Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed

Key Inclusion Criteria:

• Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 24 weeks before and at screening.

• Receiving BVY for ≥ 24 weeks prior to screening.

Key Exclusion Criteria:

• Prior use of, or exposure to LEN, GS-1720, or GS-4182.

• History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.

• Documented integrase strand-transfer inhibitor (INSTI) resistance, specifically,resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G,Q148H/K/R, N155H/S, or R263K in the integrase gene.

• Prior use of any long-acting (LA) parenteral antiretrovirals (ARV) such asmonoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targetingHIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectablerilpivirine.

• Any of the following laboratory values at screening:

• Clusters of differentiation 4 (CD4) cell count < 200 cells/mm^3 at screening

• Glomerular filtration rate < 60 mL/min according to the Modification of Diet inRenal Disease formula

• Hepatic transaminases (aspartate aminotransferase (AST) and alanineaminotransferase (ALT) > 1.5 × upper limit of normal (ULN)

• Direct bilirubin > 1.5 × ULN

• Platelets count < 50,000 cells/mm^3

• Hemoglobin < 8.0 g/dL

• Active or occult hepatitis B virus (HBV) infection.

• Active hepatitis C virus (HCV).

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