HIV Infections, Infection, Human Immunodeficiency Virus
Conditions
Keywords
antiretroviral therapy naïve, women, once daily, HIV infection, atazanavir, tenofovir/emtricitabine, dolutegravir/abacavir/lamivudine fixed dose combination, integrase inhibitor, ritonavir
Brief summary
This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)
Interventions
DRUGDolutegravir/abacavir/lamivudine FDC
Dolutegravir/abacavir/lamivudine FDC tablets, 50 mg/600 mg/300 mg
DRUGAtazanavir
Atazanavir capsule 300 mg
DRUGRitonavir
Ritonavir tablet 100 mg
DRUGTenofovir/emtricitabine FDC
Tenofovir/emtricitabine FDC tablet 300 mg/200 mg of FTC
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-1 infected females (gender at birth) \>=18 years of age * Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol) * HIV-1 infection as documented by Screening plasma HIV-1 RNA \>=500 c/mL. * Documentation that the subject is negative for the HLA-B\*5701 allele. * Antiretroviral-naïve (\<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection). * Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening.
Exclusion criteria
* Women who are pregnant or breastfeeding * Women who plan to become pregnant during the first 48 weeks of the study * Any subject who has had a medical intervention for gender reassignment * Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease * Subjects with any degree of hepatic impairment * Subjects positive for hepatitis B at Screening, or anticipated need for HCV therapy during the study * History or presence of allergy to the study drugs or their components or drugs of their class * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia * poses a significant suicidality risk * History of osteoporosis with fracture or requiring pharmacologic therapy * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening * Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses; * Treatment with any agent, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product (IP) * Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP * Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result * Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities (total cholesterol, triglycerides, High Density Lipoprotein (HDL) cholesterol, Low Density Lipoprotein (LDL) cholesterol) * Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound * Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with \>35% direct bilirubin) * Subject has CrCL of \<50 mL/min via Cockroft-Gault method * Corrected QT interval (QTc (Bazett)) ≥450msec or QTc (Bazett) ≥480msec for subjects with bundle branch block.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 | Week 48 | Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =\<vs. \>100,000 c/mL) and CD4+ cell count (=\<350 cells per millimeter cube (cells/mm\^3) or \>350 cells/mm\^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase | Week 96 and Week 432 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \<50 c/mL were reported. Percentage values are rounded off. |
| Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase | Baseline (Day 1), Week 96 and Week 432 | Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. |
| Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase | Week 96 and Week 432 | Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. |
| Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Change from Baseline in cluster of differentiation 4 (CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase | Baseline (Day 1), Week 96, Week 432 | Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. |
| Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase | Week 96 and Week 432 | Absolute values in CD4+ cell count were assessed at indicated time points. |
| Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol \[CHLS\], high density lipoprotein \[HDL\] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. |
| Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Albumin at Indicated Timepoints | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Creatinine Clearance at Indicated Time Points | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Lipase at Indicated Timepoints | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Erythrocytes at Indicated Time Points | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Hematocrit Count at Indicated Time Points | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Hematology parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Triglycerides at Week 48 | Baseline (Day 1) and Week 48 | Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. |
| Change From Baseline in TC/HDL Ratio at Week 48 | Baseline (Day 1) and Week 48 | Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. |
| Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Number of Participants With AEs by Maximum Toxicity-Randomized Phase | Up to Week 48 | Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. |
| Number of Participants With AEs by Maximum Toxicity-Continuation Phase | From Weeks 48 to 432 | Number of participants with Grade 1-4 AEs were assessed in Continuation Phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. |
| Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase | Up to Week 48 | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. |
| Number of Participants With Any AEs, and SAEs in Continuation Phase | From Weeks 48 to 432 | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. |
| Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Up to Week 48 | Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose. |
| Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | From Weeks 48 to 432 | Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose. |
| Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Up to Week 48 | Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and end of Randomized Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets. |
| Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | From Weeks 48 to 432 | Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets. |
| Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase | Up to Week 48 | An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. |
| Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase | From Weeks 48 to 432 | An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. |
| Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | Baseline (Day 1), Weeks 24 and 48 | Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints | Baseline (Day 1), Weeks 24 and 48 | Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Baseline (Day 1), Weeks 24 and 48 | Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline | Baseline (Day 1) and Week 48 | Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC. |
| Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS | Baseline (Day 1) and Week 48 | The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| HIVTSQs Total Score at Indicated Timepoints | Weeks 4, 12, 24 and 48 | The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. |
| Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 | Percentage of participants with plasma HIV-1 RNA \<50 and \<400 c/mL were assessed at Baseline, Weeks 4, 12, 24 , 36 and 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Percentage values are rounded off. |
| Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase | Up to week 48 | Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. |
| Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) | Up to week 432 | Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. |
| Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) | Up to week 432 | Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met. |
| Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase) | Up to week 48 | Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met. |
| Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Week 48 | Percentage of participants with plasma HIV-1 RNA \<50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA \[BPHR\], Baseline CD4+ cell count \[BCCC\], Baseline Centers for Disease Control and Prevention \[CDC\] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =\<versus \[vs\]. \>100,000 c/mL) and CD4+ cell count (=\<350 cells/mm\^3 or \>350 cells/mm\^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off. |
Countries
Argentina, Canada, France, Italy, Mexico, Portugal, Puerto Rico, Russia, South Africa, Spain, Thailand, United Kingdom, United States
Participant flow
Recruitment details
The study consists of a Screening (14-28 days), Randomized (48 weeks) and Continuation (Cont.) Phase. Participants were said to have completed the study if they completed the Randomized phase and did not enter the Cont. Phase. Participants entering the Cont. Phase were said to have completed the study if they completed both phases of the study.
