Effect of Sofosbuvir-Based Hepatitis C Virus Therapy on Kidney Function in Patients with CKD
Hepatitis C virus infection is common in patients with CKD and leads to accelerated progression to ESRD. Sofosbuvir is a potent direct-acting antiviral therapy against hepatitis C virus; however, there are concerns about its safety in patients with CKD. The objective of our study was to determine th...
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| Veröffentlicht in: | Clinical journal of the American Society of Nephrology 2017-10, Vol.12 (10), p.1615-1623 |
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| creator | Sise, Meghan E Backman, Elke Ortiz, Guillermo A Hundemer, Gregory L Ufere, Nneka N Chute, Donald F Brancale, Joseph Xu, Dihua Wisocky, Jessica Lin, Ming V Kim, Arthur Y Thadhani, Ravi Chung, Raymond T |
| description | Hepatitis C virus infection is common in patients with CKD and leads to accelerated progression to ESRD. Sofosbuvir is a potent direct-acting antiviral therapy against hepatitis C virus; however, there are concerns about its safety in patients with CKD. The objective of our study was to determine the safety and efficacy of sofosbuvir in patients with CKD.
We studied a retrospective observational cohort of patients with CKD defined by eGFR |
| doi_str_mv | 10.2215/CJN.02510317 |
| format | Article |
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We studied a retrospective observational cohort of patients with CKD defined by eGFR<60 ml/min per 1.73 m
, ≥30 mg albuminuria per 1 g creatinine, or ≥200 mg proteinuria per 1 g creatinine who received sofosbuvir-based therapy in a large health care system. Regression models were constructed to predict likelihood of sustained virologic response, detect adverse events, and examine changes in eGFR from baseline to follow-up.
Ninety-eight patients with CKD (42% stage 1 or 2 CKD and 58% stage 3 CKD) were included. Mean age was 62 years old, 78% were men, and 65% were white. Additionally, 49% of patients had diabetes, 38% of patients had cirrhosis, and 33% of patients had prior solid organ transplant. Overall sustained virologic response was 81% and varied by regimen used and viral genotype. Average baseline eGFR was equivalent to average on-treatment eGFR, but seven patients experienced a rise in creatinine ≥1.5 times baseline while taking sofosbuvir; all but one recovered. In patients with eGFR<60 ml/min per 1.73 m
at baseline (stage 3 CKD), regression models showed that hepatitis C cure was associated with a 9.3 (95% confidence interval, 0.44 to 18) ml/min per 1.73 m
improvement in eGFR during the 6-month post-treatment follow-up period. Adverse events were common (81%), but serious adverse events (17%) and treatment discontinuations (8%) were uncommon.
Sofosbuvir-based direct-acting antiviral therapy is safe and effective in a cohort of patients with CKD infected with hepatitis C.</description><identifier>ISSN: 1555-9041</identifier><identifier>EISSN: 1555-905X</identifier><identifier>DOI: 10.2215/CJN.02510317</identifier><identifier>PMID: 28882857</identifier><language>eng</language><publisher>United States: American Society of Nephrology</publisher><subject>Aged ; Albuminuria - complications ; Albuminuria - physiopathology ; Antiviral Agents - adverse effects ; Antiviral Agents - therapeutic use ; Drug Therapy, Combination ; Female ; Glomerular Filtration Rate - drug effects ; Hepatitis C - complications ; Hepatitis C - diagnosis ; Hepatitis C - drug therapy ; Humans ; Kidney - drug effects ; Kidney - physiopathology ; Male ; Middle Aged ; Original ; Renal Insufficiency, Chronic - complications ; Renal Insufficiency, Chronic - diagnosis ; Renal Insufficiency, Chronic - physiopathology ; Retrospective Studies ; Risk Factors ; Sofosbuvir - adverse effects ; Sofosbuvir - therapeutic use ; Sustained Virologic Response ; Time Factors ; Treatment Outcome</subject><ispartof>Clinical journal of the American Society of Nephrology, 2017-10, Vol.12 (10), p.1615-1623</ispartof><rights>Copyright © 2017 by the American Society of Nephrology.