Sofosbuvir + ledipasvir

28394611000001109

New Medicines

Harvoni · Chronic hepatitis C infection in adolescents aged 12 to <18 years

Information

Harvoni
Licence extension / variation
Gilead Sciences
Gilead Sciences

Development and Regulatory status

Launched
Launched
None

Jul 17: Approved in EU [3].


Jun 17: EU positive opinion for a licence change to recommend use to treat chronic hepatitis C infection in adolescents aged 12 to <18 years [1].

Category

A fixed-dose combination product. Sofosbuvir is a second generation uridine nucleoside analogue which inhibits the NS5B protein of HCV. Ledipasvir is a direct-acting macrocyclic antiviral agent & NS5A serine protease inhibitor.
Prevalence of HCV infection in children and adolescents has been reported to vary from 0.05% to 0.36% in the US and Europe [2]
Chronic hepatitis C infection in adolescents aged 12 to <18 years
Oral

Evidence based evaluations

SMC