HIV-1
Conditions
Brief summary
The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive participants as determined by the proportion of virologic responders defined as having (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.
Interventions
DRUGDRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
Participants will receive oral tablet containing D 800 mg /C 150 mg /F 200 mg /TAF 10 mg FDC once daily within 24 hours of the screening/ baseline visit.
Sponsors
Janssen Scientific Affairs, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed with human immunodeficiency virus type 1 (HIV-1) evidenced by any of the following within 2 weeks of the screening/baseline visit: a) HIV Rapid Antibody positive; or b) HIV Immunoassay positive; or c) Positive p24 antigen and a HIV-1 ribonucleic acid (RNA) viral load greater than or equal to (\>=) 5,000 copies per milliliter (copies/ mL); or d) Non-reactive HIV-1 antibody/antigen assays and HIV-1 RNA viral load (\>=) 5,000 copies/mL. HIV-1 RNA viral load must be confirmed once within 1 week of initial HIV-1 RNA viral load test * Antiretroviral treatment-naïve, except for the use of TRUVADA® for pre-exposure prophylaxis (PrEP) * Must be able to swallow whole tablets * A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study drug * A woman of childbearing potential must have a negative urine pregnancy test at screening
Exclusion criteria
* Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium tuberculosis infection, or another acquired immunodeficiency syndrome (AIDS) -defining condition that in the judgement of the investigator would increase the risk of morbidity or mortality * Known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgement is not compatible with Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF FDC) * Known history of cirrhosis as diagnosed based on local practices * Known history of chronic (\[\>=\] 3 months) renal insufficiency, defined as having an estimated glomerular filtration rate (eGFR) less than (\<) 50 milliliter per minute (mL/min) according to the Modification of Diet in Renal Disease (MDRD) formula * Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach | Week 48 | Percentage of participants with a HIV-1 RNA \< 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is \< 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 | Week 24 | Percentage of participants with HIV-1 RNA \< 50 copies/mL were reported. |
| Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48 | Baseline, Weeks 12, 24 and 48 | The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed. |
| Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules | Up to Week 48 | Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: a). Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula \< 50 milliliter per minute (mL/min) b). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (\>=) 2.5\*upper limit of normal (ULN); c). Serum lipase \>=1.5\*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; f). Participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC. |
| Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) | Up to Week 48 | Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Percentage of Participants Experiencing Grade 3 and 4 Adverse Events | Up to Week 48 | AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. |
| Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Up to Week 48 | Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable. |
| Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings | Up to Day 35 | Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study. |
| Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs) | Baseline (Day 1) | Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor \[NRTIs\] and non-nucleoside/nucleotide reverse transcriptase inhibitor \[NNRTIs\]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) \[\<500 copies/mL\], reduced viral fitness, compromised sample collection/handling, primer incompatibility). |
| Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48 | Week 24 and 48 | Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA \<1 log10 reduction from baseline, and HIV-1 RNA \>= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA \<50 copies/mL, a rebound in HIV 1 RNA to \>= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a \>1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result. |
| Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF) | Up to Week 48 | Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA \<1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (\>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA \<50 copies/mL, a rebound in HIV 1 RNA to \>= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a \>1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result. |
| Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment | Up to Week 48 | Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported. |
| Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit | Up to Week 48 | Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported. |
| Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48 | Change from baseline in log10 HIV-1 RNA viral load (\<50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported. |
| Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 | Weeks 4, 8, 12, 24, 36, and 48 | Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported. |
| Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48 | Weeks 4, 24, and 48 | The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the treatment satisfaction. |
| Number of Participants With Hospitalizations | Up to Week 48 | Number of participants with hospitalizations (overnight) was reported. |
| Duration of Hospitalizations | Up to Week 48 | Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM. |
| Number of Participants With Outpatient Visits | Up to Week 48 | Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported. |
| Number of Participants With Emergency Room Visits | Up to Week 48 | Number of participants with emergency room visits was reported. |
| Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU]) | Up to Week 48 | Median medical costs of care (United States of America \[USA\] dollars) based on healthcare resource utilization \[HRU\]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit. |
| Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96 | Up to Week 96 | Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96 | Up to Week 96 | AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. |
| Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96 | Up to Week 96 | Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable. |
| Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96 | Weeks 72 and 96 | Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA \<1 log10 reduction from baseline, and HIV-1 RNA \>= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA \<50 copies/mL, a rebound in HIV 1 RNA to \>= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a \>1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result. |
| Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48 | Weeks 4, 8, 12, 24, 36, and 48 | Percentage of participants with treatment adherence \>95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (\>) 95 percent (%) by pill count. |
Countries
United States
Participant flow
Recruitment details
Out of 97 participants who completed the main study, 80 participants continued into the extension phase and were treated with Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC).
Participants by arm
| Arm | Count |
|---|---|
| D/C/F/TAF Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. | 109 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Extension Period (Week 48 to Week 96) | Adverse Event | 1 |
| Extension Period (Week 48 to Week 96) | Lost to Follow-up | 6 |
| Extension Period (Week 48 to Week 96) | Other | 2 |
| Extension Period (Week 48 to Week 96) | Transition to Commercial D/C/F/TAF | 55 |
| Extension Period (Week 48 to Week 96) | Transition to Other ARV Treatment | 16 |
| Main Study Period (Week 0 to Week 48) | Adverse Event | 1 |
| Main Study Period (Week 0 to Week 48) | Lost to Follow-up | 4 |
| Main Study Period (Week 0 to Week 48) | Other | 5 |
| Main Study Period (Week 0 to Week 48) | Protocol Violation | 1 |
| Main Study Period (Week 0 to Week 48) | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | D/C/F/TAF |
|---|---|
| Age, Continuous | 32.5 years STANDARD_DEVIATION 12.02 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 65 Participants |
| Region of Enrollment United States | 109 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 80 |
| other Total, other adverse events | 92 / 109 | 45 / 80 |
| serious Total, serious adverse events | 10 / 109 | 4 / 80 |
Outcome results
Primary
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach
Percentage of participants with a HIV-1 RNA \< 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is \< 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.
Time frame: Week 48
Population: The intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach | 84.4 Percentage of participants |
Secondary
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48
The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed.
Time frame: Baseline, Weeks 12, 24 and 48
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| D/C/F/TAF: Main Study | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48 | Change at Week 12 | 149.56 Cells per millimeter cube (cells/mm^3) | Standard Error 16.621 |
| D/C/F/TAF: Main Study | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48 | Change at Week 24 | 182.11 Cells per millimeter cube (cells/mm^3) | Standard Error 16.885 |
| D/C/F/TAF: Main Study | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48 | Change at Week 48 | 222.60 Cells per millimeter cube (cells/mm^3) | Standard Error 20.618 |
Secondary
Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48
Change from baseline in log10 HIV-1 RNA viral load (\<50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48
Population: The ITT analysis set included all participants who were randomized and received at least one dose of study treatment in study. Here, n (number analyzed) signifies participants analyzed for this outcome measure (OM) at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| D/C/F/TAF: Main Study | Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 | Change at Week 4 | -2.02 log10 HIV-1 RNA copies per mL | Standard Error 0.066 |
| D/C/F/TAF: Main Study | Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 | Change at Week 2 | -1.65 log10 HIV-1 RNA copies per mL | Standard Error 0.056 |
| D/C/F/TAF: Main Study | Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 | Change at Week 8 | -2.43 log10 HIV-1 RNA copies per mL | Standard Error 0.086 |
| D/C/F/TAF: Main Study | Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 | Change at Week 12 | -2.78 log10 HIV-1 RNA copies per mL | Standard Error 0.08 |
| D/C/F/TAF: Main Study | Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 | Change at Week 24 | -3.08 log10 HIV-1 RNA copies per mL | Standard Error 0.096 |
| D/C/F/TAF: Main Study | Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 | Change at Week 36 | -3.14 log10 HIV-1 RNA copies per mL | Standard Error 0.102 |
| D/C/F/TAF: Main Study | Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 | Change at Week 48 | -3.14 log10 HIV-1 RNA copies per mL | Standard Error 0.099 |
Secondary
Duration of Hospitalizations
Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM.
Time frame: Up to Week 48
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| D/C/F/TAF: Main Study | Duration of Hospitalizations | 5.0 Days |
Secondary
Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48
The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the treatment satisfaction.
Time frame: Weeks 4, 24, and 48
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| D/C/F/TAF: Main Study | Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48 | Week 4 | 56.52 Units on a scale | Standard Error 0.472 |
| D/C/F/TAF: Main Study | Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48 | Week 24 | 57.87 Units on a scale | Standard Error 0.387 |
| D/C/F/TAF: Main Study | Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48 | Week 48 | 57.88 Units on a scale | Standard Error 0.442 |
Secondary
Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU])
Median medical costs of care (United States of America \[USA\] dollars) based on healthcare resource utilization \[HRU\]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit.
