1. Concentrations of tenofovir, lamivudine and efavirenz in mothers and children enrolled under the Option B-Plus approach in Malawi.
- Author
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Palombi, Leonardo, Pirillo, Maria F., Marchei, Emilia, Jere, Haswell, Sagno, Jean-Baptiste, Luhanga, Richard, Floridia, Marco, Andreotti, Mauro, Galluzzo, Clementina Maria, Pichini, Simona, Mwenda, Ruben, Mancinelli, Sandro, Marazzi, Maria Cristina, Vella, Stefano, Liotta, Giuseppe, and Giuliano, Marina
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TENOFOVIR , *LAMIVUDINE , *EFAVIRENZ , *BREASTFEEDING , *INFANTS , *DIAGNOSIS of HIV infections , *HIV infection transmission , *VERTICAL transmission (Communicable diseases) , *COMMUNICABLE diseases , *COMPARATIVE studies , *HETEROCYCLIC compounds , *LIQUID chromatography , *MASS spectrometry , *RESEARCH methodology , *MEDICAL cooperation , *PREGNANCY complications , *RESEARCH , *VIRAL load , *EVALUATION research , *HIGHLY active antiretroviral therapy , *ANTI-HIV agents , *CD4 lymphocyte count , *PREVENTION - Abstract
Objectives: To evaluate antiretroviral drug concentrations in mothers and infants enrolled under the Option B-Plus approach for the prevention of HIV mother-to-child transmission in Malawi and to assess the maternal virological response after 1 year of treatment.Patients and Methods: Forty-seven women and 25 children were studied. Mothers were administered during pregnancy a combination of tenofovir, lamivudine and efavirenz and continued it during breastfeeding (up to 2 years) and thereafter. Drug concentrations were evaluated in mothers (plasma and breast milk) at 1 and 12 months post-partum and in infants (plasma) at 6 and 12 months of age. Drug concentrations were determined using an LC-MS/MS validated methodology.Results: In breast milk, tenofovir concentrations were very low (breast milk/maternal plasma ratio = 0.08), while lamivudine was concentrated (breast milk/plasma ratio = 3) and efavirenz levels were 80% of those found in plasma. In infants, median levels at 6 months were 24 ng/mL tenofovir, 2.5 ng/mL lamivudine and 86.4 ng/mL efavirenz. At month 12, median levels were below the limit of quantification for the three drugs. No correlation was found between drug concentrations and laboratory parameters or indices of growth. HIV-RNA >1000 copies/mL was seen at month 1 in 15% of the women and at month 12 in 8.5%. Resistance was found in half of the women with detectable viral load.Conclusions: Breastfeeding infants under Option B-Plus are exposed to low concentrations of antiretroviral drugs. With this strategy, mothers had a good virological response 1 year after delivery. [ABSTRACT FROM AUTHOR]- Published
- 2016
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