A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain

A Phase 4, Randomized, Active-Controlled, Open-label Study to Evaluate the Safety and Tolerability of Switching to Once-Daily Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Regimen in Virologically-suppressed Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Experiencing Rapid Weight Gain With an INI + TAF/FTC ARV Regimen

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04442737

Acronym

DEFINE

Enrollment

103

Registered

2020-06-23

Start date

2020-07-01

Completion date

2023-08-30

Last updated

2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1

Brief summary

The purpose of this study is to assess the percent change in body weight when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) (Immediate Switch Arm) compared to continuing the current integrase (INI) + tenofovir alafenamide/emtricitabine (TAF/FTC) antiretroviral (ARV) regimen (Delayed Switch Arm) in virologically-suppressed human immunodeficiency virus (HIV)-1 infected participants who have experienced rapid and significant body weight gain.

Interventions

DRUGD/C/F/TAF FDC

A FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily.

DRUGTAF/FTC FDC

TAF/FTC ARV regimen will be administered once daily.

DRUGINI Based Regimen

The integrase (INI) inhibitors (for example, bictegravir, dolutegravir, elvitegravir/cobicistat, and raltegravir) will be administered in combination with TAF/FTC, as appropriate. Regimen may consist of a single tablet regimen or a combination of two separate pills.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Body Mass Index (BMI) of greater than or equal to (\>=) 18 kilogram per meter square (kg/m\^2) at time of starting an integrase (INI)-based regimen plus Tenofovir Alafenamide/Emtricitabine (TAF/FTC) antiretroviral (ARV) regimen * Documented human immunodeficiency virus (HIV)-1 infection * Currently being treated with a stable ARV regimen consisting of an INI combined with TAF/FTC for \>=6 consecutive months preceding the screening visit and experienced a \>=10 percent (%) increase in body weight within a 36-month time period prior to screening and while on the current INI + TAF/FTC ARV regimen * Documented evidence of being virologically suppressed while on the current stable INI+TAF/FTC ARV regimen prior to screening * At least one plasma HIV-1 RNA measurement less than (\<) 50 copies/milliliter (mL) occurring between 12 and 2 months prior to the screening visit while on the stable INI+ TAF/FTC ARV regimen and have HIV-1 RNA \<50 copies/ mL at the screening visit

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Percent Change From Baseline in Body Weight at Week 24	Baseline and Week 24	Percent change from baseline in body weight at Week 24 were reported.
Percent Change From Baseline in Body Weight at Week 24: Body Mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) Subgroup	Baseline and Week 24	Percent change from baseline in body weight at Week 24 in BMI \>=30 kilograms per square meter (kg/m\^2) subgroup were reported.
Percent Change From Baseline in Body Weight at Week 24: Female and Male Subgroup	Baseline and Week 24	Percent change from baseline in body weight at Week 24 in female and male subgroup were reported.
Percent Change From Baseline in Body Weight at Week 24: Black/African American and Black/African American- Female Subgroups	Baseline and Week 24	Percent change from baseline in body weight at Week 24 in Black/African American and Black/African American- Female subgroups were reported.
Percent Change From Baseline in Body Weight at Week 24: Non-Black/African American Subgroup	Baseline and Week 24	Percent change from baseline in body weight at Week 24 in Non-Black/African American subgroup were reported.

Secondary

Measure	Time frame	Description
Change From Baseline in Waist Circumference Over Time	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48	Change from baseline in waist circumference over time was reported.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48	Change from baseline in SBP and DBP over time was reported.
Change From Baseline in Fasting Lipids at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in fasting lipids at Weeks 24 and 48 was reported. Fasting lipids included: fasting total cholesterol, fasting high-density lipoprotein (HDLs) and low-density lipoprotein (LDLs), and fasting triglycerides.
Change From Baseline in Fasting Glucose at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in fasting glucose at Weeks 24 and 48 was reported.
Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in HOMA-IR at Weeks 24 and 48 was reported. HOMA-IR is calculated as fasting insulin \* fasting glucose divided by 405.
Change From Baseline in Percent of Hemoglobin A1c (HbA1c) at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in percent of HbA1c at Weeks 24 and 48 was reported.
Change From Baseline in Leptin at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in leptin at Weeks 24 and 48 was reported.
Change From Baseline in Adiponectin at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in adiponectin at Weeks 24 and 48 was reported.
Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48	Percentage of participants with advanced fibrosis as assessed by NAFLD fibrosis score at Week 24 and 48 was reported. The NAFLD is based on a combination of clinical and laboratory measurements (that is, age, glycemia, BMI, platelet, albumin and AST/ALT ratio). The set cutoffs for this scoring are: NAFLD Score \<-1.455 = F0-F2 (negative), NAFLD Score -1.455 to 0.675 = indeterminate score, NAFLD Score \>0.675 = F3 - F4 (positive). NAFLD score was calculated as: 1.675 + 0.037 \* age (years) + 0.094 \* BMI (kg/m\^2) + 1.13 \* Impaired Fasting Glucose or Diabetes (yes =1; no=0) + 0.99 \* AST/ALT ratio minus 0.013 \* platelet (10\^9/L) minus 0.66 \* albumin (g/dL).
Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Percentage of participants at high risk of NASH according to the HAIR score at Weeks 24 and 48 was reported. HAIR score (0-3) is calculated by adding Hypertension = 1, alanine aminotransferase (ALT) \>40 international unit (IU)=1, and Insulin resistance index (IR) \>5.0 = 1. A score of \>=2 is considered as high risk for NASH.
Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48	Percentage of participants with a dose-reduction or complete withdrawal of anti-hypertensive, anti-hyperglycemic, or lipid lowering agents were reported.
Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48	Percentage of participants initiating an anti-hypertensive, anti-hyperglycemic, or lipid lowering agents were reported.
Number of Participants With Any Grade Treatment-emergent Adverse Events (TEAEs)	D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48	Number of participants with any grade TEAEs was reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were those AE events that occurred at or after the initial administration of study intervention.
Number of Participants With Grade 3 and Grade 4 TEAEs	D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48	Number of participants with Grade 3 and Grade 4 TEAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were those AE events that occurred at or after the initial administration of study intervention. Grades were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table: Grade 1: mild event; Grade 2: moderate event; Grade 3: severe event; Grade 4: potentially life-threatening event; Grade 5: death. Higher grades indicated worsening of TEAEs.
Number of Participants Who Discontinued the Study Drug Due to TEAEs	D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48	Number of participants who discontinued the study drug due to TEAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were those AE events that occurred at or after the initial administration of study intervention.
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48	Number of participants with treatment-emergent SAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. Treatment-emergent SAEs were those SAE events that occurred at or after the initial administration of study intervention.
Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in biochemistry parameters: albumin and protein values at Weeks 24 and 48 were reported.
Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in biochemistry parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase values at Weeks 24 and 48 were reported.
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in biochemistry parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen values at Weeks 24 and 48 were reported.
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (segmented), Platelets, and Leukocytes values at Weeks 24 and 48 were reported.
Change From Baseline in Hematology Parameter: Hemoglobin Values at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in hematology parameter: hemoglobin values at Weeks 24 and 48 were reported.
Change From Baseline in Hematology Parameter: Erythrocytes Values at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in hematology parameter: Erythrocytes values at Weeks 24 and 48 were reported.
Change From Baseline in Urinalysis Parameter: Specific Gravity Values at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in urinalysis parameter (specific gravity) values at Weeks 24 and 48 were reported.
Change From Baseline in Urinalysis Parameter: pH Values at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in urinalysis parameter: pH values at Weeks 24 and 48 were reported. The pH scale measures how acidic or alkaline a substance is. The scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Higher the pH value, more alkaline is the substance.
Number of Participants With Grade 3 and Grade 4 Laboratory Abnormalities	D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48	Number of participants with grade 3 and grade 4 laboratory abnormalities were reported. Grades were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table: Grade 1: mild ; Grade 2: moderate ; Grade 3: severe ; Grade 4: potentially life-threatening ; Grade 5: death. Higher grades indicated worsening of abnormalities.
Percentage of Participants With Confirmed Virologic Rebound at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48	Percentage of participants with confirmed virologic rebound at Weeks 24 and 48 was reported. Virologic rebound defined as when 2 consecutive HIV-1 RNA values \>=200 copies/mL at a scheduled or unscheduled visit.
Percentage of Participants With Virologic Response (HIV-1 RNA<50 Copies/mL) at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48	Percentage of participants with virologic response (HIV-1 RNA\<50 copies/mL) at Weeks 24 and 48 was reported.
Percentage of Participants With Virologic Failure (HIV-1 RNA >=50 Copies/mL) at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48	Percentage of participants with virologic failure (HIV-1 RNA \>=50 copies/mL) at Weeks 24 and 48 was reported.
Percentage of Participants With Virologic Response (HIV-1 RNA<200 Copies/mL) at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48	Percentage of participants with virologic response (HIV-1 RNA\<200 copies/mL) at Week 24 and 48 was reported.
Percentage of Participants With Virologic Failure (HIV-1 RNA >=200 Copies/mL) at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48	Percentage of participants with virologic failure (HIV-1 RNA \>=200 copies/mL) at Weeks 24 and 48 was reported.
Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in CD4+ cell count at Weeks 24 and 48 were reported.
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Percentage of participants who had bothersome symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 were reported. HIV-SI is a validated PRO instrument to assess 20 common HIV symptoms: fatigue/loss of energy, difficulty sleeping, nervous/anxious, diarrhea/loose bowels, changes in body composition, feeling sad/down/depressed, bloating/pain/gas in stomach, muscle aches/joint pain, problems with sex, trouble remembering, headaches, pain/numbness/tingling in hands/feet, skin problems/rash/itching, cough/trouble breathing, fever/chills/sweats, dizzy/lightheadedness, body weight loss/wasting, nausea/vomiting, hair loss/changes, and loss of appetite/food taste. Symptoms were rated using a 5-point Likert scale: 0: I don't have this symptom; 1: I have this symptom and it doesn't bother me; 2: I have this symptom and it bothers me a little; 3: I have this symptom and it bothers me; 4: I have this symptom and it bothers me a lot. Higher score refers more symptoms.
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Percentage of participants who had any symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 were reported. HIV-SI is a validated PRO instrument to assess 20 common HIV symptoms: fatigue/loss of energy, difficulty sleeping, nervous/anxious, diarrhea/loose bowels, changes in body composition, feeling sad/down/depressed, bloating/pain/gas in stomach, muscle aches/joint pain, problems with sex, trouble remembering, headaches, pain/numbness/tingling in hands/feet, skin problems/rash/itching, cough/trouble breathing, fever/chills/sweats, dizzy/lightheadedness, body weight loss/wasting, nausea/vomiting, hair loss/changes, and loss of appetite/food taste. Symptoms were rated using a 5-point Likert scale: 0: I don't have this symptom; 1: I have this symptom and it doesn't bother me; 2: I have this symptom and it bothers me a little; 3: I have this symptom and it bothers me; 4: I have this symptom and it bothers me a lot. Higher score refers more symptoms.
Number of Participants With Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48	Number of participants With each bothersome symptom of the HIV-SI adjusting for baseline variables at Weeks 24 and 48 were reported.
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48	Percentage of participants with PGIC scale score at Weeks 24 and 48 were reported. The PGI-C was a patient reported outcome (PRO) where participants rated using a 7-point scale ranging from 1 to 7 where 1 indicates very much improved, 2 indicates much improved', 3 indicates minimally improved, 4 indicates No change, 5 indicates minimally worse, 6 indicates Much worse and 7 indicates Very much worse.
Change From Baseline in Absolute Body Weight Over Time	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48	Change from baseline in absolute body weight over time were reported.
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	Weeks 4, 12, 24, 36 and 48	Adherence rate to treatment at Weeks 4, 12, 24, 36 and 48 were reported. Adherence rates were reported according to the percentage of participants missing 0, 1, 2, 3 or 4 doses as 100%, 75%, 50%, 25%, and 0%, respectively, using participant self-report 4-day recall at Weeks 4, 12, 24, 36, and 48.
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48	Percentage of participants with change from baseline \>=3% to \<= 5% in body weight over time was reported.
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48	Percentage of participants with change from baseline \>5% in body weight over time was reported.
Change From Baseline in Body Mass Index (BMI) Over Time	INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48	Change from baseline in BMI over time was reported. BMI was calculated as weight (kg)/(height (m\^2).
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48	Change from baseline in body composition as measured by (DEXA) scan at Weeks 24 and 48 was reported. Body composition included Mass of Fat for Trunk, Lean Body Mass for Trunk, total Mass for Trunk, Mass of Fat for Total Body, Lean Body Mass for Total Body, Total Mass for Total Body, Mass of Fat for Adjusted Total Body, Lean Body Mass for Adjusted Total Body, Total Mass for Adjusted Total Body, Mass of Fat for Appendages, Lean Body Mass for Appendages, total Mass for Appendages, Mass of Visceral Adipose Tissue, and Volume of Visceral Adipose Tissue. Adjusted refers to not including participant's head.

