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

Key Inclusion Criteria:

• Currently receiving B/F/TAF for at least 6 months prior to screening.

• If plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA)measurements in the last 6 months prior to screening are available, all levels mustbe < 50 copies/mL.

• At least one documented HIV-1 RNA level measured between 6 and 12 months (± 2months) prior to screening. This and any other HIV-1 RNA measurements documented inthis period must be < 50 copies/mL.

• Plasma HIV-1 RNA levels < 50 copies/mL at screening.

• No documented or suspected resistance to BIC (including integrase strand-transferinhibitor resistant (INSTI-R) mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R,S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).

• No documented or suspected resistance to tenofovir alafenamide (TAF) (TAF; mutationsK65R, K65N, K70E, Q151M or T69 insertion, or ≥ 3 of the following thymidine analogmutations [M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R] in the reversetranscriptase gene).

• Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gaultformula for creatinine clearance.

Key Exclusion Criteria:

• Positive serum pregnancy test or pregnant at screening or a positive pregnancy testprior to Day 1 randomization.

• Breastfeeding (nursing).

• Prior use of, or exposure to, LEN.

• Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 daysprior to randomization.

• Active tuberculosis infection.

• Acute hepatitis < 30 days before randomization.

• Chronic hepatitis B virus (HBV) infection, as determined by either:

• Positive HBV surface antigen and negative HBV surface antibody, regardless ofHBV core antibody status, at the screening visit.

• Positive HBV core antibody and negative HBV surface antibody, regardless of HBVsurface antigen status, at the screening visit.

• Known hypersensitivity to the study drug, its metabolites, or any formulationexcipient.

• History of or current clinical decompensated liver cirrhosis (eg, ascites,encephalopathy, or variceal bleeding).

• Abnormal electrocardiogram (ECG) at the screening visit that is clinicallysignificant as determined by the investigator.

• Active malignancy requiring acute systemic therapy.

• Any of the following laboratory values at screening:

• Alanine aminotransferase > 5 × upper limit of normal (ULN).

• Direct bilirubin > 1.5 × ULN.

• Platelets < 50,000/mm^3.

• Hemoglobin < 8.0 g/dL.

• Requirement for ongoing therapy with or prior use of any prohibited medicationslisted in the protocol.

• Participation or planned participation in any other clinical study (includingobservational studies) without prior approval from the sponsor.

• Any other clinical condition or prior therapy that, in the opinion of theinvestigator, would make the participant unsuitable for the study or unable tocomply with dosing requirements.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.