Dolutegravir, the most recently licensed HIV integrase inhibitor, proved virologically superior to raltegravir, another licensed integrase inhibitor, in adults with antiretroviral experience but still naive to integrase inhibitors.
SAILING was a double-blind active-controlled trial that began enrolling participants in October 2010. Enrollees had two consecutive viral loads above 400 copies/mL or above 1000 copies/mL at screening.
No one had taken an integrase inhibitor before, but everyone had HIV resistant to two or more other antiretroviral classes. Everyone had one or two active antiretrovirals available to be taken with dolutegravir or raltegravir.
Researchers randomized 354 participants to once-daily dolutegravir at a dose of 50 mg and 361 participants to twice-daily raltegravir at a dose of 400 mg. Individuals investigators selected the background regimen for each participant. The primary endpoint was the proportion of participants with a viral load before 50 copies/mL at week 48, among people who took at least one dose of study drugs.
At the 48-week point, 251 participants randomized to dolutegravir and 230 randomized to raltegravir had a viral load below 50 copies/mL. The response rate difference (71% versus 64%, –7.4, 95% confidence interval [CI] 0.7 to 14.2) established the virologic superiority of dolutegravir in this patient population.
A significantly lower proportion of people randomized to dolutegravir than to raltegravir had virologic failure with treatment-emergent integrase-inhibitor resistance: 4 versus 17, adjusted difference –3.7%, 95% CI –6.1 to –1.2, P = 0.003).
Nine people (3%) randomized to dolutegravir and 14 (4%) randomized to raltegravir stopped treatment because of adverse events. Adverse events rates were largely similar in dolutegravir and raltegravir groups: diarrhoea (71 [20%] versus 64 [18%]), upper respiratory tract infection (38 [11%] versus 29 [8%]), and headache (33 [9%] versus 31 [9%]).
