SMC Approves Tibotec’s Prezista For Use In NHS Scotland

The Scottish Medicines Consortium (SMC) has approved Tibotec’s once daily Prezista (darunavir) for use within NHS Scotland. Darunavir is a protease inhibitor (PI) indicated for the treatment of HIV-1 infection in treatment-naive adults (those who have never taken HIV medication before) and is co-administered with low dose ritonavir and in combination with other antiretroviral medicinal products.

Reportedly, the SMC approval is based on data from 48-week analyses of plasma HIV RNA levels and CD4+ cell counts from the ongoing, randomised, controlled, open-label phase III trial known as ARTEMIS.

The study compared the efficacy and safety of once daily darunavir/r to lopinavir/r, the current most dispensed PI in the UK, in treatment-naive adults with HIV. The study met its primary endpoint, and the 48-week data showed that darunavir/r was non-inferior to lopinavir/r for virologic response. The pre-planned safety and efficacy analysis at 96 weeks was a secondary endpoint.

Roy Kilpatrick, chief executive of HIV Scotland, said: “We are delighted with this outcome, and are pleased that the SMC decision again recognises the importance of providing the effective treatments for people living with HIV.”