</rights><rights>Copyright © 2017 by the American Society of Nephrology 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c384t-4e29f0eb4503edd4a0e4408be52d9cf0261426645a7e89b6770f0f2e5cef01bb3</citedby><cites>FETCH-LOGICAL-c384t-4e29f0eb4503edd4a0e4408be52d9cf0261426645a7e89b6770f0f2e5cef01bb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5628711/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5628711/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,724,777,781,882,27905,27906,53772,53774</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28882857$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sise, Meghan E</creatorcontrib><creatorcontrib>Backman, Elke</creatorcontrib><creatorcontrib>Ortiz, Guillermo A</creatorcontrib><creatorcontrib>Hundemer, Gregory L</creatorcontrib><creatorcontrib>Ufere, Nneka N</creatorcontrib><creatorcontrib>Chute, Donald F</creatorcontrib><creatorcontrib>Brancale, Joseph</creatorcontrib><creatorcontrib>Xu, Dihua</creatorcontrib><creatorcontrib>Wisocky, Jessica</creatorcontrib><creatorcontrib>Lin, Ming V</creatorcontrib><creatorcontrib>Kim, Arthur Y</creatorcontrib><creatorcontrib>Thadhani, Ravi</creatorcontrib><creatorcontrib>Chung, Raymond T</creatorcontrib><title>Effect of Sofosbuvir-Based Hepatitis C Virus Therapy on Kidney Function in Patients with CKD</title><title>Clinical journal of the American Society of Nephrology</title><addtitle>Clin J Am Soc Nephrol</addtitle><description>Hepatitis C virus infection is common in patients with CKD and leads to accelerated progression to ESRD. Sofosbuvir is a potent direct-acting antiviral therapy against hepatitis C virus; however, there are concerns about its safety in patients with CKD. The objective of our study was to determine the safety and efficacy of sofosbuvir in patients with CKD.
We studied a retrospective observational cohort of patients with CKD defined by eGFR<60 ml/min per 1.73 m
, ≥30 mg albuminuria per 1 g creatinine, or ≥200 mg proteinuria per 1 g creatinine who received sofosbuvir-based therapy in a large health care system. Regression models were constructed to predict likelihood of sustained virologic response, detect adverse events, and examine changes in eGFR from baseline to follow-up.
Ninety-eight patients with CKD (42% stage 1 or 2 CKD and 58% stage 3 CKD) were included. Mean age was 62 years old, 78% were men, and 65% were white. Additionally, 49% of patients had diabetes, 38% of patients had cirrhosis, and 33% of patients had prior solid organ transplant. Overall sustained virologic response was 81% and varied by regimen used and viral genotype. Average baseline eGFR was equivalent to average on-treatment eGFR, but seven patients experienced a rise in creatinine ≥1.5 times baseline while taking sofosbuvir; all but one recovered. In patients with eGFR<60 ml/min per 1.73 m
at baseline (stage 3 CKD), regression models showed that hepatitis C cure was associated with a 9.3 (95% confidence interval, 0.44 to 18) ml/min per 1.73 m
improvement in eGFR during the 6-month post-treatment follow-up period. Adverse events were common (81%), but serious adverse events (17%) and treatment discontinuations (8%) were uncommon.
