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

Prior treatment

• Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization.
• Acute hepatitis < 30 days before randomization.
• Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.3 of the protocol.
• Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.
• Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements
• Prior use of, or exposure to, LEN.

Other illness

• Active tuberculosis infection.
• Chronic hepatitis B virus (HBV) infection, as determined by either: a) Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit. b) Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
• Known hypersensitivity to the study drug, its metabolites, or any formulation excipient.
• History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
• Active malignancy requiring acute systemic therapy.

Lab values

• Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization.
• Any of the following laboratory values at screening: a) Alanine aminotransferase > 5 × upper limit of normal (ULN) b) Direct bilirubin > 1.5 × ULN c) Platelets < 50,000/mm3 d) Hemoglobin < 8.0 g/dL

Other

• Participants under guardianship, curatorship, or legal protection may not participate in the study.
• Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.
• Breastfeeding (nursing).

• Aged ≥ 18 years at screening.
• Currently receiving B/F/TAF for at least 6 months prior to screening.
• If plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all levels must be < 50 copies/mL.
• At least one documented HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL.
• Plasma HIV-1 RNA levels < 50 copies/mL at screening.
• No documented or suspected resistance to BIC (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; mutations K65R, K65N, K70E, Q151M or T69 insertion, or ≥ 3 of the following thymidine analog mutations [M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R] in the reverse transcriptase gene).
• Estimated glomerular filtration rate > 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr).
• Participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.