Folks, the post I'm responding to links back to a post I made yesterday referring to Dr. Joseph Eron's review of the Sustiva data from Healthcg's website. I've read it again. Highly recommend it to you.
Eron's writing about the Schlomo Staszewski presentation, the big one that shook things up so much. The study compared Sustiva + AZT + 3TC vs. Sustiva + Crixivan vs. Crixivan + AZT + 3TC, and showed the Sustiva+2NRTI markedly superior to the Crixivan+2NRTI at reducing HIV-1 RNA levels below 400 copies.
Several points.
- this is 24 week data (however, there seems to be evidence that treatment success at 24 weeks is persistent with HAART).
- it's open label.
- the difference in the intent to treat results (Sustiva 74.7%, Crixivan 56.2%) is primarily attributable to the much higher dropout rate due to adverse events. The on treatment results were 94.5% Sustiva, 88.6% Crixivan
- these dropout rates are anomalously high for Crixivan in trials. However, clearly given Crixivan's side effect profile (same goes for Norvir), it's a toxic therapy that contributes to patient non-compliance and treatment failures (my opinion here)
- Sustiva appears to be at least as potent as the most potent PIs (Crixivan and Viracept), and is highly tolerable
- my opinion again, but I would think that the gold standard first line therapy when Sustiva hits the street later this year would be Viracept (most tolerable PI, equivalent potency), Sustiva, and one or two NRTIs. However, and this is the $64K question, there's statistical data supporting a decision to start the patient on Sustiva and 2 NRTIs as a PI sparing therapy ... it doesn't make sense to me, when you could hit the virus with an even more potent therapy than a PI or NNRTI combo alone (PI + NNRTI combo). Of course, as has been pointed out by folks on this board, especially Rick Harmon, with the data indicating Sustiva increasing Viracept levels, and decreasing the other PIs blood levels, this would be yet another reason for Viracept increasing its market share and solidifying its position as the gold standard among PIs, and as an essential part of first line treatment. |
