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Erschienen in: Digestive Diseases and Sciences 12/2018

04.08.2018 | Original Article

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

verfasst von: Ashley N. Tran, Rishabh Sachdev, Zachary P. Fricker, Michael Leber, Toni Zahorian, Bhavesh Shah, David P. Nunes, Michelle T. Long

Erschienen in: Digestive Diseases and Sciences | Ausgabe 12/2018

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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.
Literatur
1.
Zurück zum Zitat 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.CrossRef 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.CrossRef
2.
Zurück zum Zitat 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.CrossRef 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.CrossRef
3.
Zurück zum Zitat 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.CrossRef 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.CrossRef
4.
Zurück zum Zitat 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.CrossRef 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.CrossRef
5.
Zurück zum Zitat 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.CrossRef 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.CrossRef
6.
Zurück zum Zitat 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.CrossRef 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.CrossRef
7.
Zurück zum Zitat 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.CrossRef 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.CrossRef
8.
Zurück zum Zitat 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.CrossRef 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.CrossRef
9.
Zurück zum Zitat 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.CrossRef 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.CrossRef
10.
Zurück zum Zitat 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.CrossRef 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.CrossRef
11.
Zurück zum Zitat 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.CrossRef 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.CrossRef
12.
Zurück zum Zitat 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 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
13.
Zurück zum Zitat 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.CrossRef 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.CrossRef
14.
Zurück zum Zitat 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.CrossRef 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.CrossRef
15.
Zurück zum Zitat 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.CrossRef 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.CrossRef
16.
Zurück zum Zitat 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.CrossRef 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.CrossRef
17.
Zurück zum Zitat 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.CrossRef 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.CrossRef
18.
Zurück zum Zitat 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.CrossRef 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.CrossRef
19.
Zurück zum Zitat 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.CrossRef 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.CrossRef
20.
Zurück zum Zitat 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.CrossRef 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.CrossRef
21.
Zurück zum Zitat 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.CrossRef 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.CrossRef
22.
Zurück zum Zitat Agency for Healthcare R, Quality. Interventions to improve patient adherence to hepatitis c treatment: comparative effectiveness. Comp Eff Rev. 2012;20:1–16. Agency for Healthcare R, Quality. Interventions to improve patient adherence to hepatitis c treatment: comparative effectiveness. Comp Eff Rev. 2012;20:1–16.
23.
Zurück zum Zitat 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.CrossRef 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.CrossRef
24.
Zurück zum Zitat 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.PubMed 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.PubMed
25.
Zurück zum Zitat Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008;48:835–847.CrossRef Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008;48:835–847.CrossRef
26.
Zurück zum Zitat 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.CrossRef 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.CrossRef
27.
Zurück zum Zitat 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.CrossRef 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.CrossRef
28.
Zurück zum Zitat 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.CrossRef 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.CrossRef
Metadaten
Titel
Intensive Pharmacy Care Improves Outcomes of Hepatitis C Treatment in a Vulnerable Patient Population at a Safety-Net Hospital
verfasst von
Ashley N. Tran
Rishabh Sachdev
Zachary P. Fricker
Michael Leber
Toni Zahorian
Bhavesh Shah
David P. Nunes
Michelle T. Long
Publikationsdatum
04.08.2018
Verlag
Springer US
Erschienen in
Digestive Diseases and Sciences / Ausgabe 12/2018
Print ISSN: 0163-2116
Elektronische ISSN: 1573-2568
DOI
https://doi.org/10.1007/s10620-018-5231-0

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