European regulators have approved ViiV Healthcare's Dovato (dolutegravir and lamivudine), a new once-daily, single-pill, two-drug regimen for the treatment of HIV-1 infection.

The decision – which allows the therapy's use in patients aged 12 and over – rides on the back of data from the GEMINI pivotal trials, in which Dovato achieved non-inferior efficacy compared to a dolutegravir-based, three-drug regimen through 48 weeks, with no cases of resistance.

On the safety side, GEMINI 1 and 2 results were consistent with the product labelling for dolutegravir and lamivudine, the firm noted.

Four patients (1%) in both the dolutegravir and lamivudine, and the dolutegravir and TDF/FTC, study arms experienced drug-related serious adverse events, and 15 patients (2%) in the dolutegravir and lamivudine arm and 16 patients (2%) in the dolutegravir and TDF/FTC arm had adverse events that led to discontinuation.

The most common adverse reactions included headache, diarrhoea, nausea, insomnia, and fatigue, while no patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance also up to week 48.

There are around 25,000 new HIV diagnoses in Europe every year, and the firm believes Dovato's approval marks a significant milestone in the treatment of the condition.

“For many years, the standard of care for treatment-naïve people living with HIV in Europe has been a three-drug regimen. The data from our dolutegravir-based two-drug regimen development programme challenges this, and with the authorisation of Dovato, people living with HIV can for the first time start treatment on a once-daily, single-pill, two-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen whilst containing fewer antiretrovirals,” commented ViiV's chief executive Deborah Waterhouse.

“ViiV Healthcare’s ambition and innovative R&D programme aims to reduce the number of HIV drugs people living with HIV take over a lifetime and Dovato is an important addition to our portfolio of medicines to support this aim,” added John Pottage, the firm's chief scientific and medical officer.

ViiV is majority owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders.