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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD101996 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
A single-arm, single-center, open label Phase 1 study of a 12-week course of SOF/VEL in 10 HCV-infected pregnant women. Treatment will be initiated during the second trimester, reducing the risk of SOF/VEL exposure during organogenesis and ensuring treatment completion by delivery, minimizing the risk of perinatal transmission. The study will be completed in 10 or 11 visits (7 maternal visits, delivery visit and 3 infant visits) which should align with prenatal and postpartum visits. Patients will be screened between 14+0 and 22+6 weeks of gestation confirmed by ultrasound by the time of their enrollment visit who are known to have chronic HCV infection. An HCV RNA level to confirm the patient is actively infected with HCV as well as an HCV genotype will be obtained. A full laboratory evaluation of liver function will be obtained to evaluate for renal failure and decompensated cirrhosis. A Hepatitis B Virus (HBV) panel will be performed to test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. If the inclusion and exclusion criteria are met, the patient will be enrolled into the study between 23+0 and 25+6 weeks' gestation and initiated on a 12 week course of SOF/VEL. Systemic exposure of both VEL and SOF (SOF and inactive metabolite GS-331007) and intracellular SOF (GS-461203) will be assessed by pharmacokinetic sampling at 3, 6, and 9 weeks after first dose. HCV RNA viral load will be assessed at 12 weeks after completion of SOF/VEL treatment. Pregnancy and delivery outcomes will be collected prospectively. Neonatal outcomes will be assessed at birth, 8 weeks, 6 months and 12 months. HCV RNA viral load will be obtained at birth (as available), 1 to 3 months, at 6 months and then again at 12 months only if negative viral loads are not documented at 1 to 3 and 6 months. Neurodevelopmental assessments will be obtained at 6 months and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir-Velpatasvir | Experimental | Sofosbuvir-Velpatasvir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir-Velpatasvir Drug Combination | Drug | One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration of Velpatasvir in Maternal Plasma | 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. | Up to 9 weeks from initiation of treatment |
| Maximum Concentration of Sofosbuvir in Maternal Plasma | 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. | Up to 9-weeks from initiation of treatment |
| Maximum Concentration of GS-331007 in Maternal Plasma | 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. | Up to 9 weeks from initiation of treatment |
| Area Under the Maternal Plasma Concentration Versus Time Curve of Velpatasvir | 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. | Up to 9 weeks from initiation of treatment |
| Area Under the Maternal Plasma Concentration Versus Time Curve of Sofosbuvir | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intracellular Concentration of GS-461203 From Maternal Peripheral Blood Mononuclear Cells at 3 Weeks | Intracellular concentration of GS-461203, the active form of Sofosbuvir, from maternal peripheral blood mononuclear cells measured 3 weeks after initiation of treatment | Approximately 3 weeks from initiation of treatment |
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Inclusion Criteria:
Exclusion Criteria:
Participant report of any of the following at screening or enrollment:
Reports participating in any other research study involving drugs or medical devices within 60 days or less prior to enrollment
Clinically significant and habitual non-therapeutic drug abuse, not including marijuana, as determined by Protocol Chair
At Screening or Enrollment, as determined by the Protocol Chair, any significant uncontrolled active or chronic cardiovascular, renal, liver (such as evidence of decompensated cirrhosis by ascites, encephalopathy, or variceal hemorrhage), hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease (other than Hepatitis C)
Has a high risk of preterm birth defined as a history of spontaneous preterm birth at less than 34 weeks of gestation or a shortened cervical length of less than 20 millimeters
Has any of the following laboratory abnormalities at screening:
Has any other condition that, in the opinion of the investigator or designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Chappell, MD, MSc | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh, Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28782502 | Background | Society for Maternal-Fetal Medicine (SMFM). Electronic address: pubs@smfm.org; Hughes BL, Page CM, Kuller JA. Hepatitis C in pregnancy: screening, treatment, and management. Am J Obstet Gynecol. 2017 Nov;217(5):B2-B12. doi: 10.1016/j.ajog.2017.07.039. Epub 2017 Aug 4. | |
| 26297552 | Background | Gilbert EM, Darin KM, Scarsi KK, McLaughlin MM. Antiretroviral Pharmacokinetics in Pregnant Women. Pharmacotherapy. 2015 Sep;35(9):838-55. doi: 10.1002/phar.1626. Epub 2015 Aug 21. |
| Label | URL |
|---|---|
| Food and Drug Administration. Epclusa Package Insert. | View source |
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Data requests can be submitted by email to the Principal Investigator
Immediately after the primary manuscript for the study is published. Information will be available for an indefinite period of time.
