HIV Infection, Infection, Human Immunodeficiency Virus I
Conditions
Keywords
tenofovir, HIV, efavirenz, naive, lamivudine, abacavir, emtricitabine, renal
Brief summary
Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily regimens. However data from head-to-head randomized trials comparing these two FDCs as part of an initial regimen are not available at present. The long-term toxicity profiles of these regimens are of particular importance, as treatment of HIV is currently life-long and therefore, minimizing long-term toxicity and maximizing adherence and duration of regimen maintenance are critical therapy objectives. The primary endpoint is estimated glomerular filtration rate (GFR), as measured by the modified diet in renal disease (MDRD) equation, a validated estimate of renal function.
Detailed description
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
Interventions
DRUGAbacavir/lamivudine and efavirenz
DRUGTenofovir/Emtricitabine and efavirenz
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is at least 18 years of age. * Subject is antiretroviral-naïve (defined as having no previous therapy with any NNRTI and 14 days of prior therapy with any other antiretroviral). * Subject has plasma HIV-1 RNA 1,000 copies/mL at screening. This test may be repeated once within the 45-day screening window. * Subject is willing and able to understand and provide written informed consent prior to participation in this study. * A female is eligible to enter and participate in the study if she is of: 1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or, 2. Child-bearing potential, has a negative pregnancy test at screen and agrees to one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician): Complete abstinence from intercourse from 2 weeks prior to administration of the investigational products, throughout the study, and for at least 2 weeks after discontinuation of all study medications Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide). Hormonal contraception will not be considered adequate for inclusion into this study Any intrauterine device (IUD) with published data showing that the expected failure rate is \<1% per year. Sterilization (female subject or male partner of female subject). * Prior to randomization, subjects must have been screened and be negative for the HLA-B\*5701 allele. Test may be performed by local laboratory and results must be available for source document verification according to local practices.
Exclusion criteria
* Subject is in the initial acute phase of a CDC Clinical Category C infection at Baseline. * Subject is enrolled in one or more investigational drug protocols, which may impact HIV RNA suppression. * Subject is, in the opinion of the Investigator, unable to complete the study dosing period and protocol evaluations and assessments. * Subject is either pregnant or breastfeeding. * Subject suffers from a serious medical condition, which in the opinion of the Investigator would compromise the safety of the subject. * Subject has a history of inflammatory bowel disease or other gastrointestinal dysfunction. * Subject has any acute laboratory abnormality at screening. * Subject has an estimated creatinine clearance within the screening period \<50mL/min via the Cockcroft-Gault method. * Alanine aminotransferase (ALT) \>5 times the upper limit of normal. * Subjects with a history of thyroid disease, hyperparathyroid disease, chronic hyper or hypocalcemia, vitamin D deficiency, or receiving thyroid hormone or parathyroid hormone replacement within 28 days prior to screening. * Subjects with a history of systemic inflammatory arthritis. * Subjects who are hepatitis B positive at screening. * Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents. * Subject has received treatment with an HIV-1 immunotherapeutic vaccine or any agents with documented activity against HIV-1 in vitro within 28 days prior to Screening, or an anticipated need during the study. * Subjects who require treatment with any of the following medications within 28 days of commencement of investigational product, or an anticipated need during the study: * Medications with significant drug-drug interactions with efavirenz:voriconazole, terfenadine, astemizole, cisapride, ergot alkaloids (dihydroergotamine, ergonovine, ergotamine, methylergonovine), midazolam, triazolam, St. John's wort, carbamazepine, phenytoin, phenobarbital, rifampin, pimozide, bepridil * Medications which may impact on bone mineral density: oral or systemic corticosteroids, anticonvulsants, heparin, warfarin, cyclosporine, bisphosphonates, calcitonin, parathyroid hormone, Vitamin D supplements and analogues, Calcium supplements, oestrogen or progesterone replacement (oral hormonal contraception permitted), raloxifene, tamoxifen, testosterone or anabolic steroid replacement/supplements. * Systemic interleukins or interferons * Subject has a history of allergy to any of the protocol-specified medications or any excipients therein. * Subject has evidence of genotypic resistance at screening (according to central lab interpretation) or prior documented evidence of genotypic and/or phenotypic (above threshold for reduced susceptibility) resistance to any of the following drugs: efavirenz, abacavir, lamivudine, tenofovir, emtricitabine. * Subjects who are unsuitable for DEXA scanning should be excluded, including 1) Less than three vertebra in the range of L1 to L4 that are suitable for BMD measurement by DEXA, or 2) Bilateral hip replacement. * The subject has previously participated in an experimental drug and/or vaccine trial(s) within 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine - whichever is longer, prior to screening for the study. * The subject will participate simultaneously in another clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48 | Baseline, Week 48 | Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m\^2) = 175 \* (Scr)\^-1.154 \* (Age)\^-0.203 \* (0.742 if female) \* (1.212 if African American) (conventional units). mL, milliliters; min, minute; m\^2, meters squared; Scr, serum creatinine; BMI, body mass index. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48 | Week 48 | HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. |
| Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Week 96 | The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy. |
| Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24 | Week 24 | HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. |
| Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96 | Week 96 | HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. |
| Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24 | Baseline, Week 24 | CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. |
| Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48 | Baseline, Week 48 | CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. |
| Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96 | Baseline, Week 96 | CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. |
| Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 | Week 96 | Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures \>=400 cop/mL separated by at least 2-4 wk after being previously \<=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures \>400 cop/mL separated by at least 2-4 wk on/after Wk 24. |
| Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Baseline to Week 96 | Participants were asked at each visit whether or not they utilized unplanned healthcare resources. |
| Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24 | Baseline, Week 24 | Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m\^2) = 175 \* (Scr)\^-1.154 \* (Age)\^-0.203 \* (0.742 if female) \* (1.212 if African American) (conventional units). mL, milliliters; min, minute; m\^2, meters squared; Scr, serum creatinine. |
| Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96 | Baseline, Week 96 | Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m\^2) = 175 \* (Scr)\^-1.154 \* (Age)\^-0.203 \* (0.742 if female) \* (1.212 if African American) (conventional units). mL, milliliters; min, minute; m\^s, meters squared; Scr, serum creatinine. |
| Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24 | Baseline, Week 24 | Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) \* (mass in kg) \* (0.85 if female) divided by 72 \* serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault. |
| Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48 | Baseline, Week 48 | Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) \* (mass in kg) \* (0.85 if female) divided by 72 \* serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram. |
| Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96 | Baseline, Week 96 | Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) \* (mass in kg) \* (0.85 if female) divided by 72 \* serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram. |
| Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | Baseline, Week 24 | mL, milliliter; min, minute; m\^2, meters squared |
| Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | Baseline, Week 48 | mL, milliliter; min, minute; m\^2, meters squared |
| Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | Baseline, Week 96 | mL, milliliter; min, minute; m\^2, meters squared |
| Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Baseline, Week 24 | Normal: GFR \>=60 mL/min/1.73 m\^2 and creatinine ratio \<=200 mg/g GFR; Stage 1: GFR \>=90 mL/min/1.73 m\^2 and creatinine ratio \>200 mg/g; Stage 2: GFR \>=60-\<90 mL/min/1.73 m\^2 and creatinine ratio \>200 mg/g; Stage 3: GFR \>=30-\<60 mL/min/1.73 m\^2; Stage 4: GFR \>=15-\<30 mL/min/1.73 m\^2; Stage 5: GFR \<15 mL/min/1.73 m\^2. mL, milliliter; min, minute; m\^2, meters squared; mg, milligram; g, gram. |
| Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Baseline, Week 48 | Normal: GFR \>=60 mL/min/1.73 m\^2 and creatinine ratio \<=200 mg/g GFR; Stage 1: GFR \>=90 mL/min/1.73 m\^2 and creatinine ratio \>200 mg/g; Stage 2: GFR \>=60-\<90 mL/min/1.73 m\^2 and creatinine ratio \>200 mg/g; Stage 3: GFR \>=30-\<60 mL/min/1.73 m\^2; Stage 4: GFR \>=15-\<30 mL/min/1.73 m\^2; Stage 5: GFR \<15 mL/min/1.73 m\^2. mL, milliliter; min, minute; m\^2, meters squared; mg, milligram; g, gram. |
| Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Baseline, Week 96 | Normal: GFR \>=60 mL/min/1.73 m\^2 and creatinine ratio \<=200 mg/g GFR; Stage 1: GFR \>=90 mL/min/1.73 m\^2 and creatinine ratio \>200 mg/g; Stage 2: GFR \>=60-\<90 mL/min/1.73 m\^2 and creatinine ratio \>200 mg/g; Stage 3: GFR \>=30-\<60 mL/min/1.73 m\^2; Stage 4: GFR \>=15-\<30 mL/min/1.73 m\^2; Stage 5: GFR \<15 mL/min/1.73 m\^2. mL, milliliter; min, minute; m\^2, meters squared; mg, milligram; g, gram. |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 | Baseline, Week 24 | BMD is a measure (grams \[g\] per centimeters cubed \[cm\^3\]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. |
| Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 | Baseline, Week 24 | BMD is a measure (grams per cm\^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 | Baseline, Week 48 | BMD is a measure (grams per cm\^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. |
| Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 | Baseline, Week 48 | BMD is a measure (grams per cm\^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 | Baseline, Week 96 | BMD is a measure (grams per cm\^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. |
| Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 | Baseline, Week 96 | BMD is a measure (grams per cm\^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. |
| Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 | Baseline, Week 24 | BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. |
| Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 | Baseline, Week 48 | BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. |
| Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 | Baseline, Week 96 | BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. |
| Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 | Week 24 | The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD. |
| Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 | Week 48 | The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD. |
| Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 | Week 96 | The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD. |
| Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Baseline to Week 24 | An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. |
| Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Baseline to Week 48 | An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. |
| Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Baseline to Week 96 | An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. |
| Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Baseline, Week 24 | Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<200 mg/dL, desirable; 200-\<240 mg/dL, borderline high; \>=240 mg/dL, high. mg, milligram; dL, deciliter. |
| Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Baseline, Week 48 | Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<200 mg/dL, desirable; 200-\<240 mg/dL, borderline high; \>=240 mg/dL, high. mg, milligram; dL, deciliter. |
| Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Baseline, Week 96 | Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<200 mg/dL, desirable; 200-\<240 mg/dL, borderline high; \>=240 mg/dL, high. mg, milligram; dL, deciliter. |
| Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Baseline, Week 24 | Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<100 mg/dL, optimal; 100-\<130 mg/dL, near/above optimal; 130-\<160 mg/dL, borderline high; 160-\<190 mg/dL, high; \>=190 mg/dL, very high. |
| Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Baseline, Week 48 | Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<100 mg/dL, optimal; 100-\<130 mg/dL, near/above optimal; 130-\<160 mg/dL, borderline high; 160-\<190 mg/dL, high; \>=190 mg/dL, very high. |
| Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Baseline, Week 96 | Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<100 mg/dL, optimal; 100-\<130 mg/dL, near/above optimal; 130-\<160 mg/dL, borderline high; 160-\<190 mg/dL, high; \>=190 mg/dL, very high. |
| Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Baseline, Week 24 | Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<40 mg/dL, low; 40-\<60 mg/dL, normal; \>=60 mg/dL, high. |
| Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Baseline, Week 48 | Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<40 mg/dL, low; 40-\<60 mg/dL, normal; \>=60 mg/dL, high. |
| Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Baseline, Week 96 | Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<40 mg/dL, low; 40-\<60 mg/dL, normal; \>=60 mg/dL, high. |
| Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Baseline, Week 24 | Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<150 mg/dL, normal; 150-\<200 mg/dL, borderline high; 200-\<500 mg/dL, high; \>=500 mg/dL, very high. |
| Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Baseline, Week 48 | Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<150 mg/dL, normal; 150-\<200 mg/dL, borderline high; 200-\<500 mg/dL, high; \>=500 mg/dL, very high. |
| Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Week 24 | The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment. |
| Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Baseline, Week 96 | Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<150 mg/dL, normal; 150-\>200 mg/dL, borderline high; 200-\<500 mg/dL, high;\>= 500 mg/dL, very high. |
| Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Week 48 | The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96 | Baseline, Week 96 | Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol). |
| Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96 | Baseline, Week 96 | Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole \[umol/h/mmol\]). |
| Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96 | Baseline, Week 96 | Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole \[ug/mmol\]). |
| Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96 | Baseline, Week 96 | P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. |
| Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96 | Baseline, Week 96 | Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. |
| Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96 | Baseline, Week 96 | Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. |
| Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96 | Baseline, Week 96 | Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. |
| Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96 | Baseline, Week 96 | Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol). |
Countries
Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Latvia, Netherlands, Portugal, Spain, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD | 192 |
| TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD | 193 |
| Total | 385 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 28 | 26 |
| Overall Study | Disease Progression | 1 | 0 |
| Overall Study | Insufficient Viral Load Response | 4 | 2 |
| Overall Study | Investigator Decision | 4 | 3 |
| Overall Study | Lost to Follow-up | 7 | 8 |
| Overall Study | Non-compliance | 2 | 4 |
| Overall Study | No scan facilities | 0 | 2 |
| Overall Study | Not Exposed to Study Drug | 3 | 4 |
| Overall Study | Participant Moved | 2 | 0 |
| Overall Study | Participant moved.Week 96 visit, no scan | 1 | 0 |
| Overall Study | Participant not able to perform Week 96 | 1 | 0 |
| Overall Study | Participant overweight, no scan possible | 1 | 0 |
| Overall Study | Participant planning pregnancy | 1 | 0 |
| Overall Study | Pregnancy | 0 | 3 |
| Overall Study | Prohibited Medication | 1 | 2 |
| Overall Study | Protocol-defined Virological Failure | 7 | 0 |
| Overall Study | Protocol Violation | 7 | 2 |
| Overall Study | Treatment Eligibility Criteria Not Met | 3 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 7 |
Baseline characteristics
| Characteristic | ABC/3TC FDC | TDF/FTC FDC | Total |
|---|---|---|---|
| Age Continuous | 38.0 Years | 36.0 Years | 37.0 Years |
| Race/Ethnicity, Customized African American/African Heritage | 26 participants | 30 participants | 56 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 11 participants | 7 participants | 18 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 5 participants | 7 participants |
| Race/Ethnicity, Customized White | 153 participants | 151 participants | 304 participants |
| Sex: Female, Male Female | 33 Participants | 40 Participants | 73 Participants |
| Sex: Female, Male Male | 159 Participants | 153 Participants | 312 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 172 / 192 | 175 / 193 |
| serious Total, serious adverse events | 31 / 192 | 20 / 193 |
Outcome results
Primary
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48
Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m\^2) = 175 \* (Scr)\^-1.154 \* (Age)\^-0.203 \* (0.742 if female) \* (1.212 if African American) (conventional units). mL, milliliters; min, minute; m\^2, meters squared; Scr, serum creatinine; BMI, body mass index.
Time frame: Baseline, Week 48
Population: Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC FDC | Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48 | 0.22 milliliters per minute (mL/min)/1.73 m^2 | Standard Error 0.89 |
| TDF/FTC FDC | Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48 | 1.18 milliliters per minute (mL/min)/1.73 m^2 | Standard Error 0.828 |
p-value: 0.435Mixed Models Analysis
Secondary
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24
CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.
Time frame: Baseline, Week 24
Population: ITT-E Population. Some participants had withdrawn by Week 24.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ABC/3TC FDC | Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24 | 110.0 cells/millimeters cubed (mm^3) |
| TDF/FTC FDC | Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24 | 100.0 cells/millimeters cubed (mm^3) |
Secondary
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48
CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.
Time frame: Baseline, Week 48
Population: ITT-E Population. Some participants had withdrawn by Week 48.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ABC/3TC FDC | Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48 | 150.0 cells/mm^3 |
| TDF/FTC FDC | Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48 | 150.0 cells/mm^3 |
Secondary
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96
CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.
Time frame: Baseline, Week 96
Population: ITT-E Population. Some participants had withdrawn by Week 96.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ABC/3TC FDC | Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96 | 235.0 cells/mm^3 |
| TDF/FTC FDC | Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96 | 220.0 cells/mm^3 |
Secondary
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24
Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) \* (mass in kg) \* (0.85 if female) divided by 72 \* serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault.
Time frame: Baseline, Week 24
Population: ITT-E Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC FDC | Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24 | 4.27 mL/min | Standard Error 0.944 |
| TDF/FTC FDC | Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24 | 2.54 mL/min | Standard Error 0.897 |
p-value: 0.186Mixed Models Analysis
Secondary
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48
Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) \* (mass in kg) \* (0.85 if female) divided by 72 \* serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.
Time frame: Baseline, Week 48
Population: ITT-E Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC FDC | Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48 | 2.66 mL/min | Standard Error 1.005 |
| TDF/FTC FDC | Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48 | 3.80 mL/min | Standard Error 0.933 |
p-value: 0.413Mixed Models Analysis
Secondary
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96
Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) \* (mass in kg) \* (0.85 if female) divided by 72 \* serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.
Time frame: Baseline, Week 96
Population: ITT-E Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC FDC | Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96 | 4.37 mL/min | Standard Error 1.228 |
| TDF/FTC FDC | Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96 | 2.68 mL/min | Standard Error 1.133 |
p-value: 0.315Mixed Models Analysis
Secondary
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24
Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m\^2) = 175 \* (Scr)\^-1.154 \* (Age)\^-0.203 \* (0.742 if female) \* (1.212 if African American) (conventional units). mL, milliliters; min, minute; m\^2, meters squared; Scr, serum creatinine.
Time frame: Baseline, Week 24
Population: ITT-E Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC FDC | Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24 | 2.78 mL/min/1.73m^2 | Standard Error 0.884 |
| TDF/FTC FDC | Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24 | 0.43 mL/min/1.73m^2 | Standard Error 0.842 |
p-value: 0.057Mixed Models Analysis
Secondary
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96
Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m\^2) = 175 \* (Scr)\^-1.154 \* (Age)\^-0.203 \* (0.742 if female) \* (1.212 if African American) (conventional units). mL, milliliters; min, minute; m\^s, meters squared; Scr, serum creatinine.
Time frame: Baseline, Week 96
Population: ITT-E Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC FDC | Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96 | 1.48 mL/min/1.73m^2 | Standard Error 1.022 |
| TDF/FTC FDC | Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96 | -1.15 mL/min/1.73m^2 | Standard Error 0.944 |
p-value: 0.06Mixed Models Analysis
Secondary
Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96
Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures \>=400 cop/mL separated by at least 2-4 wk after being previously \<=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures \>400 cop/mL separated by at least 2-4 wk on/after Wk 24.
Time frame: Week 96
Population: On-Treatment Resistance: all participants who fulfilled the definition of protocol-defined virological failure (VF) who had paired baseline and VF genotypic data for analysis. One ABC/3TC participant took prohibited medication that potentially lowered efavirenz levels just prior to VF, allowing for the emergence of unexpected NRTI resistance.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 | Any treatment-emergent mutation | 4 participants |
| ABC/3TC FDC | Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 | NRTI | 4 participants |
| ABC/3TC FDC | Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 | NNRTI | 2 participants |
| TDF/FTC FDC | Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 | Any treatment-emergent mutation | 0 participants |
| TDF/FTC FDC | Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 | NRTI | 0 participants |
| TDF/FTC FDC | Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 | NNRTI | 0 participants |
Secondary
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.
Time frame: Baseline to Week 24
Population: Safety Population: all randomized participants who received at least one dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Any event | 26 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Drug hypersensitivity | 11 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Rash | 2 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Dizziness | 0 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Hypersensitivity | 3 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Drug eruption | 1 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Hypersensitivity | 0 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Any event | 14 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Dizziness | 2 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Drug hypersensitivity | 1 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Drug eruption | 1 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 | Rash | 3 participants |
Secondary
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.
Time frame: Baseline to Week 48
Population: Safety Population: all randomized participants who received at least one dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Bone density decreased | 0 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Dizziness | 1 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Drug hypersensitivity | 11 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Hypersensitivity | 3 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Rash | 2 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Drug eruption | 1 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Any event | 29 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Drug eruption | 1 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Any event | 21 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Drug hypersensitivity | 1 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Bone density decreased | 2 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Rash | 3 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Dizziness | 3 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 | Hypersensitivity | 0 participants |
Secondary
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.
Time frame: Baseline to Week 96
Population: Safety Population: all randomized participants who received at least one dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Drug hypersensitivity | 11 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Hypersensitivity | 3 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Rash | 2 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Abnormal dreams | 3 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Bone density decreased | 0 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Drug eruption | 1 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Dizziness | 1 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Depression | 0 participants |
| ABC/3TC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Any event | 33 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Depression | 2 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Any event | 28 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Drug hypersensitivity | 1 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Bone density decreased | 8 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Rash | 3 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Dizziness | 3 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Hypersensitivity | 0 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Abnormal dreams | 0 participants |
| TDF/FTC FDC | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 | Drug eruption | 1 participants |
Secondary
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24
The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.
Time frame: Week 24
Population: ITT-E Population. Some participants had withdrawn by Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 | Osteopenia, spine, n=147, 173 | 41 participants |
| ABC/3TC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 | Osteporosis, spine, n=147, 173 | 16 participants |
| ABC/3TC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 | Osteopenia, hip, n=149, 170 | 38 participants |
| ABC/3TC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 | Osteoporosis, hip, n=149, 170 | 4 participants |
| TDF/FTC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 | Osteoporosis, hip, n=149, 170 | 1 participants |
| TDF/FTC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 | Osteopenia, spine, n=147, 173 | 68 participants |
| TDF/FTC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 | Osteopenia, hip, n=149, 170 | 54 participants |
| TDF/FTC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 | Osteporosis, spine, n=147, 173 | 9 participants |
Secondary
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48
The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.
