Please select the outcome measures that correspond to the clinical trial below.
Title: Tenofovir Disoproxil Fumarate in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus in Highly Viremic Mothers
Brief Summary: Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to hepatitis B e antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA \> 6log10 copies/mL (or \>200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior observational studies have shown that antiviral therapy including lamivudine or telbivudine use during late pregnancy can safely reduce the rate of vertical transmission in this special population compared to untreated patients.

Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study:

1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA \> 6log10 copies/mL (or \> 200,000 IU/mL) during late pregnancy and infants.
2. Its efficacy in the reduction of HBV vertical transmission rate.


Options:
A: Measure the number of infants who have HBV infection at the age of 28 weeks (From the date of birth to age of 28 weeks); Assessment of the safety and tolerability of TDF, measure the number of participants and paired infants with adverse events (From the date of randomization until 28 weeks of postpartum.)
B: Antepartum Component: Number of Confirmed Infant HIV Infections (Measured at birth or Week 1 study visit); Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events (Measured through the Week 1 postpartum study visit); Antepartum Component: Number of Mothers With Obstetrical Complications (Measured through the Week 1 postpartum study visit); Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) (Measured at birth); Postpartum Component: Incidence of Confirmed Infant HIV Infection (Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first); Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events (Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first); Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death (From study entry until July 7, 2015, an average of 94 weeks of follow-up.)
C: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (Week 48)
D: HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study (At Month 6); Frequency and Severity of Adverse Reactions Among Participating Infants (6 weeks through 18 months)

Answer: A