Efficacy and safety of raltegravir-based therapy in antiretroviral-naive patients with HIV-1 infection: A Meta-analysis

Objective To systematically review the efficacy and safety of raltegravir-based therapy in antiretroviral-naive patients with HIV infection. Methods The data on randomized controlled trial (RCT) of raltegravir-based therapy in antiretroviral-naive patients with HIV-1 infection were collected, and analyzed using Rev Man 5.2 and Stata 12.0 software. Results A total of 17 RCTs were included. At weeks 48, 96, there were no significant differences (all P>0.05) between the raltegravir group and control group, proportion of patients with virological response (plasma viral load<50 copies/ml) in raltegravir group were 84.2% and 87.3%, respectively. At weeks 240, 70.2% versus 61.5% achieved plasma viral load <50 copies/m in the raltegravir group and control group (RR=1.15, 95% CI:1.03-1.28, P=0.010). The incidence rate of drug-related clinical common adverse events (including diarrhea, nausea, dizziness, headache, insomnia) in both groups were not significantly different (all P>0.05) at weeks 48 and 96, respectively. At weeks 96,144/156, the mean changes from baseline in LDL-cholesterol (LDL) 0.16(0.05-0.49), 0.20(0.08-0.48), triglyceride (TG) 0.12(0.02-0.59), 0.12(0.03-0.59) and total cholesterol (TC), 0.04(0.00-0.40), 0.04(0.00-0.34) concentrations, the raltegravir-based regimens group had a lower incidence rate than the control group (all P<0.05). Conclusions Current evidence shows that the raltegravir-based therapy had long-term and well tolerated antiretroviral activity, which was non-inferior to current regimens recommended for antiretroviral-native adults and adolescents with HIV-infection. Due to limited quality and quantity of the included studies, more high quality studies would be needed to verify the above conclusion.