All eight patients in the daclatasvir arm and the five remaining patients in the asuprenavir arm had week 4 and week 12 sustained virologic responses (SVR4 and SVR12).
Grade 3 or 4 adverse events occurred in one of eight patients on daclatasvir, and in four of five on asunaprevir. There were no grade 3 or 4 lab abnormalities among patients on daclatasvir. In the asunaprevir group, there was one case of hemoglobin abnormalities, three with elevated ALT, four with elevated aspartate aminotransferase, and one with elevated total bilirubin.
The authors concluded that the combination of IFN-L/RBV and daclatasvir had the best safety profile, and that the data support further investigation of the combination in patients with HCV genotype 1b.
Both the EMERGE IIb and D-LITE studies were supported by Bristol-Myers Squibb. Dr. Muir reported receiving grant and research support and serving on advisory committees or review panels for the company. Dr. Izumi reported receiving speaking and teaching fees from the company.