Data requests submitted by email will be reviewed by the Principal Investigator on a case by case basis.
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11 mother-infant dyads were enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Sofosbuvir-Velpatasvir | One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Maternal baseline characteristics are reported unless otherwise stated
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| ID | Title | Description |
|---|---|---|
| BG000 | Sofosbuvir-Velpatasvir | One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years reported for 11 maternal participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Concentration of Velpatasvir in Maternal Plasma | 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. | 10 maternal participants had results from 2 or more visits; 1 maternal participant discontinued study drug after one dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Up to 9 weeks from initiation of treatment |
|
6 months from initiation of treatment for maternal participants or 1 year from delivery for infants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sofosbuvir-Velpatasvir - Maternal Participants | One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine Chappell | University of Pittsburgh | 412-641-1403 | chappelca@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2020 | Dec 18, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 19, 2022 | Nov 22, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
Not provided
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Open-label, single arm
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| Up to 9 weeks from initiation of treatment |
| Area Under the Maternal Plasma Concentration Versus Time Curve of GS-331007 | 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. | Up to 9 weeks from initiation of treatment |
| Intracellular Concentration of GS-461203 From Maternal Peripheral Blood Mononuclear Cells at 6 Weeks |
Intracellular concentration of GS-461203, the active form of Sofosbuvir, from maternal peripheral blood mononuclear cells measured 6 weeks after initiation of treatment |
| Approximately 6 weeks from initiation of treatment |
| Intracellular Concentration of GS-461203 From Maternal Peripheral Blood Mononuclear Cells at 9 Weeks | Intracellular concentration of GS-461203, the active form of Sofosbuvir, from maternal peripheral blood mononuclear cells measured 9 weeks after initiation of treatment | Approximately 9 weeks from initiation of treatment |
| Intracellular Concentration of GS-461203 From Dried Maternal Blood Spots at 3 Weeks | Intracellular concentration of GS-461203, the active form of Sofosbuvir, from dried maternal blood spots measured 3 weeks after initiation of treatment | Approximately 3 weeks from initiation of treatment |
| Intracellular Concentration of GS-461203 From Dried Maternal Blood Spots at 6 Weeks | Intracellular concentration of GS-461203, the active form of Sofosbuvir, from dried maternal blood spots measured 6 weeks after initiation of treatment | Approximately 6 weeks from initiation of treatment |
| Intracellular Concentration of GS-461203 From Dried Maternal Blood Spots at 9 Weeks | Intracellular concentration of GS-461203, the active form of Sofosbuvir, from dried maternal blood spots measured 9 weeks after initiation of treatment | Approximately 9 weeks from initiation of treatment |
| Quantity of Hepatitis C Virus in Maternal Plasma After Completion of Velpatasvir and Sofosbuvir Treatment | Quantity of Hepatitis C RNA in maternal plasma measured at least 12 weeks after completion of Velpatasvir and Sofosbuvir treatment regimen | Approximately 24 weeks from initiation of treatment |
| Number of Maternal and Infant Participants That Experience Adverse Events Related to Sofosbuvir/Velpatasvir | Number of maternal and infant participants that experience an adverse event that is deemed related to Sofosbuvir/Velpatasvir by a study physician | Up to 16 weeks from initiation of treatment or 12 months from delivery |
| Maternal Gestational Age at Delivery | Maternal gestational age at delivery determined by medical record review | Up to 16 weeks from treatment initiation (at delivery) |
| Infant Weight at Delivery | Infant birth weight determined by medical record review | Up to 16 weeks from treatment initiation (at delivery) |
| Frequency of Delivery Modes for Maternal Participants | Frequency of delivery modes (spontaneous and assisted vaginal, scheduled and emergent cesarean section) for maternal participants determined by medical record review | Up to 16 weeks from treatment initiation (at delivery) |
| Number of Infant Participants With Congenital Anomalies | Number of infant participants with congenital anomalies determined by medical record review for up to 12 months of age. | Up to 12 months from delivery |
| Weight of Infant Participant at 1 to 3 Months | Weight of infant participant measured at 1 to 3 months of age | Approximately 3 months from delivery |
| Weight of Infant Participant at 6 Months | Weight of infant participant measured at 6 months of age | Approximately 6 months from delivery |
| Weight of Infant Participant at 12 Months | Weight of infant participant measured at 12 months of age | Approximately 12 months from delivery |
| Length of Infant Participant at 1 to 3 Months | Length of infant participant measured at 1 to 3 months of age | Approximately 3 months from delivery |
| Length of Infant Participant at 6 Months | Length of infant participant measured at 6 months of age | Approximately 6 months from delivery |
