Sovaldi (sofosbuvir; Gilead) was the first interferon-free regimen to be approved for genotype 2/3 (GT-2/3) patients, and has greatly benefited from the lucrative warehoused population and lack of competitors in this subgroup. However, Sovaldi’s GT-2/3 sales, derived from its use in combination with either ribavirin or Daklinza (daclatasvir; Bristol-Myers Squibb), are rapidly declining due to cannibalization of its patient share by Gilead’s own pan-genotypic successor regimen, Epclusa ([sofosbuvir + velpatasvir]), as well as falling patient numbers. Epclusa has shown statistically significant improvements in efficacy in GT-2/3 patients and is substantially cheaper than both of the aforementioned Sovaldi combinations, making it a highly attractive option to payers. As a result, Datamonitor Healthcare expects that Sovaldi will quickly be phased out during 2017 as payers update their formularies to mandate the use of Epclusa for first-line GT-2/3 patients.
Sovaldi is a nucleotide NS5B inhibitor marketed by Gilead. The compound was first developed by Pharmasset, which was acquired by Gilead in an $11bn merger in January 2012. Sovaldi is currently approved in the US and EU for the treatment of GT-1/2/3/4 hepatitis C virus (HCV) patients, and in Japan for the treatment of GT-2 patients only (EMA, 2017; FDA, 2017; Gilead, 2015). The table below shows the drug profile for Sovaldi
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Sovaldi : Hepatitis C
LIST OF FIGURES
10 Figure 1: Sovaldi SWOT analysis in hepatitis C
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Sovaldi for hepatitis C
11 Figure 3: Datamonitor Healthcare’s drug assessment scores and weightings for Sovaldi for
LIST OF TABLES
4 Table 1: Sovaldi drug profile
6 Table 2: Pivotal studies supporting approvals of Sovaldi
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