ViiV Healthcare’s HIV Drug OK’d for European Sales
ViiV Healthcare, a global HIV company with U.S. headquarters in Research Triangle Park, has received authorization from the European Commission to begin marketing Dovato, a treatment for HIV-1 infection.
The authorization follows Dovato’s approval by the U.S. Food and Drug Administration in April for sales in the United States.
Dovato is a combination of the drugs dolutegravir and lamivudine. It was approved in Europe for treating adults and adolescents over 12 years old who are living with HIV and have never taken antiretroviral drugs.
The approval means that patients may be able to switch from a three-drug regimen to the two-drug regimen to manage their chronic illnesses.
“For many years, the standard of care for treatment-naïve people living with HIV in Europe has been a three-drug regimen,” said Deborah Waterhouse, chief executive officer of ViiV Healthcare. “The data from our dolutegravir-based two-drug regimen development program challenges this.”
With the authorization 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 while containing fewer antiretrovirals,” Waterhouse said.
With about 25,000 new HIV diagnoses in Europe every year and many patients taking antiretroviral treatment for life, new treatment options are important, the company said.
ViiV Healthcare aims to reduce the number of HIV drugs people living with the infection take over a lifetime, “and Dovato is an important addition to our portfolio of medicines to support this aim,” said John C. Pottage Jr., M.D., chief scientific and medical officer of ViiV Healthcare.
In the United States, approval of Dovato gives HIV patients the option of a two-drug regimen “while eliminating additional toxicity and potential drug interactions from a third drug,” said Debra Birnkrant, M.D., director of the division of antiviral products. “Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time.”
European and U.S. approval of Dovato was supported by data from the global GEMINI 1 & 2 studies that included more than 1,400 HIV-1 infected adults.
In those studies, dolutegravir with lamivudine demonstrated non-inferior efficacy at week 48 when compared to a three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate and emtricitabine, in treatment-naïve, HIV-1 infected adults. The three-drug regimen is sold under the brand name Truvada by Gilead Sciences.
ViiV Healthcare, globally headquartered in Brentford, England, a town in Greater London, is majority owned by GlaxoSmithKline with Pfizer and Shionogi Limited as shareholders. The company has 700 employees in 15 countries working exclusively on HIV medicines and research.