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      저자 : ( Benedict J. Maliakkal ) (검색결과 1 건)
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      • Safety and Efficacy of Once-Daily Ledipasvir/Sofosbuvir (90/400 mg) for 12 Weeks in Genotype 1 HCV-Infected Patients with Severe Renal Impairment

        ( Eric Lawitz ),( Charles S. Landis ),( Benedict J. Maliakkal ),( Maurizio Bonacini ),( Grisell Ortiz-lasanta ),( Jin Youn ),( Jie Zhang ),( Erik Mogalian ),( Shampa De-oertel ),( Anu O. Osinusi ),( D 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1

        Aims: Despite higher concentrations of sofosbuvir (SOF) metabolite, GS-331007, in patients with severe renal impairment (RI), retrospective case series and claims database analyses have suggested substantial use of ledipasvir (LDV)/SOF in this population with no untoward effects described. The current study evaluated the safety, efficacy, and pharmacokinetics (PK) of LDV/SOF (90/400 mg) once-daily for 12 weeks in patients with genotype (GT) 1 HCV-infection and severe RI. Methods: Treatment naïve or experienced patients with or without compensated cirrhosis and creatinine clearance (CLcr) = 30 mL/min (Cockcroft-Gault equation), not on dialysis, received open-label treatment with LDV/SOF once daily for 12 weeks. Virologic response, pharmacokinetics (PK), and safety, including echocardiograms, were assessed. Results: Of the 18 patients enrolled and treated, mean (range) CLcr at baseline was 24.9 (9.0-39.6) mL/min. All had GT1 HCV infection (14 GT1a and 4 GT1b), 14 (78%) were treatment naïve, and 2 (11%) had cirrhosis. All patients completed 12 weeks of LDV/SOF treatment. There were no early discontinuations nor any on-treatment virologic failures. The SVR12 rate is 100% (18/18). Plasma concentrations of the terminal SOF metabolite GS-3310007 were approximately 6 fold higher than in the LDV/SOF Phase 3 trials. SOF and LDV concentrations were similar to those observed in patients with normal, mild or moderate RI. The most common adverse events (AEs) were fatigue (22%), headache (22%), and hyperkalemia (17%). Six serious AEs were reported among 4 patients (22%), including 2 renal events; no SAEs were considered related to study drugs. There were no treatment-related cardiac AEs, including bradycardia, and no meaningful changes in QTc intervals or other parameters. Conclusions: Treatment with LDV/SOF (90/400 mg) for 12 weeks in genotype 1 patients with and without cirrhosis and severe renal impairment resulted in 100% SVR12 rate. The regimen was safe and well-tolerated with no treatment discontinuations and no treatment-related SAEs.

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