Key result
Dolutegravir linked to ~36% higher insomnia risk versus other antiretrovirals, without increasing cardiac events.
Why the study?
Nonrandomized cohort studies suggested higher risks of CNS adverse events and IRIS with dolutegravir versus other antiretrovirals, requiring meta-analysis of randomized trials to cross-check safety signals.
Does dolutegravir increase the risk of cardiovascular, CNS, or IRIS-associated adverse events compared to other antiretrovirals?
Population
Patients receiving antiretroviral therapy excluding CDC stage C disease
Comparison
Dolutegravir versus other antiretrovirals including efavirenz
Design
Systematic review and meta-analysis of randomized trials using Mantel-Haenszel random-effects models
Authors
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Monitor for insomnia with dolutegravir; confirms cardiac, IRIS, and suicide-related safety.
Meta-Analysis
Does dolutegravir increase the risk of cardiovascular, CNS, or IRIS-associated adverse events compared to other antiretrovirals?
Absolute Event Rate: 6.1% vs 4.5%
p-value: p=0.02
Dolutegravir does not significantly increase the risk of cardiovascular, IRIS, or suicide-related serious adverse events compared to other antiretrovirals, though it is associated with a higher risk of insomnia.
Hill et al. (2017) conducted a meta-analysis in HIV. Dolutegravir vs. Other antiretrovirals was evaluated on Grade 1-4 insomnia adverse events (p=0.02). Dolutegravir was associated with a higher risk of Grade 1-4 insomnia compared to other antiretrovirals (6.1% vs 4.5%; P=0.02), with no significant effect on cardiac, IRIS or suicide-related SAEs.
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