Trial Outcomes & Findings for Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir (NCT NCT04382404)
NCT ID: NCT04382404
Last Updated: 2025-01-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Up to 9 weeks from initiation of treatment
Results posted on
2025-01-01
Participant Flow
11 mother-infant dyads were enrolled
Participant milestones
| Measure |
Sofosbuvir-Velpatasvir
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Sofosbuvir-Velpatasvir
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Age in years reported for 11 maternal participants
Baseline characteristics by cohort
| Measure |
Sofosbuvir-Velpatasvir
n=22 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
|---|---|
|
Age, Continuous
Maternal Age, years
|
30 years
n=11 Participants • Age in years reported for 11 maternal participants
|
|
Age, Continuous
Infant Age, weeks
|
39.00 weeks
n=11 Participants • Age in weeks reflects gestational age of the 11 infant participants at birth
|
|
Sex: Female, Male
Mothers · Female
|
11 Participants
n=11 Participants • Sex of maternal and infant participants reported separately
|
|
Sex: Female, Male
Mothers · Male
|
0 Participants
n=11 Participants • Sex of maternal and infant participants reported separately
|
|
Sex: Female, Male
Infants · Female
|
6 Participants
n=11 Participants • Sex of maternal and infant participants reported separately
|
|
Sex: Female, Male
Infants · Male
|
5 Participants
n=11 Participants • Sex of maternal and infant participants reported separately
|
|
Ethnicity (NIH/OMB)
Mothers · Hispanic or Latino
|
0 Participants
n=11 Participants • Ethnicity of maternal and infant participants reported separately
|
|
Ethnicity (NIH/OMB)
Mothers · Not Hispanic or Latino
|
11 Participants
n=11 Participants • Ethnicity of maternal and infant participants reported separately
|
|
Ethnicity (NIH/OMB)
Mothers · Unknown or Not Reported
|
0 Participants
n=11 Participants • Ethnicity of maternal and infant participants reported separately
|
|
Ethnicity (NIH/OMB)
Infants · Hispanic or Latino
|
1 Participants
n=11 Participants • Ethnicity of maternal and infant participants reported separately
|
|
Ethnicity (NIH/OMB)
Infants · Not Hispanic or Latino
|
10 Participants
n=11 Participants • Ethnicity of maternal and infant participants reported separately
|
|
Ethnicity (NIH/OMB)
Infants · Unknown or Not Reported
|
0 Participants
n=11 Participants • Ethnicity of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Mothers · American Indian or Alaska Native
|
0 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Mothers · Asian
|
0 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Mothers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Mothers · Black or African American
|
1 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Mothers · White
|
10 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Mothers · More than one race
|
0 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Mothers · Unknown or Not Reported
|
0 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Infants · American Indian or Alaska Native
|
0 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Infants · Asian
|
0 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Infants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Infants · Black or African American
|
1 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Infants · White
|
9 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Infants · More than one race
|
1 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Race (NIH/OMB)
Infants · Unknown or Not Reported
|
0 Participants
n=11 Participants • Race of maternal and infant participants reported separately
|
|
Region of Enrollment
United States
|
22 participants
n=22 Participants
|
|
Hepatitis C Virus Genotype
Genotype 1
|
8 Participants
n=11 Participants • Data only relevant to maternal participants
|
|
Hepatitis C Virus Genotype
Genotype 3
|
3 Participants
n=11 Participants • Data only relevant to maternal participants
|
|
Gestational Age at Treatment Start
|
23.43 weeks
n=11 Participants • Data only relevant to maternal participants
|
|
Weight
Mothers
|
73.5 kg
n=11 Participants • Weight reported separately for maternal and infant participants
|
|
Weight
Infants
|
2.9 kg
n=11 Participants • Weight reported separately for maternal and infant participants
|
|
Body Mass Index
|
27.0 kg/m2
n=11 Participants • Body mass index only measured for maternal participants
|
|
Serum Creatinine
|
0.5 mg/dL
n=11 Participants • Data only measured in maternal participants
|
|
Hematocrit
|
36 percent
n=11 Participants • Data only measured in maternal participants
|
PRIMARY outcome
Timeframe: Up to 9 weeks from initiation of treatmentPopulation: 10 maternal participants had results from 2 or more visits; 1 maternal participant discontinued study drug after one dose.
