ViiV Healthcare’s two-drug HIV regimen of Tivicay and Epivir has hit targets in late-stage trials, showing non-inferiority to a three-drug regimen and thus the potential to offer patients an alternative treatment strategy.
The Phase III GEMINI-1 and GEMINI-2 studies assessed the safety and efficacy of Tivicay (dolutegravir) and Epivir (lamivudine) versus a three-drug regimen comprised of Tivicay and two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC; Truvada).
The studies - which involved treatment-naïve HIV-1 infected adults with baseline viral loads less than 500,000 copies per ml - met their primary endpoint for non-inferiority based on plasma HIV-1 RNA <50 copies per mL, a standard measure of HIV control, at Week 48.
Safety data for the 2DR was also consistent with the product labelling for the medicines, and no patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance, ViiV stressed.
“Under current standard of care, many patients still take three or more medicines every day. The GEMINI studies demonstrate the potency, safety and tolerability of the dolutegravir plus lamivudine combination,” said John Pottage, ViiV’s chief scientific and medical officer.
“They affirm our two-drug regimen strategy, and reinforce our belief that many patients can control their disease with two drugs instead of three or more. Importantly, the studies show that this two-drug regimen could be an option for treatment naïve patients and can support a broad range of patients living with HIV around the world.”
Full data from the studies will be presented at an upcoming scientific meeting, and the company is reportedly seeking to file the two-drug regimen later this year.