(Alliance News) - GlaxoSmithKline PLC on Wednesday noted positive results from the Gemini and Tango phase three studies of a dolutegravir plus lamivudine in HIV patients.
The results were announced by ViiV Healthcare, a specialist HIV company in which pharma giant Glaxo has a majority share, with Pfizer Inc and Shionogi Ltd also as shareholders.
Gemini 1 and 2 studies of the two-drug regimen showed it was not inferior to a three-drug regimen at week 96 and there were no cases of treatment emergent resistance in patients with virologic failure.
Pedro Cahn, principal investigator for the Gemini study programme, said: "The week 96 data from the Gemini studies demonstrate that the clinical benefits of dolutegravir plus lamivudine we saw at week 48 are sustainable, allowing us to use these two drugs while still getting efficacy non-inferior to that of a dolutegravir-based 3-drug regimen.
"This provides further evidence for the benefits of this dolutegravir-based 2-drug regimen in a treatment-naive population, and enables physicians and people living with HIV to be confident in the durability of this treatment option. These latest findings are important for people living with HIV who will potentially spend decades taking medication to manage their HIV."
The Tango study, meanwhile, assessed patients who were switching from a three-drug regimen containing tenofovir alafenamide fumarate to the two-drug dolutegravir plus lamivudine regimen.
At 48 weeks, the two-drug regimen was found to have similar efficacy to the three-drug regimen in patients who switched.
Kimberley Smith, head of Global Research & Medical Strategy at ViiV Healthcare, said: "With HIV now considered a chronic condition and people living with HIV needing antiretroviral treatments for life, taking fewer medicines over a lifetime has become an important consideration for the community. The Tango study was designed to answer the question, can a 2-drug regimen of dolutegravir/lamivudine maintain viral suppression as well as a TAF-containing regimen. We're delighted that the week 48 results of the study confirm that it can. These data present evidence that a dolutegravir/lamivudine 2-drug regimen is as effective as a TAF-containing, 3-drug regimen for people living with HIV."
Shares in Glaxo closed down 0.4% at 1,653.60 pence on Wednesday.
Glaxosmithkline (GSK)