| Length of Infant Participant at 12 Months | Length of infant participant measured at 12 months of age | Approximately 12 months from delivery |
| Head Circumference of Infant Participant at 1 to 3 Months | Head circumference of infant participant measured at 1 to 3 months of age | Approximately 3 months from delivery |
| Head Circumference of Infant Participant at 6 Months | Head circumference of infant participant measured at 6 months of age | Approximately 6 months from delivery |
| Head Circumference of Infant Participant at 12 Months | Head circumference of infant participant measured at 12 months of age | Approximately 12 months from delivery |
| Quantity of Hepatitis C Virus in Infant Plasma at Birth | Quantity of Hepatitis C viral RNA measured in infant plasma assessed at birth | Up to 16 weeks from treatment initiation (at delivery) |
| Quantity of Hepatitis C Virus in Infant Plasma at 1 to 3 Months | Quantity of Hepatitis C viral RNA measured in infant plasma assessed at 1 to 3 months of age | Approximately 3 months from delivery |
| Quantity of Hepatitis C Virus in Infant Plasma at 6 Months | Quantity of Hepatitis C viral RNA measured in infant plasma assessed at 6 months of age | Approximately 6 months from delivery |
| Quantity of Hepatitis C Virus in Infant Plasma at 12 Months | Quantity of Hepatitis C viral RNA measured in infant plasma assessed at 12 months of age | Approximately 12 months from delivery |
| Number of Infant Participants Referred for Early Neurological Development Intervention | 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) | Approximately 12 months from delivery |
| Percentage of Unbound Sofosbuvir Measured in Maternal Plasma | 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. | Approximately 9 weeks from initiation of maternal treatment |
| Percentage of Unbound Velpatasvir Measured in Maternal Plasma | 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. | Approximately 9 weeks from initiation of maternal treatment |
| Background | Chappell CA, Krans EE, Bunge KE, Macio IS, Bogen D, Scarsi KK, Meyn LA, Hillier SL. A Phase 1 Study of Ledipasvir/Sofosbuvir in Pregnant Women with Hepatitis C Virus. In: Conferences on Retroviruses and Opportunistic Infections; 2010 Mar 4-7; Seattle, WA; Abstract 87 |
| 31010566 | Background | Ward RM, Varner MW. Principles of Pharmacokinetics in the Pregnant Woman and Fetus. Clin Perinatol. 2019 Jun;46(2):383-398. doi: 10.1016/j.clp.2019.02.014. Epub 2019 Mar 30. |
| 27363437 | Background | MacBrayne CE, Kiser JJ. Pharmacologic Considerations in the Treatment of Hepatitis C Virus in Persons With HIV. Clin Infect Dis. 2016 Jul 15;63 Suppl 1(Suppl 1):S12-23. doi: 10.1093/cid/ciw220. |
| 25822283 | Background | Kirby BJ, Symonds WT, Kearney BP, Mathias AA. Pharmacokinetic, Pharmacodynamic, and Drug-Interaction Profile of the Hepatitis C Virus NS5B Polymerase Inhibitor Sofosbuvir. Clin Pharmacokinet. 2015 Jul;54(7):677-90. doi: 10.1007/s40262-015-0261-7. |
| 26571066 | Background | Feld JJ, Jacobson IM, Hezode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F, Moreno C, Yoshida E, Shafran SD, Towner WJ, Tran TT, McNally J, Osinusi A, Svarovskaia E, Zhu Y, Brainard DM, McHutchison JG, Agarwal K, Zeuzem S; ASTRAL-1 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015 Dec 31;373(27):2599-607. doi: 10.1056/NEJMoa1512610. Epub 2015 Nov 16. |
| 26575258 | Background | Foster GR, Afdhal N, Roberts SK, Brau N, Gane EJ, Pianko S, Lawitz E, Thompson A, Shiffman ML, Cooper C, Towner WJ, Conway B, Ruane P, Bourliere M, Asselah T, Berg T, Zeuzem S, Rosenberg W, Agarwal K, Stedman CA, Mo H, Dvory-Sobol H, Han L, Wang J, McNally J, Osinusi A, Brainard DM, McHutchison JG, Mazzotta F, Tran TT, Gordon SC, Patel K, Reau N, Mangia A, Sulkowski M; ASTRAL-2 Investigators; ASTRAL-3 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med. 2015 Dec 31;373(27):2608-17. doi: 10.1056/NEJMoa1512612. Epub 2015 Nov 17. |
| Median |
| Full Range |
| years |
|
| Age, Continuous | Age in weeks reflects gestational age of the 11 infant participants at birth | Median | Full Range | weeks |
|
| Sex: Female, Male | Sex of maternal and infant participants reported separately | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity of maternal and infant participants reported separately | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race of maternal and infant participants reported separately | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hepatitis C Virus Genotype | Data only relevant to maternal participants | Count of Participants | Participants |
|
| Gestational Age at Treatment Start | Data only relevant to maternal participants | Median | Full Range | weeks |
|
| Weight | Weight reported separately for maternal and infant participants | Median | Full Range | kg |
|
| Body Mass Index | Body mass index only measured for maternal participants | Median | Full Range | kg/m2 |
|
| Serum Creatinine | Data only measured in maternal participants | Median | Full Range | mg/dL |
|
| Hematocrit | Data only measured in maternal participants | Median | Full Range | percent |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Maximum Concentration of Sofosbuvir in Maternal Plasma | 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. | 10 maternal participants had results from 2 or more visits; 1 maternal participant discontinued study drug after one dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Up to 9-weeks from initiation of treatment |
|
|
|
|
