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Top Ten Research Reports of 2003

10. Prognostic Importance of Initial Response in HIV-1 Infected Patients Starting Potent Antiretroviral Therapy: Analysis of Prospective Studies

February 2004

Egger M., Chere B., Sterne J. A. et al. Prognostic Importance of Initial Response in HIV-1 Infected Patients Starting Potent Antiretroviral Therapy: Analysis of Prospective Studies. Lancet. 2003 Aug. 30; 362(9385):679-86.


Baseline CD4 and HIV viral load have been reported to predict HIV disease progression among patients initiating HIV therapy.14

However, these parameters can change rather quickly within weeks of the start of antiretroviral treatment. The question of whether this initial response to therapy provides more information regarding a patient's prognosis was examined among patients being followed in 13 different cohorts in Europe and North America.

What Is New Here?

The strength of this investigation is that it includes a large enough group of patients that sufficient clinical events occurred to permit analyses of predictive factors. More than 9,300 patients initiating potent HIV therapy were included in the analysis. The patients had the typical profiles of those starting antiretroviral therapy: a mean CD4 cell count of 250/uL and mean viral load of 76,000. Most started on PI-based regimens.

The majority of patients did very well on therapy, with over 70% achieving a six-month viral load below 500 copies/mL. During follow-up, however, 263 people developed at least one AIDS event, 152 died and 374 developed AIDS or died.

The striking finding was that once the baseline viral load and CD4 cell count were controlled for a six-month response, the baseline levels were no longer predictive of a patient's disease progression. Instead the inverse was true: The six-month viral load and CD4 cell count became predictive after controlling for the baseline values.

The Bottom Line

This study suggests that we are misguided in thinking that it is the baseline values that predict what will happen after therapy starts. Rather, it is how well therapy works six months after treatment is initiated that is prognostic for advancement to AIDS and death. Said in another way, it is not the initial change in a patient's levels but where they land six months hence. The authors provide the example of a patient who experienced an increase in CD4 cell count from 175 cells/uL to 225 cells/uL six months after starting therapy. This person has a better outlook than another person whose counts rose from 25 cells/uL to 100 cells/uL, but a worse outlook than a patient with a jump from 325 cells/uL to 375 cells/uL.

This has important implications for both clinicians and patients. A patient's suboptimal response to therapy should prompt more aggressive measures by providers. For patients, an understanding that it is the response to therapy that counts may be an additional motivator for stricter adherence to therapy.

Unfortunately, even the most aggressive interventions may not help raise reluctant CD4 cell counts of patients who start therapy with basement-level counts. However, these data signal that clinicians need to pay close attention to a patient's response to treatment months into therapy.


  1. Mellors J. W., Rinaldo C. R. Jr., Gupta P. et al. Prognosis in HIV-1 Infection Predicted by the Quantity of Virus in Plasma. Science. 1996 May 24; 272(5265):1167-70.

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Please note: Knowledge about HIV changes rapidly. Note the date of this article, and before treating patients or employing any therapies described in these materials, verify all information independently. If you are a patient, please consult a doctor or other medical professional before acting on any of the information presented in this article.

© 2004 Body Health Resources Corporation

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