[Skip to Content]
[Skip to Content Landing]
November 27, 1996

Lamivudine-Zidovudine Treatment and Clinical End Points

JAMA. 1996;276(20):1637. doi:10.1001/jama.1996.03540200023021

To the Editor.  —Dr Staszewski and colleagues1 report on adult patients who are human immunodeficiency virus (HIV) —positive and who received a combination of lamivudine and zidovudine (150 or 300 mg every 12 hours, n=75 for each group) or zidovudine monotherapy (n=73) in a randomized, controlled, double-blind multicenter study over 24 weeks. The patients, who had received prior zidovudine therapy for a mean of about 2 years, nevertheless showed significantly better immunologic (increased CD4 cell counts) and virologic (decreased HIV-1 RNA) responses to the combination therapy vs zidovudine alone. However, though this improvement in "surrogate markers" is considered likely to lead to better clinical outcomes,2 the latter remains the "gold standard" of successful therapy in HIV infection. We were therefore surprised that the authors did not highlight this end point and did not refer to it in their discussion. According to their data, 6 patients in the monotherapy