by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer
December 31, 2024
Chappell CA, Kiser JJ, Brooks KM, et al. Sofosbuvir/velpatasvir pharmacokinetics, safety, and efficacy in pregnant people with hepatitis C virus. Clin Infect Dis. 2024 Dec 17:ciae595. doi: 10.1093/cid/ciae595.
Investigators evaluated plasma PK parameters of the pangenotypic regimen sofosbuvir/velatasvir (SOF/VEL) and assessed safety and efficacy in 11 participants. Participants were between 23 to 25 weeks’ gestation at enrollment and did not have HIV or hepatitis B co-infection, cirrhosis, or history of prior treatment with SOF or an NS5A inhibitor. Infants were followed for 12 months. One participant discontinued treatment due to pregnancy-related hyperemesis, and ten participants completed study medication and delivered (complete follow-up data were available for eight mother-baby pairs). Upon SOF/VEL initiation, HCV viral load was undetectable by the third PK study visit for all (i.e., nine weeks after treatment initiation, or between 32-35 weeks’ gestation). All participants reported excellent adherence, defined as not missing more than one dose per week, except for one who missed greater than one dose per week in the last three weeks of treatment. All eight participants completing the SVR12 study visit had an undetectable viral load 12 weeks after completing SOF/VEL, and another participant who subsequently re-engaged in routine clinical care was found to have an undetectable viral load. The most common medication-related adverse events were nausea/vomiting, headache, and heartburn. None of the infants had a detectable viral load, and no medication-related safety concerns were identified.
Author’s Commentary:
Along with other small studies, findings from this analysis support the tolerability, safety, and efficacy of SOF-based HCV treatment initiation during the second trimester. Further, findings from various PK measures suggest that SOF/VEL exposures were not clinically different in pregnancy. Investigators hope these data, along with results from other studies in the near future, will advance recommendations to support universal consideration and use of DAAs to treat HCV during pregnancy.
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