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      • Integrated Safety and Tolerability of Daclatasvir plus Asunaprevir in Patients with Chronic HCV Genotype 1b Infection

        ( L. Wei ),( K. Chayama ),( W. L. Chuang ),( S. H. Bae ),( J. Y. Jang ),( R. Bhore ),( V. Vazquez ),( L. Mo ),( M. Linaberry ),( M. Treitel ),( H. Kumada ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1

        Aims: The combination of daclatasvir (DCV) plus asunaprevir (ASV)has demonstrated high sustained virologic response (SVR) rates andis generally well tolerated in clinical studies. This integrated analysisevaluated the safety profile of DCV (60mg once daily) and ASV (100mgsoftgel capsule or 200mg tablets twice daily in genotype 1b (GT1b)infected patients enrolled in four phase 3 and two phase 2 clinicalstudies conducted globally, including Asia.Methods: Integrated safety data from 1218 treatment-naive or treatment-experienced patients were analyzed for adverse events (AEs),serious AEs, discontinuations due to AEs and grade 3/4 AEs andlaboratory abnormalities reported on-treatment.Results: Patients were 58% female, median age was 58 years and23% had compensated cirrhosis. DCV+ASV was associated with infrequentserious AEs and discontinuations due to AEs (Table). Twelvepatients reported treatment-related serious AEs. The most commonAEs (any grade) were diarrhea, nausea, fatigue, and headache. Onepatient died due to coronary heart disease (not treatment-related).The most common grade 3/4 laboratory abnormalities were aminotransferaseelevations (more frequent among Japanese patients); however,all grade 3/4 laboratory abnormality occurred in <5% of patientsoverall. Grade 3/4 total bilirubin elevations were reported in <1%of patients. The DCV+ASV safety profile was similar in patients withor without cirrhosis.Conclusions: DCV+ASV was generally well tolerated across globalnon-Asian patient populations and in Asian patients from Japan, mainlandChina, Korea, and Taiwan.

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