Dynamics of cellular HIV-1 DNA levels over 144 weeks of darunavir/ritonavir monotherapy versus triple therapy in the MONET trial.
Geretti AM, Arribas JR, Lathouwers E, Foster GM, Yakoob R, Kinloch S, Hill A, van Delft Y, Moecklinghoff C.
HIV Clin Trials. 2013 Jan-Feb;14(1):45-50
11 March 2013, by Dr Anton Pozniak
In the MONET Trial, 256 patients with virologic suppression were randomised, in an open-label design, to either darunavir/ritonavir 800/100 mg monotherapy once daily (n = 127) or darunavir/ritonavir 800/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (n = 129) for 144 weks. Although monotherapy showed noninferior efficacy to triple therapy when switches were not considered as failures, it was associated with a higher risk of low level plasma HIV-1 RNA elevations, between 50 and 400 copies/ml. A substudy was conducted in 146 patients to assess HIV DNA in stored PBMC. Level of HIV-1 DNA/106 PBMC was similar in both groups at baseline, with no significant changes within or between groups through 144 weeks. In both treatment groups, baseline HIV-1 DNA correlated with plasma HIV-1 RNA (< 5 ; 5-49 or > 50 copies/ml), and was significantly higher in patients with nadir CD4 counts < 200/mm3 (p < 0.05) and in patients who experienced during follow-up at least 1 HIV-1 measurement above 50 copies/ml (p < 0.05).
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