Sofosbuvir-based direct-acting antiviral therapy is safe and effective in a cohort of patients with CKD infected with hepatitis C.</description><subject>Aged</subject><subject>Albuminuria - complications</subject><subject>Albuminuria - physiopathology</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Glomerular Filtration Rate - drug effects</subject><subject>Hepatitis C - complications</subject><subject>Hepatitis C - diagnosis</subject><subject>Hepatitis C - drug therapy</subject><subject>Humans</subject><subject>Kidney - drug effects</subject><subject>Kidney - physiopathology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Renal Insufficiency, Chronic - complications</subject><subject>Renal Insufficiency, Chronic - diagnosis</subject><subject>Renal Insufficiency, Chronic - physiopathology</subject><subject>Retrospective Studies</subject><subject>Risk Factors</subject><subject>Sofosbuvir - adverse effects</subject><subject>Sofosbuvir - therapeutic use</subject><subject>Sustained Virologic Response</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1555-9041</issn><issn>1555-905X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkNFLwzAQxoMobk7ffJb8AXYmadJmL4LWzemGCk7xQQhpe3GRrS1JO9l_b2Vu6NPdcd993_FD6JSSPmNUXCT3D33CBCUhjfdQlwohggERb_u7ntMOOvL-kxDOQyYOUYdJKZkUcRe9D42BrMalwc-lKX3arKwLrrWHHI-h0rWtrccJfrWu8Xg2B6erNS4LPLF5AWs8aoqstu1sC_zUqqGoPf6y9Rwnk5tjdGD0wsPJb-2hl9FwloyD6ePtXXI1DbJQ8jrgwAaGQMoFCSHPuSbAOZEpCJYPMkNYRDmLIi50DHKQRnFMDDEMRAaG0DQNe-hy41s16RLyrH3C6YWqnF1qt1altur_prBz9VGulIiYjCltDc43BpkrvXdgdreUqB_KqqWstpRb-dnfvJ14izX8Bs-lePk</recordid><startdate>20171006</startdate><enddate>20171006</enddate><creator>Sise, Meghan E</creator><creator>Backman, Elke</creator><creator>Ortiz, Guillermo A</creator><creator>Hundemer, Gregory L</creator><creator>Ufere, Nneka N</creator><creator>Chute, Donald F</creator><creator>Brancale, Joseph</creator><creator>Xu, Dihua</creator><creator>Wisocky, Jessica</creator><creator>Lin, Ming V</creator><creator>Kim, Arthur Y</creator><creator>Thadhani, Ravi</creator><creator>Chung, Raymond T</creator><general>American Society of Nephrology</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>5PM</scope></search><sort><creationdate>20171006</creationdate><title>Effect of Sofosbuvir-Based Hepatitis C Virus Therapy on Kidney Function in Patients with CKD</title><author>Sise, Meghan E ; Backman, Elke ; Ortiz, Guillermo A ; Hundemer, Gregory L ; Ufere, Nneka N ; Chute, Donald F ; Brancale, Joseph ; Xu, Dihua ; Wisocky, Jessica ; Lin, Ming V ; Kim, Arthur Y ; Thadhani, Ravi ; Chung, Raymond T</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c384t-4e29f0eb4503edd4a0e4408be52d9cf0261426645a7e89b6770f0f2e5cef01bb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Aged</topic><topic>Albuminuria - complications</topic><topic>Albuminuria - physiopathology</topic><topic>Antiviral Agents - adverse effects</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Glomerular Filtration Rate - drug effects</topic><topic>Hepatitis C - complications</topic><topic>Hepatitis C - diagnosis</topic><topic>Hepatitis C - drug therapy</topic><topic>Humans</topic><topic>Kidney - drug effects</topic><topic>Kidney - physiopathology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Renal Insufficiency, Chronic - complications</topic><topic>Renal Insufficiency, Chronic - diagnosis</topic><topic>Renal Insufficiency, Chronic - physiopathology</topic><topic>Retrospective Studies</topic><topic>Risk Factors</topic><topic>Sofosbuvir - adverse effects</topic><topic>Sofosbuvir - therapeutic use</topic><topic>Sustained Virologic Response</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sise, Meghan E</creatorcontrib><creatorcontrib>Backman, Elke</creatorcontrib><creatorcontrib>Ortiz, Guillermo A</creatorcontrib><creatorcontrib>Hundemer, Gregory L</creatorcontrib><creatorcontrib>Ufere, Nneka N</creatorcontrib><creatorcontrib>Chute, Donald F</creatorcontrib><creatorcontrib>Brancale, Joseph</creatorcontrib><creatorcontrib>Xu, Dihua</creatorcontrib><creatorcontrib>Wisocky, Jessica</creatorcontrib><creatorcontrib>Lin, Ming V</creatorcontrib><creatorcontrib>Kim, Arthur