Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication TRUVADA is a combination of EMTRIVA and VIREAD, both nucleoside analog HIV-1 reverse transcriptase inhibitors. TRUVADA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. FDA label
Also known as FTC, Truvada®, PrEP
FTC/TDF · 10 trials · 4 indications
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm. The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.
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 |
|---|---|---|
| B/F/TAF | EXPERIMENTAL | Participants will switch to B/F/TAF FDC and receive treatment for 48 weeks. |
| Baseline Regimen | ACTIVE_COMPARATOR | Participants will remain on their baseline regimen of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF for 48 weeks. |
| Extension Phase | EXPERIMENTAL | Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF for up to 48 additional weeks. |
| FTC/RPV/TAF | EXPERIMENTAL | FTC/RPV/TAF plus EFV/FTC/TDF placebo for at least 96 weeks. |
| EFV/FTC/TDF | ACTIVE_COMPARATOR | EFV/FTC/TDF plus FTC/RPV/TAF placebo for at least 96 weeks. |
| Open Label Extension Phase | EXPERIMENTAL | After the Week 96 visit, participants will be given the option to receive open label FTC/RPV/TAF for up to an additional 48 weeks. In countries where FTC/RPV/TAF is not yet commercially available, participants will be given the option to receive open-label FTC/RPV/TAF and attend visits every 12 weeks until FTC/RPV/TAF becomes commercially available, or until Gilead elects to discontinue the study, whichever occurs first. |
| FTC/RPV/TDF | ACTIVE_COMPARATOR | FTC/RPV/TDF plus FTC/RPV/TAF placebo for at least 96 weeks. |
| F/TAF + 3rd Agent | EXPERIMENTAL | Participants will receive F/TAF (200/25 mg or 200/10 mg) plus FTC/TDF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks. Dosing of F/TAF will be dependent on the third agent of the participants' pre-existing treatment regimen. |
| FTC/TDF + 3rd Agent | ACTIVE_COMPARATOR | Participants will receive FTC/TDF plus F/TAF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks. |
| E/C/F/TDF | EXPERIMENTAL | E/C/F/TDF + ATV placebo + RTV placebo + FTC/TDF placebo |
| ATV + RTV+ FTC/TDF | ACTIVE_COMPARATOR | ATV + RTV + FTC/TDF + E/C/F/TDF placebo |
| Open-Label Extension Phase | EXPERIMENTAL | After 48 weeks of blinded treatment, participants will continue to take blinded study drug for 12 weeks and return for an unblinding visit at Week 60. Participants who are virologically suppressed at Week 48 during the double-blinded treatment phase will have the option to enter the open-label extension phase. Participants randomized to the E/C/F/TDF arm will continue to receive open-label E/C/F/TDF and participants randomized to the ATV+ RTV + FTC/TDF arm will be re-randomized to receive either open-label elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or open-label ATV + RTV+ FTC/TDF. |
| SBR/Delayed Switch | EXPERIMENTAL | Participants will stay on baseline regimen (SBR; their existing treatment regimen of PI+RTV plus 2 NRTIs) at the beginning of the study through Week 24, and may switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit. |
| 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 |
|---|---|---|
| E/C/F/TAF | DRUG | 150/150/200/10 mg FDC tablet administered orally once daily with food |
| E/C/F/TDF | DRUG | 150/150/200/300 mg FDC administered orally once daily with food |
| ATV | DRUG | ATV 300 mg capsules administered orally once daily with food |
| RTV | DRUG | RTV 100 mg tablets administered orally once daily with food |
| FTC/TDF | DRUG | 200/300 mg tablet administered orally once daily with food |
| B/F/TAF | DRUG | 50/200/25 mg FDC tablet administered orally once daily without regard to food |
| FTC/RPV/TAF | DRUG | 200/25/25 mg FDC tablets administered orally once daily |
| EFV/FTC/TDF Placebo | DRUG | Tablets administered orally once daily |
| EFV/FTC/TDF | DRUG | 600/200/300 mg FDC tablets administered orally once daily |
| FTC/RPV/TAF Placebo | DRUG | Tablets administered orally once daily |
| FTC/RPV/TDF Placebo | DRUG | Tablets administered orally once daily |
| FTC/RPV/TDF | DRUG | 200/25/300 mg FDC tablets administered orally once daily |
| F/TAF | DRUG | Tablets administered orally once daily |
| Allowed third antiretroviral agent | DRUG | An allowed third antiretroviral agent of the participant's pre-existing regimen may include one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®). |
| FTC/TDF Placebo | DRUG | Tablets administered orally once daily |
| F/TAF Placebo | DRUG | Tablets administered orally once daily |
| E/C/F/TDF Placebo | DRUG | Tablet administered orally with food once daily |
| ATV Placebo | DRUG | Tablet administered orally with food once daily |
| RTV Placebo | DRUG | Capsule administered orally with food once daily |
| PI | DRUG | Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir. PIs were administered according to prescribing information. |
| NRTIs | DRUG | NRTIs included abacavir, emtricitabine, Combivir (lamivudine/zidovudine, coformulated), Epzicom (abacavir/lamivudine, coformulated), lamivudine, stavudine, tenofovir DF, Truvada® (emtricitabine/tenofovir DF, coformulated), and zidovudine. NRTIs were administered according to prescribing information. |
| 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 Medically stable HIV-1 infected women who meet the following criteria: * Completion of the Week 48 open-label extension (OLE) visit or any post Week 48 OLE visits in Gilead-sponsored study GS-US-236-0128, or Completion of the Week 96 visit or any post Week 96 visits in Gilea...
FTC/TDF is a small molecule fixed dose combination of emtricitabine and tenofovir disoproxil fumarate developed by Gilead Sciences, Inc. (GILD). It is studied for HIV-1 infection, acquired immunodeficiency syndrome, and chronic hepatitis B. The combination has been evaluated in Phase 3 clinical development, including active controlled and double blind trials.
FTC/TDF is used for the treatment of HIV-1 infection, acquired immunodeficiency syndrome, and chronic hepatitis B. Clinical trials of the combination have enrolled adults with HIV-1 infection, including virologically suppressed patients, and have examined its use as part of antiretroviral regimens in these infectious disease indications.
FTC/TDF is developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the Phase 3 clinical program evaluating the emtricitabine and tenofovir disoproxil fumarate combination in HIV-1 infection, acquired immunodeficiency syndrome, and chronic hepatitis B.
FTC/TDF has been evaluated in Phase 3 clinical development. Seven trials of the combination are recorded, all of which are completed, with no active trials ongoing. The program enrolled a total of 3,984 participants across randomized, double blind, active controlled studies.
FTC/TDF has been studied in completed Phase 3 trials including NCT02652624, NCT02345252, NCT02345226, and NCT02121795. These trials enrolled virologically suppressed HIV-1 infected adults and evaluated switching to fixed dose combinations containing emtricitabine and tenofovir, with enrollment ranging from 472 to 881 participants per study.