The European Commission (EC) has approved ViiV Healthcare’s marketing authorisation application (MAA) for Dovato (dolutegravir/lamivudine), which is indicated to treat HIV-1 infection.

The treatment is suitable for adults and adolescents above the age of 12 that weigh at least 40kg and have no known or suspected resistance to integrase inhibitors or lamivudine.

Dovato is a once-daily, single-pill, two-drug regimen that combines integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay, 50mg) with nucleoside analogue reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, 300 mg).

ViiV Healthcare CEO Deborah Waterhouse said: “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. 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.

“Dovato strengthens ViiV Healthcare’s industry-leading portfolio of innovative treatment approaches for people living with HIV.”

Every year, around 25,000 people are diagnosed with HIV in Europe. The disease is considered a chronic condition, requiring people living with HIV (PLHIV) to remain on antiretroviral (ARV) treatment for life.

The marketing authorisation (MA) for Dovato is supported by data from the global GEMINI 1 and 2 studies, which included more than 1,400 HIV-1 infected adults.

In these studies, dolutegravir and lamivudine showed non-inferior efficacy based on plasma HIV-1 ribonucleic acid (RNA) <50 copies per millilitre (c/mL) at week 48 against a three-drug regimen of dolutegravir and NRTIs tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in treatment-naïve adults with HIV-1.

The safety results for dolutegravir and lamivudine were in line with the drugs’ labelling

Four patients (1%) in both the dolutegravir plus lamivudine, and the dolutegravir plus TDF/FTC trial arms saw serious adverse events (AE), while 15 patients (2%) in the dolutegravir plus lamivudine arm experienced AEs, and 16 patients (2%) in the dolutegravir and TDF/FTC arm saw AEs that led to discontinuation.

“Every year, around 25,000 people are diagnosed with HIV in Europe.”

Among the most common adverse reactions included diarrhoea, nausea, headache, fatifue and insomnia.

According to the company, no patient that experienced virologic failure in either treatment arm had treatment-emergent resistance up to week 48.

ViiV Healthcare chief scientific and medical officer John C Pottage, Jr, said: “The marketing authorisation of Dovato in Europe marks a significant development for people living with HIV. This treatment allows individuals to take a two-drug regimen in a single pill with dolutegravir at the core, building on the established potency and safety profiles of dolutegravir and lamivudine.

“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.”

In April 2019, the US Food and Drug Administration (FDA) authorised Dovato (dolutegravir 50mg/lamivudine 300mg tablets). Additional regulatory applications have been submitted worldwide.