Time frame: Up to Week 48
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies those participants who were evaluable for the specified categories.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| D/C/F/TAF: Main Study | Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU]) | Overnight hospitalization | 2035.0 USA dollars |
| D/C/F/TAF: Main Study | Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU]) | Hospital day care ward (without overnight) | 341.0 USA dollars |
| D/C/F/TAF: Main Study | Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU]) | Emergency room visit | 212.0 USA dollars |
| D/C/F/TAF: Main Study | Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU]) | General practitioner visit | 142.0 USA dollars |
| D/C/F/TAF: Main Study | Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU]) | Specialist visit | 94.0 USA dollars |
| D/C/F/TAF: Main Study | Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU]) | Nurse practitioner visit | 66.0 USA dollars |
| D/C/F/TAF: Main Study | Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU]) | Physician assistant visit | 47.0 USA dollars |
| D/C/F/TAF: Main Study | Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU]) | Other visit | 148.0 USA dollars |
Secondary
Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules
Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: a). Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula \< 50 milliliter per minute (mL/min) b). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (\>=) 2.5\*upper limit of normal (ULN); c). Serum lipase \>=1.5\*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; f). Participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC.
Time frame: Up to Week 48
Population: The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D/C/F/TAF: Main Study | Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules | 3 Participants |
Secondary
Number of Participants With Emergency Room Visits
Number of participants with emergency room visits was reported.
Time frame: Up to Week 48
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D/C/F/TAF: Main Study | Number of Participants With Emergency Room Visits | 19 Participants |
Secondary
Number of Participants With Hospitalizations
Number of participants with hospitalizations (overnight) was reported.
Time frame: Up to Week 48
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D/C/F/TAF: Main Study | Number of Participants With Hospitalizations | 11 Participants |
Secondary
Number of Participants With Outpatient Visits
Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported.
Time frame: Up to Week 48
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| D/C/F/TAF: Main Study | Number of Participants With Outpatient Visits | General practitioner visit | 33 Participants |
| D/C/F/TAF: Main Study | Number of Participants With Outpatient Visits | Specialist visit | 28 Participants |
| D/C/F/TAF: Main Study | Number of Participants With Outpatient Visits | Nurse practitioner visit | 16 Participants |
| D/C/F/TAF: Main Study | Number of Participants With Outpatient Visits | Physician assistant visit | 6 Participants |
| D/C/F/TAF: Main Study | Number of Participants With Outpatient Visits | Home healthcare nurse visit | 0 Participants |
| D/C/F/TAF: Main Study | Number of Participants With Outpatient Visits | Other visit | 25 Participants |
Secondary
Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF)
Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA \<1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (\>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA \<50 copies/mL, a rebound in HIV 1 RNA to \>= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a \>1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
Time frame: Up to Week 48
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF) | 0 Percentage of participants |
Secondary
Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)
Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Up to Week 48
Population: The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) | 0.9 Percentage of participants |
Secondary
Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96
Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Up to Week 96
Population: Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96 | 1.3 Percentage of participants |
Secondary
Percentage of Participants Experiencing Grade 3 and 4 Adverse Events
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
Time frame: Up to Week 48
Population: The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Adverse Events | Grade 3 | 11.9 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Adverse Events | Grade 4 | 0.9 Percentage of participants |
Secondary
Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
Time frame: Up to Week 96
Population: Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96 | Grade 3 | 7.5 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96 | Grade 4 | 2.5 Percentage of participants |
Secondary
Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities
Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
Time frame: Up to Week 48
Population: The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | ALT: Grade 3 | 0 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | ALT: Grade 4 | 2.8 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | AST: Grade 3 | 0.9 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | AST: Grade 4 | 3.7 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Calcium: Grade 3 | 0 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Calcium: Grade 4 | 0.9 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Glucose: Grade 3 | 0.9 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Glucose: Grade 4 | 0 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Hyperbilirubinemia: Grade 3 | 2.8 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Hyperbilirubinemia: Grade 4 | 0 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Hypophosphatemia: Grade 3 | 0.9 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Hypophosphatemia: Grade 4 | 0 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Sodium: Grade 3 | 0 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Sodium: Grade 4 | 0.9 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Absolute Lymphocytes Count: Grade 3 | 0.9 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Absolute Lymphocytes Count: Grade 4 | 0.9 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Platelet Count: Grade 3 | 0 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities | Platelet Count: Grade 4 | 0.9 Percentage of participants |
Secondary
Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96
Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
Time frame: Up to Week 96
Population: Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96 | Glucose: Grade 3 | 2.5 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96 | Glucose: Grade 4 | 0 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96 | Hypophosphatemia: Grade 3 | 1.3 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96 | Hypophosphatemia: Grade 4 | 0 Percentage of participants |
Secondary
Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment
Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported.
