Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISL · 1 trial · 1 indication
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 |
|---|---|---|
| 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 | DRUG | Capsules administered orally without regard to food |
| LEN | DRUG | Tablets administered orally without regard to food |
| B/F/TAF | DRUG | Tablets administered orally without regard to food |
| ISL/LEN FDC | DRUG | Tablets administered orally without regard to food |
Key Inclusion Criteria: * Received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for ≥ 24 weeks at screening. * Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used i...
Top 20 of 28 competitors
ISL, also known as ISL/LEN, is an investigational small molecule being developed for the treatment of HIV-1 infection. It is studied as a combination regimen with lenacapavir for virologically suppressed people with HIV-1. The drug is currently in Phase 2 and Phase 3 clinical trials.
ISL is a small molecule antiviral that targets HIV-1. It is being studied in combination with lenacapavir as an oral weekly regimen for the treatment of HIV-1 infection. The combination is intended to maintain viral suppression in people living with HIV-1.
ISL is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. Gilead is conducting clinical trials to evaluate the safety and efficacy of ISL in combination with lenacapavir for the treatment of HIV-1 infection.
ISL is in Phase 2 and Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trials are evaluating its safety and efficacy as part of an oral weekly regimen for virologically suppressed people with HIV-1.
ISL is being studied in three active clinical trials. NCT05052996 is a Phase 2 trial evaluating islatravir with lenacapavir in 142 participants. NCT06630286 and NCT06630299 are Phase 3 trials comparing the oral weekly regimen with standard of care in over 1,200 participants across multiple countries.
Yes, ISL is also known as ISL/LEN. The name ISL/LEN refers to the combination of islatravir and lenacapavir, which is being studied as an oral weekly regimen for the treatment of HIV-1 infection. The drug is being developed by Gilead Sciences.