Y</creatorcontrib><creatorcontrib>Thadhani, Ravi</creatorcontrib><creatorcontrib>Chung, Raymond 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>PubMed Central (Full Participant titles)</collection><jtitle>Clinical journal of the American Society of Nephrology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sise, Meghan E</au><au>Backman, Elke</au><au>Ortiz, Guillermo A</au><au>Hundemer, Gregory L</au><au>Ufere, Nneka N</au><au>Chute, Donald F</au><au>Brancale, Joseph</au><au>Xu, Dihua</au><au>Wisocky, Jessica</au><au>Lin, Ming V</au><au>Kim, Arthur Y</au><au>Thadhani, Ravi</au><au>Chung, Raymond T</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of Sofosbuvir-Based Hepatitis C Virus Therapy on Kidney Function in Patients with CKD</atitle><jtitle>Clinical journal of the American Society of Nephrology</jtitle><addtitle>Clin J Am Soc Nephrol</addtitle><date>2017-10-06</date><risdate>2017</risdate><volume>12</volume><issue>10</issue><spage>1615</spage><epage>1623</epage><pages>1615-1623</pages><issn>1555-9041</issn><eissn>1555-905X</eissn><abstract>Hepatitis C virus infection is common in patients with CKD and leads to accelerated progression to ESRD. Sofosbuvir is a potent direct-acting antiviral therapy against hepatitis C virus; however, there are concerns about its safety in patients with CKD. The objective of our study was to determine the safety and efficacy of sofosbuvir in patients with CKD.
We studied a retrospective observational cohort of patients with CKD defined by eGFR<60 ml/min per 1.73 m
, ≥30 mg albuminuria per 1 g creatinine, or ≥200 mg proteinuria per 1 g creatinine who received sofosbuvir-based therapy in a large health care system. Regression models were constructed to predict likelihood of sustained virologic response, detect adverse events, and examine changes in eGFR from baseline to follow-up.
Ninety-eight patients with CKD (42% stage 1 or 2 CKD and 58% stage 3 CKD) were included. Mean age was 62 years old, 78% were men, and 65% were white. Additionally, 49% of patients had diabetes, 38% of patients had cirrhosis, and 33% of patients had prior solid organ transplant. Overall sustained virologic response was 81% and varied by regimen used and viral genotype. Average baseline eGFR was equivalent to average on-treatment eGFR, but seven patients experienced a rise in creatinine ≥1.5 times baseline while taking sofosbuvir; all but one recovered. In patients with eGFR<60 ml/min per 1.73 m
at baseline (stage 3 CKD), regression models showed that hepatitis C cure was associated with a 9.3 (95% confidence interval, 0.44 to 18) ml/min per 1.73 m
improvement in eGFR during the 6-month post-treatment follow-up period. Adverse events were common (81%), but serious adverse events (17%) and treatment discontinuations (8%) were uncommon.
Sofosbuvir-based direct-acting antiviral therapy is safe and effective in a cohort of patients with CKD infected with hepatitis C.</abstract><cop>United States</cop><pub>American Society of Nephrology</pub><pmid>28882857</pmid><doi>10.2215/CJN.02510317</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1555-9041 |
| ispartof | Clinical journal of the American Society of Nephrology, 2017-10, Vol.12 (10), p.1615-1623 |
| issn | 1555-9041 1555-905X |
| language | eng |
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| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; PubMed Central; Alma/SFX Local Collection |
| subjects | Aged Albuminuria - complications Albuminuria - physiopathology Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Drug Therapy, Combination Female Glomerular Filtration Rate - drug effects Hepatitis C - complications Hepatitis C - diagnosis Hepatitis C - drug therapy Humans Kidney - drug effects Kidney - physiopathology Male Middle Aged Original Renal Insufficiency, Chronic - complications Renal Insufficiency, Chronic - diagnosis Renal Insufficiency, Chronic - physiopathology Retrospective Studies Risk Factors Sofosbuvir - adverse effects Sofosbuvir - therapeutic use Sustained Virologic Response Time Factors Treatment Outcome |
| title | Effect of Sofosbuvir-Based Hepatitis C Virus Therapy on Kidney Function in Patients with CKD |
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