Selzentry: Phase III data

The 96-week, double-blind, double-dummy, international Phase III MODERN trial in 797 antiretroviral-naive patients with CCR5-tropic HIV-1 infection showed that once-daily 150 mg maraviroc plus darunavir/ritonavir missed the primary endpoint of non-inferiority to once-daily Truvada emtricitabine/tenofovir plus darunavir/ritonavir in the proportion of patients who achieved HIV-1 RNA levels of <50 copies/mL at week 48 (77.3% vs. 86.8%, 95% CI: -15%, 4.4%). The predefined criterion for non-inferiority was a lower bound of a 2-sided 95% CI of -10%. Additionally, more patients in the maraviroc arm compared to the Truvada arm discontinued the trial due to lack of efficacy (8.3% vs. 2%) and there were more protocol-defined treatment failures in the maraviroc arm compared to the Truvada arm (10.1% vs. 3.2%). There were no reports of viral resistance in patients who failed in either arm. Data were presented at the International AIDS Conference in Melbourne. The MODERN trial was terminated in October 2013 following a preliminary review of the 48-week data by an independent DMC. ...