Pre-assignment details
A total of 499 participants were randomized to receive dolutegravir(DTG)/abacavir(ABC)/lamivudine(3TC) fixed dose combination(FDC) or combination of atazanavir(ATV), Ritonavir(RTV) and FDC of tenofovir disoproxil fumarate/emtricitabine(TDF/FTC). Two participants from each DTG/ABC/3TC and ATV+RTV+TDF/FTC groups were randomized but not treated. A total of 495 participants received at least single dose of investigational products(IP) and were included in Intent-to-Treat Exposed(ITT-E) Population.
Participants by arm
| Arm | Count |
|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase. | 248 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase. | 247 |
| Total | 495 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Continuation Phase(From Weeks 48 to 432) | Adverse Event | 0 | 0 | 4 |
| Continuation Phase(From Weeks 48 to 432) | Lack of Efficacy | 0 | 0 | 1 |
| Continuation Phase(From Weeks 48 to 432) | Lost to Follow-up | 0 | 0 | 8 |
| Continuation Phase(From Weeks 48 to 432) | Physician Decision | 0 | 0 | 1 |
| Continuation Phase(From Weeks 48 to 432) | Protocol Deviation | 0 | 0 | 15 |
| Continuation Phase(From Weeks 48 to 432) | Withdrawal by Subject | 0 | 0 | 7 |
| Randomized Phase (Up to 48 Weeks) | Adverse Event | 10 | 18 | 0 |
| Randomized Phase (Up to 48 Weeks) | Lack of Efficacy | 5 | 4 | 0 |
| Randomized Phase (Up to 48 Weeks) | Lost to Follow-up | 11 | 13 | 0 |
| Randomized Phase (Up to 48 Weeks) | Physician Decision | 1 | 0 | 0 |
| Randomized Phase (Up to 48 Weeks) | Protocol Deviation | 10 | 13 | 0 |
| Randomized Phase (Up to 48 Weeks) | Randomized, but did not receive treatment | 2 | 2 | 0 |
| Randomized Phase (Up to 48 Weeks) | Withdrawal by Subject | 5 | 7 | 0 |
Baseline characteristics
| Characteristic | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Total | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase |
|---|---|---|---|
| Age, Continuous | 37.8 Years STANDARD_DEVIATION 10.14 | 37.9 Years STANDARD_DEVIATION 10.65 | 38.1 Years STANDARD_DEVIATION 11.15 |
| Race/Ethnicity, Customized African American/African Heritage | 108 Participants | 210 Participants | 102 Participants |
| Race/Ethnicity, Customized American Indian Or Alaskan Native | 7 Participants | 13 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 22 Participants | 42 Participants | 20 Participants |
| Race/Ethnicity, Customized Mixed Race | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 104 Participants | 216 Participants | 112 Participants |
| Sex: Female, Male Female | 247 Participants | 495 Participants | 248 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 248 | 0 / 247 | 1 / 149 |
| other Total, other adverse events | 138 / 248 | 164 / 247 | 30 / 149 |
| serious Total, serious adverse events | 12 / 248 | 20 / 247 | 13 / 149 |
Outcome results
Primary
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48
Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =\<vs. \>100,000 c/mL) and CD4+ cell count (=\<350 cells per millimeter cube (cells/mm\^3) or \>350 cells/mm\^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.
Time frame: Week 48
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 | 82 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 | 71 Percentage of participants |
p-value: 0.00595% CI: [3.1, 17.8]Cochran-Mantel-Haenszel
Secondary
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
Absolute values in CD4+ cell count were assessed at indicated time points.
Time frame: Week 96 and Week 432
Population: ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase | Week 96, n=99 | 635.3 Cells per cubic millimeter | Standard Deviation 285.85 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase | Week 432, n=3 | 553.0 Cells per cubic millimeter | Standard Deviation 341.63 |
Secondary
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Baseline (Day 1), n=248, 247 | 369.7 Cells per cubic millimeter | Standard Deviation 225.67 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 4, n=245, 237 | 465.0 Cells per cubic millimeter | Standard Deviation 252.51 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 12, n=236, 224 | 509.5 Cells per cubic millimeter | Standard Deviation 276.79 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 24, n=226, 210 | 563.8 Cells per cubic millimeter | Standard Deviation 303.1 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 36, n=219, 204 | 592.8 Cells per cubic millimeter | Standard Deviation 291.62 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 48, n=208, 191 | 608.8 Cells per cubic millimeter | Standard Deviation 298.95 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 36, n=219, 204 | 569.2 Cells per cubic millimeter | Standard Deviation 299.77 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Baseline (Day 1), n=248, 247 | 380.3 Cells per cubic millimeter | Standard Deviation 223.6 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 24, n=226, 210 | 542.5 Cells per cubic millimeter | Standard Deviation 265.69 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 4, n=245, 237 | 455.1 Cells per cubic millimeter | Standard Deviation 244.62 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 48, n=208, 191 | 608.5 Cells per cubic millimeter | Standard Deviation 302.58 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 12, n=236, 224 | 506.2 Cells per cubic millimeter | Standard Deviation 266.84 |
Secondary
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
Absolute Values in plasma HIV-1 RNA were assessed at indicated time points.
Time frame: Week 96 and Week 432
Population: ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase | Week 432, n=3 | 1.590 Log10 copies/mL | Standard Deviation 0 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase | Week 96, n=99 | 1.591 Log10 copies/mL | Standard Deviation 0.008 |
Secondary
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Baseline (Day 1), n=248, 247 | 4.481 Log10 copies/mL | Standard Deviation 0.8111 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 4, n=245, 238 | 1.895 Log10 copies/mL | Standard Deviation 0.6872 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 12, n=236, 226 | 1.748 Log10 copies/mL | Standard Deviation 0.5458 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 24, n=225, 212 | 1.724 Log10 copies/mL | Standard Deviation 0.5935 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 36, n=221, 204 | 1.666 Log10 copies/mL | Standard Deviation 0.3982 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 48, n=207, 192 | 1.619 Log10 copies/mL | Standard Deviation 0.1986 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 36, n=221, 204 | 1.658 Log10 copies/mL | Standard Deviation 0.3362 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Baseline (Day 1), n=248, 247 | 4.441 Log10 copies/mL | Standard Deviation 0.8023 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 24, n=225, 212 | 1.710 Log10 copies/mL | Standard Deviation 0.4484 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 4, n=245, 238 | 2.516 Log10 copies/mL | Standard Deviation 0.6193 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 48, n=207, 192 | 1.657 Log10 copies/mL | Standard Deviation 0.2743 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 12, n=236, 226 | 1.908 Log10 copies/mL | Standard Deviation 0.4926 |
Secondary
Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline
Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.
