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Bictegravir

Bictegravir

Drug

Drug Profile

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.

Drug Class: Integrase strand transfer inhibitor (INSTI)
Approval Status: Approved as part of Biktarvy combination regimen in major markets including the U.S. in 2018
Mechanism of Action: Inhibits HIV integrase strand transfer activity

Brand Names

\Biktarvy (combination)\

Indications

\HIV-1 infection (in fixed-dose combination with emtricitabine and tenofovir alafenamide)\

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Related Clinical Trials

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