Harvoni is a fixed-dose combination of Gilead’s nucleotide NS5B inhibitor sofosbuvir and the company’s NS5A inhibitor ledipasvir. Within the US, Harvoni is currently approved for the treatment of genotype 1/4/5/6 (GT-1/4/5/6) hepatitis C virus patients, while in the EU the combination is approved for the treatment of GT-1/3/4/5/6 patients. Within Japan, Harvoni is only approved for the treatment of GT-1 patients.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Harvoni : Hepatitis C
LIST OF FIGURES 12 Figure 1: Harvoni for hepatitis C – SWOT analysis
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Harvoni for hepatitis C
14 Figure 3: Datamonitor Healthcare’s drug assessment summary of Harvoni for hepatitis C
16 Figure 4: Harvoni sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES 5 Table 1: Harvoni drug profile
7 Table 2: Pivotal studies supporting approvals of Harvoni
11 Table 3: Ongoing studies of Harvoni
17 Table 4: Harvoni sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017–26
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