Treatment Selection Choices Should Not Be Based on Benefits or Costs Alone: A Head-to-Head Randomized Controlled Trial of Antiviral Drugs for Hepatitis C
Publication Date
October 14, 2016
Journal
PLOS ONE
Authors
Perica Davitkov, Apoorva Krishna Chandar, Amy Hirsch, Anita Compan, et al
Volume
11
Issue
10
Pages
e0163945
DOI
https://dx.plos.org/10.1371/journal.pone.0163945
Publisher URL
http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0163945
Scopus
84992382832
Mendeley
http://www.mendeley.com/research/treatment-selection-choices-not-based-benefits-costs-alone-headtohead-randomized-controlled-trial-an
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Mendeley | Further Information

{"title"=>"Treatment selection choices should not be based on benefits or costs alone: A head-to-head randomized controlled trial of antiviral drugs for hepatitis C", "type"=>"journal", "authors"=>[{"first_name"=>"Perica", "last_name"=>"Davitkov", "scopus_author_id"=>"55090053200"}, {"first_name"=>"Apoorva Krishna", "last_name"=>"Chandar", "scopus_author_id"=>"55853655700"}, {"first_name"=>"Amy", "last_name"=>"Hirsch", "scopus_author_id"=>"54408691400"}, {"first_name"=>"Anita", "last_name"=>"Compan", "scopus_author_id"=>"54408250600"}, {"first_name"=>"Marina G.", "last_name"=>"Silveira", "scopus_author_id"=>"16317461800"}, {"first_name"=>"Donald D.", "last_name"=>"Anthony", "scopus_author_id"=>"55538019600"}, {"first_name"=>"Suzanne", "last_name"=>"Smith", "scopus_author_id"=>"57191663324"}, {"first_name"=>"Clare", "last_name"=>"Gideon", "scopus_author_id"=>"57191668604"}, {"first_name"=>"Robert A.", "last_name"=>"Bonomo", "scopus_author_id"=>"7005121269"}, {"first_name"=>"Yngve", "last_name"=>"Falck-Ytter", "scopus_author_id"=>"6603484942"}], "year"=>2016, "source"=>"PLoS ONE", "identifiers"=>{"pui"=>"612829060", "sgr"=>"84992382832", "issn"=>"19326203", "pmid"=>"27741230", "scopus"=>"2-s2.0-84992382832", "doi"=>"10.1371/journal.pone.0163945", "isbn"=>"1932-6203"}, "id"=>"e1597921-6b54-3a49-8769-4d3b97f9ffb0", "abstract"=>"BACKGROUND: Clinicians often face dilemmas with decisions related to formulary choices when two similar drugs are simultaneously available in the market. We studied the comparative safety, effectiveness, and treatment costs of the two first generation direct-acting antiviral agents (DAA), boceprevir and telaprevir as uncertainty existed regarding the drug of choice between these two seemingly equally Hepatitis-C treatment options. METHODS: We randomly assigned 50 patients in an open-label, pragmatic randomized controlled trial (RCT) at a VA Medical Center to either boceprevir or telaprevir in combination with peginterferon and ribavirin, stratified by the presence of cirrhosis and prior treatment experience. Tolerability was assessed at each visit and reasons for discontinuation of treatment and severity of adverse events due to PI treatment were adjudicated using a blinded adjudication committee. The primary outcome was difference in tolerability between boceprevir vs. telaprevir. Secondary outcomes included viral response rates and cost-per cure achieved. RESULTS: Higher rates of treatment discontinuations and/or severe DAA associated adverse events were seen in 10/25 (40%) patients randomized to telaprevir compared to 2/25 (8%) patients randomized to boceprevir (RR: 5; 95% CI: 1.2, 20; p<0.01). Cure rates did not appear to be significantly different between groups (telaprevir vs. boceprevir: RR 1.23; 95% CI: 0.76, 1.99; p = 0.39). On an intention-to-treat basis, total cost per cure was $44,329 for boceprevir vs. $57,115 for telaprevir. The significant side effect profile of telaprevir combined with the availability of highly efficacious second generation DAAs led to the early discontinuation of the trial. CONCLUSION: Telaprevir is associated with a significantly higher rate of severe adverse events leading to treatment discontinuations, hospitalizations or severe anemia and a substantially higher cost per SVR when compared to boceprevir. Real-time, point of care, pragmatic randomized controlled trials are necessary for guidance beyond just acquisition costs and to make evidence-based formulary selections when multiple effective treatments are available. (Clinicaltrials.gov registration: NCT02113631).", "link"=>"http://www.mendeley.com/research/treatment-selection-choices-not-based-benefits-costs-alone-headtohead-randomized-controlled-trial-an", "reader_count"=>7, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Other"=>1, "Student > Master"=>2, "Professor"=>2, "Student > Doctoral Student"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Other"=>1, "Student > Master"=>2, "Professor"=>2, "Student > Doctoral Student"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>1, "Nursing and Health Professions"=>2, "Medicine and Dentistry"=>4}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>4}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>2}, "Unspecified"=>{"Unspecified"=>1}}, "group_count"=>0}

Scopus | Further Information

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