Usefulness of monitoring HIV drug resistance and adherence in individuals failing highly active antiretroviral therapy: A randomized study (Argenta)

Antonella Cingolani, Andrea Antinori, Maria Gabriella Rizzo, Rita Murri, Adriana Ammassari, Francesco Baldini, Simona Di Giambenedetto, Roberto Cauda, Andrea De Luca

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To establish the influence of genotypic resistance-guided treatment decisions and patient-reported adherence on the virological and immunological responses in patients failing a potent antiretroviral regimen in a randomized, controlled trial in a tertiary care infectious diseases department. Patients: A total of 174 patients with virological failure were randomly assigned to receive standard of care (SOC) or additional genotypic resistance information (G). Adherence was measured by a self-administered questionnaire. Main outcomes measures: Primary endpoints were the proportion with HIV-RNA <500 copies/ml at 3 and 6 months by intention-to-treat analysis. Secondary end-points were changes from baseline HIV-RNA levels and CD4 cell counts. Results: At entry, 25% had failed three or more highly active antiretroviral therapy (HAART) regimens and 41% three drug classes; there were more resistance mutations in G. In 127 evaluable questionnaires, 43% reported last missed dose during the previous week. At 3 months, 11 of 89 patients (12%) in SOC and 23 of 85 (27%) in G had HIV-RNA <500 copies/ml (OR 2.63, 95% CI 1.12-6.26); the relative proportions were 17 and 21% at 6 months. CD4 cell changes did not differ between arms. Six month CD4 cell changes were +62 in adherent and -13 cells/μl in non-adherent patients (P <0.01). Being assigned to G, good adherence, previous history of virological success, fewer experienced HAART regimens and lower baseline viral load were independently predictive of 3 month virological success. Conclusion: The virological benefit of genotype-guided treatment decisions in heavily pre-exposed patients was short term. Patients adherence and residual treatment options influenced outcomes.

Original languageEnglish
Pages (from-to)369-379
Number of pages11
JournalAIDS (London, England)
Volume16
Issue number3
DOIs
Publication statusPublished - Feb 15 2002

Keywords

  • Adherence
  • Antiretroviral-therapy
  • Drug resistance
  • Genotypic resistance
  • Salvage therapy

ASJC Scopus subject areas

  • Immunology
  • Immunology and Allergy

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