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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>
<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK500824_"><span class="title" itemprop="name">Sofosbuvir</span></h1><p class="small">Last Revision: <span itemprop="dateModified">September 15, 2023</span>.</p><p><em>Estimated reading time: 2 minutes</em></p></div><div class="body-content whole_rhythm" itemprop="text"><p>CASRN: 1190307-88-0</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/135267508" title="View this structure in PubChem" class="img_link" ref="pagearea=body&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&amp;sid=135267508" alt="image 135267508 in the ncbi pubchem database" /></a><div id="LM1242.Drug_Levels_and_Effects"><h2 id="_LM1242_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM1242.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>Sofosbuvir has not been well studied in nursing mothers being treated for hepatitis C infection, although one infant was breastfed for 3 weeks and had no developmental abnormalities. If sofosbuvir alone or in combination with ledipasvir (Harvoni) is required by the mother, it is not a reason to discontinue breastfeeding.[<a class="bk_pop" href="#LM1242.REF.1">1</a>] Some sources recommend against breastfeeding when sofosbuvir is used with ribavirin.</p><p>Hepatitis C is not transmitted through breastmilk and breastmilk has been shown to inactivate hepatitis C virus (HCV).[<a class="bk_pop" href="#LM1242.REF.2">2</a>-<a class="bk_pop" href="#LM1242.REF.5">5</a>] However, the Centers for Disease Control recommends that mothers with HCV infection should consider abstaining from breastfeeding if their nipples are cracked or bleeding. It is not clear if this warning would apply to mothers who are being treated for hepatitis C.</p><p>Infants born to mothers with HCV infection should be tested for HCV infection; because maternal antibody is present for the first 18 months of life and before the infant mounts an immunologic response, nucleic acid testing is recommended.[<a class="bk_pop" href="#LM1242.REF.2">2</a>,<a class="bk_pop" href="#LM1242.REF.5">5</a>]</p></div><div id="LM1242.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> Relevant published information was not found as of the revision date.</p><p><i>Infant Levels.</i> Relevant published information was not found as of the revision date.</p></div><div id="LM1242.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>An infant was breastfed (extent not stated) for 3 weeks postpartum by a mother who took 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.[<a class="bk_pop" href="#LM1242.REF.6">6</a>]</p></div><div id="LM1242.Effects_on_Lactation_and_Breastmi"><h3>Effects on Lactation and Breastmilk</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="LM1242.Alternate_Drugs_to_Consider"><h3>Alternate Drugs to Consider</h3><p>(Hepatitis C) <a href="/books/n/lactmed/LM148/">Interferon Alfa</a>, <a href="/books/n/lactmed/LM581/">Interferon Alfacon-1</a>, <a href="/books/n/lactmed/LM1082/">Peginterferon Alfa</a></p></div><div id="LM1242.References"><h3>References</h3><dl class="temp-labeled-list"><dt>1.</dt><dd><div class="bk_ref" id="LM1242.REF.1">Spera
AM, Eldin
TK, Tosone
G, Orlando
R. Antiviral therapy for hepatitis C: Has anything changed for pregnant/lactating women?
World J Hepatol
2016;8:557-65. [<a href="/pmc/articles/PMC4840161/" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pmc">PMC free article<span class="bk_prnt">: PMC4840161</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/27134703" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 27134703</span></a>]</div></dd><dt>2.</dt><dd><div class="bk_ref" id="LM1242.REF.2">Cottrell
EB, Chou
R, Wasson
N, et al.
Reducing risk for mother-to-infant transmission of hepatitis C virus: A systematic review for the U.S. Preventive Services Task Force.
Ann Intern Med
2013;158:109-13. [<a href="https://pubmed.ncbi.nlm.nih.gov/23437438" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 23437438</span></a>]</div></dd><dt>3.</dt><dd><div class="bk_ref" id="LM1242.REF.3">Pfaender
S, Heyden
J, Friesland
M, et al.
Inactivation of hepatitis C virus infectivity by human breast milk.
J Infect Dis
2013;208:1943-52. [<a href="https://pubmed.ncbi.nlm.nih.gov/24068703" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 24068703</span></a>]</div></dd><dt>4.</dt><dd><div class="bk_ref" id="LM1242.REF.4">Tovo
PA, Calitri
C, Scolfaro
C, et al.
Vertically acquired hepatitis C virus infection: Correlates of transmission and disease progression.
World J Gastroenterol
2016;22:1382-92. [<a href="/pmc/articles/PMC4721973/" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pmc">PMC free article<span class="bk_prnt">: PMC4721973</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/26819507" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 26819507</span></a>]</div></dd><dt>5.</dt><dd><div class="bk_ref" id="LM1242.REF.5">Workowski
KA, Bachmann
LH, Chan
PA, et al.
Sexually transmitted infections treatment guidelines, 2021.
MMWR Recomm Rep
2021;70:1-187. [<a href="/pmc/articles/PMC8344968/" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pmc">PMC free article<span class="bk_prnt">: PMC8344968</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/34292926" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 34292926</span></a>]</div></dd><dt>6.</dt><dd><div class="bk_ref" id="LM1242.REF.6">Zeng
QL, Yu
ZJ, Lv
J, et al.
Sofosbuvir-based therapy for late pregnant women and infant with severe chronic hepatitis C: A case series study.
J Med Virol
2022;94:4548-53. [<a href="https://pubmed.ncbi.nlm.nih.gov/35595682" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 35595682</span></a>]</div></dd></dl></div></div><div id="LM1242.Substance_Identification"><h2 id="_LM1242_Substance_Identification_">Substance Identification</h2><div id="LM1242.Substance_Name"><h3>Substance Name</h3><p>Sofosbuvir</p></div><div id="LM1242.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>1190307-88-0</p></div><div id="LM1242.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Antiviral Agents</p><p>Nucleotides</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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