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Is there a role for treatment intensification with Maraviroc in addition to a standard cART for naïve patients with low CD4 counts, and will it decrease the risk of progression to AIDS? (ANRS 146 – GeSIDA OPTIMAL)
There is no clinical evidence that of successful treatment intensification by the addition of a 4th antiretroviral agent; despite numerous trials.
This double-blinded trial in France , Italy and Spain compared Maraviroc (+cART) to placebo (+cART). Over 400 naïve, HIV-1 infected patients with an AIDS defining illness or CD4 cells < 200cell/mm^3 were enrolled.
The primary endpoint was the occurrence of a severe morbidity (AIDS, SNAE, IRIS, Death or other HIV related disease). Baseline characteristics were comparable.
In the 72-week follow up period; treatment intensification made no impact on the risk of infections, serious events, mortality, virilogic control or on CD4 count recovery. A post hoc analysis suggested Maraviroc might demonstate benefit on the occurrence of clinical events in the first 6 months of treatment, however this benefit “subsequently disappeared”.