{"corpus_id":19188517,"paper_sha":"66300019046e898cc0743e77e9dd6f28b59fe1b8","doi":"10.1056/NEJM199811193392102","arxiv_id":null,"pmid":9819447,"pmcid":null,"mag_id":2341829866,"dblp_id":null,"acl_id":null,"title":"Interferon alfa-2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis C. International Hepatitis Interventional Therapy Group.","year":1998,"publication_date":"1998-11-19","venue":"New England Journal of Medicine","journal":{"name":"The New England journal of medicine","pages":"\n          1493-9\n        ","volume":"339 21"},"journal_issn":null,"journal_title":null,"publication_types":["Study","JournalArticle","ClinicalTrial"],"pubmed_pub_types":["Clinical Trial","Journal Article","Multicenter Study","Randomized Controlled Trial","Research Support, Non-U.S. Gov't","Research Support, U.S. Gov't, P.H.S."],"s2_fields_of_study":["Medicine"],"reference_count":46,"citation_count":1351,"influential_citation_count":20,"is_open_access":true,"arxiv_categories":null,"arxiv_license":null,"arxiv_journal_ref":null,"mesh_headings":[{"d":"Adult","mj":false,"ui":"D000328"},{"d":"Aged","mj":false,"ui":"D000368"},{"d":"Alanine Transaminase","mj":false,"qs":[{"q":"blood","mj":false,"ui":"Q000097"}],"ui":"D000410"},{"d":"Antiviral Agents","mj":false,"qs":[{"q":"adverse effects","mj":false,"ui":"Q000009"},{"q":"therapeutic use","mj":true,"ui":"Q000627"}],"ui":"D000998"},{"d":"Double-Blind Method","mj":false,"ui":"D004311"},{"d":"Drug Therapy, Combination","mj":false,"ui":"D004359"},{"d":"Female","mj":false,"ui":"D005260"},{"d":"Hepacivirus","mj":false,"qs":[{"q":"genetics","mj":false,"ui":"Q000235"},{"q":"isolation & purification","mj":false,"ui":"Q000302"}],"ui":"D016174"},{"d":"Hepatitis C, Chronic","mj":false,"qs":[{"q":"drug therapy","mj":true,"ui":"Q000188"}],"ui":"D019698"},{"d":"Humans","mj":false,"ui":"D006801"},{"d":"Interferon alpha-2","mj":false,"ui":"D000077190"},{"d":"Interferon-alpha","mj":false,"qs":[{"q":"adverse effects","mj":false,"ui":"Q000009"},{"q":"therapeutic use","mj":true,"ui":"Q000627"}],"ui":"D016898"},{"d":"Liver","mj":false,"qs":[{"q":"pathology","mj":false,"ui":"Q000473"}],"ui":"D008099"},{"d":"Male","mj":false,"ui":"D008297"},{"d":"Middle Aged","mj":false,"ui":"D008875"},{"d":"RNA, Viral","mj":false,"qs":[{"q":"blood","mj":false,"ui":"Q000097"}],"ui":"D012367"},{"d":"Recombinant Proteins","mj":false,"ui":"D011994"},{"d":"Recurrence","mj":false,"ui":"D012008"},{"d":"Ribavirin","mj":false,"qs":[{"q":"adverse effects","mj":false,"ui":"Q000009"},{"q":"therapeutic use","mj":true,"ui":"Q000627"}],"ui":"D012254"}],"chemicals":[{"n":"Antiviral Agents","ui":"D000998","reg":"0"},{"n":"Interferon alpha-2","ui":"D000077190","reg":"0"},{"n":"Interferon-alpha","ui":"D016898","reg":"0"},{"n":"RNA, Viral","ui":"D012367","reg":"0"},{"n":"Recombinant Proteins","ui":"D011994","reg":"0"},{"n":"Ribavirin","ui":"D012254","reg":"49717AWG6K"},{"n":"Alanine Transaminase","ui":"D000410","reg":"EC 2.6.1.2"}],"comments_corrections":null,"source_flags":5,"s2_open_access_pdf_url":"https://www.nejm.org/doi/pdf/10.1056/NEJM199811193392102?articleTools=true","s2_open_access_landing_url":"https://www.semanticscholar.org/paper/66300019046e898cc0743e77e9dd6f28b59fe1b8","s2_open_access_license":null,"s2_open_access_status":"BRONZE","pmc_open_access_pdf_url":null,"pmc_open_access_landing_url":null,"pmc_open_access_license":null,"pmc_open_access_status":null,"unpaywall_open_access_pdf_url":null,"unpaywall_open_access_landing_url":null,"unpaywall_open_access_license":null,"unpaywall_open_access_status":null,"abstract":"BACKGROUND: Interferon alfa is the only effective treatment for patients with chronic hepatitis C. Forty percent of patients have an initial response to this therapy, but most subsequently relapse. We compared the effect of interferon alone with that of interferon plus oral ribavirin for relapses of chronic hepatitis C. METHODS: We studied 345 patients with chronic hepatitis C who relapsed after interferon treatment. A total of 173 patients were randomly assigned to receive standard-dose recombinant interferon alfa-2b concurrently with ribavirin (1000 to 1200 mg orally per day, depending on body weight) for six months, and 172 patients were assigned to receive interferon and placebo. RESULTS: At the completion of treatment, serum levels of hepatitis