Adults 18 to 39, female only, with Hepatitis C, Chronic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Concentration of Velpatasvir in Maternal PlasmaPrimary· Up to 9 weeks from initiation of treatment
Maximum concentration of Velpatasvir measured in maternal plasma samples. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation. At the 6-week visit, a single convenience blood sample was collected.
Group
Value
95% CI
Sofosbuvir-Velpatasvir
381.93
± 38.35
Maximum Concentration of Sofosbuvir in Maternal PlasmaPrimary· Up to 9-weeks from initiation of treatment
Maximum concentration of Sofosbuvir measured in maternal plasma samples. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation. At the 6-week visit, a single convenience blood sample was collected.
Group
Value
95% CI
Sofosbuvir-Velpatasvir
1455.09
± 43.92
Maximum Concentration of GS-331007 in Maternal PlasmaPrimary· Up to 9 weeks from initiation of treatment
Maximum concentration of GS-331007, an inactive metabolite of Sofosbuvir, measured in maternal plasma samples. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation. At the 6-week visit, a single convenience blood sample was collected.
Group
Value
95% CI
Sofosbuvir-Velpatasvir
752.66
± 21.85
Area Under the Maternal Plasma Concentration Versus Time Curve of VelpatasvirPrimary· Up to 9 weeks from initiation of treatment
Area under the maternal plasma concentration of Velpatasvir versus time curve tau of the dosing interval. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation.
Group
Value
95% CI
Sofosbuvir-Velpatasvir
3244.45
± 39.89
Area Under the Maternal Plasma Concentration Versus Time Curve of SofosbuvirPrimary· Up to 9 weeks from initiation of treatment
Area under the maternal plasma concentration of Sofosbuvir versus time curve tau of the dosing interval. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation.
Group
Value
95% CI
Sofosbuvir-Velpatasvir
2039.62
± 29.75
Area Under the Maternal Plasma Concentration Versus Time Curve of GS-331007Primary· Up to 9 weeks from initiation of treatment
Area under the maternal plasma concentration of GS-331007 versus time curve tau of the dosing interval; GS-331007 is an inactive metabolite of Sofosbuvir. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation.
Group
Value
95% CI
Sofosbuvir-Velpatasvir
9558.94
± 18.75
Intracellular Concentration of GS-461203 From Maternal Peripheral Blood Mononuclear Cells at 3 WeeksSecondary· Approximately 3 weeks from initiation of treatment
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from maternal peripheral blood mononuclear cells measured 3 weeks after initiation of treatment
Group
Value
95% CI
Sofosbuvir-Velpatasvir
2111
1096 – 4066
Intracellular Concentration of GS-461203 From Maternal Peripheral Blood Mononuclear Cells at 6 WeeksSecondary· Approximately 6 weeks from initiation of treatment
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from maternal peripheral blood mononuclear cells measured 6 weeks after initiation of treatment
Group
Value
95% CI
Sofosbuvir-Velpatasvir
2808
1559 – 5058
Intracellular Concentration of GS-461203 From Maternal Peripheral Blood Mononuclear Cells at 9 WeeksSecondary· Approximately 9 weeks from initiation of treatment
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from maternal peripheral blood mononuclear cells measured 9 weeks after initiation of treatment
Group
Value
95% CI
Sofosbuvir-Velpatasvir
2212
1267 – 3864
Intracellular Concentration of GS-461203 From Dried Maternal Blood Spots at 3 WeeksSecondary· Approximately 3 weeks from initiation of treatment
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from dried maternal blood spots measured 3 weeks after initiation of treatment
Group
Value
95% CI
Sofosbuvir-Velpatasvir
340
287 – 403
Intracellular Concentration of GS-461203 From Dried Maternal Blood Spots at 6 WeeksSecondary· Approximately 6 weeks from initiation of treatment
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from dried maternal blood spots measured 6 weeks after initiation of treatment
Group
Value
95% CI
Sofosbuvir-Velpatasvir
340
278 – 418
Intracellular Concentration of GS-461203 From Dried Maternal Blood Spots at 9 WeeksSecondary· Approximately 9 weeks from initiation of treatment
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from dried maternal blood spots measured 9 weeks after initiation of treatment
Group
Value
95% CI
Sofosbuvir-Velpatasvir
356
275 – 461
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A single-arm, single-center, open label Phase 1 study of a 12-week course of Sofosbuvir (SOF)/Velpatasvir (VEL) in 10 HCV-infected pregnant women 1 that will evaluate the plasma pharmacokinetic parameters of SOF/VEL administered during pregnancy and compare them to those of a historical cohort of nonpregnant women.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04014179 — Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs
· NA
· active not recruiting
NCT04943588 — Treating Hepatitis C in Pakistan. Strategies to Avoid Resistance to Antiviral Drugs
· recruiting
NCT03520660 — People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
· Phase 4
· active not recruiting
NCT03200379 — Nation-wide Hepatitis C Virus (HCV) Registry in Taiwan
· recruiting
Other Catherine Anne Chappell trials
Trials by the same sponsor.
NCT03282799 — Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Catherine Anne Chappell
Last refreshed: 1 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04382404.