Countries

United States

Participant flow

Pre-assignment details

As per change in planned analysis, data for resistance outcome measures were not collected and analyzed due to insufficient number of participants who met the criteria for virologic rebound/failure.

Participants by arm

Arm	Count
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48 Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) (INI + TAF/FTC ARV) regimen switched to receive a fixed-dose combination (FDC) regimen of darunavir 800 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg (D/C/F/TAF), once daily from Day 1 (baseline) up to Week 48.	53
INI + TAF/FTC Delayed Switch (DS): Baseline to Week 48 Virologically suppressed adult participants with \>=10% increase in weight within 36 month period prior to screening and while on current INI + TAF/FTC ARV regimen continued to receive baseline integrase (INI) inhibitor along with tenofovir alafenamide 10 mg, emtricitabine 200 mg (TAF/FTC) antiretroviral (ARV) regimen from baseline up to Week 24 per prescribing information (delayed switch 1 \[DS1\]). After Week 24, participants switched to receive D/C/F/TAF FDC once daily from Week 25 to Week 48 (DS2).	50
Total	103

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	3	2
Overall Study	Death	0	1
Overall Study	Lost to Follow-up	1	3
Overall Study	Other	1	1
Overall Study	Protocol Violation	0	2
Overall Study	Withdrawal by Subject	3	2

Baseline characteristics

Characteristic	D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Total	INI + TAF/FTC Delayed Switch (DS): Baseline to Week 48
Age, Continuous	41.5 years STANDARD_DEVIATION 12.27	43.7 years STANDARD_DEVIATION 12.16	46.1 years STANDARD_DEVIATION 11.7
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants	16 Participants	10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants	87 Participants	40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	33 Participants	63 Participants	30 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	19 Participants	38 Participants	19 Participants
Region of Enrollment United States of America	53 Participants	103 Participants	50 Participants
Sex: Female, Male Female	16 Participants	31 Participants	15 Participants
Sex: Female, Male Male	37 Participants	72 Participants	35 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 53	0 / 49	1 / 50	0 / 46
other Total, other adverse events	10 / 53	7 / 49	13 / 50	12 / 46
serious Total, serious adverse events	3 / 53	2 / 49	4 / 50	4 / 46

Outcome results

Primary

Percent Change From Baseline in Body Weight at Week 24

Percent change from baseline in body weight at Week 24 were reported.

Time frame: Baseline and Week 24

Population: The intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm	Measure	Value (LEAST_SQUARES_MEAN)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24	0.63 Percent Change
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24	-0.24 Percent Change

Primary

Percent Change From Baseline in Body Weight at Week 24: Black/African American and Black/African American- Female Subgroups

Percent change from baseline in body weight at Week 24 in Black/African American and Black/African American- Female subgroups were reported.

Time frame: Baseline and Week 24

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified categories.

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24: Black/African American and Black/African American- Female Subgroups	Black/African American Subgroups	0.50 Percent Change	Standard Deviation 5.043
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24: Black/African American and Black/African American- Female Subgroups	Black/African American- Female Subgroups	0.62 Percent Change	Standard Deviation 5.484
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24: Black/African American and Black/African American- Female Subgroups	Black/African American Subgroups	-1.36 Percent Change	Standard Deviation 5.925
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24: Black/African American and Black/African American- Female Subgroups	Black/African American- Female Subgroups	-0.82 Percent Change	Standard Deviation 2.894

Primary

Percent Change From Baseline in Body Weight at Week 24: Body Mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) Subgroup

Percent change from baseline in body weight at Week 24 in BMI \>=30 kilograms per square meter (kg/m\^2) subgroup were reported.

Time frame: Baseline and Week 24

Arm	Measure	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24: Body Mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) Subgroup	0.26 Percent Change	Standard Deviation 4.278
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24: Body Mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) Subgroup	0.18 Percent Change	Standard Deviation 3.247

Primary

Percent Change From Baseline in Body Weight at Week 24: Female and Male Subgroup

Percent change from baseline in body weight at Week 24 in female and male subgroup were reported.

Time frame: Baseline and Week 24

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24: Female and Male Subgroup	Female Subgroup	1.26 Percent Change	Standard Deviation 5.361
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24: Female and Male Subgroup	Male Subgroup	0.46 Percent Change	Standard Deviation 3.939
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24: Female and Male Subgroup	Female Subgroup	-0.89 Percent Change	Standard Deviation 2.632
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24: Female and Male Subgroup	Male Subgroup	-0.22 Percent Change	Standard Deviation 6.609

Primary

Percent Change From Baseline in Body Weight at Week 24: Non-Black/African American Subgroup

Percent change from baseline in body weight at Week 24 in Non-Black/African American subgroup were reported.

