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A Comparison of Modified Directly Observed Therapy to Standard Care for Chronic Hepatitis C

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Abstract

Hepatitis C virus (HCV) is the most common chronic blood-borne infection in the United States. Effective treatments are available, however adherence to treatment is challenging. Modified directly observed therapy (mDOT) with weekly administration of pegylated interferon might improve adherence and outcomes for patients infected with chronic HCV. The purpose of this study was to compare two treatment protocols and examine predictors of sustained virologic response (SVR). This retrospective review compares HCV treatment outcomes in two outpatient clinics at an urban academic medical center. Gastroenterology fellows provided standard treatment (SC) in one clinic; a nurse practitioner administered weekly pegylated interferon injections weekly in a primary care clinic. All patients received oral ribavirin. Data was extracted from the medical records of all treated patients over a 5-year period. 155 treatment-naïve, chronically infected HCV patients were treated. Ninety-seven patients received mDOT treatment and 58 received standard care. Mean age was 46 years. Genotype 1 represented 59 % of the sample. The mDOT patients were significantly more likely to be younger (44 vs. 50 years), have a history of injection drug use (93.1 vs. 50.0 %), and be HIV-infected (13.5 vs. 2 %) compared to SC patients. The overall SVR rate was 45.2 % and did not differ between the groups in unadjusted analyses (p = 0.95). Genotype was the only predictor of SVR. Patients treated by nurse practitioners trained in HCV care and seen weekly for interferon injections have comparable treatment outcomes to patients treated by specialists.

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References

  1. Center For Disease Control And Prevention. (2012). Centers for Disease Control and Prevention. Retrieved May 18, 2012, from http://www.cdc.gov/hepatitis.

  2. El-Serag, H. B. (2011). Hepatocellular carcinoma. New England Journal of Medicine, 365, 1118–1127.

    Article  CAS  PubMed  Google Scholar 

  3. Backus, L. I., Boothroyd, D. B., Phillips, B. R., Belperio, P., Halloran, J., & Mole, L. A. (2011). A sustained virologic response reduces risk of all-cause mortality in patients infected with hepatitis C. Clinical Gastroenterology & Hepatology, 9, 509–516. doi:10.1016/j.cgh.2011.03.004.

    Article  Google Scholar 

  4. McGowan, C. E., Monis, A., & Bacon, B. R. et al. (2013). A global view of hepatitis C: Physician knowledge, opinions, and perceived barriers to care. Hepatology. doi:10.1002/hep.26246 (Epub ahead of print).

  5. McGowan, C. E., & Fried, M. W. (2012). Barriers to hepatitis C treatment. Liver International, 32(suppl 1), 51–56. doi:10.1111/j.1478-3231.2011.02706.x.

    Google Scholar 

  6. Stephenson, J. (2001). Former addicts face barriers to treatment for HCV. JAMA, 285, 1003–1005.

    Article  CAS  PubMed  Google Scholar 

  7. Trask, P. C., Esper, P., Riba, M., & Redman, B. (2000). Psychiatric side effects of interferon therapy: Prevalence, proposed mechanisms, and future directions. Journal of Clinical Oncology, 18(11), 2316–2326.

    CAS  PubMed  Google Scholar 

  8. Feuerstadt, P., Bunim, A. L., Garcia, H., et al. (2010). Effectiveness of hepatitis C treatment with pegylated interferon and ribavirin in urban minority patients. Hepatology, 51, 1137–1143. doi:10.1002/hep.23429.

    Article  CAS  PubMed  Google Scholar 

  9. Fried, M. W., Shiffman, M. L., Reddy, K. R., et al. (2002). Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. New England Journal of Medicine, 347, 975–982.

    Article  CAS  PubMed  Google Scholar 

  10. Manns, M. P., McHutchison, J. G., Gordon, S. C., et al. (2001). Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: A randomised trial. Lancet, 358, 958–965.

