Ledipasvir plus sofosbuvir is a potentially safe and effective antenatal treatment for hepatitis C virus (HCV), according to a phase 1 pharmacokinetic study reported in Lancet Microbe.
The primary analysis included eight women with HCV infection and their infants. Patients were enrolled between 23- and 24-weeks gestation and had a 12-week course of oral ledipasvir–sofosbuvir (daily 90 mg ledipasvir plus 400 mg sofosbuvir). The primary outcome was the ledipasvir–sofosbuvir area under the concentration–time curve of the dosing interval (AUCtau) during pregnancy compared with a reference group by geometric mean ratio. The secondary outcomes included sustained virological response 12 weeks after completion of treatment, safety in the mother and in the neonate.
Ledipasvir and sofosbuvir exposures were similar in pregnant women versus the reference group. All participants had an undetectable viral load 12 weeks after completion of treatment, meeting the definition of HCV cure. All infants were HCV negative, and no maternal or neonatal safety concerns were identified.
These data suggest that administration of ledipasvir–sofosbuvir starting at 23 weeks of gestation is safe and effective for HCV cure. However, a larger effectiveness study is warranted before this strategy can be recommended and incorporated into routine clinical practice.