Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02071082 | Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults | PHASE3 | COMPLETED | 79 | — | — | Feb 25, 2014 | Oct 26, 2016 | Nov 16, 2018 | 24 | United States, Canada +1 |
| NCT01815736 | Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants | PHASE3 | COMPLETED | 1,443 | — | — | Mar 27, 2013 | Apr 1, 2020 | Apr 13, 2021 | 167 | United States, Australia +18 |
| NCT01818596 | Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment | PHASE3 | COMPLETED | 252 | — | — | Mar 27, 2013 | Jul 18, 2018 | Mar 2, 2020 | 70 | United States, Australia +7 |
| NCT01797445 | Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults | PHASE3 | COMPLETED | 872 | — | — | Mar 12, 2013 | Oct 3, 2018 | Mar 2, 2020 | 117 | United States, Canada +9 |
| NCT01780506 | Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults | PHASE3 | COMPLETED | 872 | — | — | Dec 26, 2012 | Sep 6, 2017 | Nov 19, 2018 | 117 | United States, Australia +10 |
| NCT02276612 | Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents | PHASE2 | COMPLETED | 60 | — | — | Dec 3, 2014 | Oct 23, 2017 | Nov 19, 2018 | 7 | United States, South Africa |
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 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 with HBV DNA \< 29 IU/mL at Week 24 was calculated using the missing = failure method.
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.
eGFR is a measurement of the kidney's ability to filter blood.
eGFR is a measurement of the kidney's ability to filter blood. The eGFR\_CKD-EPI,cysC method is adjusted for age and sex.
eGFR is a measurement of the kidney's ability to filter blood. The eGFR\_CKD-EPI,creatinine method is adjusted for age, race, and sex.
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 experiencing any treatment-emergent serious adverse event was summarized.
The percentage of participants experiencing any treatment-emergent adverse event was summarized.
| Arm | Type | Description |
|---|---|---|
| HIV treatment-naive and HBV treatment-naive | EXPERIMENTAL | HIV/HBV coinfected participants who are HIV treatment-naive and HBV treatment-naive will receive E/C/F/TAF for 48 weeks. |
| HIV-suppressed | EXPERIMENTAL | HIV/HBV coinfected participants who are HIV-suppressed will receive E/C/F/TAF for 48 weeks. |
| E/C/F/TAF | EXPERIMENTAL | Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment, all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF. |
| Stay on Baseline Treatment Regimen (SBR) | ACTIVE_COMPARATOR | Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF. |
| E/C/F/TAF (Double-Blind) | EXPERIMENTAL | E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded. |
| E/C/F/TDF (Double-Blind) | ACTIVE_COMPARATOR | E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded. |
| Open-Label E/C/F/TAF | EXPERIMENTAL | After the unblinding visit, in countries where E/C/F/TAF is not commercially available, participants (except in UK) who complete 144 weeks of study will be given the option to receive open-label E/C/F/TAF and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country. |
| E/C/F/TAF (Double-Blind Phase) | EXPERIMENTAL | E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks |
| E/C/F/TDF (Double-Blind Phase) | ACTIVE_COMPARATOR | E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks |
| Open-Label Extension Phase | EXPERIMENTAL | After study unblinding, participants who complete 144 weeks of the study had the option to receive open-label E/C/F/TAF until commercially available, or until Gilead Sciences terminated the study in that country. |
| Name | Type | Description |
|---|---|---|
| E/C/F/TAF | DRUG | E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food |
| E/C/F/TDF | DRUG | 150/150/200/300 mg FDC tablet administered orally once daily |
| EFV/FTC/TDF | DRUG | 600/200/300 mg FDC tablet administered orally once daily |
| RTV | DRUG | 100 mg tablet administered orally once daily |
| ATV | DRUG | 300 mg capsule administered orally once daily |
| FTC/TDF | DRUG | 200/300 mg tablet administered orally once daily |
| COBI | DRUG | 150 mg tablet administered orally once daily |
| E/C/F/TDF Placebo | DRUG | Tablet administered orally once daily |
| E/C/F/TAF Placebo | DRUG | Tablet administered orally once daily |
Key Inclusion Criteria: * Both Cohorts 1 and 2: * The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * HIV/HBV co-infected adult males and non-pregnant and non-lactating females * No evidence of hepatocellular ca...