3rd Conference on Retroviruses and Opportunistic Infections Washington, DC - January 28-February 1, 1996

Conf Retroviruses Opportunistic Infect 1996 Jan 28-Feb 1; 3rd:58 (abstract no. 32)

Phillips AN, Hill AM*, Eron J**, Bartlett J*** for the North American Lamivudine HIV Working Group
Royal Free Hospital, UK, *Glaxo Research, **University of North Carolina at Chapel Hill, ***Duke University Medical Center, Durham, North Carolina.

OBJECTIVE:- To assess the prognostic value of the HIV RNA level. Design:- For 620 patients randomised in the NUCA3001 and NUCA3002 trials of 3TC (Lamivudine), CD4 counts and HIV RNA levels (using the Roche method) were regularly assessed (both markers available median 7 times per patient). Patients were in CDC stages A (n=439), B (n=135) or C (n=46) at baseline. For patients initially in CDC A we considered the ability of HIV RNA levels and CD4 counts to predict CDC group B (or C) disease using a Cox model. For both HIV RNA and CD4 count the ability of the most recent measurement to predict clinical outcome was assessed, as this is most relevant to the clinical situation. In a second analysis the ability to predict AIDS was assessed in patients initially AIDS-free.

RESULTS:- Baseline CD4 counts ranged (5% - 95%) from 117 to 472/mm (median 277) and HIV RNA levels from 1700 to 340,240 copies/ml (median 42,420). For patients initially in CDC group A, both HIV RNA levels and the CD4 count predicted the development of CDC B/C disease (relative hazard for HIV RNA 1.96 per 10-fold difference in HIV RNA; P=0.0001; and RH for CD4 count 0.54 per 2-fold difference in CD4 count; p =0.0009). When both markers were included in the model, each provided information additional to that given by the other (RH for HIV RNA 1.75; P= 0.002; and 0.71 for CD4 count; p=0.11). Both HIV RNA level (p=0.054) and CD4 count (p=0.005) also independently predicted development of AIDS. Results were essentially unchanged after adjustment for treatment group.

CONCLUSION:- The HIV RNA level appears to be a strong predictor of the development of clinical disease and may thus be of importance, in addition to the CD4 count, in patient monitoring.

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Copyright © 1996 - Foundation for Retrovirology and Human Health . Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health.