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.
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=10 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Maximum Concentration of Velpatasvir in Maternal Plasma
|
381.93 ng/mL
Geometric Coefficient of Variation 38.35
|
—
|
PRIMARY outcome
Timeframe: Up to 9-weeks from initiation of treatmentPopulation: 10 maternal participants had results from 2 or more visits; 1 maternal participant discontinued study drug after one dose.
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.
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=10 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Maximum Concentration of Sofosbuvir in Maternal Plasma
|
1455.09 ng/mL
Geometric Coefficient of Variation 43.92
|
—
|
PRIMARY outcome
Timeframe: Up to 9 weeks from initiation of treatmentPopulation: 10 maternal participants had results from 2 or more visits; 1 maternal participant discontinued study drug after one dose.
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.
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=10 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Maximum Concentration of GS-331007 in Maternal Plasma
|
752.66 ng/mL
Geometric Coefficient of Variation 21.85
|
—
|
PRIMARY outcome
Timeframe: Up to 9 weeks from initiation of treatmentPopulation: 10 participants had results from 2 or more visits; 1 participant discontinued study drug after one dose.
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.
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=10 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Area Under the Maternal Plasma Concentration Versus Time Curve of Velpatasvir
|
3244.45 hr*ng/mL
Geometric Coefficient of Variation 39.89
|
—
|
PRIMARY outcome
Timeframe: Up to 9 weeks from initiation of treatmentPopulation: 10 participants had results from 2 or more visits; 1 participant discontinued study drug after one dose.
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.
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=10 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Area Under the Maternal Plasma Concentration Versus Time Curve of Sofosbuvir
|
2039.62 hr*ng/mL
Geometric Coefficient of Variation 29.75
|
—
|
PRIMARY outcome
Timeframe: Up to 9 weeks from initiation of treatmentPopulation: 10 participants had results from 2 or more visits; 1 participant discontinued study drug after one dose.
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.
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=10 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Area Under the Maternal Plasma Concentration Versus Time Curve of GS-331007
|
9558.94 hr*ng/mL
Geometric Coefficient of Variation 18.75
|
—
|
SECONDARY outcome
Timeframe: Approximately 3 weeks from initiation of treatmentPopulation: One participant discontinued study medication after the second daily dose
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from maternal peripheral blood mononuclear cells measured 3 weeks after initiation of treatment
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=10 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Intracellular Concentration of GS-461203 From Maternal Peripheral Blood Mononuclear Cells at 3 Weeks
|
2111 fmol/10^6 cells
Interval 1096.0 to 4066.0
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 weeks from initiation of treatmentPopulation: One participant discontinued study medication after the second daily dose
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from maternal peripheral blood mononuclear cells measured 6 weeks after initiation of treatment
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=10 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Intracellular Concentration of GS-461203 From Maternal Peripheral Blood Mononuclear Cells at 6 Weeks
|
2808 fmol/10^6 cells
Interval 1559.0 to 5058.0
|
—
|
SECONDARY outcome
Timeframe: Approximately 9 weeks from initiation of treatmentPopulation: One participant discontinued study medication after the second daily dose
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from maternal peripheral blood mononuclear cells measured 9 weeks after initiation of treatment
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=10 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Intracellular Concentration of GS-461203 From Maternal Peripheral Blood Mononuclear Cells at 9 Weeks
|
2212 fmol/10^6 cells
Interval 1267.0 to 3864.0
|
—
|
SECONDARY outcome
Timeframe: Approximately 3 weeks from initiation of treatmentPopulation: One participant discontinued study medication after the second daily dose
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from dried maternal blood spots measured 3 weeks after initiation of treatment
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=10 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Intracellular Concentration of GS-461203 From Dried Maternal Blood Spots at 3 Weeks
|
340 fmol/punch
Interval 287.0 to 403.0
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 weeks from initiation of treatmentPopulation: One participant discontinued study medication after the second daily dose
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from dried maternal blood spots measured 6 weeks after initiation of treatment
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=10 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Intracellular Concentration of GS-461203 From Dried Maternal Blood Spots at 6 Weeks
|
340 fmol/punch
Interval 278.0 to 418.0
|
—
|
SECONDARY outcome
Timeframe: Approximately 9 weeks from initiation of treatmentPopulation: One participant discontinued study medication after the second daily dose
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from dried maternal blood spots measured 9 weeks after initiation of treatment
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=10 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Intracellular Concentration of GS-461203 From Dried Maternal Blood Spots at 9 Weeks
|
356 fmol/punch
Interval 275.0 to 461.0
|
—
|
SECONDARY outcome
Timeframe: Approximately 24 weeks from initiation of treatmentPopulation: One participant discontinued study medication after the second daily dose, one participant was lost to follow-up.
