Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DTG · 1 trial · 1 indication
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 |
|---|---|---|
| B/F/TAF | EXPERIMENTAL | B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks. |
| DTG + F/TAF | ACTIVE_COMPARATOR | DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks. |
| Open-label Phase B/F/TAF from 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 B/F/TAF from DTG + 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. |
| Name | Type | Description |
|---|---|---|
| DTG | DRUG | 50 mg tablets administered orally, once daily |
| F/TAF | DRUG | 200/25 mg tablets administered orally, once daily |
| B/F/TAF | DRUG | 50/200/25 milligrams (mg) FDC tablets administered orally, once daily |
| DTG Placebo | DRUG | Tablets administered orally, once daily |
| F/TAF Placebo | DRUG | Tablets administered orally, once daily |
| B/F/TAF Placebo | DRUG | Tablets administered orally, once daily |
Key Inclusion Criteria: * Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening * Plasma HIV-1 ribon...
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DTG is an investigational small molecule being developed for the treatment of HIV-1 infection. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. DTG is being studied in antiretroviral treatment-naive adults with HIV-1 infection.
DTG is a small molecule developed by Gilead Sciences. While the specific molecular target is not disclosed, it is being evaluated in combination with emtricitabine and tenofovir alafenamide for the treatment of HIV-1 infection. The drug is intended to be used as part of an antiretroviral regimen.
DTG is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead is conducting clinical trials to evaluate the safety and efficacy of DTG in patients with HIV-1 infection.
DTG is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied in a completed Phase 3 trial that enrolled 657 participants with HIV-1 infection.
DTG was evaluated in a Phase 3 clinical trial with the identifier NCT02607956. This randomized, double-blind, active-controlled study assessed the safety and efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir plus emtricitabine/tenofovir alafenamide in HIV-1 infected, antiretroviral treatment-naive adults. The trial has been completed.
DTG is not the same as bictegravir. DTG is a separate investigational drug being developed by Gilead Sciences. In the clinical trial NCT02607956, DTG was compared against a regimen containing bictegravir, emtricitabine, and tenofovir alafenamide, indicating they are distinct compounds.