Dolutegravir versus Raltegravir in Treatment Experienced SAILING Study

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Presentation transcript:

Dolutegravir versus Raltegravir in Treatment Experienced SAILING Study

Dolutegravir versus Raltegravir in Treatment Experienced SAILING: Study Design Study Design: SAILING Background: Randomized, double-blind, active- control phase 3 trial evaluating efficacy, safety, and emergent resistance with dolutegravir versus raltegravir in antiretroviral-experienced, integrase inhibitor-naïve patients with at least 2- class resistance Inclusion Criteria (n = 715) - Age >18 - Resistance to ≥2 ARV classes - Integrase inhibitor-naïve - 2 consecutive HIV RNA ≥400 copies/mL (unless >1000 copies/mL at screening) Treatment Arms - Dolutegravir + up to 2 background ARTs - Raltegravir + up to 2 background ARTs Dolutegravir 50 mg QD + ≤2 Background ART Drugs (n = 354) Raltegravir 400 mg BID + ≤2 Background ART Drugs (n = 361) Source: Cahn P, et al. Lancet. 2013;382:700-8.

Dolutegravir versus Raltegravir in Treatment Experienced SAILING: Results Week 48 Virologic Response, By Baseline HIV RNA Level 251/354 230/361 186/249 180/254 65/105 50/107 Source: Cahn P, et al. Lancet. 2013;382:700-8.

Dolutegravir versus Raltegravir in Treatment-Experienced SAILING: Results Week 48 Virologic Failure 21/354 45/361 2/21 19/45 4/354 17/361 VF = Virologic Failure Source: Cahn P, et al. Lancet. 2013;382:700-8.

Dolutegravir versus Raltegravir in Treatment Experienced SAILING Study: Conclusion Interpretation: “Once-daily dolutegravir, in combination with up to two other antiretroviral drugs, is well tolerated with greater virological effect compared with twice-daily raltegravir in this treatment-experienced patient group.” Source: Cahn P, et al. Lancet. 2013;382:700-8.