    Article  CAS  PubMed  Google Scholar 

  11. Hadziyannis, S. J., Sette, H., Morgan, T. R., et al. (2004). Peginterferon alfa-2a and ribavirin combination therapy in chronic hepatitis C: A randomized study of treatment duration and ribavirin dose. Annals of Internal Medicine, 140, 346–355.

    Article  CAS  PubMed  Google Scholar 

  12. Lo Re, V, I. I. I., Teal, V., Localio, R., Amorosa, V., Kaplan, D. E., & Gross, R. (2011). Relationship between adherence to hepatitis C virus therapy and virologic outcomes. Annals of Internal Medicine, 155, 353–360.

    Article  PubMed  Google Scholar 

  13. National Institutes Of Health. (2002). National Institutes of Health Consensus Development Conference Statement: Management of hepatitis C: 2002. Final statement. Retrieved from http://consensus.nih.gov/cons/116/091202116cdc_statement.htm.

  14. Batki, S. L., Gruber, V., Moon Bradley, J., Bradley, M., & Delucchi, K. (2002). A controlled trial of methadone treatment combined with daily observed isoniazid for tuberculosis prevention in injection drug users. Drug and Alcohol Dependence, 6, 283–293.

    Article  Google Scholar 

  15. Berg, K. M., Litwin, A. H., Li, X., Heo, M., & Arnsten, J. H. (2011). Lack of sustained improvement in adherence or viral load following a directly observed antiretroviral therapy intervention. Clinical Infectious Diseases, 53(9), 936–943.

    Article  CAS  PubMed  Google Scholar 

  16. Flanigan, T. P., Taylor, L. E., & Mitty, J. A. (2005). Use of community-based, directly observed therapy for HIV infection: Lessons learned for treatment of hepatitis C virus infection. Clinical Infectious Diseases, 40, S346–S348.

    Article  PubMed  Google Scholar 

  17. Gourevitch, M. N., Wasserman, W., Panero, M. S., & Selwyn, P. A. (1996). Successful adherence to observed prophylaxis and treatment of tuberculosis among drug users in a methadone program. Journal of Addictive Diseases, 15, 93–104.

    Article  CAS  PubMed  Google Scholar 

  18. McCance-Katz, E. F., Gourevitch, M. N., Arnsten, J., Sarlo, J., Rainey, P., & Jatlow, P. (2002). Modified directly observed therapy (MDOT) for injection drug users with HIV disease. American Journal of Addiction, 11, 271–278.

    Article  Google Scholar 

  19. Stein, M. D., Maksad, J., & Clarke, J. (2001). Hepatitis C disease among injection drug users: knowledge, perceived risk and willingness to receive treatment. Drug and Alcohol Dependence, 61, 211–215.

    Article  CAS  PubMed  Google Scholar 

  20. Grebely, J., Raffa, J. D., Meagher, C., et al. (2007). Directly observed therapy for the treatment of hepatitis C virus infection in current and former injection drug users. Journal of Gastroenterology and Hepatology, 22, 1519–1525. doi:10.1111/j.1440-1746.2007.05032.x.

    Article  CAS  PubMed  Google Scholar 

  21. Bonkovsky, H. L., Tice, A. D., Yapp, M. D., et al. (2008). Efficacy and safety of pegInterferon alfa-2a/ribavirin in methadone maintenance patients: Randomized comparison of direct observed therapy and self-administration. American Journal of Gastroenterology, 103, 2757–2765. doi:10.1111/j.1572-0241.2008.02065.x.

    Article  CAS  PubMed  Google Scholar 

  22. Litwin, A. H., Soloway, I., & Gourevitch, M. N. (2005). Integrating services for injection drug users infected with hepatitis C virus with methadone maintenance treatment: Challenges and opportunities. Clinical Infectious Diseases, 40, S339–S345.

