ViiV Healthcare receives EU marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine), a new once-daily single-pill regimen for the treatment of HIV

ViiV Healthcare announced today that the European Commission (EC) has granted marketing authorisation for Triumeq^® (dolutegravir 50mg / abacavir 600mg / lamivudine 300mg) tablets 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.¹ Patients who carry this genetic marker are at high risk of experiencing a hypersensitivity reaction to abacavir.

Triumeq is ViiV Healthcare’s first once-daily single-pill dolutegravir-based regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.

Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare, said: “We are delighted with today’s approval that offers people living with HIV in Europe the first single-pill regimen containing dolutegravir. Triumeq is a direct result of ViiV Healthcare’s patient-centred approach to innovation. As a company that focuses 100% on HIV, our commitment is to continue to deliver new options for care and treatment for people living with HIV.”

This EC 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 pills²,³
• 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.⁴

In the SINGLE study, a non-inferiority trial with a pre-specified superiority analysis, 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 most commonly used single-pill regimen. The difference was statistically significant and met the pre-specified test for superiority. The difference was driven by a higher rate of discontinuation due to adverse events in the Atripla arm.^2,3

• 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%).