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RISS 인기검색어
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- 저자 : ( Karen F. Murray ) (검색결과 1 건)
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High Rates of SVR12 in Adolescents Treated with the Combination of Ledipasvir/Sofosbuvir
( Kathleen Schwarz ),( Karen F. Murray ),( Philip Rosenthal ),( Sanjay Bansal ),( Chuan-hao Lin ),( Sooji Lee ),( Liyun Ni ),( Bittoo Kanwar ),( Jenna Fraser ),( Polina German ),( Diana M. Brainard ) 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Although direct acting antivirals have transformed HCV treatment of adults, the standard of care for adolescents and younger children with GT1 HCV is still limited to treatment with pegylated interferon+ribavirin for 48 weeks. The aim of this study was to evaluate the safety, efficacy and pharmacokinetics of the fixed dose single tablet regimen, ledipasvir/sofosbuvir (LDV/SOF), administered for 12weeks in GT1 HCV-infected adolescent patients. Methods: Treatment-naive and treatment-experienced adolescent patients aged 12 to less than 18 years old with chronic GT1 HCV were enrolled into this open-label ongoing study to receive 12 weeks of treatment with LDV/SOF 90mg/400 mg once daily. The primary efficacy endpoint is SVR12 (HCV RNA<lower limit of quantitation). Safety is assessed by clinical evaluation and laboratory monitoring. Intensive pharmacokinetic (PK) sampling was done on Day 10 in the first 10 patients (PK lead-in) to confirm the appropriateness of the adult dose in the adolescent population. Results: 100 GT1 patients have been enrolled and treated. The majority are GT1a (81%), female (63%), white (90%), treatment-naive (80%), and vertically infected (84%). The mean age is 15 (range 12-17) years. In the PK lead-in, administration of 1 tablet daily of LDV/SOF provided comparable plasma exposures of LDV, SOF, and GS-331007 (SOF primary metabolite) to those observed in adults. SVR12 rate was 97% (97/100). 3 patients were lost to follow-up. No serious adverse events (AEs) have been reported. AEs are generally mild in severity and grade 3/4 laboratory abnormalities have been infrequent and transient. Conclusions: The 12-week regimen of LDV/SOF 90mg/400 mg has resulted in high SVR rates and is well-tolerated. This regimen provides a safe and effective therapy for adolescents with GT1 HCV infection. Further evaluation is ongoing in children aged 3-11 years old.
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