Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt
We evaluated the efficacy and safety of ledipasvir/sofosbuvir alone and with ribavirin for 8 and 12 weeks in Egyptian patients with and without cirrhosis, who were infected with hepatitis C virus (HCV) genotype 4, including those who had failed previous treatment with sofosbuvir regimens. In this op...
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| Veröffentlicht in: | Gut 2019-04, Vol.68 (4), p.721-728 |
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| creator | Shiha, Gamal Esmat, Gamal Hassany, Mohamed Soliman, Reham Elbasiony, Mohamed Fouad, Rabab Elsharkawy, Aisha Hammad, Radi Abdel-Razek, Wael Zakareya, Talaat Kersey, Kathryn Massetto, Benedetta Osinusi, Anu Lu, Sophia Brainard, Diana M McHutchison, John G Waked, Imam Doss, Wahid |
| description | We evaluated the efficacy and safety of ledipasvir/sofosbuvir alone and with ribavirin for 8 and 12 weeks in Egyptian patients with and without cirrhosis, who were infected with hepatitis C virus (HCV) genotype 4, including those who had failed previous treatment with sofosbuvir regimens.
In this open-label, multicentre, phase III study, treatment-naive patients were randomised to receive 8 or 12 weeks of ledipasvir/sofosbuvir±ribavirin. Interferon treatment-experienced patients were randomised to receive 12 weeks of ledipasvir/sofosbuvir±ribavirin, while sofosbuvir-experienced or ledipasvir/sofosbuvir-experienced patients received 12 weeks of ledipasvir/sofosbuvir+ribavirin. Randomisation was stratified by cirrhosis status. The primary endpoint was sustained virological response 12 weeks post-treatment (SVR12).
We enrolled 255 patients from four centres in Egypt. Among treatment-naive patients, SVR12 rates were 95% and 90% for those receiving 8 weeks of ledipasvir/sofosbuvir alone and with ribavirin, respectively, and 98% for those receiving 12 weeks of ledipasvir/sofosbuvir both alone and with ribavirin. Among interferon-experienced patients, SVR rates were 94% for those receiving 12 weeks of ledipasvir/sofosbuvir and 100% for those receiving 12 weeks of ledipasvir/sofosbuvir plus ribavirin. All patients previously treated with sofosbuvir regimens who received ledipasvir/sofosbuvir plus ribavirin achieved SVR12. The most common adverse events, headache and fatigue, were more common among patients receiving ribavirin.
Among non-cirrhotic treatment-naive patients with HCV genotype 4, 8 weeks of ledipasvir/sofosbuvir±ribavirin was highly effective. Twelve weeks of ledipasvir/sofosbuvir±ribavirin was highly effective regardless of presence of cirrhosis or prior treatment experience, including previous treatment with sofosbuvir or ledipasvir/sofosbuvir.
NCT02487030. |
