Safety and Efficacy of Simeprevir/Sofosbuvir in Hepatitis C–Infected Patients With Compensated and Decompensated Cirrhosis
Risks and benefits of simeprevir plus sofosbuvir (SIM+SOF) in patients with advanced cirrhosis are unknown. We assessed the safety and sustained virological responses (SVR) of SIM+SOF with and without ribavirin (RBV) in patients with Child‐Pugh (CP)‐B/C versus CP‐A cirrhosis and compared to matched...
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| Veröffentlicht in: | Hepatology (Baltimore, Md.) Md.), 2015-09, Vol.62 (3), p.715-725 |
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| creator | Saxena, Varun Nyberg, Lisa Pauly, Marypat Dasgupta, Aditi Nyberg, Anders Piasecki, Barbara Winston, Bradley Redd, Jacquelyn Ready, Joanna Terrault, Norah A. |
| description | Risks and benefits of simeprevir plus sofosbuvir (SIM+SOF) in patients with advanced cirrhosis are unknown. We assessed the safety and sustained virological responses (SVR) of SIM+SOF with and without ribavirin (RBV) in patients with Child‐Pugh (CP)‐B/C versus CP‐A cirrhosis and compared to matched untreated controls. This study was of a multicenter cohort of adults with hepatitis C virus genotype 1 and cirrhosis treated with SIM+SOF with/without RBV for 12 weeks. Controls were matched on treatment center, age, CP class, and Model for End‐Stage Liver Disease (MELD) score. Of 160 patients treated with SIM+SOF with/without RBV, 35% had CP‐B/C and 64% had CP‐A, with median baseline MELD 9 (interquartile range, 8‐11). Sustained virological response at week 12 (SVR12) was achieved by 73% of CP‐B/C versus 91% of CP‐A (P |
| doi_str_mv | 10.1002/hep.27922 |
| format | Article |
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We assessed the safety and sustained virological responses (SVR) of SIM+SOF with and without ribavirin (RBV) in patients with Child‐Pugh (CP)‐B/C versus CP‐A cirrhosis and compared to matched untreated controls. This study was of a multicenter cohort of adults with hepatitis C virus genotype 1 and cirrhosis treated with SIM+SOF with/without RBV for 12 weeks. Controls were matched on treatment center, age, CP class, and Model for End‐Stage Liver Disease (MELD) score. Of 160 patients treated with SIM+SOF with/without RBV, 35% had CP‐B/C and 64% had CP‐A, with median baseline MELD 9 (interquartile range, 8‐11). Sustained virological response at week 12 (SVR12) was achieved by 73% of CP‐B/C versus 91% of CP‐A (P < 0.01). CP‐B/C versus CP‐A had more early treatment discontinuations (11% vs. 1%), adverse events (AEs) requiring hospitalization (22% vs. 2%), infections requiring antibiotics (20% vs. 1%), and hepatic decompensating events (20% vs. 3%; all P < 0.01). There were 2 deaths: 1 CP‐B/C (liver related) and 1 CP‐A (not liver related). In multivariate analysis, CP‐B/C independently predicted lack of SVR12 (odds ratio, 0.27; 95% confidence interval: 0.08‐0.92). In comparing SIM+SOF‐treated patients versus matched untreated controls, AEs requiring hospitalization (9% vs. 13%; P = 0.55), infections (8% vs. 6%; P = 0.47), and events of decompensation (9% vs. 10%; P = 0.78) occurred at similar frequency. Conclusions: SIM+SOF with/without RBV has lower efficacy and higher rates of AEs in patients with CP‐B/C cirrhosis, compared to CP‐A. Frequency of adverse safety outcomes were similar to matched untreated controls, suggesting that safety events reflect the natural history of cirrhosis and are not related to treatment. (Hepatology 2015;62:715–725)</description><identifier>ISSN: 0270-9139</identifier><identifier>EISSN: 1527-3350</identifier><identifier>DOI: 10.1002/hep.27922</identifier><identifier>PMID: 26033798</identifier><identifier>CODEN: HPTLD9</identifier><language>eng</language><publisher>United States: Wolters Kluwer Health, Inc</publisher><subject>Aged ; Analysis of Variance ; Antiviral Agents - administration & dosage ; Case-Control Studies ; Confidence intervals ; Drug Therapy, Combination ; Female ; Follow-Up Studies ; Hepacivirus - drug effects ; Hepatitis ; Hepatitis C ; Hepatitis C - drug therapy ; Hepatitis C - pathology ; Hepatitis C virus ; Humans ; Liver cirrhosis ; Liver Cirrhosis - drug therapy ; Liver Cirrhosis - pathology ; Liver Cirrhosis - physiopathology ; Logistic Models ; Male ; Middle Aged ; Multivariate Analysis ; Patient Safety ; Reference Values ; Retrospective Studies ; Ribavirin - administration & dosage ; Ribavirin - adverse effects ; Risk Assessment ; Severity of Illness Index ; Simeprevir - administration & dosage ; Simeprevir - adverse effects ; Sofosbuvir - administration & dosage ; Sofosbuvir - adverse effects ; Treatment Outcome</subject><ispartof>Hepatology (Baltimore, Md.), 2015-09, Vol.62 (3), p.715-725</ispartof><rights>2015 by the American Association for the Study of Liver Diseases</rights><rights>2015 by the American Association for the Study of Liver Diseases.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4762-b8ed282d3819070d789d6f0fb17f4b4be1fa1be40b63f4a73e08d2cbb8dc23473</citedby><cites>FETCH-LOGICAL-c4762-b8ed282d3819070d789d6f0fb17f4b4be1fa1be40b63f4a73e08d2cbb8dc23473</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fhep.27922$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fhep.27922$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,780,784,885,1417,27923,27924,45573,45574</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26033798$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Saxena, Varun</creatorcontrib><creatorcontrib>Nyberg, Lisa</creatorcontrib><creatorcontrib>Pauly, Marypat</creatorcontrib><creatorcontrib>Dasgupta, Aditi</creatorcontrib><creatorcontrib>Nyberg, Anders</creatorcontrib><creatorcontrib>Piasecki, Barbara</creatorcontrib><creatorcontrib>Winston, Bradley</creatorcontrib><creatorcontrib>Redd, Jacquelyn</creatorcontrib><creatorcontrib>Ready, Joanna</creatorcontrib><creatorcontrib>Terrault, Norah A.</creatorcontrib><title>Safety and Efficacy of Simeprevir/Sofosbuvir in Hepatitis C–Infected Patients With Compensated and Decompensated Cirrhosis</title><title>Hepatology (Baltimore, Md.)</title><addtitle>Hepatology</addtitle><description>Risks and benefits of simeprevir plus sofosbuvir (SIM+SOF) in patients with advanced cirrhosis are unknown. We assessed the safety and sustained virological responses (SVR) of SIM+SOF with and without ribavirin (RBV) in patients with Child‐Pugh (CP)‐B/C versus CP‐A cirrhosis and compared to matched untreated controls. This study was of a multicenter cohort of adults with hepatitis C virus genotype 1 and cirrhosis treated with SIM+SOF with/without RBV for 12 weeks. Controls were matched on treatment center, age, CP class, and Model for End‐Stage Liver Disease (MELD) score. Of 160 patients treated with SIM+SOF with/without RBV, 35% had CP‐B/C and 64% had CP‐A, with median baseline MELD 9 (interquartile range, 8‐11). Sustained virological response at week 12 (SVR12) was achieved by 73% of CP‐B/C versus 91% of CP‐A (P < 0.01). CP‐B/C versus CP‐A had more early treatment discontinuations (11% vs. 1%), adverse events (AEs) requiring hospitalization (22% vs. 2%), infections requiring antibiotics (20% vs. 1%), and hepatic decompensating events (20% vs. 3%; all P < 0.01). There were 2 deaths: 1 CP‐B/C (liver related) and 1 CP‐A (not liver related). In multivariate analysis, CP‐B/C independently predicted lack of SVR12 (odds ratio, 0.27; 95% confidence interval: 0.08‐0.92). In