Time frame: Week 48
Population: ITT-E Population. Some participants had withdrawn by Week 48.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 | Osteopenia, spine, n=132, 147 | 41 participants |
| ABC/3TC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 | Osteporosis, spine, n=132, 147 | 15 participants |
| ABC/3TC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 | Osteopenia, hip, n=130, 147 | 37 participants |
| ABC/3TC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 | Osteoporosis, hip, n=130, 147 | 4 participants |
| TDF/FTC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 | Osteoporosis, hip, n=130, 147 | 0 participants |
| TDF/FTC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 | Osteopenia, spine, n=132, 147 | 57 participants |
| TDF/FTC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 | Osteopenia, hip, n=130, 147 | 50 participants |
| TDF/FTC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 | Osteporosis, spine, n=132, 147 | 5 participants |
Secondary
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96
The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.
Time frame: Week 96
Population: ITT-E Population. Some participants had withdrawn by Week 96.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 | Osteopenia, spine, n=64, 82 | 21 participants |
| ABC/3TC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 | Osteporosis, spine, n=64, 82 | 5 participants |
| ABC/3TC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 | Osteopenia, hip, n=65, 80 | 20 participants |
| ABC/3TC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 | Osteoporosis, hip, n=65, 80 | 0 participants |
| TDF/FTC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 | Osteoporosis, hip, n=65, 80 | 0 participants |
| TDF/FTC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 | Osteopenia, spine, n=64, 82 | 34 participants |
| TDF/FTC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 | Osteopenia, hip, n=65, 80 | 31 participants |
| TDF/FTC FDC | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 | Osteporosis, spine, n=64, 82 | 3 participants |
Secondary
Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized
Participants were asked at each visit whether or not they utilized unplanned healthcare resources.
Time frame: Baseline to Week 96
Population: ITT-E Population. The number of participants analyzed differed by visit because some had withdrawn during the study and some did not have an assessment performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 4, Yes, n=178, 183 | 60 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 4, No, n=178, 183 | 118 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 12, Yes, n=162, 177 | 56 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 12, No, n=162, 177 | 106 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 24, Yes, n=156, 173 | 70 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 24, No, n=156, 173 | 86 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 36, Yes, n=148, 169 | 48 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 36, No, n=148, 169 | 100 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 48, Yes, n=137, 161 | 44 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 48, No, n=137, 161 | 93 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 60, Yes, n=129, 148 | 47 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 60, No, n=129, 148 | 82 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 72, Yes, n=126, 139 | 48 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 72, No, n=126, 139 | 78 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 84, Yes, n=121, 136 | 34 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 84, No, n=121, 136 | 87 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 96, Yes, n=113, 135 | 30 participants |
| ABC/3TC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 96, No, n=113, 135 | 83 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 72, No, n=126, 139 | 99 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 4, Yes, n=178, 183 | 49 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 48, No, n=137, 161 | 125 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 4, No, n=178, 183 | 134 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 96, No, n=113, 135 | 118 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 12, Yes, n=162, 177 | 47 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 60, Yes, n=129, 148 | 44 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 12, No, n=162, 177 | 130 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 84, Yes, n=121, 136 | 24 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 24, Yes, n=156, 173 | 59 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 60, No, n=129, 148 | 104 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 24, No, n=156, 173 | 114 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 96, Yes, n=113, 135 | 17 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 36, Yes, n=148, 169 | 50 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 72, Yes, n=126, 139 | 40 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 36, No, n=148, 169 | 119 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 84, No, n=121, 136 | 108 participants |
| TDF/FTC FDC | Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized | Week 48, Yes, n=137, 161 | 36 participants |
Secondary
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24
BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.
Time frame: Baseline, Week 24
Population: ITT-E Population. Some participants had withdrawn by Week 24/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 | >=2%, spine, n=142, 165 | 73 participants |
| ABC/3TC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 | >=6%, spine, n=142, 165 | 10 participants |
| ABC/3TC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 | >=2%, hip, n=137, 160 | 38 participants |
| ABC/3TC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 | >=6%, hip, n=137, 160 | 1 participants |
| TDF/FTC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 | >=6%, hip, n=137, 160 | 6 participants |
| TDF/FTC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 | >=2%, spine, n=142, 165 | 115 participants |
| TDF/FTC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 | >=2%, hip, n=137, 160 | 93 participants |
| TDF/FTC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 | >=6%, spine, n=142, 165 | 17 participants |
Secondary
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48
BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.
Time frame: Baseline, Week 48
Population: ITT-E Population. Some participants had withdrawn by Week 48/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 | >=2%, spine, n=125, 141 | 51 participants |
| ABC/3TC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 | >=6%, spine, n=125, 141 | 5 participants |
| ABC/3TC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 | >=2%, hip, n=119, 140 | 54 participants |
| ABC/3TC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 | >=6%, hip, n=119, 140 | 3 participants |
| TDF/FTC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 | >=6%, hip, n=119, 140 | 17 participants |
| TDF/FTC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 | >=2%, spine, n=125, 141 | 84 participants |
| TDF/FTC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 | >=2%, hip, n=119, 140 | 111 participants |
| TDF/FTC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 | >=6%, spine, n=125, 141 | 13 participants |
Secondary
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96
BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.
