Phase 3 study of integrase inhibitor doluegravir provides potential for HIV-1 adults who have developed resistance to antiretrovirals

ViiV Healthcare today announces 24 week data from the Phase III 48 week SAILING study evaluating the investigational integrase inhibitor dolutegravir for patients who are failing on current antiretroviral therapy, but have not been treated with an integrase inhibitor. Dolutegravir is a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the DNA of the host cell in patients with HIV-1.

“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.” said John Pottage, MD, chief scientific and medical officer, ViiV Healthcare.

The goal of the study is to compare the antiviral activity of dolutegravir, taken once-daily at 50mg, and raltegravir, taken twice-daily at 400mg. At 24 weeks, 79 per cent of study participants receiving the once-daily dolutegravir regimen were virologically suppressed vs. 70 per cent of participants on the twice-daily raltegravir regimen. This means that dolutegravir blocked HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells) more efficiently than raltegravir. Virological suppression is essential to stop the HIV replication cycle and ward off chronic infection.

The data was part of the comprehensive clinical data package supporting regulatory submissions for dolutegravir which will be completed at the study’s 48 week completion date. The preliminary data was presented at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta, Georgia.

SAILING is the fourth Phase III dolutegravir study reporting in 2012 and 2013. Dolutegravir is not yet approved as a treatment for HIV or any other indication anywhere in the world.

For more information on the preliminary data and methodology of the SAILING study visit: http://bit.ly/13HDWO0