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Cenicriviroc yielded similar effectiveness, fewer adverse events than efavirenz in HIV
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BRUSSELS — The dual CCR5/CCR2 inhibitor cenicriviroc was associated with higher rates of virologic success and fewer adverse events vs. efavirenz for treatment-naive patients with HIV, according to a phase 2 clinical trial presented at EACS 2013.
However, cenicriviroc (Tobira Therapeutics) also exhibited higher rates of virologic non-response when compared to efavirenz (Sustiva, Bristol-Myers Squibb).
In an analysis presented by Judith Feinberg, MD, professor of medicine specializing in infectious diseases in the department of internal medicine at the University of Cincinnati, 143 treatment-naive HIV-positive adults were randomly assigned 2:2:1 to 100 mg cenicriviroc, 200 mg cenicriviroc or efavirenz with emtricitabine/tenofovir disoproxil fumarate (Truvada, Gilead).
Feinberg and colleagues observed that attrition was high overall, with 29% in the 100-mg cenicriviroc group, 27% in the 200-mg cenicriviroc group and 39% in the efavirenz group prematurely discontinuing treatment; 13% of all patients discontinued for reasons other than efficacy or safety.
Despite this obstacle, at week 48, according to the FDA “snapshot” algorithm, cenicriviroc was found to be as effective as efavirenz, with virologic success of 68% for the 100-mg cenicriviroc group, 64% in the 200-mg cenicriviroc group and 50% for the efavirenz group.
The researchers identified virologic nonresponse rates at week 48 as 15% for 100 mg cenicriviroc, 20% for 200 mg cenicriviroc and 11% for efavirenz.
Among the 11 adults with protocol-defined virologic failure (confirmed HIV-1 RNA ≥400 cells/mL on or after week 12, or never achieved <50 cells/mL by week 24), nucleotide reverse transcriptase inhibitor resistance mutations were observed in 75% of the 100-mg cenicriviroc group, 33% of the 200-mg cenicriviroc group and 0% for the efavirenz group.
Drug-related adverse events occurred in most patients: 50% in the 100-mg cenicriviroc arm, 44% in the 200-mg cenicriviroc arm and 71% taking efavirenz. Common adverse events included abnormal dreams and insomnia (11% each in the efavirenz group vs. 0% to 2% among cenicriviroc recipients). Additionally, dermatologic adverse events and nausea were less frequent with cenicriviroc than efavirenz (0%-4% vs. 7%).
For more information:
Feinberg JP. #PS4/1. Presented at: 14th European AIDS Conference; Oct. 16-19, 2013; Brussels.