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RISS 인기검색어
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- 저자 : ( H Fainboim ) (검색결과 2 건)
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( J Mallolas ),( S Pol ),( A Rivero ),( H Fainboim ),( C Cooper ),( J Slim ),( S Thompson ),( J Wahl ),( W Greaves ),( M Sulkowski ) 대한간학회 2012 춘·추계 학술대회 (KASL) Vol.2012 No.-
Background: Addition of boceprevir (BOC) to peginterferon (P) and ribavirin (R) significantly increases SVR among HCV- monoinfected patients for whom SVR rates have been low. The objective of this phase 2 trial was to investigate the efficacy and safety of BOC+P/R in HCV/HIV-coinfected patients. Methods: In this multicenter, double-blind, international trial, patients with untreated hepatitis C genotype 1 infections and HIV RNA <50 copies/mL were randomized 2:1 to receive P (PEG 2b 1.5 ug/kg/wk)/R (600-1400 mg/day, by weight) + BOC 800mg TID or P/R+placebo for 44 weeks, after a 4-week lead-in of P/R. NNRTIs, zidovudine, or didanosine were not permitted. Patients were stratified by: cirrhosis/fibrosis (yes vs. no) and baseline HCV-RNA (<800,000 IU/mL vs ≥800,000 IU/mL). The primary efficacy endpoint was SVR, undetectable plasma HCV-RNA 24 weeks after end of treatment (EOT). Secondary endpoints and planned interim analyses included proportion of subjects with undetectable HCV-RNA at treatment week (TW) 4, 8, 12, 24 and 48/EOT. Results: 100 patients were randomized between 11/2009 and 12/2010; 2 patients in the BOC arm did not receive medication; thus, 34 control and 64 experimental patients were treated. The majority were non-cirrhotic (95%), white (82%), male (69%) with median age ~43 years. Most had high baseline HCV-RNA (88%) and HCV genotype 1a (65%). At TW48/EOT, the rate of undetectable HCV-RNA was 63.9% and 29.4% in the BOC and control arms, respectively (Table). 61% of the BOC group and 32% of the control group completed 48 weeks of treatment; 20% and 9%, respectively, discontinued due to adverse events. HCV treatment failure occurred in 9% of the BOC group and 53% of the control group. BOC patients were more likely than controls to have decreased appetite, pyrexia, dysgeusia, vomiting, asthenia, anemia, and neutropenia. By TW48, 2 patients in the BOC group and 3 in the control group had HIV virologic failure. Conclusion: The addition of BOC to P/R was associated with higher rates of undetectable HCV-RNA at all time points, including TW48/EOT. The safety and tolerability profile was consistent with that observed in HCV-monoinfected patients.
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( J Mallolas ),( S Pol ),( A Rivero ),( H Fainboim ),( C Cooper ),( J Slim ),( S Thompson ),( J Wahl ),( W Greaves ),( M Sulkowski ) 대한간학회 2012 춘·추계 학술대회 (KASL) Vol.2012 No.1
Background: Addition of boceprevir (BOC) to peginterferon (P) and ribavirin (R) significantly increases SVR among HCVmonoinfected patients for whom SVR rates have been low. The objective of this phase 2 trial was to investigate the efficacy and safety of BOC+P/R in HCV/HIV-coinfected patients. Methods: In this multicenter, double-blind, international trial, patients with untreated hepatitis C genotype 1 infections and HIV RNA <50 copies/mL were randomized 2:1 to receive P (PEG 2b 1.5 ug/kg/wk)/R (600-1400 mg/day, by weight) + BOC 800mg TID or P/R+placebo for 44 weeks, after a 4-week lead-in of P/R. NNRTIs, zidovudine, or didanosine were not permitted. Patients were stratified by: cirrhosis/fibrosis (yes vs. no) and baseline HCV-RNA (<800,000 IU/mL vs ≥800,000 IU/mL). The primary efficacy endpoint was SVR, undetectable plasma HCV-RNA 24 weeks after end of treatment (EOT). Secondary endpoints and planned interim analyses included proportion of subjects with undetectable HCV-RNA at treatment week (TW) 4, 8, 12, 24 and 48/EOT. Results: 100 patients were randomized between 11/2009 and 12/2010; 2 patients in the BOC arm did not receive medication; thus, 34 control and 64 experimental patients were treated. The majority were non-cirrhotic (95%), white (82%), male (69%) with median age ~43 years. Most had high baseline HCV-RNA (88%) and HCV genotype 1a (65%). At TW48/EOT, the rate of undetectable HCV-RNA was 63.9% and 29.4% in the BOC and control arms, respectively (Table). 61% of the BOC group and 32% of the control group completed 48 weeks of treatment; 20% and 9%, respectively, discontinued due to adverse events. HCV treatment failure occurred in 9% of the BOC group and 53% of the control group. BOC patients were more likely than controls to have decreased appetite, pyrexia, dysgeusia, vomiting, asthenia, anemia, and neutropenia. By TW48, 2 patients in the BOC group and 3 in the control group had HIV virologic failure. Conclusion: The addition of BOC to P/R was associated with higher rates of undetectable HCV-RNA at all time points, including TW48/EOT. The safety and tolerability profile was consistent with that observed in HCV-monoinfected patients. PE-136 Sustained virologic response (SVR) in prior peginterferon/ribavirin (PR) treatment failures after retreatment with boceprevir (BOC) + PR: The PROVIDE study interim results JP Bronowicki1, M Davis2, S Flamm3, S Gordon4, E Lawitz5, E Yoshida6, J Galati7, V Luketic8, J McCone9, I Jacobson10, P Marcellin11-12, A Muir13, F Poordad14, LD Pedicone15, W Deng15, M Treitel15, J Wahl15, J Vierling16 1University Henri Poincare of Nancy, Vandoeuvre-les-Nancy, France; 2South Florida Center of Gastroenterology, Wellington, FL, USA; 3Northwestern Feinberg School of Medicine, Chicago, IL, USA; 4Henry Ford Hospital, Detroit, MI, USA; 5Alamo Medical Research, San Antonio, TX, USA; 6University of British Columbia and Vancouver General Hospital, Vancouver, BC, Canada; 7Liver Specialists of Texas, Houston, TX, USA; 8Virginia Commonwealth University School of Medicine, Richmond, VA, USA; 9Mt. Vernon Endoscopy Center, Alexandria, VA, USA; 10Weill Cornell Medical College, New
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