SINGLE Trial: Dolutegravir in HIV

single trial dolutegravir hiv
2013 SINGLE TRIAL M Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection double-blind, randomized controlled trial 844 Objective: To assess the safety & efficacy of dolutegravir at a dose of 50 mg plus a fixed-dose combination of abacavir-lamivudine, as compared with fixed-dose efavirenz-tenofovir DF-emtricitabine for the treatment of HIV-1 patients Inclusion criteria: Patients aged ≥18 years who had HIV-1 infection, had not previously received ART, plasma HIV-1 RNA level of ≥1000 copies/ml without viral resistance and were negative for the HLA-B*5701 allele. Dolutegravir plus Abacavir-Lamivudine group (n=414) 888 Efavirenz-Tenofovir DF-Emtricitabine group (n=419) PRIMARY OUTCOME % of participants with HIV-1 RNA level <50 copies/ml at week 48 Diff 7; 95% CI, 2 to 12; P=0.003 SECONDARY OUTCOMES 81 267 Mean change in CD4+ T-cell count from baseline at week 48 (cells/mm3) Diff 59; 95% CI, 33 to 84; P<0.001 208 28 28 Median time to viral suppression (in days) P<0.001 84 8 10 Adverse events of grade 3 or 4 % 16 2 Therapy discontinuation due to adverse events % 100 Conclusion: Dolutegravir plus abacavir-lamivudine had a better safety profile and was more effective through 48 weeks than the regimen with efavirenz-tenofovir DF-emtricitabine. SL Walmsley et al. NEJM 2013;369:1807-1818 | Summary by Dr.Shreyash Bhoyar, MBBS M Visualmed
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