GSK to apply for new two-drug HIV combo after Gemini trial success

ViiV, which is a joint venture with Pfizer and Shionogi, said it will seek regulatory approval for the two-drug HIV combination of dolutegravir (DTG) and lamivudine (3TC) after the 'Gemini' stage III trials hit their targets. ViiV has been testing a regimen of DTG and 3TC on adults with HIV as their first treatment for the virus, with results compared to the common three-drug regimen of dolutegravir, tenofovir disoproxil fumarate and emtricitabine (TDF/FTC).

After 48 weeks, the Gemini studies showed the two-drug regimen is not inferior to the current three-drug standard. As a result, ViiV said it will seek regulatory approval for a fixed-dose combination of DTG and 3TC "later this year", as the two drug regime has not yet won approval for use by the US medical regulator.

On Gemini, Pedro Cahn, principal investigator for the studies, said: "For the last 15-20 years, the standard of care for HIV has revolved around three-drug regimens. Now that we have more potent drugs, the focus is shifting to tolerability and convenience.

"The Gemini studies show that we can get the efficacy of three drugs in a two-drug regimen with the tolerability and drug interaction profile of DTG and 3TC. These are important findings for people living with HIV who will spend their lifetime taking drugs to suppress their virus. The studies have the potential to expand the treatment paradigm for first-line therapy of people living with HIV."

Results from Gemini show broadly consistent results for virus suppression across individuals with higher viral load and lower viral load HIV-1 plasma RNA. Rates of virologic failure were no more than 1% across all arms of the study.

John C Pottage, Jr, ViiV's chief scientific and medical officer, said: "These data we have presented at AIDS 2018 provide further evidence that we should be rethinking the traditional approach to HIV treatment of using three or more drugs. The results from the GEMINI programme support our belief that the two-drug regimen of dolutegravir and lamivudine can be a valuable option for treatment-naïve patients and that no patient should take more medicine than they need."

Meanwhile, there were also 100-week results from phase III 'Sword' trials of a two-drug regimen branded Juluca, which has already been approved in the US, Europe, Canada and Australia. The Sword trials, which been examining the safety and efficacy of switching virologically-suppressed people living with HIV from a three- or four-drug antiretroviral regimen to this two-drug combination, showed 89% of participants on the 2-drug regimen maintained viral suppression.