| doi_str_mv | 10.1136/gutjnl-2017-315906 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6580781</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2188848453</sourcerecordid><originalsourceid>FETCH-LOGICAL-c430t-ab14c3a796cec3e0875dc3bacbbae4575f38249e38184b53fb78d923b48d9cdb3</originalsourceid><addsrcrecordid>eNpVUcFu1DAUtBCILoUf4ICexDnUjp3E4YCEVoWutBIX4GrZzsuul00cbKfVfk9_FC8pVTmNNfNm3rOGkLeMfmCM11e7OR3GY1FS1hScVS2tn5EVE7UseCnlc7KiZ6VqRHtBXsV4oJRK2bKX5KJs67pmjViR-y12btLx1oWr6HsfzZyfcOfSHvyCfk4QnNGZdyP0mZVniZVwh_gr_mXSHiEF1GnAMYHv4Wb9E3Y4-nSaEAS4sUebnB8_QsA4H1O2BT-AhqDHzg8uYgfTXkeEzWYDMc3dKZvgenea0mvyotfHiG8e8JL8-HL9fX1TbL993aw_bwsrOE2FNkxYrpu2tmg5UtlUneVGW2M0iqqpei5L0SKXTApT8d40smtLbkQG2xl-ST4tudNsBuxs_krQRzUFN-hwUl479b8yur3a-VtVV5I2kuWA9w8Bwf-eMSZ18HMY882qZFJKIUXF81S5TNngYwzYP25gVJ2LVUux6lysWorNpndPb3u0_GuS_wFsCKR0</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2188848453</pqid></control><display><type>article</type><title>Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt</title><source>PubMed Central</source><creator>Shiha, Gamal ; Esmat, Gamal ; Hassany, Mohamed ; Soliman, Reham ; Elbasiony, Mohamed ; Fouad, Rabab ; Elsharkawy, Aisha ; Hammad, Radi ; Abdel-Razek, Wael ; Zakareya, Talaat ; Kersey, Kathryn ; Massetto, Benedetta ; Osinusi, Anu ; Lu, Sophia ; Brainard, Diana M ; McHutchison, John G ; Waked, Imam ; Doss, Wahid</creator><creatorcontrib>Shiha, Gamal ; Esmat, Gamal ; Hassany, Mohamed ; Soliman, Reham ; Elbasiony, Mohamed ; Fouad, Rabab ; Elsharkawy, Aisha ; Hammad, Radi ; Abdel-Razek, Wael ; Zakareya, Talaat ; Kersey, Kathryn ; Massetto, Benedetta ; Osinusi, Anu ; Lu, Sophia ; Brainard, Diana M ; McHutchison, John G ; Waked, Imam ; Doss, Wahid</creatorcontrib><description>We evaluated the efficacy and safety of ledipasvir/sofosbuvir alone and with ribavirin for 8 and 12 weeks in Egyptian patients with and without cirrhosis, who were infected with hepatitis C virus (HCV) genotype 4, including those who had failed previous treatment with sofosbuvir regimens.
In this open-label, multicentre, phase III study, treatment-naive patients were randomised to receive 8 or 12 weeks of ledipasvir/sofosbuvir±ribavirin. Interferon treatment-experienced patients were randomised to receive 12 weeks of ledipasvir/sofosbuvir±ribavirin, while sofosbuvir-experienced or ledipasvir/sofosbuvir-experienced patients received 12 weeks of ledipasvir/sofosbuvir+ribavirin. Randomisation was stratified by cirrhosis status. The primary endpoint was sustained virological response 12 weeks post-treatment (SVR12).
We enrolled 255 patients from four centres in Egypt. Among treatment-naive patients, SVR12 rates were 95% and 90% for those receiving 8 weeks of ledipasvir/sofosbuvir alone and with ribavirin, respectively, and 98% for those receiving 12 weeks of ledipasvir/sofosbuvir both alone and with ribavirin. Among interferon-experienced patients, SVR rates were 94% for those receiving 12 weeks of ledipasvir/sofosbuvir and 100% for those receiving 12 weeks of ledipasvir/sofosbuvir plus ribavirin. All patients previously treated with sofosbuvir regimens who received ledipasvir/sofosbuvir plus ribavirin achieved SVR12. The most common adverse events, headache and fatigue, were more common among patients receiving ribavirin.
Among non-cirrhotic treatment-naive patients with HCV genotype 4, 8 weeks of ledipasvir/sofosbuvir±ribavirin was highly effective. Twelve weeks of ledipasvir/sofosbuvir±ribavirin was highly effective regardless of presence of cirrhosis or prior treatment experience, including previous treatment with sofosbuvir or ledipasvir/sofosbuvir.
