HIV drug receives marketing nod

GlaxoSmithKline has announced today that the European Commission has granted Marketing Authorisation for Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adults and adolescents above 12 years of age.

ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer  and Shionogi Limited as shareholders prepares Dovato.

“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. Dovato strengthens ViiV Healthcare’s industry-leading portfolio of innovative treatment approaches for people living with HIV,” Deborah Waterhouse, CEO, ViiV Healthcare has been quoted as  saying by a statement released by GSK.

Dovato (dolutegravir 50 mg/ lamivudine 300 mg tablets) was authorised by the US Food and Drug Administration in April 2019

About Dovato (dolutegravir/lamivudine)

Dovato (dolutegravir 50 mg/ lamivudine 300 mg tablets) is authorised in the EU for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine. Dolutegravir/lamivudine is a once-daily, single-pill, two-drug regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay, 50 mg) with the nucleoside analogue reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, 300 mg).

In the US the Food and Drug Administration (FDA) authorised Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC.

Like a dolutegravir-based three-drug regimen, Dolutegravir/lamivudine uses two drugs to inhibit the viral cycle at two different sites. INSTIs, like dolutegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells).

This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Lamivudine is an NRTI that works by interfering with the conversion of viral ribonucleic acid (RNA) into deoxyribonucleic acid (DNA) which in turn stops the virus from multiplying.