comparing SIM+SOF‐treated patients versus matched untreated controls, AEs requiring hospitalization (9% vs. 13%; P = 0.55), infections (8% vs. 6%; P = 0.47), and events of decompensation (9% vs. 10%; P = 0.78) occurred at similar frequency. Conclusions: SIM+SOF with/without RBV has lower efficacy and higher rates of AEs in patients with CP‐B/C cirrhosis, compared to CP‐A. Frequency of adverse safety outcomes were similar to matched untreated controls, suggesting that safety events reflect the natural history of cirrhosis and are not related to treatment. 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We assessed the safety and sustained virological responses (SVR) of SIM+SOF with and without ribavirin (RBV) in patients with Child‐Pugh (CP)‐B/C versus CP‐A cirrhosis and compared to matched untreated controls. This study was of a multicenter cohort of adults with hepatitis C virus genotype 1 and cirrhosis treated with SIM+SOF with/without RBV for 12 weeks. Controls were matched on treatment center, age, CP class, and Model for End‐Stage Liver Disease (MELD) score. Of 160 patients treated with SIM+SOF with/without RBV, 35% had CP‐B/C and 64% had CP‐A, with median baseline MELD 9 (interquartile range, 8‐11). Sustained virological response at week 12 (SVR12) was achieved by 73% of CP‐B/C versus 91% of CP‐A (P < 0.01). CP‐B/C versus CP‐A had more early treatment discontinuations (11% vs. 1%), adverse events (AEs) requiring hospitalization (22% vs. 2%), infections requiring antibiotics (20% vs. 1%), and hepatic decompensating events (20% vs. 3%; all P < 0.01). There were 2 deaths: 1 CP‐B/C (liver related) and 1 CP‐A (not liver related). In multivariate analysis, CP‐B/C independently predicted lack of SVR12 (odds ratio, 0.27; 95% confidence interval: 0.08‐0.92). In comparing SIM+SOF‐treated patients versus matched untreated controls, AEs requiring hospitalization (9% vs. 13%; P = 0.55), infections (8% vs. 6%; P = 0.47), and events of decompensation (9% vs. 10%; P = 0.78) occurred at similar frequency. Conclusions: SIM+SOF with/without RBV has lower efficacy and higher rates of AEs in patients with CP‐B/C cirrhosis, compared to CP‐A. Frequency of adverse safety outcomes were similar to matched untreated controls, suggesting that safety events reflect the natural history of cirrhosis and are not related to treatment. (Hepatology 2015;62:715–725)</abstract><cop>United States</cop><pub>Wolters Kluwer Health, Inc</pub><pmid>26033798</pmid><doi>10.1002/hep.27922</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Hepatology (Baltimore, Md.), 2015-09, Vol.62 (3), p.715-725 |
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| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; Wiley Online Library All Journals |
| subjects | Aged Analysis of Variance Antiviral Agents - administration & dosage Case-Control Studies Confidence intervals Drug Therapy, Combination Female Follow-Up Studies Hepacivirus - drug effects Hepatitis Hepatitis C Hepatitis C - drug therapy Hepatitis C - pathology Hepatitis C virus Humans Liver cirrhosis Liver Cirrhosis - drug therapy Liver Cirrhosis - pathology Liver Cirrhosis - physiopathology Logistic Models Male Middle Aged Multivariate Analysis Patient Safety Reference Values Retrospective Studies Ribavirin - administration & dosage Ribavirin - adverse effects Risk Assessment Severity of Illness Index Simeprevir - administration & dosage Simeprevir - adverse effects Sofosbuvir - administration & dosage Sofosbuvir - adverse effects Treatment Outcome |
| title | Safety and Efficacy of Simeprevir/Sofosbuvir in Hepatitis C–Infected Patients With Compensated and Decompensated Cirrhosis |
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