1463. Tolerance and Safety of Benznidazole in an US-Based Chagasic Adult Population
Session: Poster Abstract Session: Global Health
Saturday, October 5, 2013
Room: The Moscone Center: Poster Hall C
Posters
  • Tolerance of Benznidazole Poster.pdf (791.4 kB)
  • Background:

    Chagas disease (CD) has growing importance in the US where estimated prevalence is greater than 300,000, and annual economic burden greater than $100 million.  Benznidazole (BZ), the most tolerated standard therapy, has a side effect profile minimally described in adults and not described in the US population (a distinct immigrant population from Europe). The drug lacks FDA approval and is available from the CDC under investigational protocol.  The toxicities must be weighed against the natural history of CD which may remain clinically silent for decades before morbidity is apparent.  The Center of Excellence for Chagas Disease (CECD), the first dedicated Chagas clinic in the US, has received much of the BZ released from CDC.  We describe here the CECD treatment experience with the BZ tolerance and side effect profile. 

    Methods:

    Between February 2011 and April 2013, 26 patients with mean age 44 [19-67] and dual sero-confirmed chronic or indeterminate Chagas disease received an intended course of BZ 5mg/kg/day for 8 weeks, with follow up at 2-week intervals during treatment and at 1 month post-therapy.  Adverse events (AE’s) were graded using Common Terminology Criteria for Adverse Events, version 4.0. 

    Results:

    All 26 patients experienced AE’s, 7(27%) with severe grade, none life threatening.  Nineteen patients (73%) completed therapy, 1 after an AE related treatment interruption; 5(19%) discontinued secondary to an AE including 4 within 3 weeks for hypersensitivity type rash (2 with concomitant angioedema, a sparsely reported BZ AE), and one patient at week 7 for thrombocytopenia. Dysesthesias were notably prevalent (50%); around therapy completion 4 (15%) developed severe persistent peripheral neuropathy (up to 6 months by abstract submission) resulting in unemployment in 2 cases. Tolerance profiles were otherwise consistent with prior studies in regards to mild headaches (42%), anorexia (50%), and nausea (38%).

    Conclusion:

    Most patients were able to complete therapy, but BZ therapy carries a significant risk of severe non-life-threatening AE’s including hypersensitivity syndromes and ill-defined debilitating dysesthesias, as well as milder AEs.  Further clinical study is warranted to better characterize and navigate neurologic and other BZ toxicities in indeterminate CD.
    David Miller, MD, MPH1, Salvador Hernandez, M.D.2, Mahmoud Traina, MD2, Lissette Rodriguez De Armas, MD3, Sheba Meymandi, MD2 and Center of Excellence for Chagas Disease, (1)Infectious Diseases, UCLA-Harbor, Torrance, CA, (2)Cardiology, Olive View-UCLA Medical Center, Sylmar, CA, (3)School of Medicine, Texas Tech University Health Science Center, Umc, El Paso, TX

    Disclosures:

    D. Miller, None

    S. Hernandez, None

    M. Traina, None

    L. Rodriguez De Armas, None

    S. Meymandi, None

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