IBT: Immune - Based Therapy
"This study...illustrates the difficulties in using clinical endpoints to test IBTs in subjects who continue to take HAART: the proportion of subjects who progress to AIDS in the control (i.e. HAART alone) group is only ~ 2%/year. Therefore, the experimental IBT must improve upon a very effective therapy. In this setting, the risk/benefit ratio becomes very important. If the IBT improves the rate of progression to AIDS by 50%, i.e. if only 1% of the subjects/year progress to AIDS, will this small improvement in outcome be worth the risk if there is significant toxicity associated with the IBT?"
[Note: The lack of toxicity - the safety - of WF10 means that whatever gains it makes will be significant. If it also demonstrates parallel and beneficial effects on the liver (as we expect it to) it will contribute to an overall increase in the patient's health. HAART is known to prolong the lives of AIDS patients, at the expense of the liver. Given what we already know about WF10's effects on HCV, it's quite possible that WF10's contribution to overall patient health - "quality of life", decreased hospitalization, return to home or work - may be outstanding.]
(cont'd) "...The cardinal rule that the FDA uses in approving drugs for routine use is that they must be shown to result in improvement in the natural disease course. That is, a new therapy compared with the standard therapy must cure a proportion of subjects, prolong the disease-free interval, or improve the quality of life during the treatment interval. In HIV infection in the era of HAART, improvement in these parameters due to an IBT is difficult to demonstrate. As well, surrogate immunologic markers may or may not correlate with these clinical outcomes."
[This last paragraph explains the depth and complexity of the WF10 P3 protocol. The protocol was an attempt to catch all significant variables, or at least their assumed markers, in evaluating efficacy of AIDS treatments.]
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Jim |
