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( Mark Sulkowski ),( Kwang-hyub Han ),( Jia-horng Kao ),( Jenny C. Yang ),( Bing Gao ),( Diana M. Brainard ),( Wan-long Chuang ),( Edward J. Gane ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: HBV reactivation during HCV treatment with direct-acting antiviralregimens has been reported in HCV infected patients who areHB surface antigen (HBsAg) negative, HB core antibody (HBcAb) positive,and HBV DNA undetectable. To evaluate the risk of HBV reactivationin these HCV infected patients, we analyzed samples froma Phase 3b study, GS-US-337-0131, of ledipasvir/sofosbuvir (LDV/SOF)for 12 weeks conducted in Korea and Taiwan where HBV is endemic.All enrolled subjects were HBsAg negative at screening per protocol.The SVR12 rate was 98% in this trial.Methods: A serum sample per patient, collected during post-treatmentfollow up was analyzed for HBcAb. Samples positive for HBcAb wereanalyzed for HBV DNA and retested for HBsAg if HBV DNA wasdetectable.Results: 173 of 178 patients had one post-treatment sample withinthe 1 year stability limit. Of the 173 patients, 60% (n=103) wereHBcAb positive and HBsAg negative; no subject was HBsAg positive.Two of 103 patients had HBV DNA <20 IU/mL, detected and theremaining patients were <20 IU/mL, target not detected. MedianALT during treatment and post-treatment follow-up were similar betweenHBcAb positive and negative patients; all patients had ALTdeclined from baseline. No patients had clinical signs of HBV reactivationduring treatment or post-treatment follow up. No differencesin overall adverse events or laboratory abnormality observedin patients who were HBcAb positive or negative.Conclusions: Among 103 HCV-infected patients with reactive HB coreantibody and absent HB surface antigen, there was no evidence ofHBV reactivation following successful HCV treatment with LDV/SOF.These data suggest HBV reactivation in patients with HCV and reactiveHB core antibody is uncommon. A Phase 3b study evaluating 12weeks of LDV/SOF in patients with chronic HCV and overt HBV (HBsAgpositive) co-infection is ongoing in Taiwan and can provide furthersafety information.
( Mark Sulkowski ),( Kwang-hyub Han ),( Jia-horng Kao ),( Jenny C. Yang ),( Bing Gao ),( Diana M. Brainard ),( Wan-long Chuang ),( Edward J. Gane ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: HBV reactivation during HCV treatment with direct-acting antiviralregimens has been reported in HCV infected patients who areHB surface antigen (HBsAg) negative, HB core antibody (HBcAb) positive,and HBV DNA undetectable. To evaluate the risk of HBV reactivationin these HCV infected patients, we analyzed samples froma Phase 3b study, GS-US-337-0131, of ledipasvir/sofosbuvir (LDV/SOF)for 12 weeks conducted in Korea and Taiwan where HBV is endemic.All enrolled subjects were HBsAg negative at screening per protocol.The SVR12 rate was 98% in this trial.Methods: A serum sample per patient, collected during post-treatmentfollow up was analyzed for HBcAb. Samples positive for HBcAb wereanalyzed for HBV DNA and retested for HBsAg if HBV DNA wasdetectable.Results: 173 of 178 patients had one post-treatment sample withinthe 1 year stability limit. Of the 173 patients, 60% (n=103) wereHBcAb positive and HBsAg negative; no subject was HBsAg positive.Two of 103 patients had HBV DNA <20 IU/mL, detected and theremaining patients were <20 IU/mL, target not detected. MedianALT during treatment and post-treatment follow-up were similar betweenHBcAb positive and negative patients; all patients had ALTdeclined from baseline. No patients had clinical signs of HBV reactivationduring treatment or post-treatment follow up. No differencesin overall adverse events or laboratory abnormality observedin patients who were HBcAb positive or negative.Conclusions: Among 103 HCV-infected patients with reactive HB coreantibody and absent HB surface antigen, there was no evidence ofHBV reactivation following successful HCV treatment with LDV/SOF.These data suggest HBV reactivation in patients with HCV and reactiveHB core antibody is uncommon. A Phase 3b study evaluating 12weeks of LDV/SOF in patients with chronic HCV and overt HBV (HBsAgpositive) co-infection is ongoing in Taiwan and can provide furthersafety information.