IQWiG backs Sovaldi for HCV genotype 2 only

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said in a preliminary benefit assessment that Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) in combination with ribavirin has additional benefit vs. pegylated interferon and ribavirin, the comparator requested by Germany's Federal Joint Committee (G-BA), in treatment-naive patients with chronic HCV genotype 2 infection. However, IQWiG said the extent of the benefit in the population can't be quantified because it is "unclear" how often Sovaldi can prevent liver cancer. According to the institute, about 7% of the 293,381 HCV patients in Germany have genotype 2 infection.

IQWiG said Gilead did not submit "suitable data" for HCV patients with genotypes 1, 4, 5 and 6 infection or who are co-infected with HIV. Sovaldi is approved in the EU as part of an all-oral therapy for genotypes 2 and 3 infection; and in combination with ribavirin and pegylated interferon to treat HCV genotypes 1, 3, 4, 5 and 6 infection. Comments are due May 23, with a final benefit assessment from G-BA expected in mid-July. ...