Follow-up results from a Phase II study of rilpivirine (TMC-278), Tibotec’s experimental next generation NNRTI were presented at IAS 2008. The 96-week data indicate that when combined with Truvada or Combivir, rilpivirine has comparable results to the leading NNRTI, efavirenz.
A significantly lower incidence of rashes, central nervous system effects – such as dizziness, drowsiness, vertigo, abnormal dreams and nightmares – was seen among those taking rilpivirine compared with efavirenz. There were also smaller increases in triglycerides and cholesterol in the rilpivirine group.
Of possible concern were abnormal heart rhythm measurements determined by electrocardiograph (ECG) – seen in some patients treated with rilpivirine in the study. It was reported that it was most often seen in patients who also took Combivir. Abnormal ECG measurements were least pronounced in the 25 milligrams of rilpivirine dosing group – the dose Tibotec plans to study more closely in Phase III clinical trials.
Santoscoy M, et. al. TMC278 (rilpivirine), a next generation NNRTI, demonstrates long-term efficacy and tolerability in ARV-naive patients: 96 week results of study C204. International AIDS Conference. Mexico City. Abstract TUAB0103, 2008.