Time frame: Baseline (Day 1) and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline | Vitamin D, n=206, 186 | 0.987 Ratio |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline | PTP, n=202, 184 | 1.214 Ratio |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline | Osteocalcin, n=194, 178 | 1.282 Ratio |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline | Type 1 Collagen C-Telopeptide, n=202, 184 | 1.257 Ratio |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline | BSAP, n=202, 183 | 1.188 Ratio |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline | Type 1 Collagen C-Telopeptide, n=202, 184 | 1.918 Ratio |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline | BSAP, n=202, 183 | 1.629 Ratio |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline | Vitamin D, n=206, 186 | 1.158 Ratio |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline | PTP, n=202, 184 | 1.752 Ratio |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline | Osteocalcin, n=194, 178 | 2.039 Ratio |
p-value: <0.00195% CI: [0.683, 0.779]ANCOVA
p-value: <0.00195% CI: [0.647, 0.741]ANCOVA
p-value: <0.00195% CI: [0.581, 0.68]ANCOVA
p-value: <0.000195% CI: [0.609, 0.706]ANCOVA
p-value: <0.000195% CI: [0.794, 0.914]ANCOVA
Secondary
Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS
The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Week 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS | Total Score, Week 48, n=205, 192 | 0.0 Score on a scale | Standard Deviation 5.15 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS | PCS, Week 48, n=205, 192 | 1.905 Score on a scale | Standard Deviation 8.6309 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS | MCS, Week 48, n=205, 192 | 2.397 Score on a scale | Standard Deviation 10.5232 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS | MCS, Week 48, n=205, 192 | 2.329 Score on a scale | Standard Deviation 9.9782 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS | PCS, Week 48, n=205, 192 | 1.444 Score on a scale | Standard Deviation 8.3938 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS | Total Score, Week 48, n=205, 192 | 0.1 Score on a scale | Standard Deviation 5.66 |
Secondary
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: Safety Population.Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alanine aminotransferase, Week 4, n= 245, 237 | -3.3 International units per liter | Standard Deviation 27.54 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alanine aminotransferase, Week 12, n= 236, 226 | -5.2 International units per liter | Standard Deviation 27.51 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alanine aminotransferase, Week 24, n= 225, 212 | -5.4 International units per liter | Standard Deviation 27.92 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alanine aminotransferase, Week 36, n= 219, 204 | -4.9 International units per liter | Standard Deviation 36.11 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alanine aminotransferase, Week 48, n= 208, 192 | -5.7 International units per liter | Standard Deviation 28.54 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alkaline phosphatase, Week 4, n= 245, 237 | -1.5 International units per liter | Standard Deviation 14.56 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alkaline phosphatase, Week 12, n= 236, 226 | -2.1 International units per liter | Standard Deviation 17.1 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alkaline phosphatase, Week 24, n= 225, 212 | 0.5 International units per liter | Standard Deviation 17.86 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alkaline phosphatase, Week 36, n= 219, 204 | 0.6 International units per liter | Standard Deviation 19.19 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alkaline phosphatase, Week 48, n= 208, 192 | 2.9 International units per liter | Standard Deviation 28.05 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Aspartate aminotransferase, Week 4, n= 244, 237 | -3.3 International units per liter | Standard Deviation 29.8 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Aspartate aminotransferase, Week 12, n= 236, 226 | -6.2 International units per liter | Standard Deviation 21.11 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Aspartate aminotransferase, Week 24, n= 224, 212 | -6.3 International units per liter | Standard Deviation 22.44 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Aspartate aminotransferase, Week 36, n= 219, 204 | -6.4 International units per liter | Standard Deviation 31.42 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Aspartate aminotransferase, Week 48, n= 208, 192 | -7.5 International units per liter | Standard Deviation 22.19 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Creatine Kinase, Week 4, n= 245, 237 | -0.3 International units per liter | Standard Deviation 68.72 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Creatine Kinase, Week 12, n= 236, 226 | 6.9 International units per liter | Standard Deviation 73.7 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Creatine Kinase, Week 24, n= 225, 212 | 10.3 International units per liter | Standard Deviation 88.66 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Creatine Kinase, Week 36, n= 219, 204 | 11.9 International units per liter | Standard Deviation 155.68 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Creatine Kinase, Week 48, n= 208, 192 | 23.8 International units per liter | Standard Deviation 242.66 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Creatine Kinase, Week 24, n= 225, 212 | 5.8 International units per liter | Standard Deviation 77.12 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alanine