Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FTC/TDF · 2 trials · 1 indication
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.
HBV recurrence was defined as either HBV DNA ≥ 400 at 2 consecutive visits before Week 72, or HBV DNA ≥ 400 at the Week 72 visit.
| Arm | Type | Description |
|---|---|---|
| FTC/TDF | EXPERIMENTAL | - |
| FTC/TDF+HBIg | EXPERIMENTAL | Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. |
| Name | Type | Description |
|---|---|---|
| FTC/TDF | DRUG | 200/300 mg tablet administered orally once daily |
| Hepatitis B Immunoglobulin (HBIg) | DRUG | HBIg was administered either intravenously or by intramuscular injection at a dose and frequency as prescribed by the investigative site protocol. |
Key Inclusion Criteria: * Complete all end of study visit procedures and pharmacokinetic (PK) substudy (if applicable) for the GS US 203 0107 study. * A negative pregnancy test is required for female individuals at the end of study visit for GS US 203 0107 (unless surgically sterile or greater than...
FTC/RPV/TDF is a fixed-dose combination of emtricitabine, rilpivirine, and tenofovir disoproxil fumarate being developed for chronic hepatitis B and HIV-1 infection. It is an investigational small molecule therapy studied in clinical trials for these infectious disease indications.
FTC/RPV/TDF combines three antiretroviral agents: emtricitabine and tenofovir disoproxil fumarate are nucleoside reverse transcriptase inhibitors, and rilpivirine is a non-nucleoside reverse transcriptase inhibitor. Together they target HIV reverse transcriptase to block viral replication.
FTC/RPV/TDF is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. Gilead is conducting clinical trials to evaluate the combination for chronic hepatitis B and HIV-1 infection.
FTC/RPV/TDF is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Gilead has completed six trials, including Phase 2 and Phase 3 studies, with a total enrollment of 3,512 participants.
FTC/RPV/TDF has been studied in six completed trials. Key studies include NCT01252940, a Phase 3 trial in HIV-1 infection, and NCT00507689, a Phase 2 trial in chronic hepatitis B. Other trials include NCT00936715 and NCT01286740, all completed.
FTC/RPV/TDF is a combination of emtricitabine, rilpivirine, and tenofovir disoproxil fumarate. It is not the same as Complera or Atripla, which contain different components. Complera includes emtricitabine, rilpivirine, and tenofovir disoproxil fumarate, while Atripla contains efavirenz instead of rilpivirine.