Bictegravir is a second-generation HIV integrase strand transfer inhibitor used as part of fixed-dose antiretroviral combination therapy. It is included in the combination product Biktarvy with emtricitabine and tenofovir alafenamide for treatment of HIV-1 infection. The combination received approvals in major markets including the U.S. in 2018.
FDA grants Priority Review for Gilead's bictegravir/lenacapavir single-tablet HIV regimen. The NDA is supported by ARTISTRY-1 and ARTISTRY-2 trials showing noninferiority. A PDUFA target date of August 27, 2026 has been set.
Merck announced Phase 3 trial results for its investigational once-daily, two-drug HIV regimen doravirine/islatravir at CROI 2026, demonstrating non-inferiority to standard treatment in treatment-naïve adults with viral suppression rates of 91.8% at Week 48.
A once-daily single-tablet combination of bictegravir and lenacapavir demonstrated non-inferiority to existing HIV treatments in Phase 3 trials, offering simplified treatment for people living with HIV who are virologically suppressed.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06629480 |
Incidence of Metabolic Syndrome in People Living With HIV Without ExperienCe to ART Who Start DoLutegravir Based-Regimen Compared With BictegrAvir Based-RegimeN |
COMPLETED | NA |
| NCT06333808 |
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05979311 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05502341 |
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
| NCT04805944 |
Gut Microbiota, PGx and INSTIs Response |
COMPLETED | |
| NCT03499483 |
Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP) |
COMPLETED | PHASE4 |
| NCT02400307 |
Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function |
COMPLETED | PHASE1 |
| NCT02275065 |
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants |
COMPLETED | PHASE1 |
