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Intensive Pharmacy Care Improves Outcomes of Hepatitis C Treatment in a Vulnerable Patient Population at a Safety-Net Hospital

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Abstract

Background

Treatment of hepatitis C virus (HCV) with direct-acting antiviral (DAA) regimens has resulted in high rates of sustained virologic response (SVR). Treatment of vulnerable populations may be improved by incorporating an on-site intensive specialty pharmacy (ON-ISP).

Aims

To describe outcomes of HCV treatment at a safety-net hospital and proportion of subjects achieving SVR for those using the ON-ISP compared to an off-site pharmacy (OFF-SP).

Methods

A retrospective cohort study of 219 subjects treated for HCV with DAA at Boston Medical Center was conducted. Subject characteristics, virologic response, and pharmacy services used were recorded. We used multivariable logistic regression to test the association between ON-ISP and SVR after adjusting for covariates.

Results

SVR occurred in 71% of subjects by intention-to-treat (73% among ON-ISP users vs 57% among OFF-SP users) and 95% completing treatment per-protocol (96% among ON-ISP users vs 87% among OFF-SP users). Adjustment for age, sex, ethnicity, insurance, fibrosis, prior treatment, and MELD revealed an increased likelihood of SVR among users of ON-ISP: OR 6.0 (95% CI 1.18–31.0). No significant difference in treatment delay or adverse events was seen among users of either pharmacy type.

Conclusions

HCV treatment with DAA was well tolerated, but the rate of SVR was low (71%) compared to trials. This was due to loss to follow-up, as the per-protocol rate of SVR was much higher (95%). Use of ON-ISP was associated with an increase in SVR and may be valuable for improving care for vulnerable populations.

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Abbreviations

DAA:

Direct-acting antiviral

HCV:

Hepatitis C virus

OFF-SP:

Off-site specialty pharmacy

ON-ISP:

On-site intensive specialty pharmacy

SVR:

Sustained virologic response

References

  1. Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370:1889–1898.

    Article  Google Scholar 

  2. Backus LI, Belperio PS, Shahoumian TA, Loomis TP, Mole LA. Real-world effectiveness of ledipasvir/sofosbuvir in 4,365 treatment-naive, genotype 1 hepatitis C-infected patients. Hepatology. 2016;64:405–414.

    Article  CAS  Google Scholar 

  3. Berden FA, de Knegt RJ, Blokzijl H, et al. Limited generalizability of registration trials in hepatitis C: a nationwide cohort study. PLoS One. 2016;11:e0161821.

    Article  Google Scholar 

  4. Chamorro-de-Vega E, Gimenez-Manzorro A, Rodriguez-Gonzalez CG, et al. Effectiveness and safety of ombitasvir-paritaprevir/ritonavir and dasabuvir with or without ribavirin for HCV genotype 1 infection for 12 weeks under routine clinical practice. Ann Pharmacother. 2016;50:901–908.

    Article  Google Scholar 

  5. Flisiak R, Janczewska E, Wawrzynowicz-Syczewska M, et al. Real-world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study. Aliment Pharmacol Ther. 2016;44:946–956.

    Article  CAS  Google Scholar 

  6. Ioannou GN, Beste LA, Chang MF, et al. Effectiveness of sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir and dasabuvir regimens for treatment of patients with hepatitis C in the veterans affairs national health care system. Gastroenterology. 2016;151:457–471.e455.

    Article  CAS  Google Scholar 

  7. Terrault NA, Zeuzem S, Di Bisceglie AM, et al. Effectiveness of ledipasvir–sofosbuvir combination in patients with hepatitis C virus infection and factors associated with sustained virologic response. Gastroenterology. 2016;151:1131–1140.e1135.

    Article  CAS  Google Scholar 

  8. Welzel TM, Nelson DR, Morelli G, et al. Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study. Gut. 2017;66:1844–1852.

    Article  CAS  Google Scholar 

  9. Welzel TM, Petersen J, Herzer K, et al. Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort. Gut. 2016;65:1861–1870.

    Article  CAS  Google Scholar 

  10. Wong RJ, Nguyen MT, Trinh HN, et al. Community-based real-world treatment outcomes of sofosbuvir/ledipasvir in Asians with chronic hepatitis C virus genotype 6 in the United States. J Viral Hepat. 2017;24:17–21.

    Article  CAS  Google Scholar 

  11. Yee BE, Nguyen NH, Jin M, Lutchman G, Lim JK, Nguyen MH. Lower response to simeprevir and sofosbuvir in HCV genotype 1 in routine practice compared with clinical trials. BMJ Open Gastroenterol. 2016;3:e000056.

    Article  Google Scholar 

  12. Younossi ZM, Park H, Gordon SC, et al. Real-world outcomes of ledipasvir/sofosbuvir in treatment-naive patients with hepatitis C. Am J Manag Care. 2016;22:SP205–SP211.

