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

• DOI: 10.1097/qad.0b013e328011ddfa
• Publication Date: 2007-01-24T09:03:11Z
• Authors: 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
• Keywords: Efavirenz; Discontinuation; Ritonavir; Regimen; Lopinavir; Reverse-transcriptase inhibitor

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