Time frame: Baseline and Week 24

Arm	Measure	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24: Non-Black/African American Subgroup	1.00 Percent Change	Standard Deviation 3.045
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percent Change From Baseline in Body Weight at Week 24: Non-Black/African American Subgroup	1.14 Percent Change	Standard Deviation 4.756

Secondary

Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48

Adherence rate to treatment at Weeks 4, 12, 24, 36 and 48 were reported. Adherence rates were reported according to the percentage of participants missing 0, 1, 2, 3 or 4 doses as 100%, 75%, 50%, 25%, and 0%, respectively, using participant self-report 4-day recall at Weeks 4, 12, 24, 36, and 48.

Time frame: Weeks 4, 12, 24, 36 and 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	50%: Week 4	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	100%: Week 4	92.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	75%: Week 4	7.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	25%: Week 4	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	0%: Week 4	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	100%: Week 12	93.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	75%: Week 12	4.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	50%: Week 12	0.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	25%: Week 12	2.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	0%: Week 12	0.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	100%: Week 24	95.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	75%: Week 24	2.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	50%: Week 24	2.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	25%: Week 24	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	0%: Week 24	0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	50%: Week 12	0.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	50%: Week 24	0.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	50%: Week 4	0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	75%: Week 12	7.7 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	100%: Week 4	90.6 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	25%: Week 24	0.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	75%: Week 4	9.4 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	25%: Week 4	0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	0%: Week 24	0.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	0%: Week 4	0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	100%: Week 12	90.4 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	25%: Week 12	1.9 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	0%: Week 12	0.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	100%: Week 24	98.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	75%: Week 24	4.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	25%: Week 36	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	75%: Week 36	6.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	0%: Week 36	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	0%: Week 48	2.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	100%: Week 48	93.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	25%: Week 48	2.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	75%: Week 48	2.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	100%: Week 36	93.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	50%: Week 48	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48	50%: Week 36	0 Percentage of Participants

Secondary

Change From Baseline in Absolute Body Weight Over Time

Change from baseline in absolute body weight over time were reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (MEDIAN)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Absolute Body Weight Over Time	Week 4	-0.20 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Absolute Body Weight Over Time	Week 12	0.10 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Absolute Body Weight Over Time	Week 24	0.30 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Absolute Body Weight Over Time	Week 12	0.20 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Absolute Body Weight Over Time	Week 24	0.50 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Absolute Body Weight Over Time	Week 4	-0.20 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Absolute Body Weight Over Time	Week 48	-0.85 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Absolute Body Weight Over Time	Week 36	-0.90 Kilograms (kg)

Secondary

Change From Baseline in Adiponectin at Weeks 24 and 48

Change from baseline in adiponectin at Weeks 24 and 48 was reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Adiponectin at Weeks 24 and 48	Week 24	-0.16 Micrograms per liter (mcg/L)	Standard Deviation 1.596
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Adiponectin at Weeks 24 and 48	Week 24	-0.11 Micrograms per liter (mcg/L)	Standard Deviation 1.229
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Adiponectin at Weeks 24 and 48	Week 48	0.05 Micrograms per liter (mcg/L)	Standard Deviation 1.589

Secondary

Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48

Change from baseline in biochemistry parameters: albumin and protein values at Weeks 24 and 48 were reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set). Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48	Protein: Week 24	-0.4 grams per liter (g/L)	Standard Deviation 3.88
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48	Albumin: Week 24	0.1 grams per liter (g/L)	Standard Deviation 3.21
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48	Albumin: Week 24	0.4 grams per liter (g/L)	Standard Deviation 2.17
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48	Protein: Week 24	1.8 grams per liter (g/L)	Standard Deviation 3.53
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48	Albumin: Week 48	0.1 grams per liter (g/L)	Standard Deviation 2.43
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48	Protein: Week 48	0.6 grams per liter (g/L)	Standard Deviation 3.64

Secondary

Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48

Change from baseline in biochemistry parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase values at Weeks 24 and 48 were reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48	Alanine Aminotransferase: Week 24	-4.2 units per liter (U/L)	Standard Deviation 17.15
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48	Alkaline Phosphatase: Week 24	8.50 units per liter (U/L)	Standard Deviation 1.3
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48	Aspartate Aminotransferase: Week 24	-4.2 units per liter (U/L)	Standard Deviation 19.35
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48	Alanine Aminotransferase: Week 24	-3.7 units per liter (U/L)	Standard Deviation 10.96
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48	Alkaline Phosphatase: Week 24	0.0 units per liter (U/L)	Standard Deviation 10.84
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48	Aspartate Aminotransferase: Week 24	-2.6 units per liter (U/L)	Standard Deviation 6.66
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48	Alkaline Phosphatase: Week 48	-2.8 units per liter (U/L)	Standard Deviation 14.33
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48	Aspartate Aminotransferase: Week 48	-1.6 units per liter (U/L)	Standard Deviation 11.77
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48	Alanine Aminotransferase: Week 48	-0.1 units per liter (U/L)	Standard Deviation 29.6

Secondary

Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48

Change from baseline in biochemistry parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen values at Weeks 24 and 48 were reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Chloride: Week 24	-0.4 millimoles per liter (mmol/L)	Standard Deviation 3.13
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Urea Nitrogen: Week 24	-0.05 millimoles per liter (mmol/L)	Standard Deviation 1.187
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Phosphate: Week 24	0.01 millimoles per liter (mmol/L)	Standard Deviation 0.199
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Potassium: Week 24	-0.07 millimoles per liter (mmol/L)	Standard Deviation 0.296
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Bicarbonate: Week 24	0.70 millimoles per liter (mmol/L)	Standard Deviation 2.624
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Triglycerides: Week 24	0.13 millimoles per liter (mmol/L)	Standard Deviation 0.593
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Cholesterol: Week 24	0.11 millimoles per liter (mmol/L)	Standard Deviation 0.839
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Calcium: Week 24	0.00 millimoles per liter (mmol/L)	Standard Deviation 0.097
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Sodium: Week 24	0.1 millimoles per liter (mmol/L)	Standard Deviation 3.47
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Potassium: Week 24	-0.03 millimoles per liter (mmol/L)	Standard Deviation 0.421
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Bicarbonate: Week 24	0.09 millimoles per liter (mmol/L)	Standard Deviation 2.661
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Calcium: Week 24	0.02 millimoles per liter (mmol/L)	Standard Deviation 0.092
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Cholesterol: Week 24	0.86 millimoles per liter (mmol/L)	Standard Deviation 0.782
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Chloride: Week 24	-1.1 millimoles per liter (mmol/L)	Standard Deviation 3.07
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Phosphate: Week 24	-0.06 millimoles per liter (mmol/L)	Standard Deviation 0.166
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Sodium: Week 24	-1.0 millimoles per liter (mmol/L)	Standard Deviation 2.89
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Triglycerides: Week 24	0.47 millimoles per liter (mmol/L)	Standard Deviation 0.898
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Urea Nitrogen: Week 24	0.04 millimoles per liter (mmol/L)	Standard Deviation 1.24
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Cholesterol: Week 48	0.72 millimoles per liter (mmol/L)	Standard Deviation 0.823
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Bicarbonate: Week 48	0.52 millimoles per liter (mmol/L)	Standard Deviation 2.685
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Sodium: Week 48	-0.7 millimoles per liter (mmol/L)	Standard Deviation 2.68
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Calcium: Week 48	-0.02 millimoles per liter (mmol/L)	Standard Deviation 0.099
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Urea Nitrogen: Week 48	-0.27 millimoles per liter (mmol/L)	Standard Deviation 1.245
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Potassium: Week 48	-0.10 millimoles per liter (mmol/L)	Standard Deviation 0.425
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Chloride: Week 48	-0.8 millimoles per liter (mmol/L)	Standard Deviation 3.05
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Triglycerides: Week 48	0.26 millimoles per liter (mmol/L)	Standard Deviation 0.826
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48	Phosphate: Week 48	-0.05 millimoles per liter (mmol/L)	Standard Deviation 0.213