    PubMed  Google Scholar 

  13. Alam I, Brown K, Donovan C, et al. Real-world effectiveness of simeprevir-containing regimens among patients with chronic hepatitis C virus: the SONET study. Open Forum Infect Dis. 2017;4:ofw258.

    Article  Google Scholar 

  14. Buggisch P, Vermehren J, Mauss S, et al. Real-world effectiveness of 8-week treatment with ledipasvir/sofosbuvir in chronic hepatitis C. J Hepatol. 2018;68:663–671.

    Article  CAS  Google Scholar 

  15. Tapper EB, Bacon BR, Curry MP, et al. Real-world effectiveness for 12 weeks of ledipasvir–sofosbuvir for genotype 1 hepatitis C: the Trio health study. J Viral Hepat. 2017;24:22–27.

    Article  CAS  Google Scholar 

  16. Wedemeyer H, Craxi A, Zuckerman E, et al. Real-world effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in patients with hepatitis C virus genotype 1 or 4 infection: a meta-analysis. J Viral Hepat. 2017;24:936–943.

    Article  CAS  Google Scholar 

  17. Wehmeyer MH, Ingiliz P, Christensen S, et al. Real-world effectiveness of sofosbuvir-based treatment regimens for chronic hepatitis C genotype 3 infection: results from the multicenter German hepatitis C cohort (GECCO-03). J Med Virol. 2018;90:304–312.

    Article  CAS  Google Scholar 

  18. Yek C, de la Flor C, Marshall J, et al. Effectiveness of direct-acting antiviral therapy for hepatitis C in difficult-to-treat patients in a safety-net health system: a retrospective cohort study. BMC Med. 2017;15:204.

    Article  Google Scholar 

  19. Feuerstadt P, Bunim AL, Garcia H, et al. Effectiveness of hepatitis c treatment with pegylated interferon and ribavirin in urban minority patients. Hepatology. 2010;51:1137–1143.

    Article  CAS  Google Scholar 

  20. Muir AJ, Bornstein JD, Killenberg PG. Peginterferon Alfa-2b and ribavirin for the treatment of chronic hepatitis C in blacks and non-Hispanic whites. N Engl J Med. 2004;350:2265–2271.

    Article  CAS  Google Scholar 

  21. Singal AG, Dharia TD, Malet PF, Alqahtani S, Zhang S, Cuthbert JA. Long-term benefit of hepatitis C therapy in a safety net hospital system: a cross-sectional study with median 5-year follow-up. BMJ Open. 2013;3:e003231.

    Article  Google Scholar 

  22. Agency for Healthcare R, Quality. Interventions to improve patient adherence to hepatitis c treatment: comparative effectiveness. Comp Eff Rev. 2012;20:1–16.

  23. Henderson RR, Visaria J, Bridges GG, Dorholt M, Levin RJ, Frazee SG. Impact of specialty pharmacy on telaprevir-containing 3-drug hepatitis C regimen persistence. J Managed Care Spec Pharm. 2014;20:1227–1234.

    Article  Google Scholar 

  24. Lieveld FI, van Vlerken LG, Siersema PD, van Erpecum KJ. Patient adherence to antiviral treatment for chronic hepatitis B and C: a systematic review. Ann Hepatol. 2013;12:380–391.

    CAS  PubMed  Google Scholar 

  25. Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008;48:835–847.

    Article  Google Scholar 

  26. Cohen SM, Kwasny MJ, Ahn J. Use of specialty care versus standard retail pharmacies for treatment of hepatitis C. Ann Pharmacother. 2009;43:202–209.

    Article  Google Scholar 

  27. Younossi ZM, Stepanova M, Henry L, Nader F, Younossi Y, Hunt S. Adherence to treatment of chronic hepatitis C: from interferon containing regimens to interferon and ribavirin free regimens. Medicine. 2016;95:e4151.

    Article  CAS  Google Scholar 

  28. Demian MN, Shapiro RJ, Thornton WL. An observational study of health literacy and medication adherence in adult kidney transplant recipients. Clin Kidney J. 2016;9:858–865.

    Article  Google Scholar 

Download references

Funding

Dr. Long is supported in part by the National Institute of Diabetes and Digestive and Kidney Diseases K23 DK113252 and the Boston University School of Medicine Department of Medicine Career Investment Award. Dr. Fricker is supported in part by the National Center for Advancing Translational Sciences and National Institutes of Health (BU-CTSI Grant Number 1UL1TR001430). The contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

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Correspondence to Michelle T. Long.

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Tran, A.N., Sachdev, R., Fricker, Z.P. et al. Intensive Pharmacy Care Improves Outcomes of Hepatitis C Treatment in a Vulnerable Patient Population at a Safety-Net Hospital. Dig Dis Sci 63, 3241–3249 (2018). https://doi.org/10.1007/s10620-018-5231-0

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  • DOI: https://doi.org/10.1007/s10620-018-5231-0

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