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Conference Paper: Sofosbuvir plus ribavirin for 12 16 or 24 weeks results in sustained virologic response over 97% in genotype 1 and 6 HCV infection in Hong Kong

TitleSofosbuvir plus ribavirin for 12 16 or 24 weeks results in sustained virologic response over 97% in genotype 1 and 6 HCV infection in Hong Kong
Authors
KeywordsMedical sciences
Endocrinology
Issue Date2015
PublisherSpringer New York LLC. The Journal's web site is located at http://www.springer.com/west/home/medicine?SGWID=4-10054-70-173733513-0
Citation
The 24th Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL 2015), Istanbul, Turkey, 12-15 March 2015. In Hepatology International, 2015, v. 9 suppl. 1, p. S58, abstract no. 1975 How to Cite?
AbstractBACKGROUND & AIMS: In Hong Kong, most patients with hepatitis C virus (HCV) have genotype (GT) 1b or 6a infection. We evaluated the efficacy and safety of sofosbuvir (SOF) 400 mg plus weight-based ribavirin (RBV) 1000-1200 mg in treatment-naı¨ve, HCV genotype 1 or 6-infected patients in Hong Kong. METHODS: Patients in an open-label, Phase 3 study were randomized 1: 1: 1 to SOF + RBV for 12, 16, or 24 weeks. Randomization was stratified by HCV subtype and presence of cirrhosis. The primary endpoint was SVR12 (HCV RNAlower limit of quantitation (LLOQ = 25 IU/mL; COBAS TaqMan HCV Test Version 2.0) 12 weeks after completion of treatment). RESULTS: 31 patients were enrolled. Baseline characteristics are tabulated below. Most patients had favorable predictors of response: 90 % age65 years, 71 % BMI25 kg/m2, 65 % GT1b, 87 % non-cirrhotic, and 87 % IL28B CC genotype. All patients had HCV RNALLOQ by Week 4 and maintained through end-of-treatment. Overall SVR12 was 97 % (30/31); 1 patient in the 24-week group relapsed. Frequent adverse events (AE) reported in C 10 % were malaise, upper respiratory tract infection (URTI), and anemia. No Grade 3 or 4 adverse events (AE) or serious AEs were reported. One patient discontinued SOF + RBV early due to AE of URTI. Three (10 %) patients had treatment-emergent hemoglobin (Hgb)10 g/ dL; no patients had Hgb8.5 g/dL. CONCLUSIONS: The IFN-free SOF + RBV regimen for 12, 16 or 24 weeks was well-tolerated and highly effective in treatment-naı¨ve, HCV GT1b and GT6-infected patients with favorable predictors of response.
DescriptionConference Theme: New Horizons from East to west in Hepatology
Poster Presentation: Topic 11 - Hepatitis C: no. 1975
This journal suppl. entitled: Conference Abstracts: 24th Annual Conference of APASL, March 12-15, 2015, Istanbul, Turkey
Persistent Identifierhttp://hdl.handle.net/10722/214870
ISSN
2015 Impact Factor: 1.125
2015 SCImago Journal Rankings: 0.669

 

DC FieldValueLanguage
dc.contributor.authorLai, CL-
dc.contributor.authorYuen, MF-
dc.contributor.authorYang, JC-
dc.contributor.authorKnox, SJ-
dc.contributor.authorMo, HM-
dc.contributor.authorHan, LL-
dc.contributor.authorBrainard, DM-
dc.contributor.authorMchutchison, JG-
dc.contributor.authorWong, VWS-
dc.contributor.authorChan, HLY-
dc.date.accessioned2015-08-21T12:00:15Z-
dc.date.available2015-08-21T12:00:15Z-
dc.date.issued2015-
dc.identifier.citationThe 24th Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL 2015), Istanbul, Turkey, 12-15 March 2015. In Hepatology International, 2015, v. 9 suppl. 1, p. S58, abstract no. 1975-
dc.identifier.issn1936-0533-
dc.identifier.urihttp://hdl.handle.net/10722/214870-
dc.descriptionConference Theme: New Horizons from East to west in Hepatology-
dc.descriptionPoster Presentation: Topic 11 - Hepatitis C: no. 1975-
dc.descriptionThis journal suppl. entitled: Conference Abstracts: 24th Annual Conference of APASL, March 12-15, 2015, Istanbul, Turkey-
dc.description.abstractBACKGROUND & AIMS: In Hong Kong, most patients with hepatitis C virus (HCV) have genotype (GT) 1b or 6a infection. We evaluated the efficacy and safety of sofosbuvir (SOF) 400 mg plus weight-based ribavirin (RBV) 1000-1200 mg in treatment-naı¨ve, HCV genotype 1 or 6-infected patients in Hong Kong. METHODS: Patients in an open-label, Phase 3 study were randomized 1: 1: 1 to SOF + RBV for 12, 16, or 24 weeks. Randomization was stratified by HCV subtype and presence of cirrhosis. The primary endpoint was SVR12 (HCV RNAlower limit of quantitation (LLOQ = 25 IU/mL; COBAS TaqMan HCV Test Version 2.0) 12 weeks after completion of treatment). RESULTS: 31 patients were enrolled. Baseline characteristics are tabulated below. Most patients had favorable predictors of response: 90 % age65 years, 71 % BMI25 kg/m2, 65 % GT1b, 87 % non-cirrhotic, and 87 % IL28B CC genotype. All patients had HCV RNALLOQ by Week 4 and maintained through end-of-treatment. Overall SVR12 was 97 % (30/31); 1 patient in the 24-week group relapsed. Frequent adverse events (AE) reported in C 10 % were malaise, upper respiratory tract infection (URTI), and anemia. No Grade 3 or 4 adverse events (AE) or serious AEs were reported. One patient discontinued SOF + RBV early due to AE of URTI. Three (10 %) patients had treatment-emergent hemoglobin (Hgb)10 g/ dL; no patients had Hgb8.5 g/dL. CONCLUSIONS: The IFN-free SOF + RBV regimen for 12, 16 or 24 weeks was well-tolerated and highly effective in treatment-naı¨ve, HCV GT1b and GT6-infected patients with favorable predictors of response.-
dc.languageeng-
dc.publisherSpringer New York LLC. The Journal's web site is located at http://www.springer.com/west/home/medicine?SGWID=4-10054-70-173733513-0-
dc.relation.ispartofHepatology International-
dc.rightsThe final publication is available at Springer via http://dx.doi.org/10.1007/s12072-015-9609-1-
dc.subjectMedical sciences-
dc.subjectEndocrinology-
dc.titleSofosbuvir plus ribavirin for 12 16 or 24 weeks results in sustained virologic response over 97% in genotype 1 and 6 HCV infection in Hong Kong-
dc.typeConference_Paper-
dc.identifier.emailLai, CL: hrmelcl@hkucc.hku.hk-
dc.identifier.emailYuen, MF: mfyuen@hku.hk-
dc.identifier.authorityLai, CL=rp00314-
dc.identifier.authorityYuen, MF=rp00479-
dc.identifier.doi10.1007/s12072-015-9609-1-
dc.identifier.hkuros244917-
dc.identifier.hkuros248041-
dc.identifier.volume9-
dc.identifier.issuesuppl. 1-
dc.identifier.spageS58, abstract no. 1975-
dc.identifier.epageS58, abstract no. 1975-
dc.publisher.placeUnited States-

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