GSK's ViiV joint venture begins testing new HIV treatment

The ViiV Healthcare joint venture will test a two-drug regimen of dolutegravir (under the brand name Tivicay) and lamivudine (Epivir) on 1,400 men and women across the world versus the three-drug regimen of dolutegravir plus the fixed-dose tablet tenofovir/emtricitabine (Truvada).

Currently, people being treated for HIV generally can hold back the disease by taking three antiretroviral drugs for the rest of their lives.

"We believe the clinical profile for dolutegravir presents an important opportunity to investigate the possibility of first-line treatment of HIV with a two-drug regimen," said ViiV's chief scientific and medical officer, John C Pottage.

ViiV hopes that not only reducing drug exposure and therefore also improving treatment adherence can be done while still maintaining the level of efficacy achieved with three-drug regimens.

Pottage added: "With this ambitious phase III programme, we will explore whether this two-drug regimen can fundamentally change the existing HIV treatment strategy, reducing the number of medications and potentially streamlining treatment regimens for people living with HIV."

The trial will measure whether the dual-medicine treatment will be non-inferior compared to the current three-drug treatment after 48 weeks and the study will continue to evaluate the long term antiviral activity, tolerability and safety of dolutegravir plus lamivudine through Week 148.

Dolutegravir is an integrase strand transfer inhibitor (INSTI), which means it stops HIV from replicating by preventing the viral DNA from integrating into the genetic material of human immune cells, a step that would be essential for HIV to replicate and establish chronic infection.

Under the brand name Tivicay it is approved in over 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.