ArticleThe Lancet. Microbe2020
Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study.
Article in The Lancet. Microbe, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 45 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Observational Study of Mother-Infant Outcomes Following Antenatal Exposure to Direct-Acting Antivirals: the Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry
Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy
Who cites it
45 citing papers in PubMed, 110 citations in OpenAlex.
- Real-World Experience of Hepatitis C Treatment With Glecaprevir-Pibrentasvir During Pregnancy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- IMPAACT 2041: Designing the Study of Glecaprevir/Pibrentasvir Treatment During Pregnancy.Open forum infectious diseases · 2026Article
- Recent Advances in the Epidemiology, Screening, and Management of Hepatitis C Virus Infection in Pregnancy.Gastroenterology & hepatology · 2026Article
- Pharmacokinetics of Sofosbuvir and Velpatasvir for Hepatitis C Treatment in Pregnancy.Biomedicines · 2025Article
- Pathogenesis, prevention, and therapeutic advances in hepatitis B, C, and D.Virology journal · 2025Review
- Hepatitis C virus in childhood and pregnancy.Infectious diseases & immunity · 2025Review
- Sofosbuvir/Velpatasvir Pharmacokinetics, Safety, and Efficacy in Pregnant People With Hepatitis C Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Hepatitis C Virus-Pediatric and Adult Perspectives in the Current Decade.Pathogens (Basel, Switzerland) · 2024Review
- Prevalence and Modes of Transmission of Hepatitis C Virus Infection: A Historical Worldwide Review.Viruses · 2024Review
- Direct-Acting Antiviral Agents in Prevention of Maternal-Fetal Transmission of Hepatitis C Virus in Pregnancy.Pathogens (Basel, Switzerland) · 2024Review
- CDC's New Hepatitis C Virus Testing Recommendations for Perinatally Exposed Infants and Children: A Step Towards Hepatitis C Elimination.Journal of women's health (2002) · 2024Article
- HCV Antiviral Drugs Have the Potential to Adversely Perturb the Fetal-Maternal Communication Axis through Inhibition of CYP3A7 DHEA-S Oxidation.Drug metabolism and disposition: the biological fate of chemicals · 2024Article
- Pregnancy as an Opportunity for Hepatitis C Virus Elimination and Eradication.The American journal of tropical medicine and hygiene · 2024Article
- Hepatitis C virus detection and management after implementation of universal screening in pregnancy.AJOG global reports · 2024Article
- A Composite Score for Predicting Vertical Transmission of Hepatitis C: A Multicenter Study.Pathogens (Basel, Switzerland) · 2024Article
- Feasibility and Acceptability of Antenatal Hepatitis C Screening: A Pilot Study.Canadian journal of gastroenterology & hepatology · 2024Article
- Viral hepatitis management in pregnancy: practical insights from a pediatric perspective.Translational gastroenterology and hepatology · 2024Article
- SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024Review
- Hepatitis C infection seroprevalence in pregnant women worldwide: a systematic review and meta-analysis.EClinicalMedicine · 2023Article
- A Synopsis of Hepatitis C Virus Treatments and Future Perspectives.Current issues in molecular biology · 2023Review
Corrections and comments
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Authors and funding
11 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundHepatitis C virus (HCV) infection is increasing among pregnant women because of the opioid epidemic, yet there are no interventions to reduce perinatal HCV transmission or to treat HCV during pregnancy. Physiological changes in pregnancy alter the pharmacokinetics of some medications; thus, our aim was to compare the pharmacokinetic parameters of ledipasvir 90 mg plus sofosbuvir 400 mg during pregnancy with non-pregnant women.
methodsThis was an open-label, phase 1 study of pregnant women with genotype 1 HCV infection and their infants. A reference group of women who had participated in pharmacokinetic studies of ledipasvir-sofosbuvir during phase 2 and 3 trials was used. Participants were enrolled at Magee-Womens Hospital (Pittsburgh, PA, USA) between 23 and 24 weeks' gestation and had a 12-week course of oral ledipasvir-sofosbuvir (daily 90 mg ledipasvir plus 400 mg sofosbuvir). Three 12-h intensive pharmacokinetic visits were done at 25-26, 29-30, and 33-34 weeks' gestation and individual pharmacokinetics were summarised by geometric mean across the three visits. The primary outcome, analysed in all participants without suspected dosing errors, was the ledipasvir-sofosbuvir area under the concentration-time curve of the dosing interval (AUC
findingsFrom Oct 1, 2016, to Sept 30, 2018, 29 pregnant women were screened and nine (31%) were enrolled. Eight (89%) women were included in the primary analysis. Ledipasvir and sofosbuvir exposures were similar in the pregnant women versus the non-pregnant reference group (geometric mean ratio of AUC
interpretationLedipasvir-sofosbuvir was safe and effective without clinically meaningful differences in drug exposure among pregnant versus non-pregnant women.
fundingNational Institutes of Health/Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health/Office of Research on Women's Health, and Gilead Sciences.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.