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November 27, 1996

Lamivudine-Zidovudine Treatment and Clinical End Points-Reply

Author Affiliations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt, Germany

JAMA. 1996;276(20):1637-1638. doi:10.1001/jama.1996.03540200023022

In Reply.  —The primary objective of the trial described in our article was to determine the benefit of combination treatment with zidovudine and lamivudine relative to zidovudine monotherapy on changes in CD4 cell counts and measures of HIV-1 viral load. The trial was not statistically powered to detect differences between treatment arms in progression to CDC category C (acquired immunodeficiency syndrome) events or death. However, the lower rate of clinical progression in the combination therapy arms in the trial is consistent with the results of a meta-analysis of trials of zidovudine combined with lamivudine that showed a 66% reduction in progression to CDC category C events,1 and in the recently reported CAESAR trial of combined zidovudine and lamivudine, which has shown a 54% reduction in progression to CDC category C/death end points for patients adding lamivudine to zidovudine-containing regimens.2