Randomized open-label trial of two simplified, class-sparing regimens following a first suppressive three or four-drug regimen

Margaret A. Fischl, Ann C. Collier, A. Lisa Mukherjee, Judith E. Feinberg, Lisa M. Demeter, Pablo Tebas, Marina Giuliano, Marjorie Dehlinger, Kevin Garren, Barbara Brizz, Roland Bassett

Research output: Contribution to journalArticle

25 Scopus citations

Abstract

OBJECTIVES: Complex antiretroviral regimens can be associated with increased toxicity and poor adherence. Our aim was to compare the efficacy and safety of switching to two simplified, class-sparing antiretroviral regimens. METHODS: We conducted a randomized, open-label study in 236 patients with virologic suppression who were taking a three- or four-drug protease inhibitor or non-nucleoside reverse transcriptase inhibitor regimen for ≥ 18 months. Patients received lopinavir/ritonavir (LPV/r) 533 mg/133 mg twice daily + efavirenz (EFV) 600 mg once daily or EFV + two nucleoside reverse transcriptase inhibitors (NRTI). Primary study endpoint was time to first virologic failure (VF, confirmed HIV-1 RNA > 200 copies/ml) or discontinuation because of study drug-related toxicity. RESULTS: After 2.1 years of follow up, patients receiving LPV/r + EFV discontinued treatment at a greater rate than patients receiving EFV + NRTI (P < 0.001). Twenty one patients developed VF (14 receiving LPV/r + EFV and seven receiving EFV + NRTI) and 26 discontinued because of a study drug-related toxicity (20 receiving LPV/r + EFV and six receiving EFV + NRTI). Time to VF or study drug related-toxicity discontinuation was significantly shorter for LPV/r + EFV than EFV + NRTIs (P = 0.0015). A significantly higher risk of drug-related toxicity occurred with LPV/r + EFV, mainly for increased triglycerides (P = 0021). A trend toward a higher VF rate occurred with LPV/r + EFV in an intent-to-treat and as-treated analyses (P = 0.088 and P = 0.063 respectively). CONCLUSIONS: Switching to EFV + NRTI resulted in better outcomes, fewer drug-related toxicity discontinuations and a trend to fewer virologic failures compared to switching to LPV/r + EFV.

Original languageEnglish (US)
Pages (from-to)325-333
Number of pages9
JournalAIDS
Volume21
Issue number3
DOIs
StatePublished - Jan 1 2007

Keywords

  • Advanced HIV
  • Non-nucleoside reverse transcriptase inhibitor
  • Protease inhibitor
  • Simplification therapy

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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    Fischl, M. A., Collier, A. C., Mukherjee, A. L., Feinberg, J. E., Demeter, L. M., Tebas, P., Giuliano, M., Dehlinger, M., Garren, K., Brizz, B., & Bassett, R. (2007). Randomized open-label trial of two simplified, class-sparing regimens following a first suppressive three or four-drug regimen. AIDS, 21(3), 325-333. https://doi.org/10.1097/QAD.0b013e328011ddfa