    Article  PubMed  Google Scholar 

  23. Litwin, A. H., Harris, K. A., Nahvi, S., et al. (2009). Successful treatment of chronic hepatitis C with pegylated interferon in combination with ribavirin in a methadone maintenance treatment program. Journal of Substance Abuse Treatment, 37, 32–40. doi:10.1016/j.jsat.2008.09.009.

    Article  PubMed  Google Scholar 

  24. StataCorp. (2010). Stata statistical software: Release 10.1. College Station, TX: StataCorp LP.

    Google Scholar 

  25. White, I. R., Royston, P., & Wood, A. M. (2011). Multiple imputation using chained equations: Issues and guidance for practice. Statistics in Medicine, 30(4), 377–399.

    Article  PubMed  Google Scholar 

  26. Royston, P. (2007). Multiple imputation of missing values: Further update of ice, with an emphasis on interval censoring. Stata Journal, 7(4), 445–464.

    Google Scholar 

  27. Idress, M., & Riazuddin, S. (2009). A study of best positive predictors for sustained virologic response to interferon alpha plus ribavirin therapy in naive chronic hepatitis C patients. BMC Gastroenterology, 9(5). doi:10.1186/1471-230X-9-5.

  28. Neukam, K., Mira, J. A., Claro, E., et al. (2011). Efficacy of chronic hepatitis C therapy with pegylated interferon and ribavirin in patients on methadone maintenance treatment. European Journal of Clinical Microbiology and Infectious Diseases, 31(6), 1225–1232. doi:10.1007/s10096-011-1433-5.

    Google Scholar 

  29. Sylvestre, D. L., & Clements, B. J. (2007). Adherence to hepatitis C treatment in recovering heroin users maintained on methadone. European Journal of Gastroenterology and Hepatology, 19(9), 741–747.

    Article  CAS  PubMed  Google Scholar 

  30. Ebner, N., Wanner, C., Winklbaur, B., et al. (2009). Retention rate and side effects in a prospective trial on hepatitis C treatment with pegylated interferon alpha-2a and ribavirin in opioid-dependent patients. Addiction Biology, 14, 227–237. doi:10.1111/j.1369-1600.2009.00148.x.

    Article  CAS  PubMed  Google Scholar 

  31. Schaefer, M., Engelbrecht, M., Gut, O., et al. (2002). Interferon alpha (IFNalpha) and psychiatric syndromes: A review. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 26, 731–746.

    Article  CAS  PubMed  Google Scholar 

  32. Leutscher, P., Lagging, M., Buhl, M., et al. (2010). Evaluation of depression as a risk factor for treatment failure in chronic hepatitis C. Hepatology, 52, 430–435. doi:10.1002/hep.23699.

    Article  CAS  PubMed  Google Scholar 

  33. Conjeevarum, H. S., Fried, M. W., Jeffers, L. J., et al. (2006). Peginterferon and ribavirin treatment in African American and Caucasian American patients with hepatitis C genotype 1. Gastroenterology, 131, 470–477. doi:10.1053/j.gastro.2006.06.008.

    Article  Google Scholar 

  34. Muir, A. J., Bornstein, J. D., & Killenberg, P. G. (2004). Peginterferon alpha-2b and ribavirin for the treatment of chronic hepatitis C in Blacks and non-Hispanic whites. New England Journal of Medicine, 350, 2265–2271.

    Article  CAS  PubMed  Google Scholar 

  35. Rodriguez-Torres, M., Jeffers, L. J., Sheikh, M. Y., et al. (2009). Peginterferon alpha-2a and ribavirin in latino and non-latino whites with hepatitis C. New England Journal of Medicine, 360, 257–267.

    Article  CAS  PubMed  Google Scholar 

  36. Fairall, L., Bachmann, M., Lombard, C., et al. (2012). Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): A pragmatic, parallel, cluster-randomised trial. Lancet, 380, 889–898. doi:10.1016/S0140-6736(12)60730-2.

