Efficacy and safety of lopinavir/ritonavir versus efavirenz-based antiretroviral therapy in HIV-infected pregnant Ugandan women.

TitleEfficacy and safety of lopinavir/ritonavir versus efavirenz-based antiretroviral therapy in HIV-infected pregnant Ugandan women.
Publication TypeJournal Article
Year of Publication2015
AuthorsCohan, D, Natureeba, P, Koss, CA, Plenty, A, Luwedde, F, Mwesigwa, J, Ades, V, Charlebois, ED, Gandhi, M, Clark, TD, Nzarubara, B, Achan, J, Ruel, T, Kamya, MR, Havlir, DV
JournalAIDS
Volume29
Issue2
Pagination183-91
Date Published2015 Jan 14
ISSN1473-5571
KeywordsAdult, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, Benzoxazines, Breast Feeding, CD4 Lymphocyte Count, Female, HIV Infections, HIV-1, Humans, Infant, Infant, Newborn, Infectious Disease Transmission, Vertical, Lopinavir, Malaria, Pregnancy, Pregnancy Complications, Infectious, Ritonavir, Uganda, Viral Load
Abstract

OBJECTIVE: Combination antiretroviral therapy (ART) is now the global standard for HIV-infected pregnant and breastfeeding women at all CD4⁺ 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.DESIGN: Randomized clinical trial.METHODS: 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⁺ cell count were randomized. ART was provided and participants were counseled to breastfeed for 1 year postpartum.RESULTS: The median age of the 389 study participants was 29 years; median CD4⁺ 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 (P < 0.001). At 48 weeks postpartum, 91.0% of women on efavirenz and 88.4% on lopinavir/ritonavir had viral suppression (P = 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) (P = 0.10).CONCLUSION: 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.

DOI10.1097/QAD.0000000000000531
Alternate JournalAIDS
PubMed ID25426808
PubMed Central IDPMC4428759
Grant ListK23 HD060459 / HD / NICHD NIH HHS / United States
K23 P01 HD059454 / HD / NICHD NIH HHS / United States
P01 HD059454 / HD / NICHD NIH HHS / United States
P01 HD059454 / HD / NICHD NIH HHS / United States
P30 MH062246 / MH / NIMH NIH HHS / United States
R01 AI098472 / AI / NIAID NIH HHS / United States
T32 AI060530 / AI / NIAID NIH HHS / United States