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Prospective, Randomized, Open-Label Trial of Efavirenz vs. Lopinavir/Ritonavir in HIV+ Treatment-Naive Subjects With CD4+ Less Than 200

February 4, 2010

Antiretroviral therapy based on efavirenz (EFV) is more effective than lopinavir/ritonavir (LPV/r)-based therapy among treatment-naïve patients with advanced disease, a new study found.

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The study enrolled 189 patients with CD4+ counts of less than 200/mm3, and randomization into EFV or LPV/r groups was stratified by baseline CD4+ count (up to 100 or above 100). At 48 weeks, the primary endpoint was plasma HIV-1 RNA below 50 copies/mL by intention-to-treat analysis.

Among the EFV and LPV/r groups, 85 percent of whom were men, median baseline CD4+ counts were 64 and 52/mm3 respectively (P=not significant). By the 48th week, 70 percent of EFV and 53 percent of LPV/r patients had viral loads of under 50 copies/mL (estimated difference 17 percent [95 percent confidence interval 3.5 to 31], P=0.013). The proportion for under 400 copies/mL was 73 percent with EFV and 65 percent with LPV/r (P=0.25). Virologic failure occurred in seven EFV patients and 17 LPV/r patients. Increases in mean CD4+ cell counts were 234/mm3 for EFV and 239/mm3 for LPV/r. Mean change in total cholesterol and triglycerides was 50mg/dL and 48mg/dL in EFV and 63 mg/dL and 116mg/dL in LPV/r (P=0.24 and P less than 0.01).

"In these very advanced HIV-infected ARV-naïve subjects, EFV-based highly active antiretroviral therapy had superior virologic efficacy than LPV/r-based highly active antiretroviral therapy, with a more favorable lipid profile," concluded the study authors.

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Excerpted from:
JAIDS
01.2010; doi: 10.1097/QAI.obo13e3181cae4a1; Juan Sierra-Madero, M.D. and others




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