Time frame: Baseline, Week 96
Population: ITT-E Population. Some participants had withdrawn by Week 96/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 | >=2%, spine, n=59, 79 | 21 participants |
| ABC/3TC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 | >=6%, spine, n=59, 79 | 3 participants |
| ABC/3TC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 | >=2%, hip, n=58, 76 | 33 participants |
| ABC/3TC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 | >=6%, hip, n=58, 76 | 1 participants |
| TDF/FTC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 | >=6%, hip, n=58, 76 | 13 participants |
| TDF/FTC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 | >=2%, spine, n=59, 79 | 39 participants |
| TDF/FTC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 | >=2%, hip, n=58, 76 | 52 participants |
| TDF/FTC FDC | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 | >=6%, spine, n=59, 79 | 8 participants |
Secondary
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24
mL, milliliter; min, minute; m\^2, meters squared
Time frame: Baseline, Week 24
Population: ITT-E Population. Some participants had withdrawn from the study by Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=10 mL/min, Cockcroft-Gault | 16 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=10%, Cockcroft-Gault | 10 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=20 mL/min, Cockcroft-Gault | 3 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=20%, MDRD | 2 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=20 mL/min, MDRD | 4 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=20%, Cockcroft-Gault | 2 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=10%, MDRD | 15 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=10 mL/min, MDRD | 16 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=10%, MDRD | 24 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=10 mL/min, Cockcroft-Gault | 20 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=20 mL/min, MDRD | 6 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=20 mL/min, Cockcroft-Gault | 4 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=10 mL/min, MDRD | 26 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=10%, Cockcroft-Gault | 17 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=20%, MDRD | 3 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 | >=20%, Cockcroft-Gault | 3 participants |
Secondary
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48
mL, milliliter; min, minute; m\^2, meters squared
Time frame: Baseline, Week 48
Population: ITT-E Population. Some participants had withdrawn by Week 48.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=10 mL/min, MDRD | 23 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=10 mL/min, Cockcroft-Gault | 15 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=20 mL/min, MDRD | 4 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=20 mL/min, Cockcroft-Gault | 4 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=10%, MDRD | 21 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=10%, Cockcroft-Gault | 11 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=20%, MDRD | 4 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=20%, Cockcroft-Gault | 3 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=20%, Cockcroft-Gault | 0 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=10 mL/min, MDRD | 21 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=10%, MDRD | 21 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=10 mL/min, Cockcroft-Gault | 14 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=20%, MDRD | 2 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=20 mL/min, MDRD | 3 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=10%, Cockcroft-Gault | 9 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 | >=20 mL/min, Cockcroft-Gault | 2 participants |
Secondary
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96
mL, milliliter; min, minute; m\^2, meters squared
Time frame: Baseline, Week 96
Population: ITT-E Population. Some participants had withdrawn by Week 96.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=20%, MDRD | 3 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=10 mL/min, Cockcroft-Gault | 11 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=20 mL/min, MDRD | 4 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=20 mL/min, Cockcroft-Gault | 4 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=10%, MDRD | 15 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=10%, Cockcroft-Gault | 12 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=20%, Cockcroft-Gault | 3 participants |
| ABC/3TC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=10 mL/min, MDRD | 15 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=20%, MDRD | 6 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=10 mL/min, MDRD | 38 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=10%, MDRD | 27 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=10 mL/min, Cockcroft-Gault | 19 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=20%, Cockcroft-Gault | 4 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=20 mL/min, MDRD | 7 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=10%, Cockcroft-Gault | 16 participants |
| TDF/FTC FDC | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 | >=20 mL/min, Cockcroft-Gault | 5 participants |
Secondary
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24
HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.
Time frame: Week 24
Population: ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24 | <50 copies/mL | 126 participants |
| ABC/3TC FDC | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24 | <400 copies/mL | 147 participants |
| TDF/FTC FDC | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24 | <50 copies/mL | 144 participants |
| TDF/FTC FDC | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24 | <400 copies/mL | 168 participants |
Secondary
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48
HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.
Time frame: Week 48
Population: ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48 | <50 copies/mL | 121 participants |
| ABC/3TC FDC | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48 | <400 copies/mL | 130 participants |
| TDF/FTC FDC | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48 | <50 copies/mL | 145 participants |
| TDF/FTC FDC | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48 | <400 copies/mL | 151 participants |
Secondary
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96
HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.
Time frame: Week 96
Population: ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96 | <50 copies/mL | 98 participants |
| ABC/3TC FDC | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96 | <400 copies/mL | 110 participants |
| TDF/FTC FDC | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96 | <50 copies/mL | 113 participants |
| TDF/FTC FDC | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96 | <400 copies/mL | 126 participants |
Secondary
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24
Normal: GFR \>=60 mL/min/1.73 m\^2 and creatinine ratio \<=200 mg/g GFR; Stage 1: GFR \>=90 mL/min/1.73 m\^2 and creatinine ratio \>200 mg/g; Stage 2: GFR \>=60-\<90 mL/min/1.73 m\^2 and creatinine ratio \>200 mg/g; Stage 3: GFR \>=30-\<60 mL/min/1.73 m\^2; Stage 4: GFR \>=15-\<30 mL/min/1.73 m\^2; Stage 5: GFR \<15 mL/min/1.73 m\^2. mL, milliliter; min, minute; m\^2, meters squared; mg, milligram; g, gram.
Time frame: Baseline, Week 24
Population: ITT-E Population. Some participants had withdrawn by Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Normal | 97 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Stage 1 | 11 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Stage 2 | 5 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Stage 3 | 1 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Stage 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Stage 5 | 0 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Stage 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Normal | 114 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Stage 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Stage 1 | 15 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Stage 5 | 0 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 | Stage 2 | 5 participants |
Secondary
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48
Normal: GFR \>=60 mL/min/1.73 m\^2 and creatinine ratio \<=200 mg/g GFR; Stage 1: GFR \>=90 mL/min/1.73 m\^2 and creatinine ratio \>200 mg/g; Stage 2: GFR \>=60-\<90 mL/min/1.73 m\^2 and creatinine ratio \>200 mg/g; Stage 3: GFR \>=30-\<60 mL/min/1.73 m\^2; Stage 4: GFR \>=15-\<30 mL/min/1.73 m\^2; Stage 5: GFR \<15 mL/min/1.73 m\^2. mL, milliliter; min, minute; m\^2, meters squared; mg, milligram; g, gram.
Time frame: Baseline, Week 48
Population: ITT-E Population. Some participants had withdrawn by Week 48.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Missing | 12 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Normal | 90 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Stage 1 | 7 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Stage 2 | 3 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Stage 3 | 0 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Stage 5 | 0 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Stage 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Stage 2 | 3 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Missing | 19 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Stage 5 | 0 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Normal | 106 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Stage 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Stage 1 | 5 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 | Stage 4 | 0 participants |
Secondary
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96
Normal: GFR \>=60 mL/min/1.73 m\^2 and creatinine ratio \<=200 mg/g GFR; Stage 1: GFR \>=90 mL/min/1.73 m\^2 and creatinine ratio \>200 mg/g; Stage 2: GFR \>=60-\<90 mL/min/1.73 m\^2 and creatinine ratio \>200 mg/g; Stage 3: GFR \>=30-\<60 mL/min/1.73 m\^2; Stage 4: GFR \>=15-\<30 mL/min/1.73 m\^2; Stage 5: GFR \<15 mL/min/1.73 m\^2. mL, milliliter; min, minute; m\^2, meters squared; mg, milligram; g, gram.
Time frame: Baseline, Week 96
Population: ITT-E Population. Some participants had withdrawn by Week 96.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Stage 1 | 3 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Stage 3 | 0 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Normal | 75 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Stage 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Stage 2 | 4 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Stage 5 | 0 participants |
| ABC/3TC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Missing | 11 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Stage 5 | 0 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Missing | 18 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Normal | 83 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Stage 1 | 4 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Stage 2 | 4 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Stage 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 | Stage 4 | 0 participants |
Secondary
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<40 mg/dL, low; 40-\<60 mg/dL, normal; \>=60 mg/dL, high.
Time frame: Baseline, Week 24
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Low to normal | 72 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Normal to high | 26 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Normal to low | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | High to low | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Low to high | 10 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | High to normal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Normal to normal | 12 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | High to high | 10 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Low to low | 19 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | High to high | 5 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Low to low | 36 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Low to normal | 66 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Low to high | 9 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Normal to low | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Normal to normal | 30 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | Normal to high | 12 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | High to low | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 | High to normal | 3 participants |
Secondary
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<40 mg/dL, low; 40-\<60 mg/dL, normal; \>=60 mg/dL, high.
Time frame: Baseline, Week 48
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Low to normal | 67 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Normal to high | 27 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Normal to low | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | High to low | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Low to high | 18 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | High to normal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Normal to normal | 11 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | High to high | 10 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Low to low | 17 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | High to high | 5 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Low to low | 28 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Low to normal | 73 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Low to high | 10 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Normal to low | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Normal to normal | 23 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | Normal to high | 20 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | High to low | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 | High to normal | 3 participants |
Secondary
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<40 mg/dL, low; 40-\<60 mg/dL, normal; \>=60 mg/dL, high.