| Primary | Maximum Concentration of GS-331007 in Maternal Plasma | 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. | 10 maternal participants had results from 2 or more visits; 1 maternal participant discontinued study drug after one dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Up to 9 weeks from initiation of treatment |
|
|
|
|
| Primary | Area Under the Maternal Plasma Concentration Versus Time Curve of Velpatasvir | 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. | 10 participants had results from 2 or more visits; 1 participant discontinued study drug after one dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Up to 9 weeks from initiation of treatment |
|
|
|
|
| Primary | Area Under the Maternal Plasma Concentration Versus Time Curve of Sofosbuvir | 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. | 10 participants had results from 2 or more visits; 1 participant discontinued study drug after one dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Up to 9 weeks from initiation of treatment |
|
|
|
|
| Primary | Area Under the Maternal Plasma Concentration Versus Time Curve of GS-331007 | 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. | 10 participants had results from 2 or more visits; 1 participant discontinued study drug after one dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Up to 9 weeks from initiation of treatment |
|
|
|
|
| Secondary | Intracellular Concentration of GS-461203 From Maternal Peripheral Blood Mononuclear Cells at 3 Weeks | Intracellular concentration of GS-461203, the active form of Sofosbuvir, from maternal peripheral blood mononuclear cells measured 3 weeks after initiation of treatment | One participant discontinued study medication after the second daily dose | Posted | Geometric Mean | 95% Confidence Interval | fmol/10^6 cells | Approximately 3 weeks from initiation of treatment |
|
|
|
|
| Secondary | Intracellular Concentration of GS-461203 From Maternal Peripheral Blood Mononuclear Cells at 6 Weeks | Intracellular concentration of GS-461203, the active form of Sofosbuvir, from maternal peripheral blood mononuclear cells measured 6 weeks after initiation of treatment | One participant discontinued study medication after the second daily dose | Posted | Geometric Mean | 95% Confidence Interval | fmol/10^6 cells | Approximately 6 weeks from initiation of treatment |
|
|
|
|
| Secondary | Intracellular Concentration of GS-461203 From Maternal Peripheral Blood Mononuclear Cells at 9 Weeks | Intracellular concentration of GS-461203, the active form of Sofosbuvir, from maternal peripheral blood mononuclear cells measured 9 weeks after initiation of treatment | One participant discontinued study medication after the second daily dose | Posted | Geometric Mean | 95% Confidence Interval | fmol/10^6 cells | Approximately 9 weeks from initiation of treatment |
|
|
|
|
| Secondary | Intracellular Concentration of GS-461203 From Dried Maternal Blood Spots at 3 Weeks | Intracellular concentration of GS-461203, the active form of Sofosbuvir, from dried maternal blood spots measured 3 weeks after initiation of treatment | One participant discontinued study medication after the second daily dose | Posted | Geometric Mean | 95% Confidence Interval | fmol/punch | Approximately 3 weeks from initiation of treatment |
|
|
|
|
| Secondary | Intracellular Concentration of GS-461203 From Dried Maternal Blood Spots at 6 Weeks | Intracellular concentration of GS-461203, the active form of Sofosbuvir, from dried maternal blood spots measured 6 weeks after initiation of treatment | One participant discontinued study medication after the second daily dose | Posted | Geometric Mean | 95% Confidence Interval | fmol/punch | Approximately 6 weeks from initiation of treatment |
|
|
|
|
| Secondary | Intracellular Concentration of GS-461203 From Dried Maternal Blood Spots at 9 Weeks | Intracellular concentration of GS-461203, the active form of Sofosbuvir, from dried maternal blood spots measured 9 weeks after initiation of treatment | One participant discontinued study medication after the second daily dose | Posted | Geometric Mean | 95% Confidence Interval | fmol/punch | Approximately 9 weeks from initiation of treatment |
|
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|
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| Secondary | Quantity of Hepatitis C Virus in Maternal Plasma After Completion of Velpatasvir and Sofosbuvir Treatment | Quantity of Hepatitis C RNA in maternal plasma measured at least 12 weeks after completion of Velpatasvir and Sofosbuvir treatment regimen | One participant discontinued study medication after the second daily dose, one participant was lost to follow-up. | Posted | Median | Full Range | copies/mL | Approximately 24 weeks from initiation of treatment |
|
|
|
| Secondary | Number of Maternal and Infant Participants That Experience Adverse Events Related to Sofosbuvir/Velpatasvir | Number of maternal and infant participants that experience an adverse event that is deemed related to Sofosbuvir/Velpatasvir by a study physician | There were 11 maternal-infant dyads | Posted | Count of Participants | Participants | Up to 16 weeks from initiation of treatment or 12 months from delivery |
|
|
|
| Secondary | Maternal Gestational Age at Delivery | Maternal gestational age at delivery determined by medical record review | Posted | Median | Full Range | weeks | Up to 16 weeks from treatment initiation (at delivery) |
