The data was presented in late-breaking sessions at the Interscience Conference on Antimicrobial Agents and Chemotherapy meeting. This newly approved CCR5 antagonist – the first new class of oral HIV medicines introduced in more than ten years – is now available throughout the US.
Results from the planned 48-week analysis also demonstrated that Selzentry, along with an optimized background regimen, significantly increased CD4 cells, as compared to patients receiving an optimized regimen alone. The adverse event profile observed in this analysis in patients receiving Selzentry was similar to those receiving an optimized regimen alone, Pfizer said. The most common adverse events reported included diarrhea, nausea, fatigue and headache.
This longer-term analysis is consistent with the pre-planned 24-week analyses that formed the basis of Selzentry's accelerated US approval in August for CCR5-tropic treatment-experienced patients. The 48-week data are under review by the FDA for consideration of full approval of Selzentry for these patients.
Selzentry is the first in a class of drugs known as CCR5 antagonists, which block the CCR5 co-receptor, the virus' predominant entry route into T-cells. Selzentry stops the R5 virus on the outside surface of the cells before it enters, rather than fighting the virus inside as do all other classes of oral HIV medicines.