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ARTICLE | Clinical News

Cenicriviroc: Additional Phase IIb data

March 11, 2013 7:00 AM UTC

Additional data from the double-blind, double-dummy, U.S. and Puerto Rican Phase IIb Study 202 trial in 143 treatment-naïve patients with CCR-5-tropic HIV-1 infection showed that 76% of patients receiving once-daily 100 mg oral cenicriviroc plus Truvada emtricitabine/tenofovir and 73% of patients receiving 200 mg cenicriviroc plus Truvada achieved HIV-1 RNA levels <50 copies/mL at week 24, the primary endpoint, vs. 71% of patients receiving Sustiva efavirenz plus Truvada. Mean changes in CD4+ cell count from baseline to week 24 were 147 cells/mm 3 for low-dose cenicriviroc, 170 cells/mm 3 for high-dose cenicriviroc and 135 cells/mm 3 for Sustiva. Additionally, LDL-C levels decreased in patients in the cenicriviroc arm, while both LDL-C and HDL-C levels increased in the Sustiva arm. Furthermore, levels of soluble CD14, a marker of monocyte activation and an independent predictor of mortality in HIV infection according to the company, decreased in patients in the cenicriviroc arm, but increased in patients in the Sustiva arm. Cenicriviroc was well tolerated. Data were presented at the Retroviruses and Opportunistic Infections meeting in Atlanta. ...