Japan Digestive Disease Week 2016
International Poster Session(JDDW)
November 4 (Fri.), 14:00–15:04, Room 16 (Kobe International Exhibition Hall No. 2 Building Hall (North) Digital Poster Session)
IP-51_H
Sofosbuvir Population Pharmacokinetics in Japanese Subjects with Chronic Genotype 2 HCV Infection
- 1
- Dept. of Gastroenterology and Hepatology Hokkaido University
- 2
- Gilead Sciences
【Background】Sofosbuvir (SOF) is an NS5B polymerase inhibitor for use in combination with ribavirin for the treatment of GT 2 HCV patients. In a Phase 3 study pharmacokinetic (PK) data was collected for Population PK analysis of SOF and its predominant circulating nucleoside metabolite, GS-331007.
【Methods】90 treatment-naive and 63 previously-treated subjects in Japan were enrolled and received SOF 400 mg plus ribavirin. A single plasma PK sample was collected from all subjects (n ＝ 153) at each study visit. Plasma concentration data from all PK samples were combined and applied to previously developed Population PK models for SOF and GS-331007 to generate individual AUCtau and Cmax estimates for each subject. The effect of covariates on SOF and GS-331007 exposure was evaluated.
【Results】Population PK analysis estimated the mean (％CV) steady-state AUCtau and Cmax for SOF and GS-331007. SOF exposure in HCV-infected Japanese subjects was comparable to historical studies. Exposure to the renally cleared GS-331007 was modestly increased in the Japanese study population.
【Conclusion】The PK of SOF and GS-331007 in Japanese subjects were similar to those observed in historical studies. These data support the use of SOF for the treatment of GT2 HCV infection in Japanese patients.
【Methods】90 treatment-naive and 63 previously-treated subjects in Japan were enrolled and received SOF 400 mg plus ribavirin. A single plasma PK sample was collected from all subjects (n ＝ 153) at each study visit. Plasma concentration data from all PK samples were combined and applied to previously developed Population PK models for SOF and GS-331007 to generate individual AUCtau and Cmax estimates for each subject. The effect of covariates on SOF and GS-331007 exposure was evaluated.
【Results】Population PK analysis estimated the mean (％CV) steady-state AUCtau and Cmax for SOF and GS-331007. SOF exposure in HCV-infected Japanese subjects was comparable to historical studies. Exposure to the renally cleared GS-331007 was modestly increased in the Japanese study population.
【Conclusion】The PK of SOF and GS-331007 in Japanese subjects were similar to those observed in historical studies. These data support the use of SOF for the treatment of GT2 HCV infection in Japanese patients.
- Index Term 1: Pharmacokinetics
- Index Term 2: Sofosbuvir