Dolutegravir in antiretroviral-naive adults with HIV-1

• DOI: 10.1097/qad.0b013e3283612419
• Publication Date: 2013-03-22T22:25:46Z
• Authors: Hans-Jürgen Stell...; Jacques Reynes; Adriano Lazzarin; Eugene Voronin; Federico Pulido; Franco Felizarta; Steve Almond; Marty St Clair; Nancy Flack; Sherene Min
• Keywords: Tolerability; Dolutegravir; Emtricitabine; Efavirenz; Abacavir; Regimen; Clinical endpoint; Integrase inhibitor

Objective: To evaluate the efficacy and safety/tolerability of dolutegravir (DTG, S/GSK1349572), a potent inhibitor HIV integrase, through full 96 weeks SPRING-1 study. Design: ING112276 (SPRING-1) was 96-week, randomized, partially blinded, phase IIb dose-ranging Methods: Treatment-naive adults with received DTG 10, 25, or 50 mg once daily efavirenz (EFV) 600 (control arm) combined investigator-selected dual nucleos(t)ide reverse transcriptase backbone regimen (tenofovir/emtricitabine abacavir/lamivudine). The primary endpoint study proportion participants plasma HIV-1 RNA less than copies/ml, based on time to loss virologic response at 16 (conducted for purpose III dose selection), planned analysis weeks. Safety tolerability were also assessed. Results: Of 208 randomized treatment, 205 drug. At week 96, achieving copies/ml 79, 78, 88% mg, respectively, compared 72% EFV. median increase from baseline in CD4+ cells 338 cells/μl (all treatment groups combined) 301 EFV (P = 0.155). No clinically significant dose-related trends adverse events observed, fewer who withdrew because (3%) (10%). Conclusion: Throughout study, demonstrated sustained favorable treatment-naive individuals HIV-1.