ViiV Healthcare has secured marketing authorisation from the European Commission (EC) for its Dovato (dolutegravir/lamivudine) to treat HIV-1 infection.
Dovato is a new once-daily, single-pill and two-drug regimen approved for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.
The approval was based on data from the global Gemini 1 and 2 studies, which evaluated over 1,400 HIV-1 infected adults.
According to the company, dolutegravir and lamivudine showed non-inferior efficacy based on plasma HIV-1 RNA <50 copies per millilitre (c/mL), at week 48 in these studies compared against three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment-naïve, HIV-1 infected adults.
Dolutegravir/lamivudine is said to combine the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay, 50mg) with the nucleoside analogue reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, 300mg).
The US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50mg and lamivudine (3TC) 300mg, to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC.
Similar to dolutegravir-based three-drug regimen, the Dolutegravir/lamivudine uses two drugs to restrict the viral cycle at two different sites.
Like dolutegravir, INSTIs restrict HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells).
Lamivudine is an NRTI that works by interfering with the conversion of viral ribonucleic acid (RNA) into deoxyribonucleic acid (DNA), which in turn restricts the virus from multiplying.
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, 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.”