Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FTC/RPV/TDF · 6 trials · 1 indication
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 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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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 |
| FTC/TDF | DRUG | 200/300 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 |
| PI | DRUG | Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir. PIs were administered according to prescribing information. |
| RTV | DRUG | Ritonavir (RTV) was 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. |
Key Inclusion Criteria: * The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * Currently receiving EFV/FTC/TDF FDC for ≥ 6 consecutive months preceding the screening visit * Documented plasma HIV-1 RNA levels \< 50 copi...
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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.