The European Commission (EC) has granted marketing authorisation for ViiV Healthcare's 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. 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 pills; 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, 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.
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%).
Triumeq is a once-daily single-pill dolutegravir-based regimen, containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine.
Two essential steps in the HIV life cycle are replication – when the virus turns its RNA copy into DNA – and integration – the moment when viral DNA becomes part of the host cell’s DNA. These processes require two enzymes called reverse transcriptase and integrase. NRTIs and integrase inhibitors interfere with the action of the two enzymes to prevent the virus from replicating. This decrease in replication will lead to less virus being available to cause subsequent infection of uninfected cells.
Today’s approval of Triumeq is the European regulatory authorisation to market the medicine in each member state of the European Union. Triumeq will become available in each country as pricing and reimbursement processes are completed, with availability in some of the first countries anticipated in the immediate future.
The US Food and Drug Administration (FDA) approved Triumeq on 22 August 2014. Regulatory applications are also being evaluated in other markets worldwide, including Australia, Brazil and Canada.
Dolutegravir was approved in the US in August 2013 and in Europe in January 2014 under the brand name Tivicay.
Tivicay and Triumeq are registered trademarks of the ViiV Healthcare group of companies.
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as shareholder in October 2012.