RESEARCH TRIANGLE PARK –HIV patients may get a bit of a break on their daunting three-drug daily antiviral routine. ViiV Healthcare, which has U.S. headquarters in the RTP, said that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion on a two drug regimen using its Tivicay (dolutegravir).
ViiV, which is majority owned by GlaxoSmithKline, disclosed phase 3 trial results of the combo treatment in June.
The new label update includes data from the phase III GEMINI 1 & 2 studies, which evaluated the safety, efficacy and tolerability of the 2-drug regimen of dolutegravir + lamivudine compared to a three-drug regimen. This CHMP Positive Opinion provides further support for the efficacy of dolutegravir in treating HIV as a 2-drug regimen (2DR).
Deborah Waterhouse, CEO ViiV Healthcare said in a statement, “Today, thanks to advances in treatment, people living with HIV can now expect to live as long as the general population. However, we know that they still face a lifetime of antiretroviral therapy in order to maintain viral suppression.
“Our 2DR program looks to reduce the impact of a lifetime of medication, without compromising on treatment efficacy, as we believe no one should take more medicines than they need.This CHMP Positive Opinion is a key milestone in the dolutegravir 2DR journey.”
More than 70 million people have been infected with the HIV virus and some 35 million people have died of HIV, according to the World Health Organization.Though 2016, nearly 37 million people have died.
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