Second International Congress Drug Therapy in HIV Infection 18-22 November 1994 Glasgow, UK

IMMUNOLOGICAL MARKERS OF TREATMENT EFFICACY

Anthonv J Pinching
Dept of Immunology, Medical College of St Bartholomew's Mospital, London EClA 7BE, UK

Int Cong Drug Therapy HIV 1994 Nov 18-22;2:Abstract No. 2.2
AIDS 1994, Vol. 8 (Suppl. 4);S1

It is reasonable to expect that, in a virally induced disease of the immune system, there will be consistent changes in the immune system that reflect the changes induced by disease and altered by treatment. Such changes could be direct expressions of pathogenetic mechanisms (cf. bacteraemia in infective endocarditis) or of their consequences (cf. blood sugar in diabetes), or they could simply provide arbitrary but reliable measures of changes of interest (cf. serum creatinine in renal failure). While such concepts are attractive and have many precedents, they have the hazard that they are hidebound by current perceptions of disease causation, evolution and response to intervention. Additional problems arise if the markers are relatively non-specific and can be altered by extraneous and common variables.

If we dissociate the implicit emotional investment in particular markers or their significance, it may be possible to take a more pragmatic and utilitarian approach to the use of such markers. This would be based upon their ability accurately to predict a clinical outcome, and could only be validated against that standard. However, this approach is undermined by the need to assume that a previously validated marker in one setting with one therapy will also be valid, qualitatively or quantitatively, in other situations. These issues will be illustrated from experience with immunological markers of therapeutic response in HIV infection.

Ultimately, however, the clinical outcome remains the only valid basis for assessing any intervention. The use of markers, however sophisticated or well-validated, is limited to the process of defining and narrowing the set of questions to be answered in trials with clinical endpoints. They cannot be seen to predict the outcome. This remains true, however urgent the need for effective intervention. The role of markers is to assist in generating appropriate hypotheses to test with clinical end-points, to justify pursuing further investment in a particular therapy, and to guide the necessarily provisional nature of therapeutic decision-making.

Presenting author: Anthonv J Pinching

1994-11-18
2.2

Originally published in AIDS Volume 8, Supplement 4 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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