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Yerly Sabine; Kaiser, Laurent; Mermillod, Bernadette; Baumberger, Christophe; Hirschel, Bernard; Perrin, Luc

Objective:To evaluate whether early changes in viraemia in response to didanosine (ddl) predict death and occurrence of new AIDS-defining events.

Methods:Forty-three patients were followed during ddl treatment with sequential determinations of serum viraemia, mutations associated with drug resistance, CD4 counts and clinical evaluation. Patients were stratified into two groups of equal size, responders and nonresponders, using the median of individual changes in viraemia 1 month after initiation of ddl therapy.

Results:After 1 month of ddl, mean viraemia decreased by 0.35 log RNA copies/ml of serum (P<0.001) in the population. A significant difference in survival (median, 14 and 35 months in nonresponders and responders, respectively; log rank, P=0.004) and in the delay to the occurrence of new AIDS-defining events (median, 8 and 33 months in nonresponders and responders, respectively; log rank, P=0.018) was observed. After stratification for presence of AIDS before starting ddl, viraemia response at 1 month remained predictive of both overall and AIDS-defining event-free survival (log rank, P=0.0006 and P=0.01). After a similar stratification for initial CD4, viraemia response still predicted overall survival (log rank, P=0.009), but its predictive value for AIDS-defining event-free survival did not reach statistical significance (P=0.12). High initial levels of HIV RNA, presence of mutation 215 or previous duration of zidovudine therapy were not predictive of survival.

Conclusions:In patients treated with ddl, changes in viraemia at 1 month predict survival independently of initial AIDS diagnosis and initial CD4 counts.

From the Central Laboratory of Virology, the *AIDS Centre, Division of Infectious Diseases and the †Hospital Informatics Centre, Geneva University Hospital, Geneva, Switzerland.

Sponsorship: Supported by the Swiss Federal Office of Public Health (Cohort Study, Part A) and the National AIDS Research Program.

Requests for reprints to: Dr Luc Perrin, Central Laboratory of Virology, Geneva University Hospital, CH-1211 Geneva 14, Switzerland.

Date of receipt: 19 October 1994; revised: 10 November 1994; accepted: 17 November 1994.

© Lippincott-Raven Publishers.