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Efficacy and tolerability of long-term efavirenz plus nucleoside reverse transcriptase inhibitors for HIV-1 infection

Karen Tashima1, Schlomo Staszewski, Mark Nelson

  • 1Miriam Hospital, Providence, Rhode Island 02906, USA. ktashima@lifespan.org

AIDS (London, England)
|December 22, 2007
PubMed

Insights

Efavirenz-containing regimens, especially efavirenz, zidovudine, and lamivudine, show superior long-term efficacy in HIV therapy compared to indinavir-based treatments. These efavirenz regimens offer better viral suppression and tolerability for patients initiating highly active antiretroviral therapy (HAART).

Area of Science:

  • Infectious Diseases
  • Virology
  • Clinical Pharmacology

Background:

  • Highly Active Antiretroviral Therapy (HAART) is crucial for managing Human Immunodeficiency Virus type 1 (HIV-1) infection.
  • Efavirenz and indinavir are key antiretroviral drugs used in HAART regimens.
  • Long-term comparative data on the efficacy and tolerability of different initial HAART regimens are essential for clinical decision-making.

Purpose of the Study:

  • To compare the long-term efficacy and tolerability of two efavirenz-containing regimens against an indinavir-containing regimen for initial HIV-1 treatment.
  • To evaluate viral load reduction and CD4 cell count increases over 168 weeks of therapy.
  • To assess the rates and causes of treatment discontinuation, particularly adverse events.

Main Methods:

  • A randomized trial involving 1266 HIV-1 infected patients with viral loads >10,000 copies/mL and CD4 counts ≥50 cells/µL.
  • Patients were assigned to one of three regimens: efavirenz/zidovudine/lamivudine; efavirenz/indinavir; or indinavir/zidovudine/lamivudine.
  • The primary endpoint was the proportion of patients achieving a viral load <400 copies/mL at 168 weeks.

Main Results:

  • Response rates at 168 weeks were 48% for efavirenz/zidovudine/lamivudine, 40% for efavirenz/indinavir, and 30% for indinavir/zidovudine/lamivudine (P < 0.0001 and P = 0.0018, respectively).
  • Median CD4 cell counts increased by 292-300 cells/µL across regimens.
  • Discontinuation rates were 54% (EFV/ZDV/3TC), 63% (EFV/IDV), and 69% (IDV/ZDV/3TC), with adverse events causing 13%, 12%, and 26% of discontinuations, respectively.

Conclusions:

  • Efavirenz-containing regimens, particularly efavirenz/zidovudine/lamivudine, demonstrate significantly superior long-term antiviral activity compared to indinavir/zidovudine/lamivudine.
  • These efavirenz-based regimens also show improved tolerability, leading to fewer treatment discontinuations due to adverse events.
  • The findings support the use of efavirenz-containing regimens for initial HAART in HIV-1 infected patients.
Abstract

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