Triumeq is the company’s first dolutegravir-based fixed-dose combination (FDC) which provides HIV patients the option of a single-pill regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.
Patients with current or past history of resistance to any components of Triumeq are not recommended to use Triumeq alone, which is also not recommended in patients with resistance-associated integrase substitutions or clinically suspected INSTI resistance because the dose of dolutegravir in Triumeq is insufficient in these populations.
Prior to starting 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.
Additionally, products containing abacavir should not be used in patients known to carry the HLA-B*5701 allele.
ViiV Healthcare chief executive officer Dominique Limet said the approval of Triumeq offers many people living with HIV in the US the first single-pill regimen containing dolutegravir.
"ViiV Healthcare is committed to delivering advances in care and new treatment options to physicians and people living with HIV," Limet said.
"We are proud to announce this important milestone, marking the second new treatment to be approved in the US from our pipeline of medicines."
The FDA approval of Triumeq is based on data from two clinical trials including a Phase III trial (SINGLE) of dolutegravir and abacavir/lamivudine as separate pills, and a bioequivalence study of the FDC of abacavir, dolutegravir and lamivudine when taken as a single pill compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.