Time frame: Baseline, Week 96
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Low to normal | 66 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Normal to high | 30 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Normal to low | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | High to low | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Low to high | 25 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | High to normal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Normal to normal | 8 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | High to high | 10 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Low to low | 11 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | High to high | 7 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Low to low | 23 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Low to normal | 75 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Low to high | 13 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Normal to low | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Normal to normal | 17 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | Normal to high | 27 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | High to low | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 | High to normal | 1 participants |
Secondary
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<200 mg/dL, desirable; 200-\<240 mg/dL, borderline high; \>=240 mg/dL, high. mg, milligram; dL, deciliter.
Time frame: Baseline, Week 24
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Desirable to borderline high | 47 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Borderline high to high | 10 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Borderline high to desirable | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | High to desirable | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Desirable to high | 32 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | High to borderline high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Borderline high to borderline high | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | High to high | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Desirable to desirable | 54 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | High to high | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Desirable to desirable | 104 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Desirable to borderline high | 29 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Desirable to high | 9 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Borderline high to desirable | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Borderline high to borderline high | 9 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | Borderline high to high | 6 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | High to desirable | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 | High to borderline high | 0 participants |
Secondary
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<200 mg/dL, desirable; 200-\<240 mg/dL, borderline high; \>=240 mg/dL, high. mg, milligram; dL, deciliter.
Time frame: Baseline, Week 48
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Desirable to borderline high | 52 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Borderline high to high | 10 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Borderline high to desirable | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | High to desirable | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Desirable to high | 36 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | High to borderline high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Borderline high to borderline high | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | High to high | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Desirable to desirable | 46 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | High to high | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Desirable to desirable | 96 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Desirable to borderline high | 37 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Desirable to high | 9 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Borderline high to desirable | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Borderline high to borderline high | 9 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | Borderline high to high | 8 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | High to desirable | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 | High to borderline high | 0 participants |
Secondary
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<200 mg/dL, desirable; 200-\<240 mg/dL, borderline high; \>=240 mg/dL, high. mg, milligram; dL, deciliter.
Time frame: Baseline, Week 96
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Desirable to borderline high | 49 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Borderline high to high | 10 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Borderline high to desirable | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | High to desirable | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Desirable to high | 46 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | High to borderline high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Borderline high to borderline high | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | High to high | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Desirable to desirable | 39 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | High to high | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Desirable to desirable | 86 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Desirable to borderline high | 47 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Desirable to high | 10 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Borderline high to desirable | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Borderline high to borderline high | 9 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | Borderline high to high | 8 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | High to desirable | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 | High to borderline high | 0 participants |
Secondary
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<150 mg/dL, normal; 150-\<200 mg/dL, borderline high; 200-\<500 mg/dL, high; \>=500 mg/dL, very high.
Time frame: Baseline, Week 24
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Normal to normal | 63 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Normal to borderline high | 21 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Normal to high | 23 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Normal to very high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Borderline high to normal | 5 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Borderline high to borderline high | 5 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Borderline high to high | 9 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Borderline high to very high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | High to normal | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | High to borderline high | 5 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | High to high | 12 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | High to very high | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Very high to normal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Very high to high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Very high to very high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Very high to borderline high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Very high to borderline high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Normal to normal | 78 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | High to normal | 6 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Normal to borderline high | 19 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Very high to normal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Normal to high | 9 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | High to borderline high | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Normal to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Very high to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Borderline high to normal | 7 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | High to high | 15 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Borderline high to borderline high | 10 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Very high to high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Borderline high to high | 15 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | High to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 | Borderline high to very high | 0 participants |
Secondary
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<150 mg/dL, normal; 150-\<200 mg/dL, borderline high; 200-\<500 mg/dL, high; \>=500 mg/dL, very high.
Time frame: Baseline, Week 48
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Normal to normal | 55 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Normal to borderline high | 22 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Normal to high | 30 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Borderline high to normal | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Borderline high to borderline high | 5 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Borderline high to high | 11 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | High to normal | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | High to borderline high | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | High to high | 12 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | High to very high | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Normal to very high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Borderline high to very high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Very high to normal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Very high to borderline high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Very high to high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Very high to very high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Very high to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Normal to normal | 70 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | High to high | 15 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Normal to borderline high | 23 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Very high to normal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Normal to very high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Normal to high | 12 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Borderline high to normal | 6 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Very high to high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Borderline high to borderline high | 7 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Borderline high to high | 19 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Borderline high to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | Very high to borderline high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | High to normal | 5 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | High to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 | High to borderline high | 3 participants |
Secondary
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<150 mg/dL, normal; 150-\>200 mg/dL, borderline high; 200-\<500 mg/dL, high;\>= 500 mg/dL, very high.
Time frame: Baseline, Week 96
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | High to normal | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Very high to high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Borderline high to borderline high | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Very high to very high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | High to high | 11 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Borderline high to very high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Normal to borderline high | 25 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Normal to normal | 47 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | High to very high | 5 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Normal to high | 34 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Very high to normal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Normal to very high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Borderline high to high | 11 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Very high to borderline high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | High to borderline high | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Borderline high to normal | 4 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | High to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Borderline high to normal | 5 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Borderline high to borderline high | 8 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Borderline high to high | 19 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Borderline high to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | High to borderline high | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | High to high | 16 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Very high to normal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Very high to borderline high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Very high to high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Very high to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Normal to normal | 55 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Normal to borderline high | 31 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Normal to high | 20 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | Normal to very high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 | High to normal | 5 participants |
Secondary
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<100 mg/dL, optimal; 100-\<130 mg/dL, near/above optimal; 130-\<160 mg/dL, borderline high; 160-\<190 mg/dL, high; \>=190 mg/dL, very high.
Time frame: Baseline, Week 24
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Optimal to borderline high | 22 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Borderline high to high | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Near or above optimal to borderline high | 17 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Borderline high to very high | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Optimal to very high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | High to optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Near or above optimal to high | 12 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | High to near or above optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Optimal to near or above optimal | 41 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | High to borderline high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Near or above optimal to very high | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | High to high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Near or above optimal to optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | High to very high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Borderline high to optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Very high to optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Optimal to high | 6 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Very high to near or above optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Borderline high to near or above optimal | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Very high to borderline high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Near or above optimal to near or above optimal | 6 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Very high to high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Borderline high to borderline high | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Very high to very high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Optimal to optimal | 22 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Very high to very high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Optimal to optimal | 46 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Optimal to near or above optimal | 43 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Optimal to borderline high | 11 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Optimal to high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Optimal to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Near or above optimal to optimal | 5 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Near or above optimal to near or above optimal | 22 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Near or above optimal to borderline high | 11 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Near or above optimal to high | 5 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Near or above optimal to very high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Borderline high to optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Borderline high to near or above optimal | 6 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Borderline high to borderline high | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Borderline high to high | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Borderline high to very high | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | High to optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | High to near or above optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | High to borderline high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | High to high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | High to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Very high to optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Very high to near or above optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Very high to borderline high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 | Very high to high | 0 participants |
Secondary
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<100 mg/dL, optimal; 100-\<130 mg/dL, near/above optimal; 130-\<160 mg/dL, borderline high; 160-\<190 mg/dL, high; \>=190 mg/dL, very high.