Secondary

Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48

Change from baseline in body composition as measured by (DEXA) scan at Weeks 24 and 48 was reported. Body composition included Mass of Fat for Trunk, Lean Body Mass for Trunk, total Mass for Trunk, Mass of Fat for Total Body, Lean Body Mass for Total Body, Total Mass for Total Body, Mass of Fat for Adjusted Total Body, Lean Body Mass for Adjusted Total Body, Total Mass for Adjusted Total Body, Mass of Fat for Appendages, Lean Body Mass for Appendages, total Mass for Appendages, Mass of Visceral Adipose Tissue, and Volume of Visceral Adipose Tissue. Adjusted refers to not including participant's head.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (MEDIAN)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Fat for Trunk: Week 24	-0.59 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Lean Body Mass for Trunk: Week 24	-0.51 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Fat for Total Body: Week 24	-0.88 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Total Mass for Total Body: Week 24	0.22 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Total Mass for Adjusted Total Body: Week 24	-0.01 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Fat for Appendages: Week 24	0.00 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Total Mass for Appendages: Week 24	0.66 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Visceral Adipose Tissue: Week 24	-0.05 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Total Mass for Trunk: Week 24	-0.84 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Lean Body Mass for Total Body: Week 24	0.22 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Fat for Adjusted Total Body: Week 24	-0.88 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Lean Body Mass for Adjusted Total Body: Week 24	0.17 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Lean Body Mass for Appendages: Week 24	0.72 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Total Mass for Adjusted Total Body: Week 24	0.56 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Lean Body Mass for Appendages: Week 24	0.12 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Total Mass for Appendages: Week 24	0.46 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Lean Body Mass for Adjusted Total Body: Week 24	0.49 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Visceral Adipose Tissue: Week 24	0.03 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Fat for Trunk: Week 24	0.12 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Lean Body Mass for Trunk: Week 24	0.22 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Total Mass for Trunk: Week 24	0.26 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Lean Body Mass for Total Body: Week 24	0.52 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Fat for Total Body: Week 24	0.29 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Fat for Appendages: Week 24	0.34 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Total Mass for Total Body: Week 24	0.59 Kilograms (kg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Fat for Adjusted Total Body: Week 24	0.41 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Lean Body Mass for Total Body: Week 48	-0.42 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Fat for Appendages: Week 48	-0.52 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Lean Body Mass for Appendages: Week 48	-0.32 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Fat for Trunk: Week 48	-1.24 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Total Mass for Adjusted Total Body: Week 48	-1.43 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Total Mass for Appendages: Week 48	-0.69 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Total Mass for Trunk: Week 48	-1.41 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Total Mass for Total Body: Week 48	-1.32 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Visceral Adipose Tissue: Week 48	-0.05 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Fat for Adjusted Total Body: Week 48	-1.28 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Mass of Fat for Total Body: Week 48	-1.29 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Lean Body Mass for Trunk: Week 48	-0.29 Kilograms (kg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48	Lean Body Mass for Adjusted Total Body: Week 48	-0.38 Kilograms (kg)

Secondary

Change From Baseline in Body Mass Index (BMI) Over Time

Change from baseline in BMI over time was reported. BMI was calculated as weight (kg)/(height (m\^2).

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (MEDIAN)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Mass Index (BMI) Over Time	Week 12	0.03 Kilograms per meter square (kg/m^2)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Mass Index (BMI) Over Time	Week 4	-0.06 Kilograms per meter square (kg/m^2)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Body Mass Index (BMI) Over Time	Week 24	0.10 Kilograms per meter square (kg/m^2)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Mass Index (BMI) Over Time	Week 4	-0.07 Kilograms per meter square (kg/m^2)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Mass Index (BMI) Over Time	Week 24	0.20 Kilograms per meter square (kg/m^2)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Body Mass Index (BMI) Over Time	Week 12	0.07 Kilograms per meter square (kg/m^2)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Mass Index (BMI) Over Time	Week 36	-0.26 Kilograms per meter square (kg/m^2)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Body Mass Index (BMI) Over Time	Week 48	-0.26 Kilograms per meter square (kg/m^2)

Secondary

Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48

Change from baseline in CD4+ cell count at Weeks 24 and 48 were reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Arm	Measure	Group	Value (MEDIAN)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48	Week 24	9.0 Cells per cubic millimeter (cells/mm^3)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48	Week 24	61.0 Cells per cubic millimeter (cells/mm^3)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48	Week 48	-41.0 Cells per cubic millimeter (cells/mm^3)

Secondary

Change From Baseline in Fasting Glucose at Weeks 24 and 48

Change from baseline in fasting glucose at Weeks 24 and 48 was reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Fasting Glucose at Weeks 24 and 48	Week 24	0.05 mmol/L	Standard Deviation 0.933
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Fasting Glucose at Weeks 24 and 48	Week 24	-0.08 mmol/L	Standard Deviation 0.697
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Fasting Glucose at Weeks 24 and 48	Week 48	0.06 mmol/L	Standard Deviation 0.663

Secondary

Change From Baseline in Fasting Lipids at Weeks 24 and 48

Change from baseline in fasting lipids at Weeks 24 and 48 was reported. Fasting lipids included: fasting total cholesterol, fasting high-density lipoprotein (HDLs) and low-density lipoprotein (LDLs), and fasting triglycerides.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Fasting Lipids at Weeks 24 and 48	Fasting total cholesterol: Week 24	0.11 millimoles per liter (mmol/L)	Standard Deviation 0.847
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Fasting Lipids at Weeks 24 and 48	Fasting HDL: Week 24	-0.13 millimoles per liter (mmol/L)	Standard Deviation 0.337
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Fasting Lipids at Weeks 24 and 48	Fasting LDL: Week 24	0.15 millimoles per liter (mmol/L)	Standard Deviation 0.758
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Fasting Lipids at Weeks 24 and 48	Fasting triglycerides: Week 24	0.16 millimoles per liter (mmol/L)	Standard Deviation 0.575
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Fasting Lipids at Weeks 24 and 48	Fasting triglycerides: Week 24	0.49 millimoles per liter (mmol/L)	Standard Deviation 0.902
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Fasting Lipids at Weeks 24 and 48	Fasting total cholesterol: Week 24	0.86 millimoles per liter (mmol/L)	Standard Deviation 0.79
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Fasting Lipids at Weeks 24 and 48	Fasting LDL: Week 24	0.57 millimoles per liter (mmol/L)	Standard Deviation 0.768
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Fasting Lipids at Weeks 24 and 48	Fasting HDL: Week 24	0.04 millimoles per liter (mmol/L)	Standard Deviation 0.269
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Fasting Lipids at Weeks 24 and 48	Fasting triglycerides: Week 48	0.28 millimoles per liter (mmol/L)	Standard Deviation 0.832
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Fasting Lipids at Weeks 24 and 48	Fasting HDL: Week 48	0.05 millimoles per liter (mmol/L)	Standard Deviation 0.321
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Fasting Lipids at Weeks 24 and 48	Fasting LDL: Week 48	0.59 millimoles per liter (mmol/L)	Standard Deviation 0.791
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Fasting Lipids at Weeks 24 and 48	Fasting total cholesterol: Week 48	0.73 millimoles per liter (mmol/L)	Standard Deviation 0.828

Secondary

Change From Baseline in Hematology Parameter: Erythrocytes Values at Weeks 24 and 48

Change from baseline in hematology parameter: Erythrocytes values at Weeks 24 and 48 were reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Hematology Parameter: Erythrocytes Values at Weeks 24 and 48	Week 24	0.05 10^12 cells per liter	Standard Deviation 0.233
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Hematology Parameter: Erythrocytes Values at Weeks 24 and 48	Week 24	-0.06 10^12 cells per liter	Standard Deviation 0.257
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Hematology Parameter: Erythrocytes Values at Weeks 24 and 48	Week 48	-0.09 10^12 cells per liter	Standard Deviation 0.273

Secondary

Change From Baseline in Hematology Parameter: Hemoglobin Values at Weeks 24 and 48

Change from baseline in hematology parameter: hemoglobin values at Weeks 24 and 48 were reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Hematology Parameter: Hemoglobin Values at Weeks 24 and 48	Week 24	-0.1 grams per liter (g/L)	Standard Deviation 9.98
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Hematology Parameter: Hemoglobin Values at Weeks 24 and 48	Week 24	-1.2 grams per liter (g/L)	Standard Deviation 7.25
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Hematology Parameter: Hemoglobin Values at Weeks 24 and 48	Week 48	-2.7 grams per liter (g/L)	Standard Deviation 7.45

