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February 14, 1996

New Studies Say Viral Burden Tops CD4 as a Marker of HIV Disease Progression

JAMA. 1996;275(6):421-422. doi:10.1001/jama.1996.03530300005001

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EARLY FINDINGS from two large clinical studies may signal a major shift in how physicians monitor disease progression and use antiviral drugs in patients infected with the human immunodeficiency virus (HIV).

The data indicate that a change in viral burden, as measured by RNA polymerase chain reaction (RNA-PCR) at baseline and following therapy, is superior to CD4 cell count as a surrogate marker of HIV disease progression.

"This is the first large-scale trial supporting this finding," said William W. Freimuth, MD, PhD, medical monitor of the studies sponsored by Pharmacia & Upjohn Inc, Kalamazoo, Mich. Most clinicians and activists already consider viral burden testing useful, as a result of findings from smaller studies, Freimuth noted. "Now these data give it ammunition."

The findings, as yet unpublished, are "very important," said John Phair, MD, director of the Comprehensive AIDS Center at Northwestern University Medical School, Chicago, Ill, and an investigator at