ViiV Healthcare Ltd., majority-owned by GlaxoSmithKline PLC, said results from two late-stage studies showed its two-drug regimen for untreated HIV patients was just as effective as taking three drugs.
The studies, called Gemini-1 and Gemini-2, evaluated a combination of dolutegravir and lamivudine against the standard-of-care three-drug regimen of dolutegravir and tenofovir disoproxil fumarate/emtricitabine, or TDF/FTC, in HIV-infected adult patients who did not get any anti-retroviral treatment — so-called "treatment naive" patients.
At 48 weeks, taking dolutegravir and lamivudine was seen to be just as effective and safe as taking the three drugs.
The trials were started in 2016, with about 1,400 patients enrolled across Europe, Central and South America, North America, South Africa, and the Asia-Pacific.
Safety data for dolutegravir and lamivudine were consistent with their product labeling. The Gemini studies are part of ViiV's clinical trial program for two-drug regimens that seek to address concerns of long-term toxicity for people living with the infection.
The results reinforce ViiV's belief that HIV can be controlled with two drugs instead of three or more, Chief Scientific and Chief Medical Officer John Pottage said.
ViiV plans to file regulatory applications for the two-drug regimen of dolutegravir and lamivudine later this year.
One of the two drugs, dolutegravir, had drawn flak from the European Medicines Agency in May with the agency cautioning against its use in certain women due to the risk of birth defects in babies born to mothers who became pregnant while on the medicine.
Full results of the Gemini trials will be presented at an upcoming scientific meeting, the company said in the release.
The company markets dolutegravir as Tivicay, while TDF/FTC is a blockbuster HIV treatment sold by Gilead Sciences Inc. as Truvada.
ViiV, established in 2009, is majority-owned by GSK, with Pfizer Inc. and Japan's Shionogi & Co. Ltd. holding stakes in the company.