Quantity of Hepatitis C RNA in maternal plasma measured at least 12 weeks after completion of Velpatasvir and Sofosbuvir treatment regimen
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=9 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Quantity of Hepatitis C Virus in Maternal Plasma After Completion of Velpatasvir and Sofosbuvir Treatment
|
NA copies/mL
Hepatitis C Viral RNA was not detectable in all participant samples; the lower limit of detection of the assay was 12 copies/mL.
|
—
|
SECONDARY outcome
Timeframe: Up to 16 weeks from initiation of treatment or 12 months from deliveryPopulation: There were 11 maternal-infant dyads
Number of maternal and infant participants that experience an adverse event that is deemed related to Sofosbuvir/Velpatasvir by a study physician
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=11 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
n=11 Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Number of Maternal and Infant Participants That Experience Adverse Events Related to Sofosbuvir/Velpatasvir
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 16 weeks from treatment initiation (at delivery)Maternal gestational age at delivery determined by medical record review
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=11 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Maternal Gestational Age at Delivery
|
39.00 weeks
Interval 35.57 to 39.43
|
—
|
SECONDARY outcome
Timeframe: Up to 16 weeks from treatment initiation (at delivery)Infant birth weight determined by medical record review
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=11 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Infant Weight at Delivery
|
2.90 kg
Interval 2.52 to 3.81
|
—
|
SECONDARY outcome
Timeframe: Up to 16 weeks from treatment initiation (at delivery)Frequency of delivery modes (spontaneous and assisted vaginal, scheduled and emergent cesarean section) for maternal participants determined by medical record review
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=11 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Frequency of Delivery Modes for Maternal Participants
Spontaneous vaginal delivery
|
7 Participants
|
—
|
|
Frequency of Delivery Modes for Maternal Participants
Scheduled cesarean section
|
3 Participants
|
—
|
|
Frequency of Delivery Modes for Maternal Participants
Emergent cesarean section
|
1 Participants
|
—
|
|
Frequency of Delivery Modes for Maternal Participants
Assisted vaginal delivery
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 12 months from deliveryPopulation: Infant participants
Number of infant participants with congenital anomalies determined by medical record review for up to 12 months of age.
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=11 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Number of Infant Participants With Congenital Anomalies
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Approximately 3 months from deliveryPopulation: Two infant participants were lost to follow-up
Weight of infant participant measured at 1 to 3 months of age
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=9 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Weight of Infant Participant at 1 to 3 Months
|
5.6 kg
Interval 4.7 to 6.7
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 months from deliveryPopulation: Two infant participants were lost to follow-up
Weight of infant participant measured at 6 months of age
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=9 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Weight of Infant Participant at 6 Months
|
8.4 kg
Interval 6.7 to 9.8
|
—
|
SECONDARY outcome
Timeframe: Approximately 12 months from deliveryPopulation: Two infant participants were lost to follow-up
Weight of infant participant measured at 12 months of age
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=9 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Weight of Infant Participant at 12 Months
|
10.6 kg
Interval 8.0 to 11.7
|
—
|
SECONDARY outcome
Timeframe: Approximately 3 months from deliveryPopulation: Two infant participants were lost to follow-up
Length of infant participant measured at 1 to 3 months of age
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=9 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Length of Infant Participant at 1 to 3 Months
|
59.0 cm
Interval 53.0 to 65.0
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 months from deliveryPopulation: Two infant participants were lost to follow-up
Length of infant participant measured at 6 months of age
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=9 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Length of Infant Participant at 6 Months
|
67.0 cm
Interval 66.0 to 73.2
|
—
|
SECONDARY outcome
Timeframe: Approximately 12 months from deliveryPopulation: Two infant participants were lost to follow-up; length not assessed for 1 infant participant
Length of infant participant measured at 12 months of age
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=8 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Length of Infant Participant at 12 Months
|
76.2 cm
