Making Do With What We Have
Authors: Camilla S. Graham
Journal: Annals of Internal Medicine (2017)

Editorials6 June 2017Making Do With What We HaveCamilla S. Graham, MD, MPHCamilla S. Graham, MD, MPHFrom Beth Israel Deaconess Medical Center, Boston, Massachusetts.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M17-0907 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail After approval of a new class of drugs, such as direct-acting antiviral (DAA) agents against hepatitis C virus (HCV), unanticipated effects are likely. In 2015, the first 2 cases of hepatitis B virus (HBV) reactivation in patients receiving an all-oral DAA regimen for HCV were published (1). In their Annals article, Bersoff-Matcha and colleagues (2), from the U.S. Food and Drug Administration (FDA), describe data submitted to the FDA Adverse Event Reporting System (FAERS) on 29 patients receiving DAA-based HCV treatment who had HBV reactivation (2). Eight of these patients were hospitalized; 2 of them died, and 1 required liver ...References1. Collins JM, Raphael KL, Terry C, Cartwright EJ, Pillai A, Anania FA, et al. Hepatitis B Virus Reactivation During Successful Treatment of Hepatitis C Virus With Sofosbuvir and Simeprevir. Clin Infect Dis. 2015;61:1304-6. [PMID: 26082511] doi:10.1093/cid/civ474 CrossrefMedlineGoogle Scholar2. Bersoff-Matcha SJ, Cao K, Jason M, Ajao A, Jones SC, Meyer T, et al. Hepatitis B virus reactivation associated with direct-acting antiviral therapy for chronic hepatitis C virus: a review of cases reported to the U.S. Food and Drug Administration Adverse Event Reporting System. Ann Intern Med. 2017;166:792-8. doi:10.7326/M17-0377 LinkGoogle Scholar3. U.S. Department of Human Services, U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C. Accessed at www.fda.gov/Drugs/DrugSafety/ucm522932.htm on 7 April 2017. Google Scholar4. Bini EJ, Perumalswami PV. Hepatitis B virus infection among American patients with chronic hepatitis C virus infection: prevalence, racial/ethnic differences, and viral interactions. Hepatology. 2010;51:759-66. [PMID: 20140950] doi:10.1002/hep.23461 CrossrefMedlineGoogle Scholar5. Siddiqui F, Mutchnick M, Kinzie J, Peleman R, Naylor P, Ehrinpreis M. Prevalence of hepatitis A virus and hepatitis B virus immunity in patients with polymerase chain reaction-confirmed hepatitis C: implications for vaccination strategy. Am J Gastroenterol. 2001;96:858-63. [PMID: 11280565] CrossrefMedlineGoogle Scholar6. World Health Organization. Guidelines for the Prevention, Care and Treatment of Persons with Chronic Hepatitis B Infection. Geneva: WHO Pr; 2015. Google Scholar7. Gane EJ, Hyland RH, An D, Svarovskaia ES, Brainard D, McHutchison JG. Ledipasvir and sofosbuvir for HCV infection in patients coinfected with HBV. Antivir Ther. 2016;21:605-609. [PMID: 27367295] doi:10.3851/IMP3066 CrossrefMedlineGoogle Scholar8. Sulkowski MS, Chuang WL, Kao JH, Yang JC, Gao B, Brainard DM, et al. No Evidence of Reactivation of Hepatitis B Virus Among Patients Treated With Ledipasvir-Sofosbuvir for Hepatitis C Virus Infection. Clin Infect Dis. 2016;63:1202-1204. [PMID: 27486112] MedlineGoogle Scholar9. American Association for the Study of Liver Diseases, Infectious Diseases Society of America. Monitoring patients who are starting hepatitis C treatment, are on treatment, or have completed therapy. Recommendations for testing, managing, and treating hepatitis C. Accessed at www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have on 7 April 2017. Google Scholar10. Buckley GJ, Strom BL. A national strategy for the elimination of viral hepatitis emphasizes prevention, screening, and universal treatment of hepatitis C. Ann Intern Med. 2017. [PMID: 28384754]. doi:10.7326/M17-0766 LinkGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Beth Israel Deaconess Medical Center, Boston, Massachusetts.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-0907.Corresponding Author: Camilla S. Graham, MD, MPH, Division of Infectious Disease, Beth Israel Deaconess Medical Center, 110 Francis Street, LMOB Suite GB, Boston, MA 02215; e-mail, [email protected]harvard.edu.This article was published at Annals.org on 25 April 2017. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoHepatitis B Virus Reactivation Associated With Direct-Acting Antiviral Therapy for Chronic Hepatitis C Virus: A Review of Cases Reported to the U.S. Food and Drug Administration Adverse Event Reporting System Susan J. Bersoff-Matcha , Kelly Cao , Mihaela Jason , Adebola Ajao , S. Christopher Jones , Tamra Meyer , and Allen Brinker Metrics 6 June 2017Volume 166, Issue 11Page: 850-851KeywordsAdverse eventsClinical trialsDNAFood and Drug AdministrationHepatitis BLiver transplantationPatientsResearch designSafetyTreatment guidelines ePublished: 25 April 2017 Issue Published: 6 June 2017 Copyright & PermissionsCopyright © 2017 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...