CHMP gives positive opinion to approve coformulated sofosbuvir/ledipasvir

Simon Collins, HIV i-Base

On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) recommended granting market authorisation for a coformulated version of sofosbuvir (400 mg) plus ledipasvir (90 mg). [1]

This will be the first single-pill, once-daily, oral combination to treat hepatitis C.

Recommendations from the CHMP are usually followed, with full approval expected within three months.

The formulation is manufactured by Gilead and will be marketed in Europe with the brand name Harvoni.


Based on the experience with sofosbuvir alone, enthusiasm for this significant medical advance is likely to be muted by lack of access.

The US price (wholesale acquisition cost, WAC) for combined sofosbuvir/ledipasvir is $1,125 per pill. This results cost per treatment of $63,000 for 8 weeks treatment, $94,500 for 12 weeks and and $189,000 for 24 weeks of treatment.

Some US activists have called on Gilead to set a single charge per treatment. [2]


  1. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014. (26 September 2014).
  2. Fair Pricing Coalition. Fair Pricing Coalition welcomes approval of Gilead Sciences’ combination tablet for hepatitis C, urges a uniform price for curative treatment. (13 October 2014).

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