Please select the arm or intervention descriptions that belong 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: Arm Label: Control arm: HBIG & vaccine for infants; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: TDF treatment arm; Type: EXPERIMENTAL; Interventions: Drug: TDF treatment | Intervention Type: DRUG; Name: TDF treatment; Assigned to Arm(s): TDF treatment arm
B: Arm Label: Antepartum Arm A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Zidovudine (ZDV), Drug: Nevirapine (NVP): Antepartum Mothers, Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail, Drug: Nevirapine (NVP): Infant short-course | Arm Label: Antepartum Arm B; Type: EXPERIMENTAL; Interventions: Drug: Lamivudine-Zidovudine (3TC-ZDV), Drug: Lopinavir-ritonavir (LPV-RTV), Drug: Nevirapine (NVP): Infant short-course | Arm Label: Antepartum Arm C; Type: EXPERIMENTAL; Interventions: Drug: Lopinavir-ritonavir (LPV-RTV), Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]), Drug: Nevirapine (NVP): Infant short-course | Arm Label: Late Presenters; Type: OTHER; Interventions: Other: No Intervention | Arm Label: Postpartum Arm A (Maternal Prophylaxis); Type: EXPERIMENTAL; Interventions: Drug: Lopinavir-ritonavir (LPV-RTV), Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]), Drug: Nevirapine (NVP): Infant short-course | Arm Label: Postpartum Arm B (Infant Prophylaxis); Type: EXPERIMENTAL; Interventions: Drug: Nevirapine (NVP): Infant extended | Arm Label: Maternal Health Arm A (Continue triple ARVs); Type: EXPERIMENTAL; Interventions: Other: Continue triple ARVs | Arm Label: Maternal Health Arm B (Discontinue triple ARVs); Type: ACTIVE_COMPARATOR; Interventions: Other: Discontinue triple ARVs | Intervention Type: DRUG; Name: Zidovudine (ZDV); Assigned to Arm(s): Antepartum Arm A | Intervention Type: DRUG; Name: Nevirapine (NVP): Antepartum Mothers; Assigned to Arm(s): Antepartum Arm A | Intervention Type: DRUG; Name: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail; Assigned to Arm(s): Antepartum Arm A | Intervention Type: DRUG; Name: Lamivudine-Zidovudine (3TC-ZDV); Assigned to Arm(s): Antepartum Arm B | Intervention Type: DRUG; Name: Lopinavir-ritonavir (LPV-RTV); Assigned to Arm(s): Antepartum Arm B, Antepartum Arm C, Postpartum Arm A (Maternal Prophylaxis) | Intervention Type: DRUG; Name: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]); Assigned to Arm(s): Antepartum Arm C, Postpartum Arm A (Maternal Prophylaxis) | Intervention Type: DRUG; Name: Nevirapine (NVP): Infant short-course; Assigned to Arm(s): Antepartum Arm A, Antepartum Arm B, Antepartum Arm C, Postpartum Arm A (Maternal Prophylaxis) | Intervention Type: DRUG; Name: Nevirapine (NVP): Infant extended; Assigned to Arm(s): Postpartum Arm B (Infant Prophylaxis) | Intervention Type: OTHER; Name: No Intervention; Assigned to Arm(s): Late Presenters | Intervention Type: OTHER; Name: Discontinue triple ARVs; Assigned to Arm(s): Maternal Health Arm B (Discontinue triple ARVs) | Intervention Type: OTHER; Name: Continue triple ARVs; Assigned to Arm(s): Maternal Health Arm A (Continue triple ARVs)
C: Arm Label: E/C/F/TAF; Type: EXPERIMENTAL; Interventions: Drug: E/C/F/TAF | Arm Label: Stay on Baseline Treatment Regimen (SBR); Type: ACTIVE_COMPARATOR; Interventions: Drug: E/C/F/TDF, Drug: EFV/FTC/TDF, Drug: RTV, Drug: ATV, Drug: FTC/TDF, Drug: COBI | Intervention Type: DRUG; Name: E/C/F/TAF; Assigned to Arm(s): E/C/F/TAF | Intervention Type: DRUG; Name: E/C/F/TDF; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: EFV/FTC/TDF; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: RTV; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: ATV; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: FTC/TDF; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: COBI; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR)
D: Arm Label: 2A; Type: EXPERIMENTAL; Interventions: Drug: Nevirapine | Arm Label: 2B; Type: PLACEBO_COMPARATOR; Interventions: Drug: Nevirapine placebo | Intervention Type: DRUG; Name: Nevirapine; Assigned to Arm(s): 2A | Intervention Type: DRUG; Name: Nevirapine placebo; Assigned to Arm(s): 2B

Answer: A