    Article  PubMed  Google Scholar 

  37. Sanne, I., Orrell, C., Fox, M. P., et al. (2010). Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): A randomised non-inferiority trial. Lancet, 376, 33–40. doi:10.1016/S0140-6736(10)60894-X.

    Article  PubMed  Google Scholar 

  38. Shumbusho, F., Van Griensven, J., Lowrance, D., et al. (2009). Task shifting for scale-up of HIV care: Evaluation of nurse-centered antiretroviral treatment at rural health centers in Rwanda. PloS Medicine, 6(10), 1–12. doi:10.1371/journal.pmed.1000163.

    Article  Google Scholar 

  39. Bedelu, M., Ford, N., Hilderbrand, K., et al. (2007). Implementing antiretroviral therapy in rural communities: The Lusikisiki model of decentralized HIV/AIDS care. Journal of Infectious Diseases, 196, S464–S468.

    Article  PubMed  Google Scholar 

  40. Logan, A. G., Milne, B. J., Achber, C., Campbell, W. P., & Haynes, R. B. (1979). Work-site treatment of hypertension by specially trained nurses. A controlled trial. Lancet, 314, 1175–1178.

    Article  Google Scholar 

  41. Condosta, D. (2012). Comparison between nurse practitioner and MD providers in diabetes care. The Journal for Nurse Practitioners, 8, 792–796.

    Article  Google Scholar 

  42. Arora, S., Thornton, K., Murata, G., et al. (2011). Outcomes of treatment for hepatitis C virus infection by primary care providers. New England Journal of Medicine, 364(23), 2199–2207. doi:10.1056/NEJMoa1009370.

    Article  CAS  PubMed  Google Scholar 

  43. Fishbein, D. A., Lo, Y., Reinus, J. F., Gourevitch, M. N., & Klein, R. S. (2004). Factors associated with successful referral for clinical care of drug users with chronic hepatitis C who have or are at risk for HIV infection. Journal of Acquired Immune Deficiency Syndromes, 37(3), 1367–1375.

    Article  PubMed  Google Scholar 

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Acknowledgments

This research was supported in part by Grant number T32 DA016184 from the National Institute on Drug Abuse at the National Institutes of Health (Dr. Cioe). This research was supported in part by 1R01DA023570 from the National Institute on Drug Abuse (Dr. Friedmann). Dr. Stein is the recipient of a NIDA Mid-Career Investigator Award K24 DA 00512.

Conflict of interest

No author on this manuscript has any personal or financial interest that would influence the results.

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Authors and Affiliations

  1. Center for Alcohol and Addiction Studies, Brown University, Providence, RI, 02903, USA

    Patricia A. Cioe

  2. Warren Alpert School of Medicine, Brown University, Providence, RI, 02912, USA

    Michael D. Stein & Peter D. Friedmann

  3. Division of Gastroenterology and Hepatology, Warren Alpert School of Medicine, Brown University, Providence, RI, 02912, USA

    Kittichai Promrat

  4. Division of General Internal Medicine, Rhode Island Hospital, Providence, RI, 02903, USA

    Patricia A. Cioe & Peter D. Friedmann

  5. General Medicine Research Unit, Butler Hospital, Providence, RI, 02906, USA

    Michael D. Stein

  6. Providence Veterans Affairs Medical Center, Providence, RI, 02908, USA

    Kittichai Promrat & Peter D. Friedmann

  7. Center for Alcohol and Addictions Studies, Brown University, Box G-S121-4, Providence, RI, 02912, USA

    Patricia A. Cioe

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  1. Patricia A. Cioe
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Correspondence to Patricia A. Cioe.

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Cioe, P.A., Stein, M.D., Promrat, K. et al. A Comparison of Modified Directly Observed Therapy to Standard Care for Chronic Hepatitis C. J Community Health 38, 679–684 (2013). https://doi.org/10.1007/s10900-013-9663-3

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  • DOI: https://doi.org/10.1007/s10900-013-9663-3

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