Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RTV · 1 trial · 1 indication
The percentage of participants with 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 |
|---|---|---|
| B/F/TAF | EXPERIMENTAL | Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for at least 48 weeks, without regard to food. Extension Phase: After Week 48, participants in countries where B/F/TAF is not available will be given the option to receive B/F/TAF for up to 96 additional weeks or until the product becomes accessible to participants through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first. |
| Stay on Baseline Regimen (SBR) | EXPERIMENTAL | Randomized Phase: Participants remained on current antiretroviral (ARV) regimen consisting of ritonavir (RTV)-boosted or cobicistat (COBI)-boosted atazanavir (ATV) or darunavir (DRV), plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) for at least 48 weeks with food. Extension Phase: After Week 48, participants in countries where B/F/TAF is not available will be given the option to receive B/F/TAF for up to 96 additional weeks or until the product becomes accessible to participants through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| RTV | DRUG | 100 mg capsule coadministered orally with ATV or DRV once daily with food |
| ATV | DRUG | 300 mg capsule administered orally once daily with food |
| DRV | DRUG | 800 mg tablet administered orally once daily with food |
| COBI | DRUG | 150 mg tablet coadministered orally with ATV or DRV once daily with food |
| ATV/co | DRUG | 300/150 mg FDC tablet administered orally once daily with food |
| DRV/co | DRUG | 800/150 mg FDC tablet administered orally once daily with food |
| FTC/TDF | DRUG | 200/300 mg FDC tablet administered orally once daily without regard to food |
| ABC/3TC | DRUG | 600/300 mg tablet administered orally once daily with or without regard to food |
| B/F/TAF | DRUG | 50/200/25 mg FDC tablet administered orally once daily without regard to food |
Key Inclusion Criteria: * Currently receiving a once daily antiretroviral regimen consisting of ritonavir or cobicistat boosted ATV or DRV plus either FTC/TDF or ABC/3TC for ≥ 6 months preceding the screening visit * Adequate renal function: * Estimated glomerular filtration rate ≥ 50 mL/min (≥ ...
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RTV is a small molecule being developed for the treatment of HIV-1 Infection. It is currently in Phase 3 clinical development. The drug is being studied as part of a regimen switch in virologically suppressed HIV-1 infected adults.
RTV is being developed by Gilead Sciences, Inc., which is publicly traded under the ticker symbol GILD on the NASDAQ. Gilead is conducting clinical trials to evaluate the safety and efficacy of RTV in patients with HIV-1 Infection.
RTV is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, with a total enrollment of 578 participants.
RTV is associated with one completed Phase 3 clinical trial, identified as NCT02603107. This study evaluated the safety and efficacy of switching from regimens consisting of boosted atazanavir or darunavir plus either emtricitabine/tenofovir or abacavir/lamivudine to bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed HIV-1 infected adults.
RTV is not the same as bictegravir. In the clinical trial NCT02603107, RTV is part of a fixed-dose combination that includes bictegravir, emtricitabine, and tenofovir alafenamide. RTV refers to the investigational drug being studied, which is the combination product.