Early Treatment Initiation
The following tests should be performed at treatment initiation; however, you do not have to wait for the results before starting your patients on BIKTARVY, except for in individuals with a history of long-acting cabotegravir as pre-exposure prophylaxis, where genotype testing done before the start of ART should include screening for integrase strand transfer inhibitor (INSTI)-resistance mutations. Because of the long half-life of CAB-LA, persistent drug exposure at levels suboptimal to prevent infection may select for INSTI-resistant virus.1
Viral load testing
- Once test results are received, the treatment regimen can be modified if needed1
- BIKTARVY is not indicated for patients with resistance to any component of BIKTARVY2
BIKTARVY is not recommended in patients with severe hepatic impairment (Child-Pugh Class C). For patients weighing ≥25 kg, BIKTARVY is not recommended in patients with severe renal impairment (estimated CrCl <30
mL/min) except in virologically suppressed patients with CrCl <15 mL/minon chronic hemodialysis. BIKTARVY is not recommended for patients weighing ≥14 kg to <25 kg with CrCl <30 mL/min.2
Testing with BIKTARVY according to the Prescribing Information2
Prior to or when initiating BIKTARVY, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
Prior to or when initiating BIKTARVY, test for HBV infection.
ART, antiretroviral therapy; CAB-LA, long-acting injectable cabotegravir; CD4, cluster of differentiation 4; CrCl, creatinine clearance; HBV, hepatitis B virus; HLA, human leukocyte antigen; STR, single-tablet regimen.
References: 1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Updated May 26, 2023. Accessed June 26, 2023. https://