NCT02487030.</description><identifier>ISSN: 0017-5749</identifier><identifier>EISSN: 1468-3288</identifier><identifier>DOI: 10.1136/gutjnl-2017-315906</identifier><identifier>PMID: 29666174</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Antiviral drugs ; Cirrhosis ; Drug dosages ; Genotype & phenotype ; Genotypes ; Headache ; Hepatitis ; Hepatitis C ; Hepatology ; Infections ; Interferon ; Liver cirrhosis ; Patients ; Ribavirin</subject><ispartof>Gut, 2019-04, Vol.68 (4), p.721-728</ispartof><rights>Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.</rights><rights>2019 Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:http://creativecommons.org/licenses/by-nc/4.0</rights><rights>Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c430t-ab14c3a796cec3e0875dc3bacbbae4575f38249e38184b53fb78d923b48d9cdb3</citedby><cites>FETCH-LOGICAL-c430t-ab14c3a796cec3e0875dc3bacbbae4575f38249e38184b53fb78d923b48d9cdb3</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/PMC6580781/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6580781/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29666174$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shiha, Gamal</creatorcontrib><creatorcontrib>Esmat, Gamal</creatorcontrib><creatorcontrib>Hassany, Mohamed</creatorcontrib><creatorcontrib>Soliman, Reham</creatorcontrib><creatorcontrib>Elbasiony, Mohamed</creatorcontrib><creatorcontrib>Fouad, Rabab</creatorcontrib><creatorcontrib>Elsharkawy, Aisha</creatorcontrib><creatorcontrib>Hammad, Radi</creatorcontrib><creatorcontrib>Abdel-Razek, Wael</creatorcontrib><creatorcontrib>Zakareya, Talaat</creatorcontrib><creatorcontrib>Kersey, Kathryn</creatorcontrib><creatorcontrib>Massetto, Benedetta</creatorcontrib><creatorcontrib>Osinusi, Anu</creatorcontrib><creatorcontrib>Lu, Sophia</creatorcontrib><creatorcontrib>Brainard, Diana M</creatorcontrib><creatorcontrib>McHutchison, John G</creatorcontrib><creatorcontrib>Waked, Imam</creatorcontrib><creatorcontrib>Doss, Wahid</creatorcontrib><title>Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt</title><title>Gut</title><addtitle>Gut</addtitle><description>We evaluated the efficacy and safety of ledipasvir/sofosbuvir alone and with ribavirin for 8 and 12 weeks in Egyptian patients with and without cirrhosis, who were infected with hepatitis C virus (HCV) genotype 4, including those who had failed previous treatment with sofosbuvir regimens.
In this open-label, multicentre, phase III study, treatment-naive patients were randomised to receive 8 or 12 weeks of ledipasvir/sofosbuvir±ribavirin. Interferon treatment-experienced patients were randomised to receive 12 weeks of ledipasvir/sofosbuvir±ribavirin, while sofosbuvir-experienced or ledipasvir/sofosbuvir-experienced patients received 12 weeks of ledipasvir/sofosbuvir+ribavirin. Randomisation was stratified by cirrhosis status. The primary endpoint was sustained virological response 12 weeks post-treatment (SVR12).
We enrolled 255 patients from four centres in Egypt. Among treatment-naive patients, SVR12 rates were 95% and 90% for those receiving 8 weeks of ledipasvir/sofosbuvir alone and with ribavirin, respectively, and 98% for those receiving 12 weeks of ledipasvir/sofosbuvir both alone and with ribavirin. Among interferon-experienced patients, SVR rates were 94% for those receiving 12 weeks of ledipasvir/sofosbuvir and 100% for those receiving 12 weeks of ledipasvir/sofosbuvir plus ribavirin. All patients previously treated with sofosbuvir regimens who received ledipasvir/sofosbuvir plus ribavirin achieved SVR12. The most common adverse events, headache and fatigue, were more common among patients receiving ribavirin.
Among non-cirrhotic treatment-naive patients with HCV genotype 4, 8 weeks of ledipasvir/sofosbuvir±ribavirin was highly effective. Twelve weeks of ledipasvir/sofosbuvir±ribavirin was highly effective regardless of presence of cirrhosis or prior treatment experience, including previous treatment with sofosbuvir or ledipasvir/sofosbuvir.
NCT02487030.</description><subject>Antiviral drugs</subject><subject>Cirrhosis</subject><subject>Drug dosages</subject><subject>Genotype & phenotype</subject><subject>Genotypes</subject><subject>Headache</subject><subject>Hepatitis</subject><subject>Hepatitis C</subject><subject>Hepatology</subject><subject>Infections</subject><subject>Interferon</subject><subject>Liver 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weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt</title><author>Shiha, Gamal ; Esmat, Gamal ; Hassany, Mohamed ; Soliman, Reham ; Elbasiony, Mohamed ; Fouad, Rabab ; Elsharkawy, Aisha ; Hammad, Radi ; Abdel-Razek, Wael ; Zakareya, Talaat ; Kersey, Kathryn ; Massetto, Benedetta ; Osinusi, Anu ; Lu, Sophia ; Brainard, Diana M ; McHutchison, John G ; Waked, Imam ; Doss, Wahid</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c430t-ab14c3a796cec3e0875dc3bacbbae4575f38249e38184b53fb78d923b48d9cdb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Antiviral drugs</topic><topic>Cirrhosis</topic><topic>Drug dosages</topic><topic>Genotype & phenotype</topic><topic>Genotypes</topic><topic>Headache</topic><topic>Hepatitis</topic><topic>Hepatitis C</topic><topic>Hepatology</topic><topic>Infections</topic><topic>Interferon</topic><topic>Liver cirrhosis</topic><topic>Patients</topic><topic>Ribavirin</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shiha, Gamal</creatorcontrib><creatorcontrib>Esmat, Gamal</creatorcontrib><creatorcontrib>Hassany, Mohamed</creatorcontrib><creatorcontrib>Soliman, Reham</creatorcontrib><creatorcontrib>Elbasiony, Mohamed</creatorcontrib><creatorcontrib>Fouad, Rabab</creatorcontrib><creatorcontrib>Elsharkawy, Aisha</creatorcontrib><creatorcontrib>Hammad, Radi</creatorcontrib><creatorcontrib>Abdel-Razek, Wael</creatorcontrib><creatorcontrib>Zakareya, Talaat</creatorcontrib><creatorcontrib>Kersey, Kathryn</creatorcontrib><creatorcontrib>Massetto, Benedetta</creatorcontrib><creatorcontrib>Osinusi, Anu</creatorcontrib><creatorcontrib>Lu, Sophia</creatorcontrib><creatorcontrib>Brainard, Diana M</creatorcontrib><creatorcontrib>McHutchison, John 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Sophia</au><au>Brainard, Diana M</au><au>McHutchison, John G</au><au>Waked, Imam</au><au>Doss, Wahid</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt</atitle><jtitle>Gut</jtitle><addtitle>Gut</addtitle><date>2019-04-01</date><risdate>2019</risdate><volume>68</volume><issue>4</issue><spage>721</spage><epage>728</epage><pages>721-728</pages><issn>0017-5749</issn><eissn>1468-3288</eissn><abstract>We evaluated the efficacy and safety of ledipasvir/sofosbuvir alone and with ribavirin for 8 and 12 weeks in Egyptian patients with and without cirrhosis, who were infected with hepatitis C virus (HCV) genotype 4, including those who had failed previous treatment with sofosbuvir regimens.
In this open-label, multicentre, phase III study, treatment-naive patients were randomised to receive 8 or 12 weeks of ledipasvir/sofosbuvir±ribavirin. Interferon treatment-experienced patients were randomised to receive 12 weeks of ledipasvir/sofosbuvir±ribavirin, while sofosbuvir-experienced or ledipasvir/sofosbuvir-experienced patients received 12 weeks of ledipasvir/sofosbuvir+ribavirin. Randomisation was stratified by cirrhosis status. The primary endpoint was sustained virological response 12 weeks post-treatment (SVR12).
We enrolled 255 patients from four centres in Egypt. Among treatment-naive patients, SVR12 rates were 95% and 90% for those receiving 8 weeks of ledipasvir/sofosbuvir alone and with ribavirin, respectively, and 98% for those receiving 12 weeks of ledipasvir/sofosbuvir both alone and with ribavirin. Among interferon-experienced patients, SVR rates were 94% for those receiving 12 weeks of ledipasvir/sofosbuvir and 100% for those receiving 12 weeks of ledipasvir/sofosbuvir plus ribavirin. All patients previously treated with sofosbuvir regimens who received ledipasvir/sofosbuvir plus ribavirin achieved SVR12. The most common adverse events, headache and fatigue, were more common among patients receiving ribavirin.
Among non-cirrhotic treatment-naive patients with HCV genotype 4, 8 weeks of ledipasvir/sofosbuvir±ribavirin was highly effective. Twelve weeks of ledipasvir/sofosbuvir±ribavirin was highly effective regardless of presence of cirrhosis or prior treatment experience, including previous treatment with sofosbuvir or ledipasvir/sofosbuvir.
NCT02487030.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>29666174</pmid><doi>10.1136/gutjnl-2017-315906</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Gut, 2019-04, Vol.68 (4), p.721-728 |
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| language | eng |
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| source | PubMed Central |
| subjects | Antiviral drugs Cirrhosis Drug dosages Genotype & phenotype Genotypes Headache Hepatitis Hepatitis C Hepatology Infections Interferon Liver cirrhosis Patients Ribavirin |
| title | Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt |
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