C virus (HCV) RNA were undetectable in 141 of the 173 patients who were treated with interferon and ribavirin and in 80 of the 172 patients who were treated with interferon alone (82 percent vs. 47 percent, P<0.001). Serum HCV RNA levels remained undetectable 24 weeks after the end of treatment in 84 patients (49 percent) in the combination-therapy group, but in only 8 patients (5 percent) in the interferon group (P<0.001). Sustained normalization of serum alanine aminotransferase concentrations and histologic improvement were highly correlated with virologic response. Base-line serum HCV RNA levels of 2 x 10(6) copies per milliliter or less were associated with higher rates of response in both treatment groups. Viral genotypes other than type 1 were associated with sustained responses only in the combination-therapy group. Combined therapy caused a predictable fall in hemoglobin concentrations but otherwise had a safety profile similar to that of interferon alone. CONCLUSIONS: In patients with chronic hepatitis C who relapse after treatment with interferon, therapy with interferon and oral ribavirin results in higher rates of sustained virologic, biochemical, and histologic response than treatment with interferon alone.","claims":[{"public_id":"cl_0dd9fb17cd07cb6e9d974aa02dff9e7e","status":"active","text":"Baseline serum HCV RNA levels of 2 x 10(6) copies per milliliter or less were associated with higher rates of response in both treatment groups.","confidence":0.8,"contributors":[{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale (322360f1c1)","roles":["extraction"],"url":"https://sah.borca.ai/u/322360f1c1"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_0dd9fb17cd07cb6e9d974aa02dff9e7e"},{"public_id":"cl_e03902a5a6ecd6610fc35b1f4e61073a","status":"active","text":"Combination therapy with interferon alfa-2b and ribavirin produced undetectable hepatitis C virus RNA in 82 percent of patients at the completion of treatment, compared with 47 percent of patients treated with interferon alfa-2b alone (P<0.001).","confidence":0.95,"contributors":[{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale (322360f1c1)","roles":["extraction"],"url":"https://sah.borca.ai/u/322360f1c1"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_e03902a5a6ecd6610fc35b1f4e61073a"},{"public_id":"cl_9769a6cd1ab0f34782648acadf503227","status":"active","text":"Hepatitis C virus RNA remained undetectable 24 weeks after the end of treatment in 49 percent of patients who received interferon alfa-2b plus ribavirin, compared with 5 percent of patients who received interferon alfa-2b alone (P<0.001).","confidence":0.95,"contributors":[{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale (322360f1c1)","roles":["extraction"],"url":"https://sah.borca.ai/u/322360f1c1"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_9769a6cd1ab0f34782648acadf503227"},{"public_id":"cl_1c3fbb811b425d09f09af0cee5bc4fce","status":"active","text":"Sustained normalization of serum alanine aminotransferase concentrations and histologic improvement were highly correlated with virologic response.","confidence":0.85,"contributors":[{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale (322360f1c1)","roles":["extraction"],"url":"https://sah.borca.ai/u/322360f1c1"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_1c3fbb811b425d09f09af0cee5bc4fce"},{"public_id":"cl_8a545aedcc8439abd48b5ce28a4b402c","status":"active","text":"Viral genotypes other than type 1 were associated with sustained virologic response only in the combination-therapy group receiving interferon alfa-2b and ribavirin.","confidence":0.85,"contributors":[{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale (322360f1c1)","roles":["extraction"],"url":"https://sah.borca.ai/u/322360f1c1"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_8a545aedcc8439abd48b5ce28a4b402c"}],"concepts":[{"public_id":"co_14c47ab6b16d1332e2abf8dadbc82190","status":"active","name":"hepatitis C virus RNA","description":"A blood measurement of circulating hepatitis C virus genetic material used to assess virologic response to treatment.","types":["biomarker","measurement"],"aliases":["HCV RNA","serum HCV RNA"],"contributors":[{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale 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