Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

Treatment emergent adverse events (TEAEs) were defined as any AE that began on or after the date of first dose of study drug up to the date of last dose of study drug plus 30 days or any AE leading to study drug discontinuation. The severity of AEs were be graded using the Division of AIDS (DAIDS) Toxicity Grading Scale.

The DAIDS grading table provide an adverse events (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines:

• Grade 1 indicates a mild event
• Grade 2 indicates a moderate event
• Grade 3 indicates a severe event
• Grade 4 indicates a potentially life-threatening event
• Grade 5 indicates death

Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time after baseline up to and including the date of last dose of study drug plus 30 days.

The DAIDS Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that did not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening.

This outcome measure analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data were excluded in the analysis.

This outcome measure analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data were excluded in the analysis.

This outcome measure was analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation were treated as HIV-1 RNA >= 50 copies/mL (failure) in the analysis.

This outcome measure was analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation were treated as HIV-1 RNA >= 50 copies/mL (failure) in the analysis.

Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time after baseline up to and including the date of last dose of study drug plus 30 days.

The DAIDS Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that did not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening.

The HIVTSQc was a 1-12 items questionnaire. Each item was scored -3 to 3. The total score ranged from -33 to +33, based on 11 items. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change.