Secondary

Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48

Change from baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (segmented), Platelets, and Leukocytes values at Weeks 24 and 48 were reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Leukocytes: Week 24	0.05 10^9 cells per liter	Standard Deviation 1.599
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Neutrophils (segmented): Week 24	0.04 10^9 cells per liter	Standard Deviation 1.254
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Monocytes: Week 24	-0.02 10^9 cells per liter	Standard Deviation 0.117
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Eosinophils: Week 24	-0.01 10^9 cells per liter	Standard Deviation 0.07
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Basophils: Week 24	0.00 10^9 cells per liter	Standard Deviation 0.032
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Platelets: Week 24	2.0 10^9 cells per liter	Standard Deviation 30.65
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Lymphocytes: Week 24	0.04 10^9 cells per liter	Standard Deviation 0.631
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Monocytes: Week 24	0.00 10^9 cells per liter	Standard Deviation 0.094
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Basophils: Week 24	0.00 10^9 cells per liter	Standard Deviation 0.036
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Eosinophils: Week 24	-0.01 10^9 cells per liter	Standard Deviation 0.104
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Lymphocytes: Week 24	-0.15 10^9 cells per liter	Standard Deviation 0.517
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Neutrophils (segmented): Week 24	0.11 10^9 cells per liter	Standard Deviation 1.144
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Platelets: Week 24	-9.1 10^9 cells per liter	Standard Deviation 38.58
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Leukocytes: Week 24	-0.06 10^9 cells per liter	Standard Deviation 1.394
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Neutrophils (segmented): Week 48	-0.04 10^9 cells per liter	Standard Deviation 0.759
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Eosinophils: Week 48	-0.02 10^9 cells per liter	Standard Deviation 0.063
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Leukocytes: Week 48	-0.25 10^9 cells per liter	Standard Deviation 1.008
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Platelets: Week 48	-8.5 10^9 cells per liter	Standard Deviation 41.67
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Monocytes: Week 48	-0.01 10^9 cells per liter	Standard Deviation 0.105
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Lymphocytes: Week 48	-0.17 10^9 cells per liter	Standard Deviation 0.459
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48	Basophils: Week 48	-0.01 10^9 cells per liter	Standard Deviation 0.024

Secondary

Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48

Change from baseline in HOMA-IR at Weeks 24 and 48 was reported. HOMA-IR is calculated as fasting insulin \* fasting glucose divided by 405.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48	Week 24	-0.81 Milligrams per deciliter (mg/dL)	Standard Deviation 7.946
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48	Week 24	-0.05 Milligrams per deciliter (mg/dL)	Standard Deviation 6.699
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48	Week 48	0.01 Milligrams per deciliter (mg/dL)	Standard Deviation 7.164

Secondary

Change From Baseline in Leptin at Weeks 24 and 48

Change from baseline in leptin at Weeks 24 and 48 was reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Leptin at Weeks 24 and 48	Week 24	-6.85 Micrograms per liter (mcg/L)	Standard Deviation 16.077
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Leptin at Weeks 24 and 48	Week 24	-1.09 Micrograms per liter (mcg/L)	Standard Deviation 10.899
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Leptin at Weeks 24 and 48	Week 48	4.11 Micrograms per liter (mcg/L)	Standard Deviation 22.787

Secondary

Change From Baseline in Percent of Hemoglobin A1c (HbA1c) at Weeks 24 and 48

Change from baseline in percent of HbA1c at Weeks 24 and 48 was reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Percent of Hemoglobin A1c (HbA1c) at Weeks 24 and 48	Week 24	0.01 Percent of HbA1c	Standard Deviation 0.272
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Percent of Hemoglobin A1c (HbA1c) at Weeks 24 and 48	Week 24	-0.07 Percent of HbA1c	Standard Deviation 0.308
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Percent of Hemoglobin A1c (HbA1c) at Weeks 24 and 48	Week 48	-0.10 Percent of HbA1c	Standard Deviation 0.313

Secondary

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time

Change from baseline in SBP and DBP over time was reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (MEDIAN)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	SBP: Week 4	3.0 Milligrams of mercury (mmHg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	SBP: Week 12	0.0 Milligrams of mercury (mmHg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	SBP: Week 24	0.5 Milligrams of mercury (mmHg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	DBP: Week 4	0.0 Milligrams of mercury (mmHg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	DBP: Week 12	-1.0 Milligrams of mercury (mmHg)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	DBP: Week 24	0.0 Milligrams of mercury (mmHg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	SBP: Week 24	-3.0 Milligrams of mercury (mmHg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	DBP: Week 4	-2.0 Milligrams of mercury (mmHg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	SBP: Week 4	-2.0 Milligrams of mercury (mmHg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	DBP: Week 12	-2.0 Milligrams of mercury (mmHg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	SBP: Week 12	1.0 Milligrams of mercury (mmHg)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	DBP: Week 24	0.0 Milligrams of mercury (mmHg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	SBP: Week 48	-3.0 Milligrams of mercury (mmHg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	SBP: Week 36	-5.0 Milligrams of mercury (mmHg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	DBP: Week 48	-2.5 Milligrams of mercury (mmHg)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time	DBP: Week 36	-2.0 Milligrams of mercury (mmHg)

Secondary

Change From Baseline in Urinalysis Parameter: pH Values at Weeks 24 and 48

Change from baseline in urinalysis parameter: pH values at Weeks 24 and 48 were reported. The pH scale measures how acidic or alkaline a substance is. The scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Higher the pH value, more alkaline is the substance.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Arm	Measure	Group	Value (MEAN)	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Urinalysis Parameter: pH Values at Weeks 24 and 48	Week 24	0.00 Units on a scale	Standard Deviation 0.463
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Urinalysis Parameter: pH Values at Weeks 24 and 48	Week 24	-0.07 Units on a scale	Standard Deviation 0.49
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Urinalysis Parameter: pH Values at Weeks 24 and 48	Week 48	-0.06 Units on a scale	Standard Deviation 0.503

Secondary

Change From Baseline in Urinalysis Parameter: Specific Gravity Values at Weeks 24 and 48

Change from baseline in urinalysis parameter (specific gravity) values at Weeks 24 and 48 were reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Arm	Measure	Group	Dispersion
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Urinalysis Parameter: Specific Gravity Values at Weeks 24 and 48	Week 24	Standard Deviation 0.008
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Urinalysis Parameter: Specific Gravity Values at Weeks 24 and 48	Week 24	Standard Deviation 0.008
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Urinalysis Parameter: Specific Gravity Values at Weeks 24 and 48	Week 48	Standard Deviation 0.009

Secondary

Change From Baseline in Waist Circumference Over Time

Change from baseline in waist circumference over time was reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (MEDIAN)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Waist Circumference Over Time	Week 4	0.00 Centimeter (cm)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Waist Circumference Over Time	Week 12	0.20 Centimeter (cm)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Change From Baseline in Waist Circumference Over Time	Week 24	0.00 Centimeter (cm)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Waist Circumference Over Time	Week 12	0.00 Centimeter (cm)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Waist Circumference Over Time	Week 24	0.80 Centimeter (cm)
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Change From Baseline in Waist Circumference Over Time	Week 4	0.00 Centimeter (cm)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Waist Circumference Over Time	Week 48	-0.40 Centimeter (cm)
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Change From Baseline in Waist Circumference Over Time	Week 36	0.00 Centimeter (cm)

Secondary

Number of Participants Who Discontinued the Study Drug Due to TEAEs

Number of participants who discontinued the study drug due to TEAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were those AE events that occurred at or after the initial administration of study intervention.

Time frame: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48

Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Number of Participants Who Discontinued the Study Drug Due to TEAEs	0 Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Number of Participants Who Discontinued the Study Drug Due to TEAEs	3 Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Number of Participants Who Discontinued the Study Drug Due to TEAEs	0 Participants
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48	Number of Participants Who Discontinued the Study Drug Due to TEAEs	2 Participants

Secondary

Number of Participants With Any Grade Treatment-emergent Adverse Events (TEAEs)

Number of participants with any grade TEAEs was reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were those AE events that occurred at or after the initial administration of study intervention.

Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Number of Participants With Any Grade Treatment-emergent Adverse Events (TEAEs)	30 Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Number of Participants With Any Grade Treatment-emergent Adverse Events (TEAEs)	29 Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Number of Participants With Any Grade Treatment-emergent Adverse Events (TEAEs)	26 Participants
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48	Number of Participants With Any Grade Treatment-emergent Adverse Events (TEAEs)	30 Participants

Secondary

Number of Participants With Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Weeks 24 and 48

Number of participants With each bothersome symptom of the HIV-SI adjusting for baseline variables at Weeks 24 and 48 were reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Number of Participants With Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Weeks 24 and 48	Week 24	44 Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Number of Participants With Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Weeks 24 and 48	Week 24	44 Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Number of Participants With Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Weeks 24 and 48	Week 48	42 Participants

Secondary

Number of Participants With Grade 3 and Grade 4 Laboratory Abnormalities

Number of participants with grade 3 and grade 4 laboratory abnormalities were reported. Grades were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table: Grade 1: mild ; Grade 2: moderate ; Grade 3: severe ; Grade 4: potentially life-threatening ; Grade 5: death. Higher grades indicated worsening of abnormalities.

Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Number of Participants With Grade 3 and Grade 4 Laboratory Abnormalities	1 Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Number of Participants With Grade 3 and Grade 4 Laboratory Abnormalities	2 Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Number of Participants With Grade 3 and Grade 4 Laboratory Abnormalities	1 Participants
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48	Number of Participants With Grade 3 and Grade 4 Laboratory Abnormalities	1 Participants

Secondary

Number of Participants With Grade 3 and Grade 4 TEAEs

Number of participants with Grade 3 and Grade 4 TEAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were those AE events that occurred at or after the initial administration of study intervention. Grades were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table: Grade 1: mild event; Grade 2: moderate event; Grade 3: severe event; Grade 4: potentially life-threatening event; Grade 5: death. Higher grades indicated worsening of TEAEs.

Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Number of Participants With Grade 3 and Grade 4 TEAEs	Grade 4	0 Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Number of Participants With Grade 3 and Grade 4 TEAEs	Grade 3	3 Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Number of Participants With Grade 3 and Grade 4 TEAEs	Grade 4	1 Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Number of Participants With Grade 3 and Grade 4 TEAEs	Grade 3	3 Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Number of Participants With Grade 3 and Grade 4 TEAEs	Grade 3	3 Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Number of Participants With Grade 3 and Grade 4 TEAEs	Grade 4	0 Participants
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48	Number of Participants With Grade 3 and Grade 4 TEAEs	Grade 4	1 Participants
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48	Number of Participants With Grade 3 and Grade 4 TEAEs	Grade 3	5 Participants

Secondary

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Number of participants with treatment-emergent SAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. Treatment-emergent SAEs were those SAE events that occurred at or after the initial administration of study intervention.

Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	4 Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	3 Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	2 Participants
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48	Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	4 Participants

Secondary

Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48

Percentage of participants at high risk of NASH according to the HAIR score at Weeks 24 and 48 was reported. HAIR score (0-3) is calculated by adding Hypertension = 1, alanine aminotransferase (ALT) \>40 international unit (IU)=1, and Insulin resistance index (IR) \>5.0 = 1. A score of \>=2 is considered as high risk for NASH.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48	>=2: Week 24	12.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48	<2: Week 24	62.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48	<2: Week 24	60.4 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48	>=2: Week 24	3.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48	<2: Week 48	56.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48	>=2: Week 48	5.7 Percentage of Participants

Secondary

Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents

Percentage of participants initiating an anti-hypertensive, anti-hyperglycemic, or lipid lowering agents were reported.

Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hypertensive	7.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Lipid lowering agents	3.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hyperglycemic agents	0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hypertensive	5.7 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Lipid lowering agents	1.9 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hyperglycemic agents	0. Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hyperglycemic agents	4.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hypertensive	18.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Lipid lowering agents	4.0 Percentage of Participants
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48	Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hypertensive	12.0 Percentage of Participants
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48	Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Lipid lowering agents	4.0 Percentage of Participants
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48	Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hyperglycemic agents	2.0 Percentage of Participants

Secondary

Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48

Percentage of participants who had any symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 were reported. HIV-SI is a validated PRO instrument to assess 20 common HIV symptoms: fatigue/loss of energy, difficulty sleeping, nervous/anxious, diarrhea/loose bowels, changes in body composition, feeling sad/down/depressed, bloating/pain/gas in stomach, muscle aches/joint pain, problems with sex, trouble remembering, headaches, pain/numbness/tingling in hands/feet, skin problems/rash/itching, cough/trouble breathing, fever/chills/sweats, dizzy/lightheadedness, body weight loss/wasting, nausea/vomiting, hair loss/changes, and loss of appetite/food taste. Symptoms were rated using a 5-point Likert scale: 0: I don't have this symptom; 1: I have this symptom and it doesn't bother me; 2: I have this symptom and it bothers me a little; 3: I have this symptom and it bothers me; 4: I have this symptom and it bothers me a lot. Higher score refers more symptoms.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fever, chills or sweats?: Week 24	29.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with weight loss or wasting?: Baseline	36.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Loss of appetite or a change in the taste of food?: Week 24	29.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with weight loss or wasting?: Week 24	38.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Bloating, pain or gas in your stomach?: Week 24	45.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fever, chills or sweats?: Baseline	34.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Muscle aches or joint pain?: Baseline	57.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Trouble remembering? : Baseline	59.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Bloating, pain or gas in your stomach?: Baseline	46.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Trouble remembering? : Week 24	47.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Nausea or vomiting?: Baseline	24.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Hair loss or changes in the way your hair looks?: Week 24	27.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Nausea or vomiting?: Week 24	15.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Diarrhea or loose bowel movements?: Baseline	46.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with having sex, such as loss of interest or lack of satisfaction?: Baseline	51.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Diarrhea or loose bowel movements?: Week 24	36.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Feeling dizzy or lightheaded?: Baseline	34.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt sad, down or depressed?: Baseline	73.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with having sex, such as loss of interest or lack of satisfaction?: Week 24	31.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt sad, down or depressed?: Week 24	61.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt nervous or anxious?: Baseline	63.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Changes in the way your body looks such as fat deposits or weight gain?: Baseline	77.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt nervous or anxious?: Week 24	59.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fatigue or loss of energy?: Baseline	73.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Difficulty falling or staying asleep? : Baseline	65.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Muscle aches or joint pain?: Week 24	47.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Difficulty falling or staying asleep?: Week 24	63.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Feeling dizzy or lightheaded?: Week 24	36.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Skin problems, such as rash, dryness or itching?: Baseline	42.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Hair loss or changes in the way your hair looks?: Baseline	34.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fatigue or loss of energy?: Week 24	61.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Changes in the way your body looks such as fat deposits or weight gain?: Week 24	77.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Skin problems, such as rash, dryness or itching?: Week 24	40.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Pain, numbness or tingling in the hands or feet?: Baseline	53.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Cough or trouble catching your breath?: Baseline	46.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Cough or trouble catching your breath?: Week 24	29.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Pain, numbness or tingling in the hands or feet?: Week 24	47.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Headache? : Baseline	46.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Headache? : Week 24	29.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Loss of appetite or a change in the taste of food?: Baseline	36.7 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with weight loss or wasting?: Week 24	25.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fatigue or loss of energy?: Week 24	59.1 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Trouble remembering? : Week 24	45.5 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt nervous or anxious?: Week 24	50.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Cough or trouble catching your breath?: Week 24	31.8 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Bloating, pain or gas in your stomach?: Week 24	54.5 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Diarrhea or loose bowel movements?: Week 24	43.2 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Changes in the way your body looks such as fat deposits or weight gain?: Week 24	72.7 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Difficulty falling or staying asleep?: Week 24	61.4 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt sad, down or depressed?: Week 24	50.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Headache? : Week 24	29.5 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Muscle aches or joint pain?: Week 24	43.2 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Feeling dizzy or lightheaded?: Week 24	27.3 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Hair loss or changes in the way your hair looks?: Week 24	38.6 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Pain, numbness or tingling in the hands or feet?: Week 24	34.1 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with having sex, such as loss of interest or lack of satisfaction?: Week 24	52.3 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Nausea or vomiting?: Week 24	18.2 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Skin problems, such as rash, dryness or itching?: Week 24	34.1 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Loss of appetite or a change in the taste of food?: Week 24	25.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fever, chills or sweats?: Week 24	20.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Muscle aches or joint pain?: Baseline	43.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Trouble remembering? : Week 48	47.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Loss of appetite or a change in the taste of food?: Week 48	31.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with weight loss or wasting?: Baseline	21.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Muscle aches or joint pain?: Week 48	52.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with having sex, such as loss of interest or lack of satisfaction?: Baseline	47.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fatigue or loss of energy?: Baseline	45.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fatigue or loss of energy?: Week 48	47.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fever, chills or sweats?: Baseline	17.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fever, chills or sweats?: Week 48	26.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with having sex, such as loss of interest or lack of satisfaction?: Week 48	40.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Changes in the way your body looks such as fat deposits or weight gain?: Baseline	80.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Feeling dizzy or lightheaded?: Baseline	17.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Feeling dizzy or lightheaded?: Week 48	28.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Pain, numbness or tingling in the hands or feet?: Baseline	43.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Changes in the way your body looks such as fat deposits or weight gain?: Week 48	76.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Pain, numbness or tingling in the hands or feet?: Week 48	42.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Trouble remembering? : Baseline	47.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Nausea or vomiting?: Baseline	8.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Nausea or vomiting?: Week 48	16.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Diarrhea or loose bowel movements?: Baseline	17.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Diarrhea or loose bowel movements?: Week 48	35.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt sad, down or depressed?: Baseline	54.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt sad, down or depressed?: Week 48	47.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt nervous or anxious?: Baseline	63.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with weight loss or wasting?: Week 48	35.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt nervous or anxious?: Week 48	54.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Difficulty falling or staying asleep? : Baseline	50.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Difficulty falling or staying asleep?: Week 48	64.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Hair loss or changes in the way your hair looks?: Baseline	26.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Hair loss or changes in the way your hair looks?: Week 48	35.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Skin problems, such as rash, dryness or itching?: Baseline	41.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Skin problems, such as rash, dryness or itching?: Week 48	45.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Cough or trouble catching your breath?: Baseline	19.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Cough or trouble catching your breath?: Week 48	21.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Headache? : Baseline	30.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Headache? : Week 48	38.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Loss of appetite or a change in the taste of food?: Baseline	21.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Bloating, pain or gas in your stomach?: Baseline	56.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Bloating, pain or gas in your stomach?: Week 48	52.4 Percentage of Participants

