SINGLE Trial: Dolutegravir in 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
Tags: abacavir, dolutegravir, HIV, lamivudine
Comments are closed.