Los Angeles, USA-based biopharmaceutical company Gilead Sciences, says that the results of a study illustrate that its HIV integrase inhibitor GS 9137 (elvitegravir), in combination with ritonavir, brought about a statistically-superior reduction in viral load compared with a boosted protease inhibitor-based therapeutic regimen.
The data, which were presented at the 14th Conference on Retroviruses and Opportunistic Infections in Los Angeles, are derived from a Phase II clinical trial that was designed to demonstrate the product's non-inferiority to boosted protease inhibitors. In the program, 278 patients were randomized to receive one of three doses of GS 9137 (20mg, 50mg or 125mg) plus ritonavir, or a comparator protease inhibitor and ritonavir. The firm added that both treatments were given in combination with two or more nucleoside reverse transcriptase inhibitors. The primary endpoint was defined as viral load reduction at 24 weeks, DAVG24.
Gilead said that rapid and potent antiviral activity was observed in the 50mg and 125mg groups, with mean DAVG24 levels of -1.4 log10 copies/ml and -1.7 log 10 copies/ml, respectively, compared with an average of -1.2 log 10 copies/ml in the CPI/r group.
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