Time frame: Baseline, Week 48
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Very high to borderline high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Very high to high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Very high to very high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Optimal to optimal | 20 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Optimal to near or above optimal | 38 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Optimal to borderline high | 27 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Optimal to high | 8 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Optimal to very high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Near or above optimal to optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Near or above optimal to near or above optimal | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Near or above optimal to borderline high | 19 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Near or above optimal to high | 12 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Near or above optimal to very high | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Borderline high to optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Borderline high to near or above optimal | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Borderline high to borderline high | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Borderline high to high | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Borderline high to very high | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | High to optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | High to near or above optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | High to borderline high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | High to high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | High to very high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Very high to optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Very high to near or above optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | High to near or above optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Borderline high to optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Very high to high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Very high to near or above optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Very high to very high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Borderline high to near or above optimal | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Optimal to optimal | 42 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | High to borderline high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Optimal to near or above optimal | 46 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Borderline high to borderline high | 5 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Optimal to borderline high | 12 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Very high to optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Optimal to high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Borderline high to high | 4 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Optimal to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | High to high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Near or above optimal to optimal | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Borderline high to very high | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Near or above optimal to near or above optimal | 21 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Very high to borderline high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Near or above optimal to borderline high | 13 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | High to optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Near or above optimal to high | 6 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | High to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 | Near or above optimal to very high | 1 participants |
Secondary
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. \<100 mg/dL, optimal; 100-\<130 mg/dL, near/above optimal; 130-\<160 mg/dL, borderline high; 160-\<190 mg/dL, high; \>=190 mg/dL, very high.
Time frame: Baseline, Week 96
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Near or above optimal to near or above optimal | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Optimal to near or above optimal | 35 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Optimal to borderline high | 29 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Optimal to high | 9 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Optimal to very high | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Near or above optimal to optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Optimal to optimal | 18 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Near or above optimal to borderline high | 17 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Near or above optimal to high | 12 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Near or above optimal to very high | 6 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Borderline high to optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Borderline high to near or above optimal | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Borderline high to borderline high | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Borderline high to high | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Borderline high to very high | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | High to optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | High to near or above optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | High to borderline high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | High to high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | High to very high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Very high to near or above optimal | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Very high to borderline high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Very high to high | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Very high to very high | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Very high to optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Borderline high to borderline high | 5 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Optimal to optimal | 37 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Very high to borderline high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Optimal to near or above optimal | 46 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Borderline high to high | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Optimal to borderline high | 17 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | High to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Optimal to high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Borderline high to very high | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Optimal to very high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Very high to optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Near or above optimal to optimal | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | High to optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Near or above optimal to near or above optimal | 19 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Very high to very high | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Near or above optimal to borderline high | 16 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | High to near or above optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Near or above optimal to high | 7 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Very high to near or above optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Near or above optimal to very high | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | High to borderline high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Borderline high to optimal | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Very high to high | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | Borderline high to near or above optimal | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 | High to high | 1 participants |
Secondary
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.
Time frame: Week 24
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Total neutrophils, Grade 4 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | LDL cholesterol, Grade 3 | 8 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Non-HDL cholesterol, Grade 3 | 19 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Non-HDL cholesterol, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Triglycerides, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Alanine aminotransferase, Grade 3 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Alanine aminotransferase, Grade 4 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Aspartate aminotransferase, Grade 3 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Aspartate aminotransferase, Grade 4 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Alkaline phosphatase, Grade 3 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Alkaline phosphatase, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Creatinine kinase, Grade 3 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Creatinine kinase, Grade 4 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Phosphorus inorganic, Grade 3 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Phosphorus inorganic, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Lipase, Grade 3 | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Hyperkalaemia, Grade 3 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Hyperkalaemia, Grade 4 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Glomerular filtration rate, MDRD, Grade 3 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Thrombocytopenia, Grade 3 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Thrombocytopenia, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Cholesterol, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | LDL cholesterol, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Triglycerides, Grade 3 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Lipase, Grade 4 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Glomerular filtration rate, MDRD, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Total neutrophils, Grade 3 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Cholesterol, Grade 3 | 6 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Total neutrophils, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Cholesterol, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Phosphorus inorganic, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | LDL cholesterol, Grade 3 | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | LDL cholesterol, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Total neutrophils, Grade 4 | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Non-HDL cholesterol, Grade 3 | 5 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Phosphorus inorganic, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Non-HDL cholesterol, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Triglycerides, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Cholesterol, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Triglycerides, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Lipase, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Alanine aminotransferase, Grade 3 | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Lipase, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Alanine aminotransferase, Grade 4 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Thrombocytopenia, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Aspartate aminotransferase, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Hyperkalaemia, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Aspartate aminotransferase, Grade 4 | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Glomerular filtration rate, MDRD, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Alkaline phosphatase, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Hyperkalaemia, Grade 4 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Alkaline phosphatase, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Thrombocytopenia, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Creatinine kinase, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Glomerular filtration rate, MDRD, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 | Creatinine kinase, Grade 4 | 1 participants |
Secondary
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.
Time frame: Week 48
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Cholesterol, Grade 3 | 7 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Cholesterol, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | LDL cholesterol, Grade 3 | 9 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | LDL cholesterol, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Non-HDL cholesterol, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Triglycerides, Grade 3 | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Triglycerides, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Aspartate aminotransferase, Grade 4 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Total bilirubin, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Creatinine kinase, Grade 4 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Phosphorus inorganic, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Lipase, Grade 3 | 5 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Hyperkalaemia, Grade 3 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Hyperkalaemia, Grade 4 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Glomerular filtration rate, MDRD, Grade 3 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Glomerular filtration rate, MDRD, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Total neutrophils, Grade 4 | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Thrombocytopenia, Grade 4 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Thrombocytopenia, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Non-HDL cholesterol, Grade 3 | 20 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Alanine aminotransferase, Grade 3 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Alanine aminotransferase, Grade 4 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Aspartate aminotransferase, Grade 3 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Alkaline phosphatase, Grade 3 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Alkaline phosphatase, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Total bilirubin Grade 3 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Creatinine kinase, Grade 3 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Phosphorus inorganic, Grade 3 | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Lipase, Grade 4 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Total neutrophils, Grade 3 | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Hyperkalaemia, Grade 4 | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Cholesterol, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Alanine aminotransferase, Grade 3 | 4 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Cholesterol, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Glomerular filtration rate, MDRD, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | LDL cholesterol, Grade 3 | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Alkaline phosphatase, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | LDL cholesterol, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Total neutrophils, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Alanine aminotransferase, Grade 4 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Triglycerides, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Glomerular filtration rate, MDRD, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Triglycerides, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Aspartate aminotransferase, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Thrombocytopenia, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Aspartate aminotransferase, Grade 4 | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Total bilirubin Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Total bilirubin, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Creatinine kinase, Grade 3 | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Thrombocytopenia, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Creatinine kinase, Grade 4 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Phosphorus inorganic, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Alkaline phosphatase, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Phosphorus inorganic, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Non-HDL cholesterol, Grade 3 | 6 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Lipase, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Lipase, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Non-HDL cholesterol, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Hyperkalaemia, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 | Total neutrophils, Grade 4 | 2 participants |
Secondary
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy.
