Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIC · 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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BIC is an investigational small molecule being developed for the treatment of HIV-1 infection. It is studied in combination with emtricitabine and tenofovir alafenamide as a fixed-dose regimen. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
BIC is an integrase strand transfer inhibitor that targets the HIV-1 integrase enzyme. By inhibiting this enzyme, BIC blocks the integration of viral DNA into the host cell genome, which is a critical step in the HIV-1 replication cycle. This mechanism is shared with other drugs in its class.
BIC is being developed by Gilead Sciences, Inc., a biopharmaceutical company headquartered in the United States. Gilead Sciences is publicly traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the safety and efficacy of BIC in patients with HIV-1 infection.
BIC is currently in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, active-controlled study. The drug is still investigational and has not received approval from the U.S. Food and Drug Administration or any other regulatory agency.
BIC has been evaluated in one completed clinical trial with the identifier NCT02397694. This Phase 2 study compared the safety and efficacy of 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.
BIC is also known as BIC/LEN FDC or BIC/LEN, which refers to a fixed-dose combination of bictegravir and lenacapavir. However, the clinical trial data provided for BIC specifically evaluates bictegravir in combination with emtricitabine and tenofovir alafenamide, not with lenacapavir. The alternative names may reflect a different formulation or combination under investigation.