<p><strong>Pregnancy</strong>&nbsp;Category B. There are no adequate and well-controlled studies with Ledipasvir and Sofosbuvir&nbsp;in pregnant women. Because animal reproduction&nbsp;studies are not always predictive of human response, this should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.<br />
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<strong>Lactation</strong>: It is not known whether Ledipasvir and Sofosbuvir&nbsp;and its metabolites are present in human breast milk.</p>