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

Herwaldt, Barbara L.; Dougherty, Cindy P.; Allen, C.K.; Jolly, Julian; Brown, Megan N.; Yu, Patricia; Yu, Yon

doi:10.15585/mmwr.mm6729a3

Cited by 26 publications

(17 citation statements)

References 6 publications

(13 reference statements)

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“…FDA approval of benznidazole and resulting changes. Until May 2018, when benznidazole became commercially available, prescribing antitrypanosomal treatment necessitated a consultation with CDC epidemiologists (330). Confirmation of the diagnosis, recommendations for treatment, and advice on side effects monitoring and management were necessary components of these consultations, and reporting of adverse events was mandatory under the investigational protocol.…”

Section: Physician Awareness Surveys Indicate That the Majority Of Pmentioning

confidence: 99%

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Chagas Disease in the United States: a Public Health Approach

et al. 2019

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SUMMARY Trypanosoma cruzi is the etiological agent of Chagas disease, usually transmitted by triatomine vectors. An estimated 20 to 30% of infected individuals develop potentially lethal cardiac or gastrointestinal disease. Sylvatic transmission cycles exist in the southern United States, involving 11 triatomine vector species and infected mammals such as rodents, opossums, and dogs. Nevertheless, imported chronic T. cruzi infections in migrants from Latin America vastly outnumber locally acquired human cases. Benznidazole is now FDA approved, and clinical and public health efforts are under way by researchers and health departments in a number of states. Making progress will require efforts to improve awareness among providers and patients, data on diagnostic test performance and expanded availability of confirmatory testing, and evidence-based strategies to improve access to appropriate management of Chagas disease in the United States.

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Section: Physician Awareness Surveys Indicate That the Majority Of Pmentioning

confidence: 99%

“…October 2011 to May 2018, CDC released benznidazole for 365 patients with confirmed T. cruzi infection(330). Four (1.1%) patients had acute phase infection, two organderived, one congenital and one presumed to be vector-borne.…”

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confidence: 99%

Chagas Disease in the United States: a Public Health Approach

et al. 2019

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“…Before benznidazole became commercially available in May 2018, the CDC worked with providers to confirm diagnosis and assess patient eligibility for treatment. Currently, the CDC continues to provide teleconsultation services regarding CD treatment [9], however, no institution is playing a gatekeeping role and providers can obtain benznidazole on their own initiative. No information is available to understand how often Exeltis USA's benznidazole was dispensed for treatment of a patient whose infection was not confirmed.…”

Section: Plos Neglected Tropical Diseasesmentioning

confidence: 99%

“…In the US, benznidazole had been available since 2011 under investigational protocols from the Center of Disease Control and Prevention (CDC) [9]. However, a study in 2015 showed that less than 1% of those estimated to be infected in the US had been identified and few had received treatment [10].…”

Section: Introductionmentioning

confidence: 99%

Access to Chagas disease treatment in the United States after the regulatory approval of benznidazole

et al. 2020

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Approximately 300,000 persons in the United States (US) are infected with Trypanosoma cruzi, the protozoan that causes Chagas disease, but less than 1% are estimated to have received antiparasitic treatment. Benznidazole was approved by the US Food and Drug Administration (FDA) for treatment of T. cruzi infection in 2017 and commercialized in May 2018. This paper analyzes factors that affect access to benznidazole following commercialization and suggests directions for future actions to expand access. We applied an access framework to identify barriers, facilitators, and key actors that influence the ability of people with Chagas disease to receive appropriate treatment with benznidazole. Data were collected from the published literature, key informants, and commercial databases. We found that the mean number of persons who obtained benznidazole increased from just under 5 when distributed by the CDC to 13 per month after the commercial launch (from May 2018 to February 2019). Nine key barriers to access were identified: lack of multi-sector coordination, failure of health care providers to use a specific order form, lack of an emergency delivery system, high medical costs for uninsured patients, narrow indications for use of benznidazole, lack of treatment guidelines, limited number of qualified treaters, difficulties for patients to make medical appointments, and inadequate evaluation by providers to determine eligibility for treatment. Our analysis shows that access to benznidazole is still limited after FDA approval. We suggest six areas for strategic action for the pharmaceutical company that markets benznidazole and its allied private foundation to expand access to benznidazole in the US. In addition, we recommend expanding the existing researcher-clinician network by including government agencies, companies and others. This paper's approach could be applied to access programs for benznidazole in other countries or for other health products that target neglected populations throughout the world.

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“…Moreover, three states are habitats for local triatomines, led by Texas, where at least eight species capable of transmitting T. cruzi can be found [4]. Texas is also the only state where CD is reportable [50], although more patients were treated with benznidazole in California in recent years than in the other three combined [46]. The Medicaid expansion of 2014 is a key health care access indicator, because it permitted greater insurance coverage for immigrants and other socially vulnerable populations, including rural residents, who might be at risk for CD.…”

Section: State-level Comparisonsmentioning

confidence: 99%

Current Gaps and Needs for Increasing Access to Healthcare for People with Chagas Disease in the USA

et al. 2019

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Purpose of Review In the USA, fewer than 1% of people with Chagas disease (CD) are diagnosed and treated. Patients and physicians confront significant barriers to initiating testing and treatment, which are not systematically available in the US health care system. What are these barriers and how can they be overcome? We discuss the broader challenges and state-level dynamics of CD in several of the US states with the highest burdened populations. Recent Findings The principal challenges for expanding access to testing and treatment include confusion surrounding testing procedures, limitations in available drugs and diagnostic tools, gaps in surveillance and epidemiological knowledge, low patient awareness, and, particularly, low awareness among providers. States have key differences concerning health care access, transmission dynamics, and programmatic resources. Local initiatives in Texas and California are discussed. Summary Reducing the burden of CD will require improvement of diagnostic capacity and treatment guidelines, significant strengthening of provider awareness, greater understanding of transmission dynamics, and provision of accessible health care to the diverse population at risk.

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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

Cited by 26 publications

References 6 publications

Chagas Disease in the United States: a Public Health Approach

Chagas Disease in the United States: a Public Health Approach

Access to Chagas disease treatment in the United States after the regulatory approval of benznidazole

Current Gaps and Needs for Increasing Access to Healthcare for People with Chagas Disease in the USA

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