Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)
Summary
This study will evaluate the safety and efficacy of a switch to Doravirine/Islatravir (DOR/ISL) (MK-8591A) (a fixed dose combination of doravirine 100 mg and islatravir 0.75 mg) in participants living with human immunodeficiency virus-1 (HIV-1) virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to DOR/ISL (MK-8591A) will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.
Timeline
- Start
- 2020-02-18
- Primary completion
- 2021-08-26
- Completion
- 2025-02-27
Outcome
Met primary endpoint
registry analysis (non-inferiority test); DOR/ISL vs BIC/FTC/TAF; p <.001; Estimated difference 0.31 (95% CI -1.19 to 1.96) NCT04223791 ↗
paper Switching to daily doravirine (100 mg) and islatravir (0·75 mg) was non-inferior to bictegravir, emtricitabine, and tenofovir alafenamide at week 48. PMID 38734016 ↗
release “both trials met their primary efficacy endpoint” merck.com ↗
release “ART; ILLUMINATE SWITCH A) or bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF; ILLUMINATE SWITCH B). At 48 weeks, both trials met their primary efficacy endpoint” merck.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bictegravir | Small molecule | 50 mg | Oral |
| Subject | Doravirine | Small molecule | 100 mg | Oral |
| Subject | Islatravir | Other / unclassified | 0.75 mg | Oral |
| Comparator | emtricitabine | Other / unclassified | 200 mg | Oral |
| Comparator | tenofovir alafenamide | Small molecule | 25 mg | Oral |