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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Class-sparing regimens for initial treatment of HIV-1 infection
New England Journal of Medicine, Volume 358, No. 20, Year 2008
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Description
Background: The use of either efavirenz or lopinavir-ritonavir plus two nucleoside reverse-transcriptase inhibitors (NRTIs) is recommended for initial therapy for patients with human immunodeficiency virus type 1 (HIV-1) infection, but which of the two regimens has greater efficacy is not known. The alternative regimen of lopinavir-ritonavir plus efavirenz may prevent toxic effects associated with NRTIs. Methods: In an open-label study, we compared three regimens for initial therapy: efavirenz plus two NRTIs (efavirenz group), lopinavir-ritonavir plus two NRTIs (lopinavir-ritonavir group), and lopinavir-ritonavir plus efavirenz (NRTI-sparing group). We randomly assigned 757 patients with a median CD4 count of 191 cells per cubic millimeter and a median HIV-1 RNA level of 4.8 log10 copies per milliliter to the three groups. Results: At a median follow-up of 112 weeks, the time to virologic failure was longer in the efavirenz group than in the lopinavir-ritonavir group (P = 0.006) but was not significantly different in the NRTI-sparing group from the time in either of the other two groups. At week 96, the proportion of patients with fewer than 50 copies of plasma HIV-1 RNA per milliliter was 89% in the efavirenz group, 77% in the lopinavir-ritonavir group, and 83% in the NRTI-sparing group (P = 0.003 for the comparison between the efavirenz group and the lopinavir-ritonavir group). The groups did not differ significantly in the time to discontinuation because of toxic effects. At virologic failure, antiretroviral resistance mutations were more frequent in the NRTI-sparing group than in the other two groups. Conclusions: Virologic failure was less likely in the efavirenz group than in the lopinavir-ritonavir group. The virologic efficacy of the NRTI-sparing regimen was similar to that of the efavirenz regimen but was more likely to be associated with drug resistance. (ClinicalTrials.gov number, NCT00050895.) Copyright © 2008 Massachusetts Medical Society.
Authors & Co-Authors
Riddler, Sharon A.
Unknown Affiliation
Haubrich, R.
Unknown Affiliation
DiRienzo, A. Gregory
Unknown Affiliation
Peeples, Lynne
Unknown Affiliation
Powderly, William G.
Unknown Affiliation
Klingman, Karin L.
Unknown Affiliation
Garren, Kevin W.
Unknown Affiliation
George, Tania
Unknown Affiliation
Rooney, James F.
Unknown Affiliation
Brizz, Barbara
Unknown Affiliation
Lalloo, Umesh Gangaram
Unknown Affiliation
Murphy, Robert L.
Unknown Affiliation
Swindells, Susan N.
Unknown Affiliation
Havlir, Diane V.
Unknown Affiliation
Mellors, John W.
Unknown Affiliation
Statistics
Citations: 714
Authors: 15
Affiliations: 15
Identifiers
Doi:
10.1056/NEJMoa074609
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Environmental
Infectious Diseases
Study Design
Cohort Study