aminotransferase, Week 4, n= 245, 237 | -3.4 International units per liter | Standard Deviation 15.86 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Aspartate aminotransferase, Week 4, n= 244, 237 | -3.6 International units per liter | Standard Deviation 18.83 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alanine aminotransferase, Week 12, n= 236, 226 | -2.3 International units per liter | Standard Deviation 20.26 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Creatine Kinase, Week 4, n= 245, 237 | 35.6 International units per liter | Standard Deviation 549.1 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alanine aminotransferase, Week 24, n= 225, 212 | -3.7 International units per liter | Standard Deviation 20.7 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Aspartate aminotransferase, Week 12, n= 236, 226 | -4 International units per liter | Standard Deviation 13.79 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alanine aminotransferase, Week 36, n= 219, 204 | -5.3 International units per liter | Standard Deviation 20.08 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Creatine Kinase, Week 48, n= 208, 192 | 3.8 International units per liter | Standard Deviation 98.58 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alanine aminotransferase, Week 48, n= 208, 192 | -1.5 International units per liter | Standard Deviation 31.53 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Aspartate aminotransferase, Week 24, n= 224, 212 | -5.1 International units per liter | Standard Deviation 13.8 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alkaline phosphatase, Week 4, n= 245, 237 | 9.4 International units per liter | Standard Deviation 28.69 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Creatine Kinase, Week 12, n= 236, 226 | 7.3 International units per liter | Standard Deviation 90.39 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alkaline phosphatase, Week 12, n= 236, 226 | 15.1 International units per liter | Standard Deviation 30.82 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Aspartate aminotransferase, Week 36, n= 219, 204 | -6.5 International units per liter | Standard Deviation 16.63 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alkaline phosphatase, Week 24, n= 225, 212 | 22.4 International units per liter | Standard Deviation 41.59 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Creatine Kinase, Week 36, n= 219, 204 | 7.2 International units per liter | Standard Deviation 132.74 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alkaline phosphatase, Week 36, n= 219, 204 | 20.4 International units per liter | Standard Deviation 30.7 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Aspartate aminotransferase, Week 48, n= 208, 192 | -3.7 International units per liter | Standard Deviation 25.28 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points | Alkaline phosphatase, Week 48, n= 208, 192 | 21.9 International units per liter | Standard Deviation 25.35 |
Secondary
Change From Baseline in Albumin at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Albumin at Indicated Timepoints | Week 4, n= 245, 237 | 0.1 Grams per liter | Standard Deviation 2.36 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Albumin at Indicated Timepoints | Week 36, n= 219, 204 | 1.4 Grams per liter | Standard Deviation 3.09 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Albumin at Indicated Timepoints | Week 24, n= 225, 212 | 1.4 Grams per liter | Standard Deviation 3.2 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Albumin at Indicated Timepoints | Week 48, n= 208, 192 | 1.7 Grams per liter | Standard Deviation 3.17 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Albumin at Indicated Timepoints | Week 12, n= 236, 226 | 0.5 Grams per liter | Standard Deviation 2.95 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Albumin at Indicated Timepoints | Week 48, n= 208, 192 | 1.3 Grams per liter | Standard Deviation 3.04 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Albumin at Indicated Timepoints | Week 4, n= 245, 237 | -0.5 Grams per liter | Standard Deviation 2.59 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Albumin at Indicated Timepoints | Week 12, n= 236, 226 | 0.1 Grams per liter | Standard Deviation 2.59 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Albumin at Indicated Timepoints | Week 24, n= 225, 212 | 0.8 Grams per liter | Standard Deviation 2.95 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Albumin at Indicated Timepoints | Week 36, n= 219, 204 | 0.6 Grams per liter | Standard Deviation 2.96 |
Secondary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Basophils, Week 4, n= 241, 234 | 0.003 10^9 cells per liter | Standard Deviation 0.0182 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Basophils, Week 12, n= 228, 216 | 0.002 10^9 cells per liter | Standard Deviation 0.0174 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Basophils, Week 24, n= 221, 208 | 0.004 10^9 cells per liter | Standard Deviation 0.0187 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Basophils, Week 36, n= 214, 203 | 0.004 10^9 cells per liter | Standard Deviation 0.0182 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Basophils, Week 48, n= 206, 189 | 0.005 10^9 cells per liter | Standard Deviation 0.0199 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Eosinophils, Week 4, n= 241, 234 | 0.040 10^9 cells per liter | Standard Deviation 0.1486 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Eosinophils, Week 12, n= 228, 216 | 0.037 10^9 cells per liter | Standard Deviation 0.1982 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Eosinophils, Week 