ViiV Healthcare has submitted an application in Europe for a single-tablet, two-drug regimen of dolutegravir (DTG) and lamivudine (3TC) for the treatment of HIV-1 infection.
The submission is based on the global GEMINI 1 & 2 studies, which confirmed non-inferiority of the two-drug regimen against to a standard three-drug scenario.
In a pooled analysis, 91% of patients taking of the two-drug regimen had HIV-1 RNA<50 copies/mL compared with 93 percent of patients taking dolutegravir and two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine.
The percentage of patients that withdrew due to adverse events was 2% in each study arm, while pooled results show that the most common adverse events across the studies were headache, diarrhoea and nasopharyngitis.
However, drug-related adverse events were less frequent in patients taking the two-drug regimen, with data showing 18 percent versus 24 percent.
“This regulatory submission, if approved, will make available a two-drug regimen option with dolutegravir and lamivudine instead of the traditional three-drug regimen and is an important step in the evolution of HIV treatment,” said Deborah Waterhouse, the firm’s chief executive.
“We want to make HIV a smaller part of people’s lives throughout their treatment journey and are committed to challenging the status quo with innovations that are based on our belief that no one should take more medicines than they need,” added John Pottage, ViiV’s chief scientific and medical officer.
“If approved, a single-tablet, 2-drug regimen of dolutegravir and lamivudine would mark a new era in HIV treatment for people newly diagnosed with HIV.”
A new drug application (NDA) to the US FDA is planned for this single tablet regimen for October, using a priority review voucher, the firm confirmed.