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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p><p>Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. </p></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK588746_"><span class="title" itemprop="name">Dapivirine</span></h1><p class="small">Last Revision: <span itemprop="dateModified">October 15, 2024</span>.</p><p><em>Estimated reading time: 2 minutes</em></p></div><div class="body-content whole_rhythm" itemprop="text"><p>CASRN: 244767-67-7</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/389401710" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=389401710" alt="image 389401710 in the ncbi pubchem database" /></a><div id="dapivirine.Drug_Levels_and_Effects"><h2 id="_dapivirine_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="dapivirine.Summary_of_Use_during_Lactati"><h3>Summary of Use during Lactation</h3><p>Dapivirine is investigational in the United States, but available overseas as a vaginal ring for pre-exposure prophylaxis of HIV infections (PrEP). In this dosage form, it is acceptable to use during breastfeeding.</p></div><div id="dapivirine.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> Sixteen lactating women who had weaned their infants used the dapivirine vaginal ring for 14 days and provided milk, blood and cervicovaginal fluid samples for analysis. Milk samples were obtained on days 0, 1, 7 and 14 during use of the insert and on day 16, two days after its removal. The mean breastmilk concentration was 676 ng/L (range 297 to 1,420 ng/L). This translated to an estimated average infant dosage of 74.3 ng/kg daily. The average half-life in milk was 45.8 hours.[<a class="bk_pop" href="#dapivirine.REF.1">1</a>]</p><p>A clinical trial compared the dapivirine vaginal ring 25 mg monthly to emtricitabine and tenofovir disoproxil fumarate as prophylaxis against HIV infection. In women randomized to dapivirine (n = 148), dapivirine concentrations in breastmilk averaged 698.3 ng/L during the first week of use and trended downward to 596.1 ng/L in the third month of use. At 2 weeks after discontinuation, milk dapivirine averaged 50.1 ng/L.[<a class="bk_pop" href="#dapivirine.REF.2">2</a>]</p><p><i>Infant Levels.</i> A clinical trial compared the dapivirine vaginal ring 25 mg monthly to emtricitabine and tenofovir disoproxil fumarate as prophylaxis against HIV infection. In the infants of women randomized to dapivirine (n = 148), dapivirine was detected in 15% of infants’ serum after 2 weeks of use, with an average concentration of 14.5 ng/L. In the third month of use, the drug was detectable in the serum of only 5.1% of infants with an average concentration of 10.7 ng/L. At 2 weeks after drug discontinuation, no infants had detectable dapivirine in their serum.[<a class="bk_pop" href="#dapivirine.REF.2">2</a>]</p></div><div id="dapivirine.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>A study compared the dapivirine vaginal ring to emtricitabine plus tenofovir for prophylaxis of HIV infections. Of 148 mother-infant pairs who received the dapivirine vaginal ring, no adverse effects in infants were attributed to dapivirine.[<a class="bk_pop" href="#dapivirine.REF.3">3</a>]</p></div><div id="dapivirine.Effects_on_Lactation_and_Brea"><h3>Effects on Lactation and Breastmilk</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="dapivirine.References"><h3>References</h3><dl class="temp-labeled-list"><dt>1.</dt><dd><div class="bk_ref" id="dapivirine.REF.1">Noguchi
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LM, Hoesley
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C, Kelly
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C, et al.
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Pharmacokinetics of dapivirine transfer into blood plasma, breast milk, and cervicovaginal fluid of lactating women using the dapivirine vaginal ring.
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Antimicrob Agents Chemother
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2019;63:e01930-18.
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[<a href="/pmc/articles/PMC6395928/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6395928</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30602513" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30602513</span></a>]</div></dd><dt>2.</dt><dd><div class="bk_ref" id="dapivirine.REF.2">Owor
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M, Noguchi
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L, Horne
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E, et al.
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Dapivirine ring safety and drug detection in breastfeeding mother-infant pairs. In, Special Issue: Abstracts From CROI 2023 Conference on Retroviruses and Opportunistic Infections.
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Top Antiviral Med
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2023;31:314. <a href="https://www.iasusa.org/tam/april-2023/" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>.iasusa.org/tam/april-2023/</a></div></dd><dt>3.</dt><dd><div class="bk_ref" id="dapivirine.REF.3">Noguchi
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L, Beigi
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R, Biggio
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J, et al.
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Breast milk dapivirine pharmacokinetics and estimated infant exposure during dapivirine intravaginal ring use among lactating women.
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J Int AIDS Soc
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2017;20 (Suppl 5):121. doi:10.7448/IAS.20.6.22188 [<a href="http://dx.crossref.org/10.7448/IAS.20.6.22188" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl></div></div><div id="dapivirine.Substance_Identification"><h2 id="_dapivirine_Substance_Identification_">Substance Identification</h2><div id="dapivirine.Substance_Name"><h3>Substance Name</h3><p>Dapivirine</p></div><div id="dapivirine.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>244767-67-7</p></div><div id="dapivirine.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Anti-Infective Agents</p><p>Antiviral Agents</p><p>Anti-HIV Agents</p><p>Anti-Retroviral Agents</p><p>Reverse Transcriptase Inhibitors</p></div></div><div><dl class="temp-labeled-list small"><dt></dt><dd><div><p class="no_top_margin"><p><b>Disclaimer: </b>Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.</p></p></div></dd></dl></div><div id="bk_toc_contnr"></div></div></div>
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