Interval 74.5 to 80.0
|
—
|
SECONDARY outcome
Timeframe: Approximately 3 months from deliveryPopulation: Two infant participants were lost to follow-up
Head circumference of infant participant measured at 1 to 3 months of age
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=9 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Head Circumference of Infant Participant at 1 to 3 Months
|
39.5 cm
Interval 37.0 to 42.0
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 months from deliveryPopulation: Two infant participants were lost to follow-up
Head circumference of infant participant measured at 6 months of age
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=9 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Head Circumference of Infant Participant at 6 Months
|
43.4 cm
Interval 42.0 to 45.8
|
—
|
SECONDARY outcome
Timeframe: Approximately 12 months from deliveryPopulation: Two infant participants were lost to follow-up; head circumference not assessed for 2 infant participants
Head circumference of infant participant measured at 12 months of age
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=7 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Head Circumference of Infant Participant at 12 Months
|
46.4 cm
Interval 45.0 to 48.0
|
—
|
SECONDARY outcome
Timeframe: Up to 16 weeks from treatment initiation (at delivery)Population: One infant delivered at a non-study site hospital where Hepatitis C viral RNA in plasma was not assessed; 1 infant born maternal participant that did not complete study medication
Quantity of Hepatitis C viral RNA measured in infant plasma assessed at birth
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=9 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Quantity of Hepatitis C Virus in Infant Plasma at Birth
|
NA copies/mL
Hepatitis C Viral RNA was not detectable in all participant samples; the lower limit of quantification for the assay was 12 copies/mL
|
—
|
SECONDARY outcome
Timeframe: Approximately 3 months from deliveryPopulation: Unable to obtain blood draw on 1 infant, 2 infants were lost to follow-up, 1 infant born maternal participant that did not complete study medication
Quantity of Hepatitis C viral RNA measured in infant plasma assessed at 1 to 3 months of age
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=7 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Quantity of Hepatitis C Virus in Infant Plasma at 1 to 3 Months
|
NA copies/mL
Hepatitis C Viral RNA was not detectable in all participant samples; the lower limit of quantification for the assay was 15 copies/mL
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 months from deliveryPopulation: Unable to obtain blood draw on 2 infants, 3 infants were lost to follow-up, 1 infant born maternal participant that did not complete study medication
Quantity of Hepatitis C viral RNA measured in infant plasma assessed at 6 months of age
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=5 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Quantity of Hepatitis C Virus in Infant Plasma at 6 Months
|
NA copies/mL
Hepatitis C Viral RNA was not detectable in all participant samples; the lower limit of quantification for the assay was 15 copies/mL
|
—
|
SECONDARY outcome
Timeframe: Approximately 12 months from deliveryPopulation: Unable to obtain blood draw on 1 infant, 3 infants were lost to follow-up, 1 infant born maternal participant that did not complete study medication, Hepatitis C viral RNA assessment not required from 4 infants per protocol
Quantity of Hepatitis C viral RNA measured in infant plasma assessed at 12 months of age
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=2 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Quantity of Hepatitis C Virus in Infant Plasma at 12 Months
|
NA copies/mL
Hepatitis C Viral RNA was not detectable in all participant samples; the lower limit of quantification for the assay was 12 copies/mL
|
—
|
SECONDARY outcome
Timeframe: Approximately 12 months from deliveryPopulation: Two infant participants were lost to follow-up
Number of infant participants referred for early intervention based on neurological development assessments using Bayley Scales of Infant and Toddler Development. Infant participants with a Bayley's score of less than 6 on either cognitive, motor or language development assessments indicates an infant at risk for delayed development; Bayley's score ranges from 1 (extremely low) to 19 (very superior)
Outcome measures
| Measure |
Sofosbuvir-Velpatasvir
n=9 Participants
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Number of Infant Participants Referred for Early Neurological Development Intervention
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Approximately 9 weeks from initiation of maternal treatmentPopulation: Assay was not done.
Percentage of Sofosbuvir not bound to protein out of total protein- unbound and bound 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 9 weeks from initiation of maternal treatmentPopulation: Assay was not done
Percentage of Velpatasvir not bound to protein out of total protein- unbound and bound 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.
