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Structured Treatment Interruptions Workshop Summary

January 31, 2001

Observational Databases

Short and Longer-Term Safety Experience from Observational Databases
Caroline Sabin, PhD
Royal Free and University College Medical School, London, UK
Veronica Miller, PhD
Klinikum der J.W. Goethe Universitat, Frankfurt, Germany

What happens during an interruption and what happens when treatment is restarted? What factors are predictive of poor outcomes?

After TI
CD4+ (cells/mm3)
CD8+ (cell/mm3)
HIV RNA (log copies/mL)

A retrospective review was performed of 252 cases of treatment interruption lasting two months or longer that were initiated due to failing regimens. Data was collected from participants in the Frankfort HIV Cohort, the Royal Free Hospital, the San Francisco Cohort, ICONA and the Southern Alberta cohort.

Patients with the highest CD4+ counts and lowest pre-treatment CD4+ nadirs experienced the greatest loss of CD4+ cells during the interruption. CD4+ cell loss was correlated with HIV RNA increase during the interruption.

Of 182 patients who re-challenged and were followed-up, 98/182 (53.8%) achieved HIV RNA <500 copies/mL. Success of viral control after re-challenge was correlated with baseline CD4+ cell count and with the magnitude of CD4+ cell loss while on interruption.

The San Francisco Cohort: Who is Interrupting Treatment?
Jody Lawrence, MD
University of California, San Francisco, San Francisco, California

In a preliminary analysis of a cohort of 1000 patients, 56 have interrupted treatment for longer than one month. Eighty percent interrupted due to treatment failure or toxicity. Twenty-five percent had CD4+ counts <50 cells/mm3.

Individuals with higher baseline viral load (>100,000) or lower CD4+ counts experienced the smallest changes during interruption. Those with higher CD4+ counts had the greatest changes during TI.

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