Intensive Pharmacy Care Improves Outcomes of Hepatitis C Treatment in a Vulnerable Patient Population at a Safety-Net Hospital
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 outcom...
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description | 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. |
doi_str_mv | 10.1007/s10620-018-5231-0 |
format | Article |
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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.</description><identifier>ISSN: 0163-2116</identifier><identifier>EISSN: 1573-2568</identifier><identifier>DOI: 10.1007/s10620-018-5231-0</identifier><identifier>PMID: 30078116</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject><![CDATA[Antiviral agents ; Antiviral Agents - therapeutic use ; Antiviral drugs ; Biochemistry ; Biological products industry ; Clinical outcomes ; Comparative analysis ; Female ; Gastroenterology ; Hepacivirus - drug effects ; Hepacivirus - isolation & purification ; Hepatitis ; Hepatitis C ; Hepatitis C - diagnosis ; Hepatitis C - drug therapy ; Hepatitis C - epidemiology ; Hepatitis C virus ; Hepatology ; Humans ; Lost to Follow-Up ; Male ; Medical centers ; Medicine ; Medicine & Public Health ; Middle Aged ; Oncology ; Original Article ; Patient compliance ; Pharmaceutical Services - statistics & numerical data ; Pharmaceutical Services - supply & distribution ; Pharmacy ; Quality Improvement - organization & administration ; Retrospective Studies ; Safety and security measures ; Sustained Virologic Response ; Transplant Surgery ; United States - epidemiology ; Vulnerable Populations - statistics & numerical data]]></subject><ispartof>Digestive diseases and sciences, 2018-12, Vol.63 (12), p.3241-3249</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature 2018</rights><rights>COPYRIGHT 2018 Springer</rights><rights>Digestive Diseases and Sciences is a copyright of Springer, (2018). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c537t-e9b78b8d6e23f36da3f4b1a250a80aadc3f37470301e3610eacf3be7879c2fae3</citedby><cites>FETCH-LOGICAL-c537t-e9b78b8d6e23f36da3f4b1a250a80aadc3f37470301e3610eacf3be7879c2fae3</cites><orcidid>0000-0001-6131-3981</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10620-018-5231-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10620-018-5231-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,780,784,885,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30078116$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tran, Ashley N.</creatorcontrib><creatorcontrib>Sachdev, Rishabh</creatorcontrib><creatorcontrib>Fricker, Zachary P.</creatorcontrib><creatorcontrib>Leber, Michael</creatorcontrib><creatorcontrib>Zahorian, Toni</creatorcontrib><creatorcontrib>Shah, Bhavesh</creatorcontrib><creatorcontrib>Nunes, David P.</creatorcontrib><creatorcontrib>Long, Michelle T.</creatorcontrib><title>Intensive Pharmacy Care Improves Outcomes of Hepatitis C Treatment in a Vulnerable Patient Population at a Safety-Net Hospital</title><title>Digestive diseases and sciences</title><addtitle>Dig Dis Sci</addtitle><addtitle>Dig Dis Sci</addtitle><description>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.</description><subject>Antiviral agents</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Antiviral drugs</subject><subject>Biochemistry</subject><subject>Biological products industry</subject><subject>Clinical outcomes</subject><subject>Comparative analysis</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Hepacivirus - drug effects</subject><subject>Hepacivirus - isolation & purification</subject><subject>Hepatitis</subject><subject>Hepatitis C</subject><subject>Hepatitis C - diagnosis</subject><subject>Hepatitis C - drug therapy</subject><subject>Hepatitis C - epidemiology</subject><subject>Hepatitis C virus</subject><subject>Hepatology</subject><subject>Humans</subject><subject>Lost to Follow-Up</subject><subject>Male</subject><subject>Medical centers</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Patient compliance</subject><subject>Pharmaceutical Services - statistics & numerical data</subject><subject>Pharmaceutical Services - supply & distribution</subject><subject>Pharmacy</subject><subject>Quality Improvement - organization & administration</subject><subject>Retrospective Studies</subject><subject>Safety and security measures</subject><subject>Sustained Virologic Response</subject><subject>Transplant Surgery</subject><subject>United States - epidemiology</subject><subject>Vulnerable Populations - statistics & numerical data</subject><issn>0163-2116</issn><issn>1573-2568</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kk1v1DAQhiMEokvhB3BBlrhwSfFH1k4uSNUK2JUqWonC1Zp4J1tXiR1sZ6W98NtxtKWlCOSDRzPPvPbYb1G8ZvSMUareR0YlpyVldbnkgpX0SbFgSyVKvpT102JBmcwxY_KkeBHjLaW0UUw-L05E7q5zflH83LiELto9kqsbCAOYA1lBQLIZxuD3GMnllIwfcuA7ssYRkk02khW5DghpQJeIdQTI96l3GKDts1Bm5vyVH6c-xz7XU0a-QofpUH7BRNY-jjZB_7J41kEf8dXdflp8-_TxerUuLy4_b1bnF6VZCpVKbFpVt_VWIhedkFsQXdUy4EsKNQXYmpxVlaKCMhSSUQTTiRZVrRrDO0BxWnw46o5TO-DW5OsF6PUY7ADhoD1Y_bji7I3e-b2WSuVHk1ng3Z1A8D8mjEkPNhrse3Dop6g5rStRNbyiGX37F3rrp-DyeDPFGzr_yAO1gx61dZ3P55pZVJ8rxhuhhOSZOvsHldcWB2u8w87m_KMGdmwwwccYsLufkVE9m0YfTaOzafRsGj1f-M2fj3Pf8dslGeBHIOaS22F4mOj_qr8ANorM4w</recordid><startdate>20181201</startdate><enddate>20181201</enddate><creator>Tran, Ashley N.