Annotation of U.S. Food and Drug Administration (FDA) label information
for daclatasvir
and IFNL3
Summary
Daclatasvir (DAKLINZA) is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of chronic HCV genotype 1 or 3 infection. Within the clinical studies section, the label mentions frequency of the rs12979860 non-CC genotype.
Annotation
Excerpts from daclatasvir (DAKLINZA) drug label:
Clinical Trials in HCV Genotype 3 (ALLY-3)...40% had the IL28B rs12979860 CC genotype...SVR12 rates were comparable regardless of HCV treatment history, age, gender, IL28B allele status, or baseline HCV RNA level.
Clinical Trials in HCV/HIV Coinfected Subjects (ALLY-2)...73% had IL28B rs12979860 non-CC genotype...SVR12 rates were comparable regardless of antiretroviral therapy, HCV treatment history, age, race, gender, IL28B allele status, HCV genotype 1 subtype, or baseline HCV RNA level.
Clinical Trials in Subjects with Child-Pugh A, B, or C Cirrhosis or with HCV Recurrence after Liver Transplantation (ALLY-1)...77% had IL28B rs12979860 non-CC genotype...SVR12 rates were comparable regardless of age, gender, IL28B allele status, or baseline HCV RNA level.
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the daclatasvir drug label.
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