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Clinical Trial
. 2008 May 15;358(20):2095-106.
doi: 10.1056/NEJMoa074609.

Class-sparing regimens for initial treatment of HIV-1 infection

Sharon A Riddler  1 , Richard Haubrich, A Gregory DiRienzo, Lynne Peeples, William G Powderly, Karin L Klingman, Kevin W Garren, Tania George, James F Rooney, Barbara Brizz, Umesh G Lalloo, Robert L Murphy, Susan Swindells, Diane Havlir, John W Mellors; AIDS Clinical Trials Group Study A5142 Team
Collaborators, Affiliations
Clinical Trial

Class-sparing regimens for initial treatment of HIV-1 infection

Sharon A Riddler et al. N Engl J Med. .

Abstract

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 [ClinicalTrials.gov].).

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Conflict of interest statement

No other potential conflict of interest relevant to this article was reported.

Figures

Figure 1
Figure 1. Time to Virologic Failure and Time to Regimen Failure
Shown are the times to virologic failure for the entire study population (Panel A), for patients with a screening HIV-1 RNA level of 100,000 copies per milliliter or more (Panel B), and for patients with a screening HIV-1 RNA level of fewer than 100,000 copies per milliliter (Panel C). Panel D shows the time to regimen failure for the entire study population.
Figure 2
Figure 2. Virologic Response, According to Study Group
Shown are the percentage of patients in each study group with an HIV-1 RNA level of fewer than 200 copies per milliliter (Panel A) and the percentage with an HIV-1 RNA level of fewer than 50 copies per milliliter (Panel B).
See this image and copyright information in PMC

Comment in

References

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