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 weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or Lamivudine.
Marketing Authorisation for Dovato is supported by data from the landmark global GEMINI 1 and 2 studies that included more than 1,400 HIV-1 infected adults.
In these studies, Dolutegravir and Lamivudine have demonstrated non-inferior efficacy based on plasma HIV-1 RNA less than 50 copies per millilitre ( c/mL ), a standard measure of HIV control, at week 48 when compared to a 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.
The safety results for Dolutegravir and Lamivudine seen in GEMINI 1 and 2 were consistent with the product labelling for Dolutegravir and Lamivudine.
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.
No patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance also up to week.
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 ).
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.
With around 25,000 new HIV diagnoses in European Union every year, and the fact that HIV is considered a chronic condition which requires people living with HIV to remain on antiretroviral treatment for life, it is ever more important to provide innovative treatment options. ( Xagena )
Source: ViiV Healthcare, 2019