European positive opinion for tenofovir for first-line therapy

The Committee for Proprietary Medicinal Products (CPMP), the scientific committee of European Medicines Evaluation Agency (EMEA), adopted a positive opinion to extend the indication of tenofovir disoproxil fumarate (Viread) to include the product’s use in antiretroviral-naive HIV-positive patients.

The label extension is based on 48-week results from Gilead’s Study 903 in 600 treatment-naive HIV-positive patients. The European Commission will consider granting of the label extension on the basis of the CPMP’s recommendation. Gilead anticipates a decision by the European Commission in the next few months.

The indication recommended by the CPMP is for tenofovir to be taken in combination with other antiretroviral medicinal products for the treatment of HIV-1-positive adults over 18 years of age. This indication is based on the demonstration of benefit of tenofovir from results of one study in treatment-naive patients, including patients with a high viral load (>100,000 copies/mL), and studies in which tenofovir was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (<10,000 copies/mL, with the majority of patients having <5,000 copies/mL).

Tenofovir was first authorised for sale in the European Union in February 2002. On the basis of the safety and efficacy data submitted for tenofovir in the original submission, which only included data from studies of the drug in treatment-experienced HIV-positive patients, the committee recommended authorisation under exceptional circumstances. The indication recommended by the CPMP was for tenofovir taken in combination with other antiretroviral agents in HIV-positive patients over 18 years of age experiencing early virological failure. Full approval for the indication in treatment-naïve patients is expected within four months.