CROI 2013Interim 24-week results from a Phase III study comparing the investigatory dolutegravir to raltegravir among HIV-positive individuals who have experienced treatment failure suggest that dolutegravir is superior at suppressing virus. ViiV Healthcare announced these midway results from their 48-week, double-blind, double-dummy Phase III SAILING study at the 20th annual Conference of Retroviruses and Opportunistic Infections (CROI) in Atlanta.  

At the outset, the study's 715 participants had resistance to at least two classes of antiretrovirals (ARVs). They also had replicating virus, a median baseline viral load of 63,000 and a median baseline CD4 count of 200. The participants were divided evenly into two study groups: One received once-daily dolutegravir and the other twice-daily raltegravir, both with a background regimen of no more than two other ARVs that the investigators selected.

At week 24 of the study, 79 percent of those taking dolutegravir achieved a suppressed viral load, compared with 70 percent of those on raltegravir. This difference was statistically significant, meaning that it was too great to have occurred by chance. At the same point, 15 percent of those on dolutegravir and 24 percent of those taking raltegravir had a virologic nonresponse. Two of those on the dolutegravir regimen failed therapy, compared with 10 of those taking raltegravir.

The tolerability of the two drugs was about even. At the 24-week mark, 2 percent of the participants taking dolutegravir discontinued because of adverse events, compared with 4 percent of those on raltegravir. Drug-related adverse events occurred in 20 percent of those on dolutegravir and 23 percent of those taking raltegravir. The most common adverse events were diarrhea and upper respiratory tract infection.

To read the ViiV release, click here.

To read the aidsmap story, click here.

To read the conference abstract, click here.