Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TDF/FTC/ fixed-dose combination · 1 trial · 1 indication
Number of HIV infections defined by the presence of HIV ribonucleic acid (RNA) in plasma through study completion (an average of two years) in the event-driven F/TAF arm.
| Arm | Type | Description |
|---|---|---|
| Event-driven PrEP with TDF/FTC | ACTIVE_COMPARATOR | Participants randomly assigned to the event-driven TDF/FTC arm will be instructed to take a loading dose of two single tablets containing coformulated TDF/FTC (300/200mg) 2 to 24 hours before sexual intercourse, followed by a third pill 24 hours after the first drug intake and a fourth pill 24 hours later. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse, then to take the two post-exposure pills. |
| Event-driven PrEP with TAF/FTC | EXPERIMENTAL | Participants randomly assigned to the event-driven TAF/FTC arm will be instructed to take one single tablet containing coformulated TAF/FTC (25/200mg) with or without food 2 to 24 hours before sexual intercourse followed by a second pill 24 hours after the first drug intake. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse and then a last pill 24 hours later. |
| Name | Type | Description |
|---|---|---|
| TDF/FTC 300mg/200mg fixed-dose combination tablets | DRUG | Event-driven dosing regimen |
| TAF/FTC 25mg/200mg fixed-dose combination tablets | DRUG | Event-driven dosing regimen. |
Inclusion Criteria: * Male at birth age ≥ 18 years old * Reporting having sex with men * Negative 4th generation HIV-1 and HIV-2 test * Reporting condomless anal sex with men not more often than two days during the previous month and able to plan their sexual activity * Risk of HIV acquisition base...
TDF, also known as tenofovir disoproxil fumarate, is used for the treatment of chronic hepatitis B and HIV/AIDS. In clinical trials, it has been studied as a monotherapy for chronic hepatitis B and as part of combination regimens for HIV pre-exposure prophylaxis (PrEP).
TDF is a nucleotide reverse transcriptase inhibitor that works by inhibiting the reverse transcriptase enzyme, which is essential for viral replication. It is active against both hepatitis B virus and HIV, blocking the virus from multiplying in the body.
TDF is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead has conducted multiple clinical trials evaluating TDF for chronic hepatitis B and HIV.
TDF is in Phase 3 clinical development for HIV/AIDS, with an ongoing trial evaluating its use as event-driven HIV pre-exposure prophylaxis. It has completed Phase 3 trials for chronic hepatitis B, and it is also being studied in combination with other agents.
TDF is being evaluated in an ongoing Phase 3 trial (NCT05813964) for HIV pre-exposure prophylaxis in men who have sex with men. Completed trials include NCT00116805 and NCT00117676, which compared TDF to adefovir dipivoxil for chronic hepatitis B, and NCT02579382, which studied TDF with vesatolimod.
TDF refers to tenofovir disoproxil fumarate alone, while TDF/FTC is a fixed-dose combination tablet containing TDF and emtricitabine. The combination product is used in HIV treatment and prevention, whereas TDF alone is studied for hepatitis B.