Sofosbuvir + ledipasvir

28394611000001109

New Medicines

Harvoni · Chronic hepatitis C infection in children aged 3 to 11 years - new granule and 45/200mg tablet formulations

Information

Harvoni
New formulation and licence extension / variation
Gilead Sciences
Gilead Sciences

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
None
Jul 20 · Low-dose tablets (45mg/200mg) and granule formulations not yet available [4].
Jul 20 · Approved in EU [3].
Apr 20 · EU positive opinion for a licence change to recommend use to treat chronic hepatitis C infection in children aged 3 to <12 years. The new indication is treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above. The CHMP also recommended the addition of a new 45 mg/200 mg strength for the film-coated tablets and the introduction of a new pharmaceutical form, coated granules, which will be available in two strengths: 33.75 mg/150 mg and 45 mg/200 mg [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 children aged 3 to 11 years - new granule and 45/200mg tablet formulations
Oral

Evidence based evaluations