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• W4319294966 abstract "Breastfeeding MedicineVol. 18, No. 3 LactMed® UpdateFree AccessNew Information on Antivirals and BreastfeedingPhilip O. AndersonPhilip O. AndersonAddress correspondence to: Philip O. Anderson, PharmD, Division of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0657, USA E-mail Address: [email protected]Division of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla, California, USA.Search for more papers by this authorPublished Online:15 Mar 2023https://doi.org/10.1089/bfm.2023.0007AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail This column focuses primarily on prophylaxis of human immunodeficiency virus (HIV) infection. It also reviews new information on COVID-19 prophylaxis and therapy and some information on antihepatitis C therapy during breastfeeding. Information on the specific drugs during breastfeeding comes from LactMed® where additional information and references can be found.HIV Pre-Exposure ProphylaxisHIV infection is transmissible through breast milk. In cases in which a nursing mother is likely to be exposed to a partner with HIV infection, pre-exposure prophylaxis (PrEP) can prevent HIV infection in the mother and potentially her breastfed infant.Two oral drug regimens are used for PrEP: tenofovir disoproxil fumarate (TDF) 300 mg plus emtricitabine 200 mg daily and tenofovir alfenamide (TAF) 25 mg plus emtricitabine 200 mg daily. The two tenofovir products differ in dosage because TAF is a prodrug that remains intact until it enters the cell where it is converted to tenofovir. TDF is converted to tenofovir in the bloodstream and does not penetrate into cells as well as TAF. A third regimen is cabotegravir extended-release suspension given by gluteal intramuscular injection every 2 months.Tenofovir–emtricitabine has been studied for PrEP during breastfeeding. Fifty HIV-negative women who were nursing their infants were given PrEP with TDF–emtricitabine daily for 10 days. The median peak milk tenofovir concentration in milk provided an estimated infant daily dosage of 0.47–0.49 mcg/kg, which is <0.01% of the proposed infant therapeutic dosage. Of 49 infant blood samples collected, 46 had an undetectable concentration of tenofovir.The median peak and trough milk emtricitabine concentrations represent an estimated infant daily dosage of 27.5–31.5 mcg/kg, which is ∼0.5% of the proposed infant therapeutic dosage. In contrast to tenofovir, 47 infant blood samples had low but detectable concentrations of emtricitabine. Infants <13 weeks of age had a lower average emtricitabine plasma concentration than those who were 13 weeks of age or older. During the study, two infants reportedly had diarrhea lasting 2–3 days. No other side effects were reported in this study and no infant side effects attributable to tenofovir have been reported in several other studies. No other studies have evaluated side effects in breastfed infant with emtricitabine.Studies done with TAF have found higher levels of tenofovir in milk than with TDF, even though the dose is considerably lower. Nevertheless, both tenofovir regimens are acceptable to use in nursing mothers. Tenofovir is also available overseas as a vaginal gel for PrEP. Most women have no detectable tenofovir in their milk after using this product.No published information is available on the use of cabotegravir during breastfeeding. The drug can be found in the recipient's bloodstream for 12 months or longer after discontinuing treatment, so there is some concern about prolonged exposure of the breastfed infant. Although it is not contraindicated in breastfeeding, one of the tenofovir–emtricitabine regimens is preferred.Dapivirine is an antiviral recommended by the World Health Organization for use in PrEP in the form of a vaginal ring. It is investigational in the United States at this time, but has been studied in nursing mothers. The amounts of dapivirine in milk were low in a pharmacokinetic study of 16 women who were lactating, but not feeding their infants breast milk. In a recent study, 148 nursing mother–infant pairs were studied during use of the dapivirine vaginal ring. No adverse reactions in breastfed infants were reported that were thought to be caused by the drug.Adherence to oral PrEP was low in one study.1 A preprint of a survey of women in southern Africa taking oral PrEP found that most would prefer a long-acting injection to oral PrEP. However, opinions on the dapivirine vaginal ring were rather negative, with most expressing a preference for the oral regimen.2HIV Postexposure ProphylaxisHIV