Approval Probability
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Adjusted LOA
ML Risk
Lepetegravir · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Phase 2: Lepetegravir + Lenacapavir pacfosacil (Treatment Group 1) | EXPERIMENTAL | Participants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will switch to lepetegravir (650 mg tablet) and lenacapavir pacfosacil (300 mg tablet) coadministered. Participants will receive a 1-day loading dose of lepetegravir (1300 mg) and lenacapavir pacfosacil (600 mg) on Day 1. Thereafter, participants will take weekly doses of single agent lepetegravir (650 mg) and lenacapavir pacfosacil (300 mg) coadministered for at least 48 weeks. |
| Phase 2: Bictegravir/emtricitabine/tenofovir alafenamide (BVY) (Treatment Group 2) | ACTIVE_COMPARATOR | Participants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will continue receiving BVY daily for at least 48 weeks. |
| Phase 2 Extension Phase: Lepetegravir /Lenacapavir pacfosacil Fixed-dose Combination (FDC) | EXPERIMENTAL | At the end of the randomized treatment, Phase 2 participants will be given the option to participate in the Extension Phase. Phase 2 Treatment Group 1 will switch to lepetegravir /lenacapavir pacfosacil FDC weekly. Phase 2 Treatment Group 2 will receive a loading dose of lepetegravir /lenacapavir pacfosacil FDC on Extension Phase Day 1 then, lepetegravir/lenacapavir pacfosacil FDC weekly. Participants who choose to enter the Extension Phase will receive lepetegravir /lenacapavir pacfosacil FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first. |
| Phase 3: Lepetegravir /Lenacapavir pacfosacil FDC + Placebo to Match (PTM) BVY (Treatment Group 1) | EXPERIMENTAL | Participants who have been virologically suppressed on BVY will switch from BVY to lepetegravir/lenacapavir pacfosacil FDC tablets weekly + placebo-to-match (PTM) BVY once daily. In addition, participants will receive a 1-day loading dose regimen of lepetegravir /lenacapavir pacfosacil FDC on Day 1. Participants will receive treatment for at least 96 weeks. |
| Phase 3: BVY Placebo to Match Lepetegravir /Lenacapavir pacfosacil FDC + BVY (Treatment Group 2) | ACTIVE_COMPARATOR | Participants who have been virologically suppressed on BVY will continue receiving oral BVY daily. In addition, participants will receive a 1-day loading dose of PTM lepetegravir /lenacapavir pacfosacil on Day 1 and weekly PTM thereafter. Participants will receive treatment for at least 96 weeks. |
| Phase 3 Extension Phase: Lepetegravir/Lenacapavir pacfosacil Fixed-dose Combination (FDC) | EXPERIMENTAL | After the end of blinded treatment, Phase 3 participants will be given the option to participate in the Extension Phase. Phase 3 Treatment Group 1 will switch to lepetegravir/lenacapavir pacfosacil FDC weekly. Phase 3 Treatment Group 2 will receive a 1-day loading dose of lepetegravir/lenacapavir pacfosacil FDC on Extension Phase Day 1, then lepetegravir/lenacapavir pacfosacil FDC weekly. Participants who choose to enter the Extension Phase will receive lepetegravir/lenacapavir pacfosacil FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| Lepetegravir | DRUG | Tablets administered orally without regard to food |
| Lenacapavir pacfosacil | DRUG | Tablets administered orally without regard to food |
| Placebo to Match BVY | DRUG | Tablets administered orally without regard to food |
| Bictegravir/emtricitabine/tenofovir alafenamide | DRUG | Tablets administered orally without regard to food |
| Lepetegravir/Lenacapavir pacfosacil FDC | DRUG | Tablets administered orally without regard to food |
| Placebo to Match GS1720/GS-4182 FDC | DRUG | Tablets administered orally without regard to food |
Key Inclusion Criteria: * Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 24 weeks before and at screening. * Receiving BVY for ≥ 24 weeks prior to screening. Key Exclusion Criteria: * Prior use of, or exposure to LEN, lepetegravir, or lenacapavir pacfosacil. * History of virologic failure whil...
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Lepetegravir is an investigational small molecule being developed for the treatment of HIV-1 infection. It is currently in Phase 2 clinical development, studied in combination with lenacapavir pacfosacil as an oral weekly regimen for people with HIV-1 who are virologically suppressed.
Lepetegravir is an integrase inhibitor, targeting the HIV-1 integrase enzyme to block viral integration into host DNA. This mechanism is being evaluated in a Phase 2 trial for HIV-1 infection, where it is administered orally once weekly in combination with lenacapavir pacfosacil.
Lepetegravir is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. The drug is currently in Phase 2 clinical development for the treatment of HIV-1 infection.
Lepetegravir is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied in an active, not recruiting Phase 2 trial for HIV-1 infection.
Lepetegravir is being evaluated in one Phase 2 clinical trial, NCT06544733, which is active but not recruiting. The study compares oral weekly lepetegravir and lenacapavir pacfosacil versus Biktarvy in 675 participants with HIV-1 who are virologically suppressed, conducted in the United States and Puerto Rico.
Lepetegravir was formerly known as GS-1720. The Phase 2 trial NCT06544733 references the drug as 'Lepetegravir (Formerly GS-1720)', indicating that both names refer to the same investigational compound.