Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BIC
Bictegravir/lenacapavir · 1 trial · 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.
| Arm | Type | Description |
|---|---|---|
| BIC + F/TAF | EXPERIMENTAL | Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks. * Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF. |
| DTG + F/TAF | ACTIVE_COMPARATOR | Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks. * Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF. |
| Open Label Extension Phase | EXPERIMENTAL | After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF. |
| Name | Type | Description |
|---|---|---|
| BIC | DRUG | 75 mg tablet administered orally once daily |
| F/TAF | DRUG | 200/25 mg FDC tablet administered orally once daily |
| DTG | DRUG | 50 mg tablet administered orally once daily |
| BIC Placebo | DRUG | Tablet administered orally once daily |
| DTG Placebo | DRUG | Tablet administered orally once daily |
| B/F/TAF | DRUG | 50/200/25 mg FDC tablet administered orally once daily |
Key Inclusion Criteria: * Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent) * Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening * Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC) * Adequate rena...
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Bictegravir/lenacapavir is an investigational fixed-dose combination of two small molecule antivirals being developed by Gilead Sciences for the treatment of HIV-1 infection. It is in Phase 2 clinical development and is not yet approved. The combination pairs bictegravir with lenacapavir in a single regimen.
Bictegravir/lenacapavir is being developed for the treatment of HIV-1 infection. The clinical program has studied it in antiretroviral treatment-naive adults living with HIV-1. It remains investigational, so it is not currently available as a prescribed treatment outside of clinical research.
Bictegravir/lenacapavir is being developed by Gilead Sciences, Inc., which trades on Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program evaluating the fixed-dose combination in HIV-1 infection.
Bictegravir/lenacapavir is in Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently listed as active. The drug is investigational and has not been approved by the FDA for any indication.
Bictegravir/lenacapavir has been studied in the completed Phase 2 trial NCT02397694, which evaluated bictegravir plus emtricitabine/tenofovir alafenamide versus dolutegravir plus emtricitabine/tenofovir alafenamide in HIV-1 infected, antiretroviral treatment-naive adults. The trial enrolled 98 participants in the United States and was randomized, double-blind, and active-controlled.