Outcome measures
Outcome data not reported
Adverse Events
Sofosbuvir-Velpatasvir - Maternal Participants
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Sofosbuvir-Velpatasvir - Infant Participants
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sofosbuvir-Velpatasvir - Maternal Participants
n=11 participants at risk
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
n=11 participants at risk
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Gastrointestinal disorders
Cholelithiasis
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Infections and infestations
Acute Pyelonephritis
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Renal and urinary disorders
Renal calculi
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Congenital, familial and genetic disorders
Clubfoot
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Reproductive system and breast disorders
Cryptorchidism
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Respiratory, thoracic and mediastinal disorders
Transient tachypnea
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Injury, poisoning and procedural complications
Positive toxicology screen
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
Other adverse events
| Measure |
Sofosbuvir-Velpatasvir - Maternal Participants
n=11 participants at risk
One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks
|
Sofosbuvir-Velpatasvir - Infant Participants
n=11 participants at risk
Infants born to mothers that took one oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks during pregnancy
|
|---|---|---|
|
Nervous system disorders
Headache
|
36.4%
4/11 • Number of events 5 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Blood and lymphatic system disorders
Anemia
|
36.4%
4/11 • Number of events 4 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
27.3%
3/11 • Number of events 3 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Pregnancy, puerperium and perinatal conditions
Hemorrhage, postpartum
|
27.3%
3/11 • Number of events 3 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
3/11 • Number of events 3 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • Number of events 2 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
General disorders
Fatigue
|
18.2%
2/11 • Number of events 2 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
18.2%
2/11 • Number of events 2 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
18.2%
2/11 • Number of events 2 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Gastrointestinal disorders
Cholelithiasis
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Infections and infestations
Dental abscess
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Skin and subcutaneous tissue disorders
Dermatitis, contact
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
General disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
General disorders
Dry mouth
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Pregnancy, puerperium and perinatal conditions
Fetal growth restriction
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Pregnancy, puerperium and perinatal conditions
Fluid overload, postpartum
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Gastrointestinal disorders
Gastroenteritis
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Pregnancy, puerperium and perinatal conditions
Hypertension, gestational
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Infections and infestations
Group B Streptococcus
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Gastrointestinal disorders
Heartburn
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Cardiac disorders
Hypotension
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
General disorders
Opioid withdrawal
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Pregnancy, puerperium and perinatal conditions
Preeclampsia
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Infections and infestations
Pyelonephritis
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Gastrointestinal disorders
Rectal bleeding
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Vascular disorders
Thrombophlebitis
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Infections and infestations
Urinary Tract Infection
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Metabolism and nutrition disorders
Weight gain
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
54.5%
6/11 • Number of events 11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
27.3%
3/11 • Number of events 3 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Skin and subcutaneous tissue disorders
Atopic dermatitis
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
18.2%
2/11 • Number of events 2 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
18.2%
2/11 • Number of events 2 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
18.2%
2/11 • Number of events 2 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Blood and lymphatic system disorders
Jaundice
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
18.2%
2/11 • Number of events 2 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
18.2%
2/11 • Number of events 2 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Metabolism and nutrition disorders
Weight loss
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Eye disorders
Vision screen, abnormal
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Respiratory, thoracic and mediastinal disorders
Croup
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Eye disorders
Dacrocystitis
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Skin and subcutaneous tissue disorders
Diaper dermatitis
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Eye disorders
Eye nystagmus
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
General disorders
Fever
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Nervous system disorders
Gross motor scores borderline to below average
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
General disorders
Hand, foot and mouth disease
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Musculoskeletal and connective tissue disorders
Nursemaid's elbow
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
General disorders
Nasolacrimal duct obstruction
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Infections and infestations
Oral thrush
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Infections and infestations
Orolabial Herpes Simplex Virus
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Syncytial Virus
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
General disorders
Roseola
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Skin and subcutaneous tissue disorders
Seborrhea of scalp
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Blood and lymphatic system disorders
Sickle cell trait
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
General disorders
Temperature instability
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Musculoskeletal and connective tissue disorders
Tibial torsion of lower legs
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Skin and subcutaneous tissue disorders
Urogenital candidiasis
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/11 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
9.1%
1/11 • Number of events 1 • 6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place