Secondary

Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48

Percentage of participants who had bothersome symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 were reported. HIV-SI is a validated PRO instrument to assess 20 common HIV symptoms: fatigue/loss of energy, difficulty sleeping, nervous/anxious, diarrhea/loose bowels, changes in body composition, feeling sad/down/depressed, bloating/pain/gas in stomach, muscle aches/joint pain, problems with sex, trouble remembering, headaches, pain/numbness/tingling in hands/feet, skin problems/rash/itching, cough/trouble breathing, fever/chills/sweats, dizzy/lightheadedness, body weight loss/wasting, nausea/vomiting, hair loss/changes, and loss of appetite/food taste. Symptoms were rated using a 5-point Likert scale: 0: I don't have this symptom; 1: I have this symptom and it doesn't bother me; 2: I have this symptom and it bothers me a little; 3: I have this symptom and it bothers me; 4: I have this symptom and it bothers me a lot. Higher score refers more symptoms.

Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Trouble remembering? : Week 24	38.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Headache? : Baseline	36.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with weight loss or wasting?: Baseline	32.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with weight loss or wasting?: Week 24	29.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Difficulty falling or staying asleep?: Week 24	56.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Hair loss or changes in the way your hair looks?: Baseline	26.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Hair loss or changes in the way your hair looks?: Week 24	20.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fever, chills or sweats?: Baseline	26.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fatigue or loss of energy?: Baseline	61.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Skin problems, such as rash, dryness or itching?: Baseline	34.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Pain, numbness or tingling in the hands or feet?: Baseline	42.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Skin problems, such as rash, dryness or itching?: Week 24	31.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt nervous or anxious?: Week 24	43.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Diarrhea or loose bowel movements?: Week 24	27.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Pain, numbness or tingling in the hands or feet?: Week 24	38.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt sad, down or depressed?: Baseline	59.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt sad, down or depressed?: Week 24	52.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fever, chills or sweats?: Week 24	20.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt nervous or anxious?: Baseline	55.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Trouble remembering? : Baseline	53.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Cough or trouble catching your breath?: Baseline	36.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Cough or trouble catching your breath?: Week 24	22.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Headache? : Week 24	18.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fatigue or loss of energy?: Week 24	54.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Loss of appetite or a change in the taste of food?: Baseline	30.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Nausea or vomiting?: Baseline	14.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Loss of appetite or a change in the taste of food?: Week 24	20.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Feeling dizzy or lightheaded?: Baseline	28.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Bloating, pain or gas in your stomach?: Baseline	40.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Nausea or vomiting?: Week 24	11.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Bloating, pain or gas in your stomach?: Week 24	40.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Muscle aches or joint pain?: Baseline	53.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Muscle aches or joint pain?: Week 24	45.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with having sex, such as loss of interest or lack of satisfaction?: Baseline	42.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Diarrhea or loose bowel movements?: Baseline	32.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with having sex, such as loss of interest or lack of satisfaction?: Week 24	22.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Changes in the way your body looks such as fat deposits or weight gain?: Baseline	71.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Feeling dizzy or lightheaded?: Week 24	29.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Changes in the way your body looks such as fat deposits or weight gain?: Week 24	70.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Difficulty falling or staying asleep? : Baseline	59.2 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Trouble remembering? : Week 24	34.1 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fever, chills or sweats?: Week 24	11.4 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Headache? : Week 24	22.7 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with having sex, such as loss of interest or lack of satisfaction?: Week 24	38.6 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt nervous or anxious?: Week 24	38.6 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Difficulty falling or staying asleep?: Week 24	52.3 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Skin problems, such as rash, dryness or itching?: Week 24	22.7 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Loss of appetite or a change in the taste of food?: Week 24	22.7 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Hair loss or changes in the way your hair looks?: Week 24	34.1 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Changes in the way your body looks such as fat deposits or weight gain?: Week 24	63.6 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Pain, numbness or tingling in the hands or feet?: Week 24	20.5 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Cough or trouble catching your breath?: Week 24	18.2 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Bloating, pain or gas in your stomach?: Week 24	38.6 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Nausea or vomiting?: Week 24	13.6 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Feeling dizzy or lightheaded?: Week 24	13.6 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Diarrhea or loose bowel movements?: Week 24	31.8 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Muscle aches or joint pain?: Week 24	38.6 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fatigue or loss of energy?: Week 24	47.7 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with weight loss or wasting?: Week 24	15.9 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt sad, down or depressed?: Week 24	34.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Hair loss or changes in the way your hair looks?: Week 48	23.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Diarrhea or loose bowel movements?: Baseline	8.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Muscle aches or joint pain?: Baseline	34.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fatigue or loss of energy?: Baseline	43.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fatigue or loss of energy?: Week 48	42.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fever, chills or sweats?: Baseline	13.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Fever, chills or sweats?: Week 48	16.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Feeling dizzy or lightheaded?: Baseline	8.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Feeling dizzy or lightheaded?: Week 48	21.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Pain, numbness or tingling in the hands or feet?: Baseline	30.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Pain, numbness or tingling in the hands or feet?: Week 48	33.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Trouble remembering? : Baseline	32.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Trouble remembering? : Week 48	38.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Nausea or vomiting?: Baseline	4.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Nausea or vomiting?: Week 48	9.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt nervous or anxious?: Week 48	47.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Difficulty falling or staying asleep? : Baseline	45.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Difficulty falling or staying asleep?: Week 48	54.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Skin problems, such as rash, dryness or itching?: Baseline	34.8 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Skin problems, such as rash, dryness or itching?: Week 48	38.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Diarrhea or loose bowel movements?: Week 48	21.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt sad, down or depressed?: Baseline	39.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt sad, down or depressed?: Week 48	40.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Felt nervous or anxious?: Baseline	32.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Cough or trouble catching your breath?: Baseline	10.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Cough or trouble catching your breath?: Week 48	9.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Headache? : Baseline	19.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Headache? : Week 48	26.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Loss of appetite or a change in the taste of food?: Baseline	10.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Loss of appetite or a change in the taste of food?: Week 48	21.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Bloating, pain or gas in your stomach?: Baseline	39.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Bloating, pain or gas in your stomach?: Week 48	33.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Muscle aches or joint pain?: Week 48	42.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with having sex, such as loss of interest or lack of satisfaction?: Baseline	39.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with having sex, such as loss of interest or lack of satisfaction?: Week 48	26.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Changes in the way your body looks such as fat deposits or weight gain?: Baseline	71.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Changes in the way your body looks such as fat deposits or weight gain?: Week 48	59.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with weight loss or wasting?: Baseline	17.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Problems with weight loss or wasting?: Week 48	26.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48	Hair loss or changes in the way your hair looks?: Baseline	19.6 Percentage of Participants

Secondary

Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents

Percentage of participants with a dose-reduction or complete withdrawal of anti-hypertensive, anti-hyperglycemic, or lipid lowering agents were reported.

Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention (that is, ITT analysis set).

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Lipid lowering agents	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hyperglycemic agents	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hypertensive	0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Lipid lowering agents	0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hypertensive	0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hyperglycemic agents	0. Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hypertensive	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Lipid lowering agents	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hyperglycemic agents	0 Percentage of Participants
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48	Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hyperglycemic agents	0 Percentage of Participants
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48	Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Lipid lowering agents	0 Percentage of Participants
INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25-Week 48	Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents	Anti-hypertensive	0 Percentage of Participants

Secondary

Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48

Percentage of participants with advanced fibrosis as assessed by NAFLD fibrosis score at Week 24 and 48 was reported. The NAFLD is based on a combination of clinical and laboratory measurements (that is, age, glycemia, BMI, platelet, albumin and AST/ALT ratio). The set cutoffs for this scoring are: NAFLD Score \<-1.455 = F0-F2 (negative), NAFLD Score -1.455 to 0.675 = indeterminate score, NAFLD Score \>0.675 = F3 - F4 (positive). NAFLD score was calculated as: 1.675 + 0.037 \* age (years) + 0.094 \* BMI (kg/m\^2) + 1.13 \* Impaired Fasting Glucose or Diabetes (yes =1; no=0) + 0.99 \* AST/ALT ratio minus 0.013 \* platelet (10\^9/L) minus 0.66 \* albumin (g/dL).

