Efficacy and safety of lopinavir/ritonavir versus efavirenz-based antiretroviral therapy in HIV-infected pregnant Ugandan women. (14th January 2015)

• Record Type: Journal Article
• Authors: Cohan, Deborah; Natureeba, Paul; Koss, Catherine A.; Plenty, Albert; Luwedde, Flavia; Mwesigwa, Julia; Ades, Veronica; Charlebois, Edwin D.; Gandhi, Monica; Clark, Tamara D.; Nzarubara, Bridget; Achan, Jane; Ruel, Theodore; Kamya, Moses R.; Havlir, Diane V.
• Is Part Of: AIDS. Volume 29:Number 2(2015)
• Publication Date: 2015-01-14
• Subjects: AIDS (Disease) -- Periodicals; Acquired Immunodeficiency Syndrome; AIDS (Disease); Periodicals; Periodicals; 616.9792005
• DOI: 10.1097/QAD.0000000000000531
• Languages: English
• ISSNs: 0269-9370

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <sec> <title>Objective:</title> <p>Combination antiretroviral therapy (ART) is now the global standard for HIV-infected pregnant and breastfeeding women at all CD4<sup>+</sup> cell counts. We compared the efficacy and safety of an efavirenz versus lopinavir/ritonavir regimen for HIV-infected pregnant women initiating ART in rural Uganda.</p> </sec> <sec> <title>Design:</title> <p>Randomized clinical trial.</p> </sec> <sec> <title>Methods:</title> <p>We performed a planned secondary analysis comparing viral load suppression (HIV-1 RNA ⩽400 copies/ml), safety, and HIV transmission to infants in a trial designed to test the hypothesis that lopinavir/ritonavir versus efavirenz-based ART would reduce placental malaria (PROMOTE, ClinicalTrials.gov, NCT00993031). HIV-infected, ART-naive pregnant women at 12–28 weeks gestation and any CD4<sup>+</sup> cell count were randomized. ART was provided and participants were counseled to breastfeed for 1 year postpartum.</p> </sec> <sec> <title>Results:</title> <p>The median age of the 389 study participants was 29 years; median CD4<sup>+</sup> cell count was 370 cells/μl. At delivery, virologic suppression was 97.6% in the efavirenz arm and 86.0% in the lopinavir/ritonavir arm (<italic>P</italic> < 0.001). At 48 weeks postpartum, 91.0% of women on efavirenz and 88.4% on lopinavir/ritonavir had viral suppression (<italic>P</italic> = 0.49). Grade 1 or 2 gastrointestinal adverse events were higher among women on lopinavir/ritonavir versus efavirenz. Only two infants acquired HIV (both in the lopinavir/ritonavir arm), and HIV-free infant survival was similar between study arms: 92.9% (lopinavir/ritonavir) versus 97.2% (efavirenz) (<italic>P</italic> = 0.10).</p> </sec> <sec> <title>Conclusion:</title> <p>Virologic suppression at delivery was higher with an efavirenz versus lopinavir/ritonavir-based regimen. However, women in both arms achieved high levels of virologic suppression through 1 year postpartum and the risk of transmission to infants was low.</p> </sec> </abstract>