Phase III trial of Maraviroc combo fails to meet endpoint for HIV - ViiV HealthCare

The 48-week results from the Phase III MODERN study comparing Celsentri/Selzentry (maraviroc), from ViiV Healthcare, dosed once daily with darunavir/ritonavir (DRV/r) to emtricitabine/tenofovir (FTC /TDF) with DRV/r in antiretroviral-na�ve HIV subjects did not meet the -10% non-inferiority endpoint. The proportion of study participants who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) at week 48 was 77.3% for MVC+DRV/r compared to 86.8% for FTC /TDF +DRV/r. More MVC subjects discontinued due to lack of efficacy (8.3% for MVC+DRV/r vs 2.0% for FTC /TDF +DRV/r) and there were more protocol defined treatment failures in the maraviroc arm (10.1% for MVC and 3.2% for FTC /TDF). There were no reports of viral resistance in subjects who failed in either arm of the study.

The secondary endpoints included safety and tolerability of maraviroc as well as the utility of genotypic and phenotypic testing and tropism change. There were no new or unique safety findings, and discontinuations due to adverse events were 4.8% for MVC+DRV/r and 4.5% for FTC /TDF +DRV/r. Category C events, grade 3/4 adverse events and laboratory abnormalities were similar between the two treatment arms. ViiV Healthcare decided to terminate the MODERN study in October 2013 following a preliminary review of the 48-week primary clinical efficacy data by the study�s external Independent Data Monitoring Committee (IDMC). Data were presented at the 20th International AIDS Congress.