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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