Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABC/3TC · 3 trials · 1 indication
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 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 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 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.
| Arm | Type | Description |
|---|---|---|
| E/C/F/TAF | EXPERIMENTAL | Participants will switch to E/C/F/TAF FDC and receive treatment for 48 weeks. |
| ABC/3TC+3rd Agent | ACTIVE_COMPARATOR | Participants will maintain prior regimen of ABC/3TC plus a third antiretroviral agent for 24 weeks followed by a delayed switch to E/C/F/TAF FDC. Note: the prior regimen is determined by the participant's clinician (prior to entry into the study) and will consist of one of the third antiretroviral agents listed. |
| B/F/TAF | EXPERIMENTAL | B/F/TAF + ABC/DTG/3TC placebo administered without regard to food for at least 144 weeks. |
| ABC/DTG/3TC | ACTIVE_COMPARATOR | ABC/DTG/3TC + B/F/TAF placebo administered without regard to food for at least 144 weeks. |
| Open-label Phase B/F/TAF to B/F/TAF | EXPERIMENTAL | After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first. |
| Open-label Phase ABC/DTG/3TC to B/F/TAF | EXPERIMENTAL | After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first. |
| Blinded Phase: B/F/TAF | EXPERIMENTAL | B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks |
| Blinded Phase: ABC/DTG/3TC | ACTIVE_COMPARATOR | ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks |
| Open-Label Phase | EXPERIMENTAL | At the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF is demonstrated following review of unblinded data, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 96 weeks, or until the product becomes accessible to subjects through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| E/C/F/TAF | DRUG | 150/150/200/10 mg FDC tablets administered orally once daily |
| ABC/3TC | DRUG | 600/300 mg tablets administered orally once daily |
| Third Antiretroviral Agent | DRUG | Third antiretroviral agents could include one of the following: * ATV+cobicistat (COBI; Tybost®) or ATV/COBI FDC * DRV+COBI or DRV/COBI FDC * darunavir (DRV; Prezista®) + RTV * lopinavir/ritonavir (LPV/r; Kaletra®) * atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®) * efavirenz (EFV; Sustiva®) * etravirine (ETR; Intelence®) * nevirapine (NVP; Viramune®) * rilpivirine (RPV; Edurant®) * dolutegravir (DTG; Tivicay®) * raltegravir (RAL; Isentress®) * fosamprenavir (FPV; Lexiva®) + RTV * saquinavir (SQV; Invirase®) + RTV * ATV (no booster) Drug classes: * Protease inhibitors (PI): LPV/r, ATV, RTV, ATV, DRV, FPV and SQV * Pharmacokinetic enhancer: COBI * Non-nucleoside reverse transcriptase inhibitors (NNRTI): EFV, RPV, NVP, and ETR * Integrase inhibitors: RAL and DTG |
| ABC/DTG/3TC | DRUG | 600/50/300 milligrams (mg) tablets administered orally, once daily |
| B/F/TAF | DRUG | 50/200/25 mg tablets administered orally, once daily, without regard to food |
| ABC/DTG/3TC Placebo | DRUG | Tablets administered orally, once daily |
| B/F/TAF Placebo | DRUG | Tablets administered orally, once daily |
Key Inclusion Criteria: HIV-infected adult participants who meet the following criteria will be given the option to participate in the study: * Currently receiving ABC/3TC plus a third antiretroviral (ARV) agent for ≥ 6 consecutive months preceding the screening visit. For subjects with 3 or more ...
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ABC/DTG/3TC is an investigational small molecule combination therapy being studied for the treatment of HIV-1 infection. It is in Phase 3 clinical development and has been evaluated in two completed trials involving a total of 1,198 participants. The drug is not yet approved and remains under clinical investigation.
ABC/DTG/3TC is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting Phase 3 clinical trials to evaluate the safety and efficacy of this combination therapy for HIV-1 infection.
ABC/DTG/3TC is in Phase 3 clinical development. Two Phase 3 trials have been completed, both with active-controlled, randomized, double-blind designs. The drug is investigational and has not been approved by regulatory authorities for the treatment of HIV-1 infection.
ABC/DTG/3TC has been studied in two completed Phase 3 trials. NCT02603120 evaluated switching from dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in virologically suppressed adults with HIV-1, enrolling 567 participants. NCT02607930 compared bictegravir/emtricitabine/tenofovir alafenamide versus ABC/DTG/3TC in treatment-naive adults, enrolling 631 participants.
No, ABC/DTG/3TC is not the same as B/F/TAF. ABC/DTG/3TC contains abacavir, dolutegravir, and lamivudine, while B/F/TAF contains bictegravir, emtricitabine, and tenofovir alafenamide. In clinical trials, B/F/TAF has been studied as a comparator or switch option relative to ABC/DTG/3TC in HIV-1 infected adults.