Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

Prior treatment

• Prior use of, or exposure to, lenacapavir (LEN)

Other illness

• Active tuberculosis infection
• Chronic hepatitis B virus (HBV) infection

• Documented plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels must be < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months prior to the screening visit (Phase 2 only).
• If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be < 50 copies/mL (Phase 3 only).
• Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to the components of existing single-tablet regimens, and on this regimen for at least 6 months prior to the screening visit. The criteria to define a complex regimen in this study are as follows: A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or A regimen containing parenteral agent(s) (excluding a complete long acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
• No documented or suspected resistance to bictegravir (BIC).
• Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft- Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy.