Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options
In two randomized trials, the oral nucleotide polymerase inhibitor sofosbuvir combined with ribavirin for 12 or 16 weeks was effective in patients with chronic HCV genotype 2 or 3 infection for whom interferon therapy either was not an option or had failed. When studied in clinical trials, the curre...
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| Veröffentlicht in: | The New England journal of medicine 2013-05, Vol.368 (20), p.1867-1877 |
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| creator | Jacobson, Ira M Gordon, Stuart C Kowdley, Kris V Yoshida, Eric M Rodriguez-Torres, Maribel Sulkowski, Mark S Shiffman, Mitchell L Lawitz, Eric Everson, Gregory Bennett, Michael Schiff, Eugene Al-Assi, M. Tarek Subramanian, G. Mani An, Di Lin, Ming McNally, John Brainard, Diana Symonds, William T McHutchison, John G Patel, Keyur Feld, Jordan Pianko, Stephen Nelson, David R |
| description | In two randomized trials, the oral nucleotide polymerase inhibitor sofosbuvir combined with ribavirin for 12 or 16 weeks was effective in patients with chronic HCV genotype 2 or 3 infection for whom interferon therapy either was not an option or had failed.
When studied in clinical trials, the current standard-of-care therapy for patients with hepatitis C virus (HCV) genotype 2 or 3 infection — pegylated interferon in combination with ribavirin for 24 weeks — resulted in a sustained virologic response in 70 to 85% of patients who had not received prior treatment and in 55 to 60% of those who had received treatment.
1
–
4
However, a substantial proportion of patients with HCV infection remain untreated owing to absolute or relative contraindications to interferon therapy, such as hepatic decompensation, autoimmune disease, and psychiatric illness.
5
In addition, interferon causes a range of constitutional symptoms . . . |
| doi_str_mv | 10.1056/NEJMoa1214854 |
| format | Article |
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When studied in clinical trials, the current standard-of-care therapy for patients with hepatitis C virus (HCV) genotype 2 or 3 infection — pegylated interferon in combination with ribavirin for 24 weeks — resulted in a sustained virologic response in 70 to 85% of patients who had not received prior treatment and in 55 to 60% of those who had received treatment.
1
–
4
However, a substantial proportion of patients with HCV infection remain untreated owing to absolute or relative contraindications to interferon therapy, such as hepatic decompensation, autoimmune disease, and psychiatric illness.
5
In addition, interferon causes a range of constitutional symptoms . . .</description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJMoa1214854</identifier><identifier>PMID: 23607593</identifier><identifier>CODEN: NEJMAG</identifier><language>eng</language><publisher>Waltham, MA: Massachusetts Medical Society</publisher><subject>Adult ; Aged ; Antiviral Agents - adverse effects ; Antiviral Agents - therapeutic use ; Antiviral drugs ; Biological and medical sciences ; Chronic infection ; Cirrhosis ; Clinical trials ; Drug therapy ; Drug Therapy, Combination ; Fatigue ; Female ; General aspects ; Genotype ; Genotype & phenotype ; Genotypes ; Headache ; Hepacivirus - genetics ; Hepatitis ; Hepatitis C ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - virology ; Human viral diseases ; Humans ; Infections ; Infectious diseases ; Interferon ; Liver cirrhosis ; Liver Cirrhosis - virology ; Logistic Models ; Male ; Medical sciences ; Middle Aged ; Nausea ; Patients ; Ribavirin ; Ribavirin - adverse effects ; Ribavirin - therapeutic use ; RNA, Viral - blood ; Sleep disorders ; Sofosbuvir ; Treatment Outcome ; Uridine Monophosphate - adverse effects ; Uridine Monophosphate - analogs & derivatives ; Uridine Monophosphate - therapeutic use ; Viral diseases ; Viral hepatitis ; Young Adult</subject><ispartof>The New England journal of medicine, 2013-05, Vol.368 (20), p.1867-1877</ispartof><rights>Copyright © 2013 Massachusetts Medical Society. All rights reserved.