EMEA approves once-daily darunavir/ritonavir (800mg/100mg) for treatment-naive patients in Europe
On 3 February 2009, the European Commission approved once-daily dosing of 800 mg darunavir (Prezista) with low-dose ritonavir as part of combination therapy in treatment-naïve adults.
The approval is based on 48-week analyses from the Artemis Study, an open label phase III trial in antiretroviral treatment naïve HIV-1-infected adults which compared darunavir/r vs. lopinavir/r in combination with other antiretrovirals. The results showed that darunavir was non-inferior to the lopinavir/r, (84% vs. 78% achieved viral load <50 copies/mL compared to lopinavir/r ). The common adverse drug reactions reported of at least moderate intensity (≥Grade 2) in the darunavir/r arm were
hypertriglyceridaemia, hypercholesterolaemia, headache, diarrhoea, nausea, and increased alanine aminotransferase.
Darunavir was given conditional marketing authorisation by the European Commission in February 2007, and received full marketing authorisation in December 2008.
The recommended dosing for treatment-naïve adult patients is 800 mg (two 400 mg tablets) taken with 100 mg ritonavir once daily.
For treatment-experienced adult patients, the dosing for darunavir remains 600 mg taken with 100 mg ritonavir twice daily.
Darunavir must be taken with food and in combination with other ARVs. Darunavir is not recommended for use in patients with severe hepatic impairment.
Tibotec Press Release ‘Once-daily darunavir/r for treatment-naive adults with HIV-1 receives approval in the European Union as part of combination therapy’. (3 February 2009)