Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

Key Inclusion Criteria:

- Must be at high risk of sexual acquisition of HIV

- HIV-1 negative status

- MSM and TGW (male at birth) who have at least one of the following:

- condomless anal intercourse with at least two unique male partners in the past 12
weeks (partners must be either HIV-infected or of unknown HIV status)

- documented history of syphilis in the past 24 weeks

- documented history of rectal gonorrhea or chlamydia in the past 24 weeks

- Adequate renal function: estimated glomerular filtration rate ≥ 60 mL/min according to
the Cockcroft-Gault formula

- Adequate liver and hematologic function:

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper
limit of normal (ULN) and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

- Absolute neutrophil count ≥ 1000/mm^3; platelets ≥ 75,000/mm^3; hemoglobin ≥ 10
g/dL

Key Exclusion Criteria

- Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically
manageable.

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