100 likes | 114 Views
This study evaluates the efficacy and safety of daclatasvir and sofosbuvir in the treatment of hepatitis C genotype 3 patients, both those who are treatment-naïve and those who have experienced previous treatment. The study provides detailed information on drug dosing, patient characteristics, treatment outcomes, and adverse events.
E N D
Phase 3 Treatment-Naïve and Treatment-Experienced Daclatasvir + Sofosbuvir in Genotype 3ALLY-3 Study Nelson DR, et al. Hepatology 2015;61:1127-35.
Daclatasvir + Sofosbuvir for HCVGT 3ALLY-3 Trial: Study Features Source: Nelson DR, et al. Hepatology2015;61:1127-35.
Daclatasvir + Sofosbuvir for HCV GT 3ALLY-3 Trial: Design 0 12 24 Week Daclatasvir + Sofosbuvir Treatment-Naïve n=101 SVR12 Treatment-Experienced n=51 Daclatasvir + Sofosbuvir SVR12 Drug DosingDaclatasvir: 60 mg once dailySofosbuvir: 400 mg once daily Source: Nelson DR, et al. Hepatology 2015;61:1127-35.
Daclatasvir + Sofosbuvir for HCV GT 3ALLY-3 Trial: Patient Characteristics a Intolerant of therapy (n=6), virologic breakthrough (n=2), HCV never undetectable on treatment (n=2) Source: Nelson DR, et al. Hepatology 2015;61:1127-35.
Daclatasvir + Sofosbuvir for HCV GT 3ALLY-3 Trial: Results ALLY-3: SVR12, by Baseline Characteristics Status 58/62 128/142 7/10 40/44 95/108 55/60 80/92 77/90 Male Female <65 ≥65 <800K ≥800K CC Non-CC Note: SVR 12 based on HCV RNA less than lower limit of quantitation (25 IU/mL), detectable or undetectable Source: Nelson DR, et al. Hepatology 2015;61:1127-35.
Daclatasvir + Sofosbuvir for HCV GT 3ALLY-3 Trial: Results ALLY-3: SVR12, by Cirrhosis Status 91/101 44/51 135/152 Source: Nelson DR, et al. Hepatology 2015;61:1127-35.
Daclatasvir + Sofosbuvir for HCV GT 3ALLY-3 Trial: Results ALLY-3: SVR12, by Cirrhosis Status 73/75 32/34 11/19 9/13 20/32 73/75 11/19 32/34 9/13 105/109 Note:11 had missing or inconclusive findings for cirrhosis and not included in denominators Source: Nelson DR, et al. Hepatology 2015;61:1127-35.
Daclatasvir + Sofosbuvir for HCV GT 3ALLY-3 Trial: Adverse Events Source: Nelson DR, et al. Hepatology 2015;61:1127-35.
Daclatasvir + Sofosbuvir for HCV GT 3ALLY-3 Trial: Conclusion Source: Nelson DR, et al. Hepatology 2015;61:1127-35.
This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Onlinewww.hepatitisc.uw.edu Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.