24, n= 221, 208 | 0.028 10^9 cells per liter | Standard Deviation 0.1927 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Eosinophils, Week 36, n= 214, 203 | 0.048 10^9 cells per liter | Standard Deviation 0.2244 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Eosinophils, Week 48, n= 206, 189 | 0.030 10^9 cells per liter | Standard Deviation 0.1744 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Lymphocytes, Week 4, n= 241, 234 | 0.208 10^9 cells per liter | Standard Deviation 0.4914 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Lymphocytes, Week 12, n= 228, 216 | 0.257 10^9 cells per liter | Standard Deviation 0.55 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Lymphocytes, Week 24, n= 221, 208 | 0.317 10^9 cells per liter | Standard Deviation 0.4889 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Lymphocytes, Week 36, n= 214, 203 | 0.362 10^9 cells per liter | Standard Deviation 0.5199 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Lymphocytes, Week 48, n= 206, 189 | 0.359 10^9 cells per liter | Standard Deviation 0.5235 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Monocytes, Week 4, n= 241, 234 | -0.001 10^9 cells per liter | Standard Deviation 0.1558 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Monocytes, Week 12, n= 228, 216 | -0.010 10^9 cells per liter | Standard Deviation 0.1412 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Monocytes, Week 24, n= 221, 208 | 0.008 10^9 cells per liter | Standard Deviation 0.1498 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Monocytes, Week 36, n= 214, 203 | -0.006 10^9 cells per liter | Standard Deviation 0.1448 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Monocytes, Week 48, n= 206, 189 | 0.001 10^9 cells per liter | Standard Deviation 0.1379 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Monocytes, Week 24, n= 221, 208 | -0.015 10^9 cells per liter | Standard Deviation 0.1581 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Basophils, Week 4, n= 241, 234 | 0.003 10^9 cells per liter | Standard Deviation 0.0198 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Lymphocytes, Week 4, n= 241, 234 | 0.119 10^9 cells per liter | Standard Deviation 0.5493 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Basophils, Week 12, n= 228, 216 | 0.003 10^9 cells per liter | Standard Deviation 0.0162 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Monocytes, Week 4, n= 241, 234 | -0.015 10^9 cells per liter | Standard Deviation 0.1391 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Basophils, Week 24, n= 221, 208 | 0.003 10^9 cells per liter | Standard Deviation 0.0155 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Lymphocytes, Week 12, n= 228, 216 | 0.156 10^9 cells per liter | Standard Deviation 0.669 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Basophils, Week 36, n= 214, 203 | 0.003 10^9 cells per liter | Standard Deviation 0.0158 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Monocytes, Week 48, n= 206, 189 | -0.024 10^9 cells per liter | Standard Deviation 0.1638 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Basophils, Week 48, n= 206, 189 | 0.006 10^9 cells per liter | Standard Deviation 0.0146 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Lymphocytes, Week 24, n= 221, 208 | 0.192 10^9 cells per liter | Standard Deviation 0.591 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Eosinophils, Week 4, n= 241, 234 | 0.021 10^9 cells per liter | Standard Deviation 0.1648 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Monocytes, Week 12, n= 228, 216 | -0.031 10^9 cells per liter | Standard Deviation 0.1369 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Eosinophils, Week 12, n= 228, 216 | -0.001 10^9 cells per liter | Standard Deviation 0.161 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Lymphocytes, Week 36, n= 214, 203 | 0.178 10^9 cells per liter | Standard Deviation 0.6441 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Eosinophils, Week 24, n= 221, 208 | 0.005 10^9 cells per liter | Standard Deviation 0.1973 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Monocytes, Week 36, n= 214, 203 | -0.028 10^9 cells per liter | Standard Deviation 0.15 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Eosinophils, Week 36, n= 214, 203 | 0.014 10^9 cells per liter | Standard Deviation 0.2139 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Lymphocytes, Week 48, n= 206, 189 | 0.261 10^9 cells per liter | Standard Deviation 0.7098 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points | Eosinophils, Week 48, n= 206, 189 | 0.007 10^9 cells per liter | Standard Deviation 0.2274 |
Secondary
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Bilirubin, Week 4, n= 244, 237 | -0.8 Micromoles per liter | Standard Deviation 2.59 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Bilirubin, Week 12, n= 236, 226 | -0.6 Micromoles per liter | Standard Deviation 2.65 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Bilirubin, Week 24, n= 225, 212 | -0.2 Micromoles per liter | Standard Deviation 3.06 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Bilirubin, Week 36, n= 219, 204 | -0.2 Micromoles per liter | Standard Deviation 3.01 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Bilirubin, Week 48, n= 208, 192 | -0.3 Micromoles per liter | Standard Deviation 3.08 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Creatinine, Week 4, n= 245, 237 | 8.4 Micromoles per liter | Standard Deviation 7.057 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Creatinine, Week 12, n= 236, 226 | 9.2 Micromoles per liter | Standard Deviation 8.288 