ARTICLE | Clinical News

Dolutegravir: Interim Phase IIb data

July 25, 2011 7:00 AM UTC

Interim data from the ongoing, double-blind, dose-ranging Phase IIb SPRING-1 trial (ING112276) in 205 treatment-naïve HIV patients showed that once-daily 10, 25 and 50 mg dolutegravir reduced mean HIV-1 RNA levels from baseline to week 48 by 4.42, 4.38 and 4.58 log10 copies/mL, respectively, vs. 4.46 log10 copies/mL for once-daily 600 mg Sustiva efavirenz. Additionally, the proportion of patients with HIV-1 RNA levels <50 copies/mL at week 48 was 91%, 88% and 90% for low, mid- and high-dose dolutegravir, respectively, vs. 82% for Sustiva. Additionally, across all doses dolutegravir non-significantly increased CD4+ T cells from baseline to week 48 by 231 cell/mm 3 vs. 174 cells/mm 3 for Sustiva (p<0.076). Mean change from baseline in LDL-C for dolutegravir was 0.55 mg/dL compared to 15.88 mg/dL for Sustiva. Patients received Epzicom abacavir/lamivudine or Truvada emtricitabine/tenofovir in combination with either dolutegravir or Sustiva. Data were presented at the International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Rome. ...