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| Secondary | Infant Weight at Delivery | Infant birth weight determined by medical record review | Posted | Median | Full Range | kg | Up to 16 weeks from treatment initiation (at delivery) |
|
|
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| Secondary | Frequency of Delivery Modes for Maternal Participants | Frequency of delivery modes (spontaneous and assisted vaginal, scheduled and emergent cesarean section) for maternal participants determined by medical record review | Posted | Count of Participants | Participants | Up to 16 weeks from treatment initiation (at delivery) |
|
|
|
| Secondary | Number of Infant Participants With Congenital Anomalies | Number of infant participants with congenital anomalies determined by medical record review for up to 12 months of age. | Infant participants | Posted | Count of Participants | Participants | Up to 12 months from delivery |
|
|
|
| Secondary | Weight of Infant Participant at 1 to 3 Months | Weight of infant participant measured at 1 to 3 months of age | Two infant participants were lost to follow-up | Posted | Median | Full Range | kg | Approximately 3 months from delivery |
|
|
|
| Secondary | Weight of Infant Participant at 6 Months | Weight of infant participant measured at 6 months of age | Two infant participants were lost to follow-up | Posted | Median | Full Range | kg | Approximately 6 months from delivery |
|
|
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| Secondary | Weight of Infant Participant at 12 Months | Weight of infant participant measured at 12 months of age | Two infant participants were lost to follow-up | Posted | Median | Full Range | kg | Approximately 12 months from delivery |
|
|
|
| Secondary | Length of Infant Participant at 1 to 3 Months | Length of infant participant measured at 1 to 3 months of age | Two infant participants were lost to follow-up | Posted | Median | Full Range | cm | Approximately 3 months from delivery |
|
|
|
| Secondary | Length of Infant Participant at 6 Months | Length of infant participant measured at 6 months of age | Two infant participants were lost to follow-up | Posted | Median | Full Range | cm | Approximately 6 months from delivery |
|
|
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| Secondary | Length of Infant Participant at 12 Months | Length of infant participant measured at 12 months of age | Two infant participants were lost to follow-up; length not assessed for 1 infant participant | Posted | Median | Full Range | cm | Approximately 12 months from delivery |
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| Secondary | Head Circumference of Infant Participant at 1 to 3 Months | Head circumference of infant participant measured at 1 to 3 months of age | Two infant participants were lost to follow-up | Posted | Median | Full Range | cm | Approximately 3 months from delivery |
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| Secondary | Head Circumference of Infant Participant at 6 Months | Head circumference of infant participant measured at 6 months of age | Two infant participants were lost to follow-up | Posted | Median | Full Range | cm | Approximately 6 months from delivery |
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| Secondary | Head Circumference of Infant Participant at 12 Months | Head circumference of infant participant measured at 12 months of age | Two infant participants were lost to follow-up; head circumference not assessed for 2 infant participants | Posted | Median | Full Range | cm | Approximately 12 months from delivery |
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| Secondary | Quantity of Hepatitis C Virus in Infant Plasma at Birth | Quantity of Hepatitis C viral RNA measured in infant plasma assessed at birth | 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 | Posted | Median | Full Range | copies/mL | Up to 16 weeks from treatment initiation (at delivery) |
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| Secondary | Quantity of Hepatitis C Virus in Infant Plasma at 1 to 3 Months | Quantity of Hepatitis C viral RNA measured in infant plasma assessed at 1 to 3 months of age | 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 | Posted | Median | Full Range | copies/mL | Approximately 3 months from delivery |
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| Secondary | Quantity of Hepatitis C Virus in Infant Plasma at 6 Months | Quantity of Hepatitis C viral RNA measured in infant plasma assessed at 6 months of age | 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 | Posted | Median | Full Range | copies/mL | Approximately 6 months from delivery |
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| Secondary | Quantity of Hepatitis C Virus in Infant Plasma at 12 Months | Quantity of Hepatitis C viral RNA measured in infant plasma assessed at 12 months of age | 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 | Posted | Median | Full Range | copies/mL | Approximately 12 months from delivery |
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| Secondary | Number of Infant Participants Referred for Early Neurological Development Intervention | 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) | Two infant participants were lost to follow-up | Posted | Count of Participants | Participants | Approximately 12 months from delivery |
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| Secondary | Percentage of Unbound Sofosbuvir Measured in Maternal Plasma | 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. | Assay was not done. | Posted | Approximately 9 weeks from initiation of maternal treatment |
