ViiV Healthcare starts HIV prevention study with cabotegravir

Cabotegravir is yet to be approved by regulatory authorities anywhere in the world.  It is the first injectable to be studied for efficacy in pre-exposure prophylaxis.

Dubbed HPTN 083, the 4,500-subject global phase III study will compare cabotegravir, administered once every other month, with once-daily oral Truvada from Gilead Sciences. The primary endpoint is the number of documented HIV infections over up to 4.5 years.

The trial will feature participants aged 18 years and above and at a high risk of getting HIV infection.

A second cabotegravir phase III study to evaluate the long-acting investigational integrase strand transfer inhibitor (INSTI) is likely to be started in 2017, to evaluate its prevention of HIV in young women.

ViiV Healthcare chief scientific and medical officer John C Pottage, Jr, MD said: “Twenty years ago we couldn’t have imagined a future with so many effective medicines to treat HIV. However, there remains a need to provide more options for preventing HIV infection, such as long-acting regimens that don’t require daily dosing.

“ViiV Healthcare is committed to studying new prevention options and through our public-private collaboration on this large phase III study, we will evaluate whether long-acting injectable cabotegravir could be an option in the pre-exposure prophylaxis setting.”

In another development, ViiV Healthcare announced that the phase III studies of two-drug HIV treatment regimen of dolutegravir and rilpivirine (Janssen Sciences Ireland UC) met the primary endpoint of non inferiority at Week 48.

The primary endpoint, depending on FDA’s snapshot analysis, was evaluated as the proportion of patients with plasma HIV-1 RNA <50 copies per milliliter (c/mL) at Week 48.

ViiV Healthcare was established in November 2009 by GlaxoSmithKline and Pfizer. Shionogi joined in October 2012.