- Known history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
|
-
Known allergies, hypersensitivity, or intolerance to D/C/F/TAF fixed-dose combination (FDC) tablet or its excipients
|
-
Active hepatitis B (HBV) or hepatitis C virus (HCV) infection
|
-
Uncontrolled diabetes that will require treatment with insulin during the study period
|
-
Evidence of Child Pugh Class C based on clinical laboratory testing and clinical evaluation
|
-
History of failure on darunavir (DRV) treatment or known documented history of >/=1 DRV resistance-associated mutations (RAM)
|
-
Screening hepatic transaminases >5x the upper limit of the normal range
|
-
Screening creatinine based estimated glomerular filtration rate (eGFRcr) <30 ml/min according to the Cockcroft-Gault formula for creatinine clearance
|
-
Participants initiating or discontinuing concomitant medications associated with significant changes in weight within the last 90 days
|