postexposure prophylaxis (PEP) is used in persons who have potentially been exposed to someone with HIV, such as an occupational exposure, needle sharing, or sexual assault. Because there is a possibility of transmitting HIV to the infant, some guidelines recommend avoiding breastfeeding for 3 months after exposure. At least the risk should be carefully discussed with the nursing mother. The drug regimen should be started no later than 72 hours after the exposure.Drug regimens for PEP are similar to those used for PrEP, except that a third drug is added to the combination. The third drug is usually dolutegravir or raltegravir. Lamivudine can also be substituted for emtricitabine.Dolutegravir was detectable in maternal milk in low amounts in ∼30 mothers. A computer model based on these patient data estimated the average concentration of dolutegravir in breast milk over 24 hours to be 0.05 mg/L, corresponding to an absolute infant dose of 2.2 mcg/kg daily. This translates to a weight-adjusted infant dosage of 0.27% of the maternal dose. Elimination by newborn infants may be prolonged and the drug has been detected in infant plasma during breastfeeding. Dolutegravir has been used safely in HIV-positive mothers during breastfeeding in several reports. In addition, dolutegravir is approved for use in infants weighing 3 kg or more.In contrast to dolutegravir, raltegravir has not been studied well during breastfeeding. In one mother taking raltegravir at 4 months postpartum, the average milk concentration over 12 hours was 0.66 mg/L with an estimated daily infant dose of 0.099 mg/kg or 0.8% of the approved daily infant raltegravir dosage. Single blood samples taken from the infant at 4 hours after a maternal dose at 4 and 8 months postpartum were below the lower limit of quantification of the assay. Raltegravir is also approved for use in newborn and older infants.Lamivudine has been extensively studied in HIV-positive nursing mothers, mostly in Africa. Although it can often be detected in infant plasma in low levels, no adverse effects in breastfed infants have been attributed to lamivudine.COVID-19Some new information has become available on COVID-19 vaccines since the last review in 2022.3 A clearer picture of the effect of vaccination on antibody levels has emerged. In one study, both IgA and IgG milk levels were higher at 6 months postvaccination than at prevaccination, but both were lower at 6 months than after 7–30 days postvaccination. However, neutralization capacity was 75% higher 6 months after COVID-19 vaccination than the neutralization capacity in prevaccination milk.Despite these high milk antibody levels, infant serum antibody concentrations do not appear to be affected. In one study, 13 breastfed infants of COVID-19 naive mothers who received the Pfizer–BioNTech vaccine had blood samples obtained at 8 weeks after the first maternal dose of the vaccine. Antispike (anti-S) SARS CoV-2 IgM and IgA antibodies were detected in only 1 of the 13 infant serum samples. None contained anti-S SARS CoV-2 IgG above the cutoff specified by the manufacturer.Another small study found that 6–12 months after two doses of the Pfizer–BioNTech vaccine postpartum, SARS-CoV-2 S IgG antibodies in serum were positive in only 2 of 13 infants. Other studies have shown that immunization of the mother during pregnancy is much more effective in providing passive antibodies to infants than vaccination solely during breastfeeding. In addition, T-cell transfer to the infant can confer long-term immunity against COVID-19.Several studies and reviews have reiterated the safety of giving COVID-19 vaccines to nursing mothers for both the mother and infant. One interesting finding from two studies is that some women have short-term increases in menstrual cycle length averaging <1 day, although this effect is not limited to women who are nursing.On the drug treatment front, new information from one patient indicates that milk levels of remdesivir and its active metabolite are very low in milk. In addition, remdesivir is poorly absorbed orally, and the metabolite is only partially absorbed orally, so infants are not likely to absorb clinically important amounts of the drug from milk. Newborn infants have received intravenous remdesivir therapy for Ebola and for COVID-19 with no serious adverse drug reactions.Given this limited information, it does not appear that mothers receiving remdesivir need to avoid nursing, but until more data are available, remdesivir should be used with careful infant monitoring during breastfeeding. The most common adverse effects reported after intravenous