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Creatinine, Week 24, n= 225, 212 | 9.16 Micromoles per liter | Standard Deviation 9.983 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Creatinine, Week 36, n= 219, 204 | 10.08 Micromoles per liter | Standard Deviation 10.473 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Creatinine, Week 48, n= 208, 192 | 9.29 Micromoles per liter | Standard Deviation 8.614 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Creatinine, Week 24, n= 225, 212 | 5.8 Micromoles per liter | Standard Deviation 8.063 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Bilirubin, Week 4, n= 244, 237 | 27.2 Micromoles per liter | Standard Deviation 23.15 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Creatinine, Week 4, n= 245, 237 | 4.89 Micromoles per liter | Standard Deviation 7.109 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Bilirubin, Week 12, n= 236, 226 | 22.8 Micromoles per liter | Standard Deviation 16.49 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Creatinine, Week 48, n= 208, 192 | 5.86 Micromoles per liter | Standard Deviation 10.252 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Bilirubin, Week 24, n= 225, 212 | 25 Micromoles per liter | Standard Deviation 18.38 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Creatinine, Week 12, n= 236, 226 | 5.83 Micromoles per liter | Standard Deviation 8.357 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Bilirubin, Week 36, n= 219, 204 | 23.8 Micromoles per liter | Standard Deviation 16.31 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Creatinine, Week 36, n= 219, 204 | 5.37 Micromoles per liter | Standard Deviation 9.013 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints | Bilirubin, Week 48, n= 208, 192 | 23.7 Micromoles per liter | Standard Deviation 17 |
Secondary
Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | BSAP, Week 24, n=219, 207 | 1.33 Micrograms per liter | Standard Deviation 3.934 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | BSAP, Week 48, n=202, 184 | 2.64 Micrograms per liter | Standard Deviation 5.746 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | Osteocalcin, Week 24, n=209, 197 | 3.73 Micrograms per liter | Standard Deviation 7.484 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | Osteocalcin, Week 48, n=194, 178 | 5.15 Micrograms per liter | Standard Deviation 9.018 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | PTP, Week 24, n=223, 206 | 10.1 Micrograms per liter | Standard Deviation 20.11 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | PTP, Week 48, n=205, 186 | 11.2 Micrograms per liter | Standard Deviation 23.05 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | PTP, Week 24, n=223, 206 | 32.0 Micrograms per liter | Standard Deviation 27.89 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | BSAP, Week 24, n=219, 207 | 6.00 Micrograms per liter | Standard Deviation 5.962 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | Osteocalcin, Week 48, n=194, 178 | 16.30 Micrograms per liter | Standard Deviation 25.043 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | BSAP, Week 48, n=202, 184 | 7.60 Micrograms per liter | Standard Deviation 7.144 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | PTP, Week 48, n=205, 186 | 34.1 Micrograms per liter | Standard Deviation 27.28 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints | Osteocalcin, Week 24, n=209, 197 | 14.38 Micrograms per liter | Standard Deviation 22.205 |
Secondary
Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol \[CHLS\], high density lipoprotein \[HDL\] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypokalemia, Week 4, n= 244, 237 | -0.01 Millimoles per liter | Standard Deviation 0.344 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | CHLS, Week 12, n= 224, 221 | 0.298 Millimoles per liter | Standard Deviation 0.7492 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypokalemia, Week 12, n= 236, 226 | 0.03 Millimoles per liter | Standard Deviation 0.355 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | HDL CHLS, Direct, Week 36, n= 205, 191 | 0.204 Millimoles per liter | Standard Deviation 0.2943 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypokalemia, Week 24, n= 224, 212 | -0.04 Millimoles per liter | Standard Deviation 0.339 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Chloride, Week 12, n= 236, 226 | 1 Millimoles per liter | Standard Deviation 2.51 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypokalemia, Week 36, n= 219, 204 | 0.03 Millimoles per liter | Standard Deviation 0.332 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | HDL CHLS, Direct, Week 48, n= 195, 175 | 0.231 Millimoles per liter | Standard Deviation 0.2911 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypokalemia, Week 48, n= 208, 192 | -0.04 Millimoles per liter | Standard Deviation 0.346 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | CHLS, Week 24, n= 218, 201 | 0.317 Millimoles per liter | Standard Deviation 0.7254 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyponatremia, Week 4, n= 245, 237 | 0 Millimoles per liter | Standard Deviation 2.11 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperglycaemia, Week 12, n= 226, 224 | 0.3 Millimoles per liter | Standard Deviation 1.359 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyponatremia, Week 12, n= 236, 226 | 0.7 Millimoles per liter | Standard Deviation 2.3 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Carbon Dioxide, Week 24, n= 224, 212 | -0.5 Millimoles per liter | Standard Deviation 2.31 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyponatremia, Week 24, n= 225, 212 | 0.6 Millimoles per