</rights><rights>2014 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c486t-f88660caf6a5856852a31c72fbe64712cd048b9e100b0c09b2260e4e3971b4003</citedby><cites>FETCH-LOGICAL-c486t-f88660caf6a5856852a31c72fbe64712cd048b9e100b0c09b2260e4e3971b4003</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.nejm.org/doi/pdf/10.1056/NEJMoa1214854$$EPDF$$P50$$Gmms$$H</linktopdf><linktohtml>$$Uhttps://www.nejm.org/doi/full/10.1056/NEJMoa1214854$$EHTML$$P50$$Gmms$$H</linktohtml><link.rule.ids>314,776,780,2746,2747,26080,27901,27902,52357,54039</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27285975$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23607593$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jacobson, Ira M</creatorcontrib><creatorcontrib>Gordon, Stuart C</creatorcontrib><creatorcontrib>Kowdley, Kris V</creatorcontrib><creatorcontrib>Yoshida, Eric M</creatorcontrib><creatorcontrib>Rodriguez-Torres, Maribel</creatorcontrib><creatorcontrib>Sulkowski, Mark S</creatorcontrib><creatorcontrib>Shiffman, Mitchell L</creatorcontrib><creatorcontrib>Lawitz, Eric</creatorcontrib><creatorcontrib>Everson, Gregory</creatorcontrib><creatorcontrib>Bennett, Michael</creatorcontrib><creatorcontrib>Schiff, Eugene</creatorcontrib><creatorcontrib>Al-Assi, M. Tarek</creatorcontrib><creatorcontrib>Subramanian, G. Mani</creatorcontrib><creatorcontrib>An, Di</creatorcontrib><creatorcontrib>Lin, Ming</creatorcontrib><creatorcontrib>McNally, John</creatorcontrib><creatorcontrib>Brainard, Diana</creatorcontrib><creatorcontrib>Symonds, William T</creatorcontrib><creatorcontrib>McHutchison, John G</creatorcontrib><creatorcontrib>Patel, Keyur</creatorcontrib><creatorcontrib>Feld, Jordan</creatorcontrib><creatorcontrib>Pianko, Stephen</creatorcontrib><creatorcontrib>Nelson, David R</creatorcontrib><creatorcontrib>POSITRON Study</creatorcontrib><creatorcontrib>FUSION Study</creatorcontrib><title>Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options</title><title>The New England journal of medicine</title><addtitle>N Engl J Med</addtitle><description>In two randomized trials, the oral nucleotide polymerase inhibitor sofosbuvir combined with ribavirin for 12 or 16 weeks was effective in patients with chronic HCV genotype 2 or 3 infection for whom interferon therapy either was not an option or had failed.
When studied in clinical trials, the current standard-of-care therapy for patients with hepatitis C virus (HCV) genotype 2 or 3 infection — pegylated interferon in combination with ribavirin for 24 weeks — resulted in a sustained virologic response in 70 to 85% of patients who had not received prior treatment and in 55 to 60% of those who had received treatment.
1
–
4
However, a substantial proportion of patients with HCV infection remain untreated owing to absolute or relative contraindications to interferon therapy, such as hepatic decompensation, autoimmune disease, and psychiatric illness.
5
In addition, interferon causes a range of constitutional symptoms . . .</description><subject>Adult</subject><subject>Aged</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Antiviral drugs</subject><subject>Biological and medical sciences</subject><subject>Chronic infection</subject><subject>Cirrhosis</subject><subject>Clinical trials</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Fatigue</subject><subject>Female</subject><subject>General aspects</subject><subject>Genotype</subject><subject>Genotype & phenotype</subject><subject>Genotypes</subject><subject>Headache</subject><subject>Hepacivirus - genetics</subject><subject>Hepatitis</subject><subject>Hepatitis C</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatitis C, Chronic - virology</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infections</subject><subject>Infectious diseases</subject><subject>Interferon</subject><subject>Liver cirrhosis</subject><subject>Liver Cirrhosis - virology</subject><subject>Logistic Models</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nausea</subject><subject>Patients</subject><subject>Ribavirin</subject><subject>Ribavirin - adverse effects</subject><subject>Ribavirin - therapeutic use</subject><subject>RNA, Viral - blood</subject><subject>Sleep disorders</subject><subject>Sofosbuvir</subject><subject>Treatment