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Conference
"Nucleoside Analogue Spring 2008 Update - Part 2" Dr. Jaime Hernandez (biography) English - 2008-04-25 - 18 minutes
(25 slides)
Summary : Dr. Hernandez discusses the results of the ATCG5202 study in which patients with a high viral load were unblinded due to concerns of the Data Safety and Monitoring Boards (DSMB) that Kivexa was demonstrating lower efficacy in comparison with Truvada. This was a phase IV, randomized, double-blind study lasting 96 weeks.
Dr. Hernandez compares these results with that of the HEAT study, which was also a phase IV, randomized, double-blind study of the same length. The main difference between this study and that of ATCG5202 is the definition of virologic failure, which is evaluated by HEAT after 24 weeks rather than 16. This study demonstrated no difference between Kivexa and Truvada in terms of adverse effects, virologic failure, and viral load, and the CD4 cell increase was found to be greater in the group treated with Kivexa.
Dr. Hernandez also presents results from CNA30024, a phase III, randomized, double-blind, multicenter study that demonstrated similar results, regardless of the patients' viral load, from Zidovudine and Abacavir, both of which were combined with 3CT and Efavirenz. This study also compared the time it took for patients to reach a viral load below 400 copies/mL, and found no difference in the results obtained from groups of patients treated with Kivexa compared to those treated with Combivir.
As Dr. Hernandez summarizes the results from different clinical trials, he concludes that the findings from the ACTG5205 are inconsistent with the above stated results as well as with what is seen in clinical practice. Furthermore, Kivexa is still listed as the recommended agent by the Department of Health and Human Services (DHHS) as well as by the International AIDS Society-USA.
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