Biotech Values

[DewDiligence]

GILD’s Elvitegravir non-inferior to Isentress in second-line pivotal trial:

http://finance.yahoo.com/news/Gileads-Investigational-bw-670748534.html?x=0&.v=1

After 48 weeks of treatment, 59 percent of elvitegravir patients compared to 58 percent of raltegravir patients achieved and maintained a viral load of less than 50 copies/mL using the TLOVR algorithm (ITT population; non-inferiority p=0.001; 95% CI, -6.0% to +8.2%). Patients receiving elvitegravir experienced a similar mean increase in CD4 cell counts from baseline at week 48 compared to those receiving raltegravir (138 vs. 147 cells/mm3, respectively).

Nine patients (3 percent) receiving elvitegravir and 15 patients (4 percent) receiving raltegravir discontinued treatment due to adverse events.

With these results, Elvitegravir should be a lock for FDA approval in the second-line setting as a component of a 3-drug cocktail. By prior agreement with the FDA, GILD was required to run only one phase-3 trial of Elvitegravir apart from the 4-in-1 pill known as ‘Quad’ (Elvitegravir + Truvada + Cobicistat).

Results from two phase-3 trials testing Quad in the first- and second-line settings will be available during 3Q11 (the current quarter).