EU approves Triumeq for HIV-ViiV Healthcare

The European Commission (EC) has granted marketing authorisation for Triumeq (dolutegravir 50mg / abacavir 600mg / lamivudine 300mg) tablets, from ViiV Healthcare, for the treatment of HIV in adults and adolescents aged 12 years and older and weighing at least 40kg. Before initiating treatment with abacavir-containing products, screening for the presence of a genetic marker, the HLA-B*5701 allele, should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

This approval is based primarily upon data from two clinical trials: the Phase III study (SINGLE) of treatment-naive adults, conducted with dolutegravir and abacavir/lamivudine as separate pills, and a bioequivalence study of the fixed-dose combination of dolutegravir, abacavir and lamivudine when taken as a single pill compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.

In the SINGLE study, more patients were undetectable (HIV-1 RNA <50 copies/mL) in the dolutegravir and abacavir/lamivudine arm (the separate components of Triumeq) than in the Atripla (efavirenz, emtricitabine and tenofovir) arm. The difference was statistically significant. At 96 weeks, 80% of participants on the dolutegravir-based regimen were virologically suppressed compared to 72% of participants on Atripla. Grade 2-4 treatment emergent adverse reactions occurring in 2% or more participants taking the dolutegravir-based regimen were insomnia (3%), headache (2%) and fatigue (2%).