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48	Positive (F3-F4): Week 24	6.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48	Negative (F0-F2): Week 24	44.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48	Indeterminate: Week 24	5.7 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48	Positive (F3-F4): Week 24	5.7 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48	Indeterminate: Week 24	12.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48	Negative (F0-F2): Week 24	50.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48	Positive (F3-F4): Week 48	1.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48	Indeterminate: Week 48	9.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48	Negative (F0-F2): Week 48	54.7 Percentage of Participants

Secondary

Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time

Percentage of participants with change from baseline \>5% in body weight over time was reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% gain: Week 4	4.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% loss: Week 4	2.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% gain: Week 12	6.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% loss: Week 12	4.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% gain: Week 24	10.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% loss: Week 24	10.9 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% gain: Week 12	3.8 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% loss: Week 12	1.9 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% gain: Week 24	14.3 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% gain: Week 4	0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% loss: Week 24	4.1 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% loss: Week 4	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% gain: Week 48	13.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% gain: Week 36	17.0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% loss: Week 48	23.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time	>5% loss: Week 36	14.9 Percentage of Participants

Secondary

Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time

Percentage of participants with change from baseline \>=3% to \<= 5% in body weight over time was reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% gain: Week 12	8.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% loss: Week 12	4.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% gain: Week 24	2.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% loss: Week 4	4.1 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% loss: Week 24	8.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% gain: Week 4	2.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% gain: Week 12	5.8 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% gain: Week 4	3.8 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% loss: Week 4	7.5 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% loss: Week 12	17.3 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% gain: Week 24	8.2 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% loss: Week 24	10.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% gain: Week 36	6.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% loss: Week 36	14.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% gain: Week 48	6.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time	3-5% loss: Week 48	6.5 Percentage of Participants

Secondary

Percentage of Participants With Confirmed Virologic Rebound at Weeks 24 and 48

Percentage of participants with confirmed virologic rebound at Weeks 24 and 48 was reported. Virologic rebound defined as when 2 consecutive HIV-1 RNA values \>=200 copies/mL at a scheduled or unscheduled visit.

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Confirmed Virologic Rebound at Weeks 24 and 48	Week 24	4.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Confirmed Virologic Rebound at Weeks 24 and 48	Week 24	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Confirmed Virologic Rebound at Weeks 24 and 48	Week 48	0 Percentage of Participants

Secondary

Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48

Percentage of participants with PGIC scale score at Weeks 24 and 48 were reported. The PGI-C was a patient reported outcome (PRO) where participants rated using a 7-point scale ranging from 1 to 7 where 1 indicates very much improved, 2 indicates much improved', 3 indicates minimally improved, 4 indicates No change, 5 indicates minimally worse, 6 indicates Much worse and 7 indicates Very much worse.

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48

Population: The ITT analysis set included all the participants who were randomized and received at least 1 dose of treatment subsequent to randomization in the study. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. Here, n=0 signifies that participants were not planned to be analyzed at those timepoints in the respective arms.

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Minimally Worse: Week 24	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Very Much Improved: Week 24	11.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Much Improved: Week 24	13.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Minimally Improved: Week 24	18.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	No Change: Week 24	52.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Much Worse: Week 24	2.3 Percentage of Participants
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Very Much Worse: Week 24	2.3 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	No Change: Week 24	19.5 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Much Worse: Week 24	4.9 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Very Much Improved: Week 24	4.9 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Minimally Worse: Week 24	7.3 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Much Improved: Week 24	22.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Very Much Worse: Week 24	0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Minimally Improved: Week 24	19.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Very Much Improved: Week 48	11.9 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Much Worse: Week 48	2.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Very Much Worse: Week 48	2.4 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Minimally Worse: Week 48	9.5 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Much Improved: Week 48	16.7 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	Minimally Improved: Week 48	26.2 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48	No Change: Week 48	31.0 Percentage of Participants

Secondary

Percentage of Participants With Virologic Failure (HIV-1 RNA >=200 Copies/mL) at Weeks 24 and 48

Percentage of participants with virologic failure (HIV-1 RNA \>=200 copies/mL) at Weeks 24 and 48 was reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Virologic Failure (HIV-1 RNA >=200 Copies/mL) at Weeks 24 and 48	Week 24	4.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Virologic Failure (HIV-1 RNA >=200 Copies/mL) at Weeks 24 and 48	Week 24	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Virologic Failure (HIV-1 RNA >=200 Copies/mL) at Weeks 24 and 48	Week 48	0 Percentage of Participants

Secondary

Percentage of Participants With Virologic Failure (HIV-1 RNA >=50 Copies/mL) at Weeks 24 and 48

Percentage of participants with virologic failure (HIV-1 RNA \>=50 copies/mL) at Weeks 24 and 48 was reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Virologic Failure (HIV-1 RNA >=50 Copies/mL) at Weeks 24 and 48	Week 24	10.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Virologic Failure (HIV-1 RNA >=50 Copies/mL) at Weeks 24 and 48	Week 24	0 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Virologic Failure (HIV-1 RNA >=50 Copies/mL) at Weeks 24 and 48	Week 48	3.8 Percentage of Participants

Secondary

Percentage of Participants With Virologic Response (HIV-1 RNA<200 Copies/mL) at Weeks 24 and 48

Percentage of participants with virologic response (HIV-1 RNA\<200 copies/mL) at Week 24 and 48 was reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Virologic Response (HIV-1 RNA<200 Copies/mL) at Weeks 24 and 48	Week 24	86.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Virologic Response (HIV-1 RNA<200 Copies/mL) at Weeks 24 and 48	Week 24	90.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Virologic Response (HIV-1 RNA<200 Copies/mL) at Weeks 24 and 48	Week 48	84.9 Percentage of Participants

Secondary

Percentage of Participants With Virologic Response (HIV-1 RNA<50 Copies/mL) at Weeks 24 and 48

Percentage of participants with virologic response (HIV-1 RNA\<50 copies/mL) at Weeks 24 and 48 was reported.

Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48

Arm	Measure	Group	Value (NUMBER)
D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24	Percentage of Participants With Virologic Response (HIV-1 RNA<50 Copies/mL) at Weeks 24 and 48	Week 24	80.0 Percentage of Participants
INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24	Percentage of Participants With Virologic Response (HIV-1 RNA<50 Copies/mL) at Weeks 24 and 48	Week 24	90.6 Percentage of Participants
D/C/F/TAF Immediate Switch (IS): Baseline to Week 48	Percentage of Participants With Virologic Response (HIV-1 RNA<50 Copies/mL) at Weeks 24 and 48	Week 48	81.1 Percentage of Participants

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026

A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percent Change From Baseline in Body Weight at Week 24

Percent Change From Baseline in Body Weight at Week 24: Black/African American and Black/African American- Female Subgroups

Percent Change From Baseline in Body Weight at Week 24: Body Mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) Subgroup

Percent Change From Baseline in Body Weight at Week 24: Female and Male Subgroup

Percent Change From Baseline in Body Weight at Week 24: Non-Black/African American Subgroup

Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48

Change From Baseline in Absolute Body Weight Over Time

Change From Baseline in Adiponectin at Weeks 24 and 48

Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48

Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48

Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48

Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48

Change From Baseline in Body Mass Index (BMI) Over Time

Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48

Change From Baseline in Fasting Glucose at Weeks 24 and 48

Change From Baseline in Fasting Lipids at Weeks 24 and 48

Change From Baseline in Hematology Parameter: Erythrocytes Values at Weeks 24 and 48

Change From Baseline in Hematology Parameter: Hemoglobin Values at Weeks 24 and 48

Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48

Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48

Change From Baseline in Leptin at Weeks 24 and 48

Change From Baseline in Percent of Hemoglobin A1c (HbA1c) at Weeks 24 and 48

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time

Change From Baseline in Urinalysis Parameter: pH Values at Weeks 24 and 48

Change From Baseline in Urinalysis Parameter: Specific Gravity Values at Weeks 24 and 48

Change From Baseline in Waist Circumference Over Time

Number of Participants Who Discontinued the Study Drug Due to TEAEs

Number of Participants With Any Grade Treatment-emergent Adverse Events (TEAEs)

Number of Participants With Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Weeks 24 and 48

Number of Participants With Grade 3 and Grade 4 Laboratory Abnormalities

Number of Participants With Grade 3 and Grade 4 TEAEs

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48

Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents

Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48

Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48

Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents

Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48

Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time

Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time

Percentage of Participants With Confirmed Virologic Rebound at Weeks 24 and 48

Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48

Percentage of Participants With Virologic Failure (HIV-1 RNA >=200 Copies/mL) at Weeks 24 and 48

Percentage of Participants With Virologic Failure (HIV-1 RNA >=50 Copies/mL) at Weeks 24 and 48

Percentage of Participants With Virologic Response (HIV-1 RNA<200 Copies/mL) at Weeks 24 and 48

Percentage of Participants With Virologic Response (HIV-1 RNA<50 Copies/mL) at Weeks 24 and 48