Triumeq is a combination of the integrase strand transfer inhibitor (INSTI) dolutegravir and the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.
Irrespective of racial origin, patients with HIV should be screened for the presence of a genetic marker, the HLA-B 5701 allele, before starting treatment with abacavir-containing products.
The company said that abacavir should not be administered to patients known to carry the HLA-B 5701 allele as they will be at high risk of experiencing a hypersensitivity reaction to the drug.
ViiV Healthcare chief executive officer Dr Dominique Limet said the company is happy with the approval that provides 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," Limet said.
"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."
The approval of Triumeq (dolutegravir 50mg/ abacavir 600mg/ lamivudine 300mg) is based primarily upon data from two clinical trials.
First of the two trials, is a Phase III study (SINGLE) of treatment-naive adults, carried out with dolutegravir and abacavir/lamivudine as separate pills.
The second trial is 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.
Image: Triumeq is a combination of dolutegravir 50mg, abacavir 600mg and lamivudine 300mg. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net.