TN = Treatment-naïve; TE = Treatment-experienced

a.         Subjects with genotype 2 CHC treated with SOVALDI + RBV for 24 weeks (N=15) and subjects with genotype 3 CHC treated with SOVALDI + RBV for 12 weeks (N=42) are not included in the table.
b.         The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on treatment assessment.
c.         Other includes subjects who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow up).

In subjects with HCV genotype 1 infection, the SVR rate was 82% (74/90) in subjects with genotype 1a infection and 54% (13/24) in subjects with genotype 1b infection, with relapse accounting for the majority of treatment failures. SVR rates in subjects with HCV genotype 1 infection were 80% (24/30) in subjects with baseline IL28B C/C allele and 75% (62/83) in subjects with baseline IL28B non-C/C alleles.

In the 223 CHC subjects with HIV-1 co-infection, the percentage of CD4+ cells did not change during treatment. Median CD4+ cell count decreases of 85 cells/mm3 and 84 cells/mm3 were observed at the end of treatment with SOVALDI + ribavirin for 12 or 24 weeks, respectively. HIV-1 rebound during SOVALDI + ribavirin treatment occurred in 2 subjects (0.9%) on antiretroviral therapy.

The complete label will be posted at Drug@FDA1.

FDA Press Release2

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration