Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ISL
Islatravir/lenacapavir · 3 trials · 2 indications
The percentage of participants with 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 the applicable study drug discontinuation status. Week 24 window was between Day 148 and 189 (inclusive). Percentages were rounded off.
| Arm | Type | Description |
|---|---|---|
| Blinded Phase: ISL/LEN + Placebo-to-Match (PTM) B/F/TAF | EXPERIMENTAL | Participants will receive an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards up to Week 96. Participants will also receive PTM B/F/TAF once daily from Day 1 up to Week 96. |
| Blinded Phase: PTM ISL/LEN + B/F/TAF | EXPERIMENTAL | Participants will receive an initial dose of PTM ISL/LEN (Dose A), followed by once weekly PTM ISL/LEN (Dose B) from Day 8 onwards up to Week 96. Participants will also receive B/F/TAF (50/200/25 mg) once daily up from Day 1 up to Week 96. |
| Open- Label Extension (OLE) Phase | EXPERIMENTAL | After the end of Blinded Phase at Week 96, if safety and efficacy of ISL/LEN are demonstrated following review of unblinded data, all participants will be given an option to enter the open-label extension phase to receive ISL/LEN in an extension phase until ISL/LEN becomes available or until the sponsor elects to discontinue the study, whichever occurs first. Participants receiving ISL/LEN and PTM B/F/TAF during the blinded phase will continue to take ISL/LEN weekly. Participants receiving B/F/TAF and PTM ISL/LEN during the blinded phase will take an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards. |
| ISL/LEN | EXPERIMENTAL | Participants will receive an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards up to Week 96. |
| Standard of Care Treatment | ACTIVE_COMPARATOR | Participants will continue standard of care treatment with 2-3 ARVs up to Week 96: * Integrase Strand Transfer Inhibitor (INSTI) class: INSTI combined with 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs; bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®), dolutegravir (DTG)/abacavir (ABC)/lamivudine (3TC), DTG+ TAF or TDF (TXF)/emtricitabine (FTC; Emtriva®), DTG/tenofovir disoproxil fumarate (TDF; Viread®)/3TC, DTG/3TC, raltegravir (RAL) + TXF/FTC, RAL+TDF/3TC, elvitegravir (EVG; Vitekta®)/cobicistat (c; Tybost®)/TXF/FTC), or * PI class: Boosted protease inhibitor (PI) combined with 2 NRTIs (darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF; coformulated), boosted darunavir (DRV)+TXF/FTC, boosted DRV+TDF/3TC), or * NNRTI class: Nonnucleoside reverse transcriptase inhibitor (NNRTI) combined with 2 NRTIs (doravirine (DOR)/TDF/3TC, DOR+TXF/FTC, DOR+TDF/3TC, rilpivirine (RPV)/TXF/FTC, RPV+TXF/FTC, RPV+TDF/3TC) |
| Extension Phase | EXPERIMENTAL | At the end of randomized treatment visit, if safety and efficacy of ISL/LEN are demonstrated following review of randomized data, participants will be given the option to receive ISL/LEN tablets in an extension phase until ISL/LEN becomes available or until the sponsor elects to discontinue the study, whichever occurs first. Participants receiving ISL/LEN during the randomized phase will continue to take ISL/LEN weekly. Participants receiving standard of care during the randomized phase will take an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards. |
| Cohort 1 (ISL+LEN) | EXPERIMENTAL | Participants will receive the following for at least 48 weeks: * Day 1 and Day 2: ISL 40 and LEN 600 mg * Day 8 and weekly thereafter (ie, every 7 days): ISL 20 mg and LEN 300 mg |
| Cohort 1 (B/F/TAF to ISL+LEN) | EXPERIMENTAL | Participants will receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg once daily for at least 48 weeks After 48 weeks, participants will switch from B/F/TAF to ISL+LEN * ISL 40 and LEN 600 mg on Day 1 and Day 2 * ISL 20 mg and LEN 300 mg weekly Participants who do not switch from B/F/TAF to ISL+LEN at Week 48 will be discontinued from the study. |
