A possible explanation is that our project is specifically designed to assess these AE, whereas Study 26 was not. Arkansas has increasingly offered 3HP to LTBI cases, helped by the price of rifapentine dropping from $160 to $110 per course of treatment.

    Naveen Patil, MD MHSA MA1, Elizabeth Karpoff2, Leonard Mukasa, MBChB PhD3, Xiaoyan Egbe, BBA2, Nathaniel Smith, MD, MPH, DTM&H4 and Joseph Bates, MD, MS4, (1)TB, HIV, STD, Hepatitis, Arkansas Department of Health, Little Rock, AR, (2)TB, Arkansas Department of Health, Little Rock, AR, (3)Tuberculosis Control Program, Arkansas Department of Health, Little Rock, AR, (4)Arkansas Department of Health, Little Rock, AR

    Disclosures:

    N. Patil, None

    E. Karpoff, None

    L. Mukasa, None

    X. Egbe, None

    N. Smith, None

    J. Bates, None

    Findings in the abstracts are embargoed until 12:01 a.m. PST, Oct. 2nd with the exception of research findings presented at the IDWeek press conferences.