Sofosbuvir/Velpatasvir

Analyst Outlook

As the first triple combination to show strong efficacy in difficult to treat cirrhotic patients after just

eight weeks of treatment, sofosbuvir/velpatasvir/GS-9857 (Gilead) is expected to set the standard for

pan-genotypic regimens following its anticipated US and EU approvals in September 2017 and

November 2017, respectively. Sofosbuvir/velpatasvir/GS-9857 will face fierce competition from

AbbVie’s glecaprevir/pibrentasvir (ABT-493/ABT-530), which is also expected to be approved as an

eight-week regimen in non-cirrhotic patients, but will retain greater patient share in cirrhotic

patients, where glecaprevir/pibrentasvir is being investigated in a longer 12-week course. From Q4

2018, sofosbuvir/velpatasvir/GS-9857 will also face threats from Merck & Co’s and Johnson &

Johnson/Achillion’s pan-genotypic regimens, which are also expected to be approved in shorter

treatment durations and priced at discounts to promote uptake.

Drug Overview

Sofosbuvir/velpatasvir/GS-9857 is Gilead’s third-generation, pan-genotypic, interferon-free regimen.

The fixed-dose combination contains the hepatitis C virus (HCV) nucleotide NS5B inhibitor, sofosbuvir,

a second-generation NS5A inhibitor, velpatasvir, and the company’s NS3 protease inhibitor, GS-9857.

Gilead is developing the combination as a replacement for its first pan-genotypic regimen,

sofosbuvir/velpatasvir, in the hope that the addition of a third direct-acting antiviral (DAA) agent will

allow the shortening of treatment to eight weeks for all six genotypes. Sofosbuvir/velpatasvir/GS-

9857 is currently in Phase III development in the US and five major EU markets (France, Germany,

Italy, Spain, and the UK).