Time frame: Up to Week 48
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment | 3.67 Percentage of participants |
Secondary
Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings
Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study.
Time frame: Up to Day 35
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings | 0 Percentage of participants |
Secondary
Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48
Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported.
Time frame: Weeks 4, 8, 12, 24, 36, and 48
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 | Week 4 | 99.76 Percentage of participants | Standard Deviation 2.44 |
| D/C/F/TAF: Main Study | Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 | Week 8 | 99.50 Percentage of participants | Standard Deviation 3.518 |
| D/C/F/TAF: Main Study | Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 | Week 12 | 99.02 Percentage of participants | Standard Deviation 6.967 |
| D/C/F/TAF: Main Study | Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 | Week 24 | 98.04 Percentage of participants | Standard Deviation 10.949 |
| D/C/F/TAF: Main Study | Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 | Week 36 | 99.49 Percentage of participants | Standard Deviation 3.535 |
| D/C/F/TAF: Main Study | Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 | Week 48 | 99.48 Percentage of participants | Standard Deviation 3.571 |
Secondary
Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs)
Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor \[NRTIs\] and non-nucleoside/nucleotide reverse transcriptase inhibitor \[NNRTIs\]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) \[\<500 copies/mL\], reduced viral fitness, compromised sample collection/handling, primer incompatibility).
Time frame: Baseline (Day 1)
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs) | Primary PI RAM | 4.9 Percentage of Participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs) | Secondary PI RAM | 98.0 Percentage of Participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs) | Darunavir RAM | 0 Percentage of Participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs) | Emtricitabine RAM | 2.0 Percentage of Participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs) | NNRTI RAM | 27.5 Percentage of Participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs) | Primary INI RAM | 0 Percentage of Participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs) | Secondary INI RAM | 4.9 Percentage of Participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
Percentage of participants with HIV-1 RNA \< 50 copies/mL were reported.
Time frame: Week 24
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 | 81.7 Percentage of Participants |
Secondary
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48
Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA \<1 log10 reduction from baseline, and HIV-1 RNA \>= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA \<50 copies/mL, a rebound in HIV 1 RNA to \>= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a \>1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
Time frame: Week 24 and 48
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48 | Week 24 | 0 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48 | Week 48 | 0 Percentage of participants |
Secondary
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96
Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA \<1 log10 reduction from baseline, and HIV-1 RNA \>= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA \<50 copies/mL, a rebound in HIV 1 RNA to \>= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a \>1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
Time frame: Weeks 72 and 96
Population: Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase. Here 'n' (number analyzed) signifies number of participants with observed virologic response at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96 | Week 72 | 10.6 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96 | Week 96 | 9.1 Percentage of participants |
Secondary
Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit
Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported.
Time frame: Up to Week 48
Population: The modified ITT analysis set included all participants who were randomized and received at least one dose of study treatment and are HIV-1 positive after enrollment. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM. Here, n (number analyzed) signifies participants analyzed at specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit | Retention in care: Completed | 63.6 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit | Documented Clinical Visit | 85.7 Percentage of participants |
Secondary
Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48
Percentage of participants with treatment adherence \>95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (\>) 95 percent (%) by pill count.
Time frame: Weeks 4, 8, 12, 24, 36, and 48
Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| D/C/F/TAF: Main Study | Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48 | >95% at Week 4 | 83.5 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48 | >95% at Week 8 | 84.5 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48 | >95% at Week 12 | 79.4 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48 | >95% at Week 24 | 76.5 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48 | >95% at Week 36 | 75.8 Percentage of participants |
| D/C/F/TAF: Main Study | Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48 | >95% at Week 48 | 65.6 Percentage of participants |