Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Epzicom, Kivexa
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/3TC is a small molecule antiretroviral combination studied for the treatment of HIV-1 infection. It has been evaluated in Phase 3 clinical trials in antiretroviral treatment-naive adults and in virologically suppressed adults, including as a comparator regimen in studies of switching HIV therapies.
ABC/3TC is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead sponsored the Phase 3 HIV-1 clinical trials in which ABC/3TC was studied as a comparator regimen.
ABC/3TC has been studied in Phase 3 clinical development for HIV-1 infection. Three Phase 3 trials of ABC/3TC have been completed, and no active trials are currently listed. The program enrolled a total of 1,473 participants across those completed studies.
ABC/3TC has been evaluated in three completed Phase 3 trials: NCT02607930, which compared bictegravir/emtricitabine/tenofovir alafenamide with abacavir/dolutegravir/lamivudine in treatment-naive adults; NCT02605954, a switch study; and NCT02603120, which studied switching from dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF.
ABC/3TC has been studied in randomized, double-blind, active-controlled Phase 3 trials in adults with HIV-1 infection. The trials enrolled participants aged 18 years and older across sites in the United States, Canada, and multiple European countries, and all three studies have been completed.