Antiretroviral Prophylaxis for Breastfeeding Transmission in Malawi: Drug Concentrations, Virological Efficacy and Safety

Palombi, Leonardo; Pirillo, Maria Franca; Andreotti, Mauro; Liotta, Giuseppe; Erba, Fulvio; Sagno, Jean Baptiste; Maulidi, Martin; Ceffa, Susanna; Jere, Haswell; Marchei, Emilia; Pichini, Simona; Galluzzo, Clementina Maria; Marazzi, Maria Cristina; Vella, Stefano; Giuliano, Marina

doi:10.3851/imp2315

Cited by 41 publications

(52 citation statements)

References 21 publications

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“…The remaining three studies 23,29,45 found that lamivudine BM : MP ratios were <1. The overall pooled estimate was 0.93 (95% CI 0.89–0.98).…”

Section: Resultsmentioning

confidence: 97%

“…25 and Palombi et al . 23 performed longitudinal analyses on MP, BM and IP; given the half-life of 30 h for nevirapine in infants from a similar population, 26 by 3 months we presumed that detectable infant levels reflected BM transfer of drug. Both studies reported similar IP concentrations of ∼12% of MP at 14 weeks and <5% by 24 weeks.…”

Section: Resultsmentioning

confidence: 99%

“…Both studies reported similar IP concentrations of ∼12% of MP at 14 weeks and <5% by 24 weeks. 23,25 …”

Section: Resultsmentioning

confidence: 99%

“…The overall pooled estimate was 0.93 (95% CI 0.89–0.98). The majority of studies 15,16,23–25 demonstrated the BM : MP ratios were constant from delivery throughout post-partum. However, in studies that performed intensive PK sampling, 15,16 there was evidence of differential PK within the MP and BM compartments; a slower elimination rate of lamivudine was observed in BM than in MP, which resulted in a gradual increase in the BM : MP ratio across the dosing interval.…”

Section: Resultsmentioning

confidence: 99%

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Is infant exposure to antiretroviral drugs during breastfeeding quantitatively important? A systematic review and meta-analysis of pharmacokinetic studies

Waitt

Garner

Bonnett

et al. 2015

Journal of Antimicrobial Chemotherapy

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ObjectivesThe objectives of this study were to summarize antiretroviral drug concentrations in breast milk (BM) and exposure of breast-fed infants.MethodsThis was a systematic review of pharmacokinetic studies of HIV-positive women taking antiretrovirals that measured drugs in BM. The quality of pharmacokinetic and laboratory methods was assessed using pre-defined criteria. Pooled ratios and 95% CIs were calculated using the generalized inverse variance method and heterogeneity was estimated by the I2 statistic. PubMed Central, SCOPUS and LactMed databases were searched. No date or language restrictions were applied. Searches were conducted up to 10 November 2014. Clinical relevance was estimated by comparing ingested dose with the recommended therapeutic dose for each drug.ResultsTwenty-four studies were included. There was substantial variability in the clinical and laboratory methods used and in reported results. Relative to maternal plasma (MP), NRTIs accumulate in BM, with BM : MP ratios (95% CI estimates) from 0.89 to 1.21 (14 studies, 1159 paired BM and MP samples). NNRTI estimates were from 0.71 to 0.94 (17 studies, 965 paired samples) and PI estimates were from 0.17 to 0.21 (8 studies, 477 paired samples). Relative to the recommended paediatric doses, a breast-fed infant may ingest 8.4% (95% CI 1.9–15.0), 12.5% (95% CI 2.6–22.3) and 1.1% (95% CI 0–3.6) of lamivudine, nevirapine and efavirenz, respectively, via BM.ConclusionsTransfer to untreated infants appears quantitatively important for some NRTIs and NNRTIs. The pharmacokinetic methods varied widely and we propose standards for the design, analysis and reporting of future pharmacokinetic studies of drug transfer during breastfeeding.

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“…The remaining three studies 23,29,45 found that lamivudine BM : MP ratios were <1. The overall pooled estimate was 0.93 (95% CI 0.89–0.98).…”

Section: Resultsmentioning

confidence: 97%

Section: Resultsmentioning

confidence: 99%

“…Both studies reported similar IP concentrations of ∼12% of MP at 14 weeks and <5% by 24 weeks. 23,25 …”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Is infant exposure to antiretroviral drugs during breastfeeding quantitatively important? A systematic review and meta-analysis of pharmacokinetic studies

Waitt

Garner

Bonnett

et al. 2015

Journal of Antimicrobial Chemotherapy

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show abstract

“…Lamivudine freely crosses the placenta and also is concentrated and excreted in breast milk [50][51][52][53][54][55]. Despite this, antiviral blood concentrations in breastfeeding neonates decrease over time, suggesting that lamivudine is either inefficiently absorbed by the newborn or that the total amount of lamivudine ingested from breast milk is negligible [56][57][58]. Tenofovir also crosses the placenta, but less freely than lamivudine.…”

Section: Breastfeedingmentioning

confidence: 91%

Management of HBV in Pregnancy

Kelly¹,

Peters²

2015

Curr Hepatology Rep

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Hepatitis B in pregnancy must include diagnosis and management of the pregnant woman as well as modalities to decrease mother to child transmission (MTCT). MTCT remains the most important mode of hepatitis B virus (HBV) transmission, although effective strategies exist to reduce this risk. Universal screening for HBV can identify women with previously unrecognized infection and allow for targeted therapy to prevent MTCT. All children of HBV-infected mothers should receive passive active immunoprophylaxis with hepatitis B immune globulin (HBIG) and HBV vaccination within 12 h of birth. With such measures, the risk of transmission can be decreased to less than 1 % in women with low viral loads. Immunoprophylaxis failures occur in as many as 15 % of children born to mothers with high viral loads at the time of delivery (>6 log copies/ml or >200,000 IU/ml), and therefore, additional treatment in the third trimester is warranted in this group. Antiviral therapy with lamivudine, tenofovir, or telbivudine in the third trimester can decrease MTCT to less than 5 % and should be used in women with high viral loads in the third trimester. Postpartum flares of liver disease are common, and therefore, careful monitoring is warranted in women who stop therapy. The decision to breastfeed while on antiviral therapy should be individualized, but current evidence suggests that it is safe.

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Drug monographs

2014

Neonatal Formulary 7

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Antiretroviral Prophylaxis for Breastfeeding Transmission in Malawi: Drug Concentrations, Virological Efficacy and Safety

Cited by 41 publications

References 21 publications

Is infant exposure to antiretroviral drugs during breastfeeding quantitatively important? A systematic review and meta-analysis of pharmacokinetic studies

Is infant exposure to antiretroviral drugs during breastfeeding quantitatively important? A systematic review and meta-analysis of pharmacokinetic studies

Management of HBV in Pregnancy

Drug monographs

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