CDC Advises That Benznidazole Now Only Available Through Drug Company

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The CDC has ended the IND program that exclusively provided benznidazole and nifurtimox for Chagas patients in the US from October 2011 to May 2018.
The CDC has ended the IND program that exclusively provided benznidazole and nifurtimox for Chagas patients in the US from October 2011 to May 2018.

The Centers for Disease Control and Prevention (CDC) announced recently in the Morbidity and Mortality Weekly Report that, effective May 14 2018, the CDC Investigational New Drug (IND) treatment protocols will no longer be providing benznidazole for the treatment of Chagas disease. Physician requests for benznidazole should now be directed to the drug company Exeltis online at http://www.benznidazoletablets.com/en/, by telephone at 877-303-7181, or by e-mail at FastAccess@exeltis.com.

Chagas disease is a chronic and potentially fatal vector-borne parasitic disease largely occurring in Latin America. Benznidazole and nifurtimox are the 2 drugs used for the treatment of Chagas disease; however, US Food and Drug Administration-approved, commercially available options for these drugs were not available in the United States until August 29, 2017, when the US Food and Drug Administration approved the first benznidazole product for the treatment of Chagas disease. In response, the CDC has ended the IND program that exclusively provided benznidazole and nifurtimox for people in the United States who have Chagas disease and received the drugs during October 2011 to May 2018.

Along with this announcement, the report also summarized select patient characteristics of individuals with Chagas disease for which the CDC provided treatment. Data from 365 patients were included in an intention-to-treat analysis. Median patient age was 42.9 years (range, 0.1-76.0 years) and 8.8% were younger than19 years of age. Only 4 patients had acute-phase infections, all of whom were born in and infected with Chagas disease in the United States. The routes of infection for these 4 were solid organ transplants from Central American immigrants (2 individuals), congenital transmission from a Bolivian immigrant (1 individual), and presumed vector-borne transmission (1 individual). The remaining 361 patients had chronic-phase infections and were born in and acquired the infection in Latin America.

The CDC continues to provide reference diagnostic testing for Trypanosoma cruzi, the causative agent of Chagas disease, through its website (https://www.cdc.gov/dpdx) and also provides telephone consultation services regarding Chagas disease. Healthcare providers and health departments can contact CDC Parasitic Diseases Branch by telephone at 404-718-4745 or by e-mail at parasites@cdc.gov.

Reference

Herwaldt BL, Dougherty CP, Allen CK, et al. Characteristics of patients for whom benznidazole was released through the CDC-sponsored Investigational New Drug Program for Treatment of Chagas Disease - United States, 2011-2018. MMWR Morb Mortal Wkly Rep. 2018;67: 803-805.

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