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| Secondary | Percentage of Unbound Velpatasvir Measured in Maternal Plasma | 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. | Assay was not done | Posted | Approximately 9 weeks from initiation of maternal treatment |
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|
| 0 |
| 11 |
| 3 |
| 11 |
| 11 |
| 11 |
| EG001 | 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 | 0 | 11 | 5 | 11 | 11 | 11 |
| Acute Pyelonephritis | Infections and infestations | Non-systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | Non-systematic Assessment | Renal calculi, obstructing with hydronephrosis |
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| Clubfoot | Congenital, familial and genetic disorders | Non-systematic Assessment |
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| Cryptorchidism | Reproductive system and breast disorders | Non-systematic Assessment |
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| Hyperbilirubinemia | Hepatobiliary disorders | Non-systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Transient tachypnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Positive toxicology screen | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hemorrhage, postpartum | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sciatica | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cholelithiasis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dental abscess | Infections and infestations | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Dermatitis, contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Dizziness | General disorders | Non-systematic Assessment |
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| Dry mouth | General disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Fetal growth restriction | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Fluid overload, postpartum | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
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| Hypertension, gestational | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Group B Streptococcus | Infections and infestations | Non-systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Non-systematic Assessment |
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| Hypotension | Cardiac disorders | Non-systematic Assessment |
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| Opioid withdrawal | General disorders | Non-systematic Assessment |
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| Preeclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | Non-systematic Assessment |
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| Rectal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
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| Thrombophlebitis | Vascular disorders | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
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| Vaginal bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
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| Weight gain | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Otitis media | Ear and labyrinth disorders | Non-systematic Assessment |
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| Atopic dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hyperbilirubinemia | Hepatobiliary disorders | Non-systematic Assessment |
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| Jaundice | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Weight loss | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Vision screen, abnormal | Eye disorders | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Croup | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dacrocystitis | Eye disorders | Non-systematic Assessment |
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| Diaper dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Eye nystagmus | Eye disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Gross motor scores borderline to below average | Nervous system disorders | Non-systematic Assessment |
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| Hand, foot and mouth disease | General disorders | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Nursemaid's elbow | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Nasolacrimal duct obstruction | General disorders | Non-systematic Assessment |
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| Oral thrush | Infections and infestations | Non-systematic Assessment |
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| Orolabial Herpes Simplex Virus | Infections and infestations | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Respiratory Syncytial Virus | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Roseola | General disorders | Non-systematic Assessment |
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| Seborrhea of scalp | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Sickle cell trait | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Temperature instability | General disorders | Non-systematic Assessment |
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| Tibial torsion of lower legs | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Urogenital candidiasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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Not provided
Not provided
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Assisted vaginal delivery |
|