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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
Title | 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 |
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Authors | |
Keywords | Medical sciences Endocrinology |
Issue Date | 2015 |
Publisher | Springer 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? |
Abstract | BACKGROUND & 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. |
Description | Conference 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 Identifier | http://hdl.handle.net/10722/214870 |
ISSN | 2023 Impact Factor: 5.9 2023 SCImago Journal Rankings: 1.813 |
DC Field | Value | Language |
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dc.contributor.author | Lai, CL | - |
dc.contributor.author | Yuen, MF | - |
dc.contributor.author | Yang, JC | - |
dc.contributor.author | Knox, SJ | - |
dc.contributor.author | Mo, HM | - |
dc.contributor.author | Han, LL | - |
dc.contributor.author | Brainard, DM | - |
dc.contributor.author | Mchutchison, JG | - |
dc.contributor.author | Wong, VWS | - |
dc.contributor.author | Chan, HLY | - |
dc.date.accessioned | 2015-08-21T12:00:15Z | - |
dc.date.available | 2015-08-21T12:00:15Z | - |
dc.date.issued | 2015 | - |
dc.identifier.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 | - |
dc.identifier.issn | 1936-0533 | - |
dc.identifier.uri | http://hdl.handle.net/10722/214870 | - |
dc.description | Conference Theme: New Horizons from East to west in Hepatology | - |
dc.description | Poster Presentation: Topic 11 - Hepatitis C: no. 1975 | - |
dc.description | This journal suppl. entitled: Conference Abstracts: 24th Annual Conference of APASL, March 12-15, 2015, Istanbul, Turkey | - |
dc.description.abstract | BACKGROUND & 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.language | eng | - |
dc.publisher | Springer 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.ispartof | Hepatology International | - |
dc.rights | The final publication is available at Springer via http://dx.doi.org/10.1007/s12072-015-9609-1 | - |
dc.subject | Medical sciences | - |
dc.subject | Endocrinology | - |
dc.title | 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 | - |
dc.type | Conference_Paper | - |
dc.identifier.email | Lai, CL: hrmelcl@hkucc.hku.hk | - |
dc.identifier.email | Yuen, MF: mfyuen@hku.hk | - |
dc.identifier.authority | Lai, CL=rp00314 | - |
dc.identifier.authority | Yuen, MF=rp00479 | - |
dc.identifier.doi | 10.1007/s12072-015-9609-1 | - |
dc.identifier.scopus | eid_2-s2.0-85047596667 | - |
dc.identifier.hkuros | 244917 | - |
dc.identifier.hkuros | 248041 | - |
dc.identifier.volume | 9 | - |
dc.identifier.issue | suppl. 1 | - |
dc.identifier.spage | S58, abstract no. 1975 | - |
dc.identifier.epage | S58, abstract no. 1975 | - |
dc.publisher.place | United States | - |
dc.identifier.issnl | 1936-0533 | - |