ViiV Healthcare presents data from dolutegravir study

ViiV Healthcare has released new data from the Phase III SAILING study, which looks into the effects of inhibitor dolutegravir in patients with HIV-1 who are failing on current therapy.

At the 24 week point, 79 per cent of participants who received the dolutegravir regimen were virologically suppressed, while this fell to 70 per cent for participants on the twice-daily raltegravir regimen.

The SAILING study aimed to show the non-inferiority of dolutegravir versus raltegravir and the statistics were found as part of a pre-specified testing procedure.

John Pottage, chief scientific and medical officer, ViiV Healthcare, said: "People living with HIV who have developed resistance to more than one antiretroviral drug class face increasingly narrow treatment options and clinical decisions become increasingly complex.

"We welcome these initial results supporting the efficacy and tolerability of dolutegravir as a potentially useful addition in the management of HIV in treatment-experienced patients"

Mr Pottage went on to say that the data included as part of the study will support regulatory submissions for dolutegravir and we look forward to obtaining the analysis.

The primary objective of the ongoing SAILING study is to show the antiviral activity of once-daily dolutegravir 50mg compared to twice-daily raltegravir 400mg over 48 weeks.

Some 715 participants were randomised 1:1 to obtain either of the two drugs as well as investigator-selected background regimen of 2 or agents or less.

As well as this, all of the subjects had documented genotypic or phenotypic resistance to agents from a minimum of two antiretroviral therapy drug classes.

Dolutegravir is currently in development for the treatment of HIV, with integrase inhibitors that feature as part of the product blocking HIV replication by stopping viral DNA from integrating into human immune cells' genetic material.

SAILING is the fourth Phase III dolutegravir study, though the drug is yet to be approved as a treatment for HIV in the world.

Posted by Ben Evans