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Session 7 Oral Abstract Session Opportunistic Infections and Complications of Antiretroviral Therapy Session Time: Monday, 10 am - 12:30 pm Room 6E

12:00   39. CMV Viraemia is an Independent Predictor of Disease Progression and Death in the Era of HAART J. Deayton *, C. Sabin, M. A. Johnson, V. Emery, and P. Griffiths Royal Free and Univ. Coll. Sch. of Med., London, UK Background: Studies conducted prior to the introduction of HAART associated CMV viraemia with an increased risk of both development of CMV disease and death. As the natural history of CMV has since altered, this study aims to investigate whether CMV viraemia remains independently associated with disease progression and survival in the era of HAART. Methods: All patients attending between January 1997 and December 2000 whose CD4 count had ever been <100/muL were prospectively monitored for CMV viraemia by qualitative PCR at each visit; this was continued even if CD4 levels increased after HAART. End points were defined as progression to new AIDS event, CMV disease, and death. Event rates were estimated using Kaplan-Meier methods. Cox proportional hazard regression models with time-updated covariates were used to quantify the independent effects of CMV viraemia, CD4 count, and HIV load. Results: 390 patients were studied for a median of 26 months; 92% received HAART. Progression to new AIDS event was significantly associated with CD4 count (relative hazard [RH] 1.08, p=0.005) and HIV load (RH 1.28, p=0.02) but more strongly associated with CMV viraemia (RH 2.66, p=0.0008). CMV viraemia was strongly associated with progression to CMV disease (RH 32.33, p= 0.001) and was also associated with an increased risk of death with a progression rate of 20.4% in CMV viraemic patients compared with 8.2% in non-viraemic individuals (p=0.003). RH of death associated with CMV viraemia was 4.16 (p=0.0002) and 1.18 for CD4 count (p=0.0001). HIV load was not associated with CMV disease or death. Conclusions: CMV viraemia is independently associated with disease progression and death in the era of HAART and is more strongly correlated with risk of death than CD4 count or HIV load. The risks associated with CMV viraemia appear greater in this cohort than in comparable studies conducted in the pre-HAART era. CMV viraemia appears to be a more sensitive predictor of prognosis than other markers and may thus provide a marker for sustained functional immune performance subsequent to HAART. Short-term changes in CMV PCR status are important for outcome in the time-updated model suggesting that treatment of CMV viraemia should be evaluated in a placebo-controlled trial.

©2002 9th Conference on Retroviruses and Opportunistic Infections