Time frame: Week 96
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Cholesterol, Grade 3 | 9 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | LDL cholesterol, Grade 3 | 13 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | LDL cholesterol, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Non-HDL cholesterol, Grade 3 | 22 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Non-HDL cholesterol, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Triglycerides, Grade 3 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Triglycerides, Grade 4 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Alanine aminotransferase, Grade 3 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Alanine aminotransferase, Grade 4 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Aspartate aminotransferase, Grade 3 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Aspartate aminotransferase, Grade 4 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Alkaline phosphatase, Grade 3 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Alkaline phosphatase, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Total bilirubin, Grade 3 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Total bilirubin, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Creatinine kinase, Grade 3 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Creatinine kinase, Grade 4 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Phosphorus inorganic, Grade 3 | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Phosphorus inorganic, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Lipase, Grade 3 | 6 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Lipase, Grade 4 | 4 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Hyperkalaemia, Grade 3 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Hyperkalaemia, Grade 4 | 2 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Glomerular filtration rate, MDRD, Grade 3 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Glomerular filtration rate, MDRD, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Total neutrophils, Grade 3 | 3 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Total neutrophils, Grade 4 | 5 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Thrombocytopenia, Grade 3 | 1 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Thrombocytopenia, Grade 4 | 0 participants |
| ABC/3TC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Cholesterol, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Hyperkalaemia, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Cholesterol, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Cholesterol, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Creatinine kinase, Grade 3 | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | LDL cholesterol, Grade 3 | 5 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Total neutrophils, Grade 4 | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | LDL cholesterol, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Creatinine kinase, Grade 4 | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Non-HDL cholesterol, Grade 3 | 5 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Glomerular filtration rate, MDRD, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Non-HDL cholesterol, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Phosphorus inorganic, Grade 3 | 3 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Triglycerides, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Thrombocytopenia, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Triglycerides, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Phosphorus inorganic, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Alanine aminotransferase, Grade 3 | 4 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Glomerular filtration rate, MDRD, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Alanine aminotransferase, Grade 4 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Lipase, Grade 3 | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Aspartate aminotransferase, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Thrombocytopenia, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Aspartate aminotransferase, Grade 4 | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Lipase, Grade 4 | 2 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Alkaline phosphatase, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Total neutrophils, Grade 3 | 1 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Alkaline phosphatase, Grade 4 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Hyperkalaemia, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Total bilirubin, Grade 3 | 0 participants |
| TDF/FTC FDC | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 | Total bilirubin, Grade 4 | 0 participants |
Secondary
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
BMD is a measure (grams per cm\^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Time frame: Baseline, Week 24
Population: ITT-E Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC FDC | Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 | -1.19 percent change | Standard Error 0.0007 |
| TDF/FTC FDC | Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 | -2.73 percent change | Standard Error 0.0007 |
p-value: <0.001Mixed Models Analysis
Secondary
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
BMD is a measure (grams per cm\^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Time frame: Baseline, Week 48
Population: ITT-E Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC FDC | Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 | -1.90 percent change | Standard Error 0.001 |
| TDF/FTC FDC | Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 | -3.56 percent change | Standard Error 0.0009 |
p-value: <0.001Mixed Models Analysis
Secondary
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
BMD is a measure (grams per cm\^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Time frame: Baseline, Week 96
Population: ITT-E Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC FDC | Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 | -2.17 percent change | Standard Error 0.0013 |
| TDF/FTC FDC | Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 | -3.55 percent change | Standard Error 0.0012 |
p-value: <0.001Mixed Models Analysis
Secondary
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
BMD is a measure (grams \[g\] per centimeters cubed \[cm\^3\]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Time frame: Baseline, Week 24
Population: ITT-E Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC FDC | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 | -2.12 percent change | Standard Error 0.0011 |
| TDF/FTC FDC | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 | -3.30 percent change | Standard Error 0.0011 |
p-value: <0.001Mixed Models Analysis
Secondary
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
BMD is a measure (grams per cm\^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Time frame: Baseline, Week 48
Population: ITT-E Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC FDC | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 | -1.59 percent change | Standard Error 0.0013 |
| TDF/FTC FDC | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 | -2.41 percent change | Standard Error 0.0012 |
p-value: 0.036Mixed Models Analysis
Secondary
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
BMD is a measure (grams per cm\^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Time frame: Baseline, Week 96
Population: ITT-E Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC FDC | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 | -0.87 percent change | Standard Error 0.0017 |
| TDF/FTC FDC | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 | -1.70 percent change | Standard Error 0.0015 |
p-value: 0.112Mixed Models Analysis
Other Pre-specified
Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol).
Time frame: Baseline, Week 96
Population: Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ABC/3TC FDC | Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96 | 0.872 ratio |
| TDF/FTC FDC | Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96 | 0.973 ratio |
p-value: 0.3025ANOVA
Other Pre-specified
Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol).
Time frame: Baseline, Week 96
Population: Safety Population. Some participants had withdrawn by Week 96.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ABC/3TC FDC | Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96 | 0.542 ratio |
| TDF/FTC FDC | Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96 | 0.984 ratio |
p-value: <0.0001ANOVA
Other Pre-specified
Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96
Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.
Time frame: Baseline, Week 96
Population: Safety Biomarker Population. Some participants had withdrawn by Week 96.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ABC/3TC FDC | Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96 | 1.111 ug/L |
| TDF/FTC FDC | Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96 | 2.542 ug/L |
p-value: 0.0266ANOVA
Other Pre-specified
Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole \[umol/h/mmol\]).
Time frame: Baseline, Week 96
Population: Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ABC/3TC FDC | Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96 | 0.868 ratio |
| TDF/FTC FDC | Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96 | 0.939 ratio |
p-value: 0.3323ANOVA
Other Pre-specified
Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96
Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.
Time frame: Baseline, Week 96
Population: Safety Biomarker Population. Some participants had withdrawn by Week 96.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ABC/3TC FDC | Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96 | 3.01 ug/L |
| TDF/FTC FDC | Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96 | 5.79 ug/L |
p-value: 0.0019ANOVA
Other Pre-specified
Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96
P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.
Time frame: Baseline, Week 96
Population: Safety Biomarker Population. Some participants had withdrawn by Week 96.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ABC/3TC FDC | Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96 | 1.2 micrograms per Liter (ug/L) |
| TDF/FTC FDC | Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96 | 1.4 micrograms per Liter (ug/L) |
p-value: <0.0001ANOVA
Other Pre-specified
Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole \[ug/mmol\]).
Time frame: Baseline, Week 96
Population: Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ABC/3TC FDC | Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96 | 1.099 ratio |
| TDF/FTC FDC | Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96 | 1.550 ratio |
p-value: <0.0001ANOVA
Other Pre-specified
Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96
Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.
Time frame: Baseline, Week 96
Population: Safety Biomarker Population. Some participants had withdrawn by Week 96.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ABC/3TC FDC | Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96 | 89.9 nanograms per Liter (ng/L) |
| TDF/FTC FDC | Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96 | 203.6 nanograms per Liter (ng/L) |
p-value: 0.0019ANOVA