Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tenofovir alafenamide · 2 trials · 2 indications
Levels of TFV-DP (geometric mean), comparing the drugs TAF to TDF, observed in pregnancy. Note: Observation of daily PrEP dosing spanned 16 weeks in total, including 8 weeks during pregnancy and 8 weeks in postpartum. Once participants had completed their 8 weeks of in-pregnancy observation, observation of therapy was paused until they entered the postpartum phase.
Levels of TFV-DP (geometric mean), comparing the drugs TAF to TDF, observed in postpartum period. Note: Observation of daily PrEP dosing spanned 16 weeks in total, including 8 weeks during pregnancy and 8 weeks in postpartum. Once participants had completed their 8 weeks of in-pregnancy observation, observation of therapy was paused until they entered the postpartum phase.
Functional cure was defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than the lower limit of quantitation (LLOQ) at follow-up Week 24. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. The HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. Percentages were rounded off.
| Arm | Type | Description |
|---|---|---|
| TAF arm | EXPERIMENTAL | Fixed dose combination of 200 mg emtricitabine (FTC) and 25 mg tenofovir alafenamide (TAF) delivered under direct observation for 8 weeks during pregnancy and 8 weeks in postpartum period |
| TDF arm | ACTIVE_COMPARATOR | Fixed dose combination of 200 mg emtricitabine (FTC) and 300 mg tenofovir disoproxil fumarate (TDF) delivered under direct observation for 8 weeks during pregnancy and 8 weeks in postpartum period |
| Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | EXPERIMENTAL | Nucleos(t)ide(s) (NUC)-suppressed participants with chronic hepatitis B (CHB) will receive tenofovir alafenamide (TAF) 25 mg orally once daily (QD) for 36 weeks and VIR-2218 200 mg subcutaneously (SC) once every 4 weeks (Q4W) for 24 weeks. From Week 12 onwards, participants will receive selgantolimod (SLGN) 3 mg orally once a week (QW) for 24 weeks and nivolumab 0.3 mg/kg intravenously (IV) Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who are on TAF treatment will continue TAF treatment over the duration of study follow-up. Participants will be followed up for 48 weeks post treatment. |
| Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | EXPERIMENTAL | Viremic participants with CHB will receive VIR-2218, 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants will receive SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who meet the criteria to initiate NUC treatment will receive TAF 25, mg orally, QD during the study. Participants will be followed up for 48 weeks post treatment. |
| Cohort 2 Group B: SLGN + Nivolumab | EXPERIMENTAL | Viremic participants with CHB will receive SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. . Viremic participants who meet the criteria to initiate NUC treatment will receive TAF 25 mg orally QD during the study. Participants will be followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision. |
| Name | Type | Description |
|---|---|---|
| Tenofovir alafenamide | DRUG | Daily DOT fixed dose combination of 200 mg emtricitabine (FTC) and 25 mg tenofovir alafenamide (TAF) |
| Tenofovir Disoproxil Fumarate | DRUG | Daily DOT fixed dose combination of 200 mg emtricitabine (FTC) and 300 mg tenofovir disoproxil fumarate (TDF) |
| VIR-2218 | DRUG | Administered as a sub-cutaneous (SC) injection |
| Nivolumab | DRUG | Administered intravenously |
| Selgantolimod | DRUG | Administered as film-coated oral tablets |
Inclusion Criteria: 1. \>18 years old 2. confirmed HIV-negative (confirmed with a 4th generation antigen HIV test) at time of study entry 3. intend on giving birth in the MOU facility 4. confirmed to be 14-24 weeks pregnant 5. without psychiatric or medical contraindications to PrEP 6. estimated cr...
Tenofovir Alafenamide is a small molecule being studied for chronic Hepatitis B and HIV. It is developed by Gilead Sciences, Inc. (GILD). The drug is currently in clinical development and is not approved for these indications.
Tenofovir Alafenamide is a nucleotide reverse transcriptase inhibitor that works by blocking the action of reverse transcriptase, an enzyme needed for viral replication. This helps reduce the amount of virus in the body.
Tenofovir Alafenamide is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker GILD. The company is conducting clinical trials to evaluate the drug for chronic Hepatitis B and HIV.
Tenofovir Alafenamide is in Phase 2 clinical development for chronic Hepatitis B. It has completed a Phase 2 trial and a Phase 3 trial for HIV. The drug is investigational and has not been approved by regulatory authorities.
Tenofovir Alafenamide has been studied in two completed trials. NCT04891770 is a Phase 2 trial for chronic Hepatitis B with 103 participants. NCT04937881 is a Phase 3 trial for HIV in pregnant and postpartum women with 39 participants.
Yes, Tenofovir Alafenamide is commonly abbreviated as TAF. It is a prodrug of tenofovir and is being studied for the treatment of chronic Hepatitis B and HIV.