</creator><creator>Sachdev, Rishabh</creator><creator>Fricker, Zachary P.</creator><creator>Leber, Michael</creator><creator>Zahorian, Toni</creator><creator>Shah, Bhavesh</creator><creator>Nunes, David P.</creator><creator>Long, Michelle T.</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6131-3981</orcidid></search><sort><creationdate>20181201</creationdate><title>Intensive Pharmacy Care Improves Outcomes of Hepatitis C Treatment in a Vulnerable Patient Population at a Safety-Net Hospital</title><author>Tran, Ashley N. ; Sachdev, Rishabh ; Fricker, Zachary P. ; Leber, Michael ; Zahorian, Toni ; Shah, Bhavesh ; Nunes, David P. ; Long, Michelle T.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c537t-e9b78b8d6e23f36da3f4b1a250a80aadc3f37470301e3610eacf3be7879c2fae3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Antiviral agents</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Antiviral drugs</topic><topic>Biochemistry</topic><topic>Biological products industry</topic><topic>Clinical outcomes</topic><topic>Comparative analysis</topic><topic>Female</topic><topic>Gastroenterology</topic><topic>Hepacivirus - drug effects</topic><topic>Hepacivirus - isolation & purification</topic><topic>Hepatitis</topic><topic>Hepatitis C</topic><topic>Hepatitis C - diagnosis</topic><topic>Hepatitis C - drug therapy</topic><topic>Hepatitis C - epidemiology</topic><topic>Hepatitis C virus</topic><topic>Hepatology</topic><topic>Humans</topic><topic>Lost to Follow-Up</topic><topic>Male</topic><topic>Medical centers</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Patient compliance</topic><topic>Pharmaceutical Services - statistics & numerical data</topic><topic>Pharmaceutical Services - supply & distribution</topic><topic>Pharmacy</topic><topic>Quality Improvement - organization & administration</topic><topic>Retrospective Studies</topic><topic>Safety and security measures</topic><topic>Sustained Virologic Response</topic><topic>Transplant Surgery</topic><topic>United States - epidemiology</topic><topic>Vulnerable Populations - statistics & numerical data</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tran, Ashley N.</creatorcontrib><creatorcontrib>Sachdev, Rishabh</creatorcontrib><creatorcontrib>Fricker, Zachary P.</creatorcontrib><creatorcontrib>Leber, Michael</creatorcontrib><creatorcontrib>Zahorian, Toni</creatorcontrib><creatorcontrib>Shah, Bhavesh</creatorcontrib><creatorcontrib>Nunes, David P.</creatorcontrib><creatorcontrib>Long, Michelle T.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Digestive diseases and sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tran, Ashley N.</au><au>Sachdev, Rishabh</au><au>Fricker, Zachary P.</au><au>Leber, Michael</au><au>Zahorian, Toni</au><au>Shah, Bhavesh</au><au>Nunes, David P.</au><au>Long, Michelle T.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Intensive Pharmacy Care Improves Outcomes of Hepatitis C Treatment in a Vulnerable Patient Population at a Safety-Net Hospital</atitle><jtitle>Digestive diseases and sciences</jtitle><stitle>Dig Dis Sci</stitle><addtitle>Dig Dis Sci</addtitle><date>2018-12-01</date><risdate>2018</risdate><volume>63</volume><issue>12</issue><spage>3241</spage><epage>3249</epage><pages>3241-3249</pages><issn>0163-2116</issn><eissn>1573-2568</eissn><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.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>30078116</pmid><doi>10.1007/s10620-018-5231-0</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-6131-3981</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Antiviral agents Antiviral Agents - therapeutic use Antiviral drugs Biochemistry Biological products industry Clinical outcomes Comparative analysis Female Gastroenterology Hepacivirus - drug effects Hepacivirus - isolation & purification Hepatitis Hepatitis C Hepatitis C - diagnosis Hepatitis C - drug therapy Hepatitis C - epidemiology Hepatitis C virus Hepatology Humans Lost to Follow-Up Male Medical centers Medicine Medicine & Public Health Middle Aged Oncology Original Article Patient compliance Pharmaceutical Services - statistics & numerical data Pharmaceutical Services - supply & distribution Pharmacy Quality Improvement - organization & administration Retrospective Studies Safety and security measures Sustained Virologic Response Transplant Surgery United States - epidemiology Vulnerable Populations - statistics & numerical data |
title | Intensive Pharmacy Care Improves Outcomes of Hepatitis C Treatment in a Vulnerable Patient Population at a Safety-Net Hospital |
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