Effect of persistent moderate viremia on disease progression during HIV therapy

Stephen P. Raffanti*, Jennifer S. Fusco, Beth H. Sherrill, Nellie I. Hansen, Amy C. Justice, Richard D'Aquila, Wendy J. Mangialardi, Gregory P. Fusco

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

55 Scopus citations


Objective: Although highly active antiretroviral therapy has been shown to lower plasma HIV-1 RNA in HIV infection, many patients do not reach the target goal of undetectable viremia. We evaluated whether risk of clinical progression varies by level of viral suppression achieved. Design: Patients in the Collaborations in HIV Outcomes Research/United States cohort who maintained stable HIV-1 RNA levels of either <400, 400 to 20,000, or >20,000 copies/mL during a run-in period of at least 6 months were studied. Baseline was the first day after this period. Methods: Proportional hazards models were used to quantify the relation between baseline HIV-1 RNA levels and risk of a new AIDS-defining diagnosis or death after adjusting for CD4 count, age, gender, ethnicity, study site, prior AIDS-defining diagnosis, and antiretroviral therapy history. Results: Patients (N = 3010) were followed for up to 4.3 years after the 6-month run-in period, with 343 deaths or AIDS-defining diagnoses reported. The risk of a new AIDS-defining diagnosis or death was not significantly different in the 400 to 20,000- and <400-copies/mL groups (6% vs. 7%, hazard ratio [HR] = 1.0, 95% confidence interval [CI]: 0.7-1.4; P = 0.9) but was significantly higher in the >20,000-copies/mL group (26%, HR = 3.3, 95% CI: 2.5-4.4; P < 0.001 vs. the <400-copies/mL group). Median CD4 count changes during the first year of follow-up showed increases of 75 and 13 cells/mm 3 for the <400- and 400 to 20,000-copies/mL groups, respectively, whereas the >20,000-copies/mL group had a decrease of 23 cells/mm 3. Conclusions: Patients who maintained baseline HIV-1 RNA levels of 400 to 20,000 copies/mL for at least 6 months preserved immunologic status and were no more likely to die or develop a new AIDS-defining diagnosis in the time frame studied than those with baseline levels <400 copies/mL. Patients with HIV-1 RNA levels >20,000 copies/mL at baseline had greater clinical and immunologic deterioration. These data suggest that maintenance of moderate viremia may confer clinical benefit not seen when viremia exceeds 20,000 copies/mL, and this should be taken into account when considering the risks and benefits of continuing failing therapy.

Original languageEnglish (US)
Pages (from-to)1147-1154
Number of pages8
JournalJournal of Acquired Immune Deficiency Syndromes
Issue numberSUPPL. 1
StatePublished - Sep 1 2004


  • Collaborations in HIV Outcomes Research/United States
  • HIV disease progression
  • HIV viremia
  • Plasma HIV-1 RNA

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)


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