Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Teropavimab · 1 trial · 1 indication
Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; or b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL. Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off.
| Arm | Type | Description |
|---|---|---|
| Randomized Phase Treatment Group 1: LEN + TAB + ZAB | EXPERIMENTAL | Participants will receive loading dose of lenacapavir (LEN) 600 mg tablets, orally, on Day 1 and Day 2. They will receive LEN 927 mg subcutaneous (SC) injection along with teropavimab (TAB) 2550 mg intravenous (IV) infusion and zinlirvimab (ZAB) 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL will be given the option to participate in the study extension phase. In the study extension phase, participants will continue to receive their randomized study drugs every 26 weeks. |
| Randomized Phase Treatment Group 3: SBR | EXPERIMENTAL | Participants in Stay on Baseline Regimen (SBR) group will continue their baseline oral antiretroviral therapy (ART) up to Week 52. Antiretroviral therapy will include drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study will switch from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants will switch to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52. |
| Extension Phase: Treatment Group 1: LEN + TAB + ZAB | EXPERIMENTAL | At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL will be given the option to participate in the study extension phase. In the study extension phase, participants will receive LEN 927 mg SC, TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion. |
| Extension Phase Treatment Group 3: SBR | EXPERIMENTAL | At Week 52, participants in this group will be given the option to participate in the Extension Phase to switch from oral ART to LEN 927 mg SC, TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion, every 26 weeks at the dose specified for Treatment Group 1. |
| Name | Type | Description |
|---|---|---|
| Teropavimab | DRUG | Administered intravenously |
| Zinlirvimab | DRUG | Administered intravenously |
| Lenacapavir Tablet | DRUG | Administered orally |
| Lenacapavir Injection | DRUG | Administered subcutaneously |
| Antiretroviral Therapy | DRUG | Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide. |
Key Inclusion Criteria: * On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. A change in ART regimen ≥ 28 days prior to screening visit 2 for reasons ot...
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Teropavimab is an investigational monoclonal antibody being studied for the treatment of HIV-1 infection. It is being evaluated in virologically suppressed adults as part of a combination regimen, rather than as a standalone therapy. It has not been approved for any indication and remains in clinical development.
Teropavimab is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program evaluating the antibody in combination with other agents for HIV-1 infection.
Teropavimab is in Phase 2 clinical development. One Phase 2 trial is currently active, and no Phase 3 studies have been initiated. The drug is investigational and has not received FDA approval for any indication.
Teropavimab is being studied in the Phase 2 trial NCT05729568, titled A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection. The trial has enrolled 83 participants across the United States, Australia, Canada, and Puerto Rico and is currently active but not recruiting.
In the Phase 2 trial NCT05729568, Teropavimab is administered in combination with zinlirvimab and the capsid inhibitor lenacapavir. The study enrolls virologically suppressed adults with HIV-1 infection who are 18 years or older, and it is a randomized, controlled trial.