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

TitleRandomized open-label trial of two simplified, class-sparing regimens following a first suppressive three or four-drug regimen.
Publication TypeJournal Article
Year of Publication2007
AuthorsFischl MA, Collier AC, A Mukherjee L, Feinberg JE, Demeter LM, Tebas P, Giuliano M, Dehlinger M, Garren K, Brizz B, Bassett R
JournalAIDS
Volume21
Issue3
Pagination325-33
Date Published2007 Jan 30
ISSN0269-9370
KeywordsAdult, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, Benzoxazines, CD4 Lymphocyte Count, Drug Resistance, Viral, Female, Follow-Up Studies, HIV Infections, HIV Protease Inhibitors, HIV-1, Humans, Lopinavir, Male, Middle Aged, Pyrimidinones, Reverse Transcriptase Inhibitors, Ritonavir, Treatment Outcome
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 > or = 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.

DOI10.1097/QAD.0b013e328011ddfa
Alternate JournalAIDS
PubMed ID17255739
Grant ListAI 25868 / AI / NIAID NIH HHS / United States
AI 25897 / AI / NIAID NIH HHS / United States
AI 25924 / AI / NIAID NIH HHS / United States
AI 27658 / AI / NIAID NIH HHS / United States
AI 27664 / AI / NIAID NIH HHS / United States
AI 27665 / AI / NIAID NIH HHS / United States
AI 27668 / AI / NIAID NIH HHS / United States
AI 27673 / AI / NIAID NIH HHS / United States
AI 27675 / AI / NIAID NIH HHS / United States
AI 32770 / AI / NIAID NIH HHS / United States
AI 34853 / AI / NIAID NIH HHS / United States
AI 38844 / AI / NIAID NIH HHS / United States
AI 38858 / AI / NIAID NIH HHS / United States
AI 50410 / AI / NIAID NIH HHS / United States
RR 00044 / RR / NCRR NIH HHS / United States
RR 00046 / RR / NCRR NIH HHS / United States
RR 00047 / RR / NCRR NIH HHS / United States
RR 00051 / RR / NCRR NIH HHS / United States
RR 00052 / RR / NCRR NIH HHS / United States
RR 00096 / RR / NCRR NIH HHS / United States
RR 05096 / RR / NCRR NIH HHS / United States