infusion include elevated aminotransferase and bilirubin levels and other liver enzyme elevations, diarrhea, rash, renal impairment, and hypotension.Favipiravir is an antiviral that is available overseas, but not in the United States. In a new case report, a lactating woman took a single 200 mg dose of favipiravir and provided milk samples at 0.5, 2, and 4 hours after the dose. Favipiravir concentrations in milk were 0.3, 5.5, and 2.7 mg/L, respectively. This study adds to the information on this drug during breastfeeding.A previous case report found no adverse reactions in an infant who was breastfed by a mother receiving favipiravir. In that case, the infant was 15 months old and breastfed only twice daily before the mother's doses of favipiravir. Favipiravir has caused liver enzyme abnormalities, gastrointestinal symptoms, and serum uric acid elevations. So, if favipiravir is used in a nursing mother, these parameters should be monitored in the breastfed infant until further safety data become available.The most commonly used oral treatment for COVID-19 is the combination of nirmatrelvir and ritonavir. No information is available on nirmatrelvir, which is the active component, during breast feeding. A considerable amount of information in HIV+ women indicates that the low booster dose of ritonavir causes no adverse effects in nursing infants. Due to the lack of information, recommendations vary among various national regulators and professional societies. The combination is not contraindicated in drug labeling in the United States or by the Society for Maternal-Fetal Medicine, but the typically more cautious European regulators recommend against breastfeeding during its use.4Hepatitis CThe first case report on direct-acting antivirals for hepatitis C was recently published. An infant was breastfed for 3 weeks postpartum by a mother who took the standard dose of sofosbuvir 400 mg plus ledipasvir 90 mg daily for 12 weeks beginning at 31 weeks of gestation for her chronic hepatitis C infection. The infant was followed for 1 year and found to have normal growth and development. Based on protein binding of the drugs, it is unlikely that substantial amounts of ledipasvir enter milk, but it is likely that sofosbuvir and its metabolite do enter milk. This case is reassuring, but obviously not sufficient to consider these drugs to be safe during breastfeeding.SummaryGood evidence indicates that oral PrEP regimens containing tenofovir are acceptable for use in HIV-negative nursing mothers. Maternal use of prophylactic vaginal tenofovir or dapivirine also does not appear to present a risk to the breastfed infant. Cabotegravir is not preferred in nursing mothers until further data become available. PEP regimens are acceptable for nursing mothers, but the risk of HIV transmission is an important consideration.Preliminary evidence indicates that remdesivir and favipiravir for COVID-19 may be acceptable for nursing mothers. Sofosbuvir–ledipasvir might be acceptable for hepatis C during breastfeeding, but much more data are needed on direct-acting antivirals.Disclosure StatementNo competing financial interests exist.Funding InformationNo funding was received for this article.References1. Joseph Davey D, Nyemba DC, Castillo-Mancilla J, et al. Adherence challenges with daily oral pre-exposure prophylaxis during pregnancy and the postpartum period in South African women: A cohort study. J Int AIDS Soc 2022;25:e26044; doi: 10.1002/jia2.26044 Crossref, Medline, Google Scholar2. Wara NJ, Mvududu R, Marwa MM, et al. Preferences and acceptability for long-acting PrEP agents among pregnant and postpartum women with experience using daily oral PrEP in South Africa and Kenya. medRxiv 2022; doi: 10.1101/2022.10.29.22281701 Crossref, Google Scholar3. Anderson PO. COVID-19 drugs and breastfeeding update. Breastfeed Med 2022;17:377–379; doi: 10.1089/bfm.2022.0066 Link, Google Scholar4. Chourasia P, Maringanti BS, Edwards-Fligner M, et al. Paxlovid (nirmatrelvir and ritonavir) use in pregnant and lactating woman: Current evidence and practice guidelines-a scoping review. Vaccines (Basel) 2023;11:107; doi: 10.3390/vaccines11010107 Crossref, Medline, Google ScholarFiguresReferencesRelatedDetails Volume 18Issue 3Mar 2023 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:Philip O. Anderson.New Information on Antivirals and Breastfeeding.Breastfeeding Medicine.Mar 2023.169-171.http://doi.org/10.1089/bfm.2023.0007Published in Volume: 18 Issue 3: March 15, 2023Online Ahead of Print:February 6, 2023PDF download" @default.
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