| Cohort 2 (ISL+LEN) | EXPERIMENTAL | Participants will receive the following for at least 48 weeks * Day 1: LEN oral 600 mg (2 x 300 mg) and ISL 2 mg (2 x 1 mg) * Day 2: LEN only oral 600 mg (2 x 300 mg) * Day 8 and weekly thereafter (ie, every 7 days): LEN oral 300 mg (1 x 300 mg) and ISL 2 mg |
| Cohort 2 (B/F/TAF to ISL+LEN) | EXPERIMENTAL | Participants will receive B/F/TAF 50/200/25 mg once daily for at least 48 weeks. |
| Extension Phase Cohort 2 of ISL/LEN Fixed Dose Combination (FDC) | EXPERIMENTAL | After 48 Weeks of randomized treatment, all participants will be given an option to participate in an Extension Phase to receive ISL+LEN or ISL/LEN FDC tablet (when available) until ISL/LEN becomes available or until the sponsor elects to discontinue the study, whichever occurs first. Participants receiving ISL+LEN during the randomized phase will continue to take ISL + LEN weekly. Participants receiving B/F/TAF during the randomized phase will switch to ISL+LEN: * Day 1: LEN oral 600 mg (2 x 300 mg) and ISL 2 mg (2 x 1 mg) * Day 2: LEN only oral 600 mg (2 x 300 mg) * Day 8 and weekly thereafter (ie, every 7 days): LEN oral 300 mg (1 x 300 mg) and ISL 2 mg Participants who do not switch from B/F/TAF to ISL+LEN at Week 48 will be discontinued from the study. All participants in the extension phase will be transitioned to weekly ISL/LEN FDC (Dose A) tablet when it becomes available. |
| Name | Type | Description |
|---|---|---|
| ISL/LEN | DRUG | Tablet administered orally |
| B/F/TAF | DRUG | Tablet administered orally |
| PTM B/F/TAF | DRUG | Tablet administered orally |
| PTM ISL/LEN | DRUG | Tablet administered orally |
| Antiretroviral Combinations | DRUG | 2 or 3 antiretrovirals (ARVs) administered as defined by the investigator, according to the prescribing information. |
| ISL | DRUG | Capsules administered orally without regard to food |
| LEN | DRUG | Tablets administered orally without regard to food |
| ISL/LEN FDC | DRUG | Tablets administered orally without regard to food |
Key Inclusion Criteria: * HIV-1 RNA \< 50 copies/mL for ≥ 6 months before screening, as documented by: 1. One HIV-1 RNA \< 50 copies/mL immediately preceding the 24 week period prior to screening. 2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be \< ...
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Islatravir/lenacapavir is an investigational oral combination regimen being developed for the treatment of HIV-1 infection. It pairs two small molecule antivirals in a once-weekly oral dosing strategy, and is currently in Phase 3 clinical development. It is also referred to as ISL/LEN or ISL.
Islatravir/lenacapavir is being studied as a once-weekly oral regimen for virologically suppressed adults living with HIV-1 infection. The Phase 3 program compares the combination against standard of care and against bictegravir/emtricitabine/tenofovir alafenamide in people whose viral load is already suppressed.
Gilead Sciences, Inc. (ticker GILD) is developing islatravir/lenacapavir for HIV-1 infection. The company is running the Phase 3 clinical program evaluating the once-weekly oral combination in virologically suppressed adults.
Islatravir/lenacapavir is in Phase 3 clinical development for HIV-1 infection. It is investigational and has not been approved. Three trials are listed for the program, all currently active, with a combined enrollment of 1,351 participants.
The program includes three registered trials. NCT06630299 and NCT06630286 are Phase 3 studies comparing the oral weekly regimen with standard of care and with bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed adults. NCT05052996 is a Phase 2 study of islatravir combined with lenacapavir in virologically suppressed people with HIV.