Outcome</subject><subject>Uridine Monophosphate - adverse effects</subject><subject>Uridine Monophosphate - analogs & derivatives</subject><subject>Uridine Monophosphate - therapeutic use</subject><subject>Viral diseases</subject><subject>Viral hepatitis</subject><subject>Young Adult</subject><issn>0028-4793</issn><issn>1533-4406</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp10EtLxDAQB_Agiq6Po1cJiOClOnk2PcriE1-gnksaU8yybWqSKn57I66KgrkMZH7MDH-EtgkcEBDy8Pr44sprQglXgi-hCRGMFZyDXEYTAKoKXlZsDa3HOIP8CK9W0RplEkpRsQm6vfOtj8344gJufcBndtDJJRfxFJ_a3qe3wWKKc4dh1-Pb3LR9ivjVpSc_JnwfrE5d_sI3Q3K-j5topdXzaLcWdQM9nBzfT8-Ky5vT8-nRZWG4kqlolZISjG6lFkpIJahmxJS0bazkJaHmEbhqKksAGjBQNZRKsNyyqiQNB2AbaP9z7hD882hjqjsXjZ3PdW_9GGvCBANOiKwy3f1DZ34Mfb7uQ9GS5zRYVsWnMsHHGGxbD8F1OrzVBOqPqOtfUWe_s5g6Np19_NZf2WawtwA6Gj1vg-6Niz-upEpUpfhxXRfr3s66fxa-AxjKjxM</recordid><startdate>20130516</startdate><enddate>20130516</enddate><creator>Jacobson, Ira M</creator><creator>Gordon, Stuart C</creator><creator>Kowdley, Kris V</creator><creator>Yoshida, Eric M</creator><creator>Rodriguez-Torres, Maribel</creator><creator>Sulkowski, Mark S</creator><creator>Shiffman, Mitchell L</creator><creator>Lawitz, Eric</creator><creator>Everson, Gregory</creator><creator>Bennett, Michael</creator><creator>Schiff, Eugene</creator><creator>Al-Assi, M. 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Tarek</au><au>Subramanian, G. Mani</au><au>An, Di</au><au>Lin, Ming</au><au>McNally, John</au><au>Brainard, Diana</au><au>Symonds, William T</au><au>McHutchison, John G</au><au>Patel, Keyur</au><au>Feld, Jordan</au><au>Pianko, Stephen</au><au>Nelson, David R</au><aucorp>POSITRON Study</aucorp><aucorp>FUSION Study</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options</atitle><jtitle>The New England journal of medicine</jtitle><addtitle>N Engl J Med</addtitle><date>2013-05-16</date><risdate>2013</risdate><volume>368</volume><issue>20</issue><spage>1867</spage><epage>1877</epage><pages>1867-1877</pages><issn>0028-4793</issn><eissn>1533-4406</eissn><coden>NEJMAG</coden><abstract>In two randomized trials, the oral nucleotide polymerase inhibitor sofosbuvir combined with ribavirin for 12 or 16 weeks was effective in patients with chronic HCV genotype 2 or 3 infection for whom interferon therapy either was not an option or had failed.
When studied in clinical trials, the current standard-of-care therapy for patients with hepatitis C virus (HCV) genotype 2 or 3 infection — pegylated interferon in combination with ribavirin for 24 weeks — resulted in a sustained virologic response in 70 to 85% of patients who had not received prior treatment and in 55 to 60% of those who had received treatment.
1
–
4
However, a substantial proportion of patients with HCV infection remain untreated owing to absolute or relative contraindications to interferon therapy, such as hepatic decompensation, autoimmune disease, and psychiatric illness.
5
In addition, interferon causes a range of constitutional symptoms . . .</abstract><cop>Waltham, MA</cop><pub>Massachusetts Medical Society</pub><pmid>23607593</pmid><doi>10.1056/NEJMoa1214854</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; New England Journal of Medicine |
| subjects | Adult Aged Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Antiviral drugs Biological and medical sciences Chronic infection Cirrhosis Clinical trials Drug therapy Drug Therapy, Combination Fatigue Female General aspects Genotype Genotype & phenotype Genotypes Headache Hepacivirus - genetics Hepatitis Hepatitis C Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - virology Human viral diseases Humans Infections Infectious diseases Interferon Liver cirrhosis Liver Cirrhosis - virology Logistic Models Male Medical sciences Middle Aged Nausea Patients Ribavirin Ribavirin - adverse effects Ribavirin - therapeutic use RNA, Viral - blood Sleep disorders Sofosbuvir Treatment Outcome Uridine Monophosphate - adverse effects Uridine Monophosphate - analogs & derivatives Uridine Monophosphate - therapeutic use Viral diseases Viral hepatitis Young Adult |
| title | Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options |
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