HSV for tumour lysis

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This house believes that virus shedding is a surrogate marker for genital herpes transmission: The case against

Presented by S Self, Fred Hutchinson Cancer Research Center, Seattle, USA.

We assume that the amount of herpes simplex virus type 2 (HSV-2) shed is related directly to infectiousness when all other factors are held constant. This concept is graphically displayed by a sigmoid-shaped curve relating amount of virus shed to probability of transmission per contact with a susceptible, where the curve takes value zero when no virus is shed and plateaus at some point where copious amounts of virus are shed. However, the issue of surrogacy is an exceedingly practical matter that is far removed from this conceptual, cartoon curve. Specifically, a surrogate is a biomarker-based measurement that is used to replace another measurement (the ‘clinical outcome’) as primary end-point in a randomized controlled trial. The curve that describes utility of the surrogate is the predicted change in the clinical outcome as a function of the change in the surrogate outcome induced by the treatment of interest. We discuss issues involved and various assumptions required to traverse from concept to the reality of using measurements of viral shedding as a surrogate end-point. We comment on the empirical basis for these assumptions, and question whether the current state of knowledge is sufficient to reliably define shedding as a surrogate end-point for HSV-2 transmission.

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Last Updated : 15/04/2004 09:25:11