liter | Standard Deviation 2.3 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperglycaemia, Week 24, n= 219, 204 | 0.17 Millimoles per liter | Standard Deviation 0.811 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyponatremia, Week 36, n= 219, 204 | 0.9 Millimoles per liter | Standard Deviation 2.32 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | CHLS, Week 36, n= 205, 191 | 0.33 Millimoles per liter | Standard Deviation 0.7328 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyponatremia, Week 48, n= 208, 192 | 0.6 Millimoles per liter | Standard Deviation 2.24 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperglycaemia, Week 36, n= 211, 196 | 0.17 Millimoles per liter | Standard Deviation 1.24 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS Calculation, Week 4, n= 1, 3 | 0.08 Millimoles per liter | — |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Chloride, Week 24, n= 225, 212 | 0.7 Millimoles per liter | Standard Deviation 2.71 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS Calculation, Week 12, n= 221, 219 | 0.125 Millimoles per liter | Standard Deviation 0.6045 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperglycaemia, Week 48, n= 197, 180 | 0.18 Millimoles per liter | Standard Deviation 1.01 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS Calculation, Week 24, n= 213, 201 | 0.111 Millimoles per liter | Standard Deviation 0.6209 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | CHLS, Week 48, n= 195, 175 | 0.447 Millimoles per liter | Standard Deviation 0.7441 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS Calculation, Week 36, n= 201, 188 | 0.112 Millimoles per liter | Standard Deviation 0.6385 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperkalemia, Week 4, n= 244, 237 | -0.01 Millimoles per liter | Standard Deviation 0.344 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS Calculation, Week 48, n= 190, 175 | 0.213 Millimoles per liter | Standard Deviation 0.6499 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Carbon Dioxide, Week 48, n= 208, 192 | -0.6 Millimoles per liter | Standard Deviation 2.55 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperkalemia, Week 12, n= 236, 226 | 0.03 Millimoles per liter | Standard Deviation 0.355 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS, Direct, Week 24, n= 1, 0 | -0.64 Millimoles per liter | — |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS, Direct, Week 36, n= 1, 0 | -0.23 Millimoles per liter | — |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Phosphate, Week 4, n= 245, 237 | 0 Millimoles per liter | Standard Deviation 0.1461 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Glucose, Week 12, n= 226, 224 | 0.3 Millimoles per liter | Standard Deviation 1.359 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Phosphate, Week 12, n= 236, 226 | 0.02 Millimoles per liter | Standard Deviation 0.1694 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperkalemia, Week 24, n= 224, 212 | -0.04 Millimoles per liter | Standard Deviation 0.339 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Phosphate, Week 24, n= 225, 212 | 0.021 Millimoles per liter | Standard Deviation 0.1628 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Chloride, Week 36, n= 219, 204 | 0.9 Millimoles per liter | Standard Deviation 2.65 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Phosphate, Week 36, n= 219, 204 | 0.029 Millimoles per liter | Standard Deviation 0.1736 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperkalemia, Week 36, n= 219, 204 | 0.03 Millimoles per liter | Standard Deviation 0.332 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Phosphate, Week 48, n= 208, 192 | 0.016 Millimoles per liter | Standard Deviation 0.1736 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Glucose, Week 24, n= 219, 204 | 0.17 Millimoles per liter | Standard Deviation 0.811 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Potassium, Week 4, n= 244, 237 | -0.01 Millimoles per liter | Standard Deviation 0.344 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperkalemia, Week 48, n= 208, 192 | -0.04 Millimoles per liter | Standard Deviation 0.346 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Potassium, Week 12, n= 236, 226 | 0.03 Millimoles per liter | Standard Deviation 0.355 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Carbon Dioxide, Week 12, n= 236, 226 | -0.2 Millimoles per liter | Standard Deviation 2.2 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Potassium, Week 24, n= 224, 212 | -0.04 Millimoles per liter | Standard Deviation 0.339 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypernatremia, Week 4, n= 245, 237 | 0 Millimoles per liter | Standard Deviation 2.11 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Potassium, Week 36, n= 219, 204 | 0.03 Millimoles per liter | Standard Deviation 0.332 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Glucose, Week 36, n= 211, 196 | 0.17 Millimoles per liter | Standard Deviation 1.24 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Potassium, Week 48, n= 208, 192 | -0.04 Millimoles per liter | Standard Deviation 0.346 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypernatremia, Week 12, n= 236, 226 | 0.7 Millimoles per liter | Standard Deviation 2.3 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Sodium, Week 4, n= 245, 237 | 0 Millimoles per liter | Standard Deviation 2.11 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Chloride, Week 48, n= 208, 192 | 0.7 Millimoles per liter | Standard Deviation 2.42 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Sodium, Week 12, n= 236, 226 | 0.7 Millimoles per liter | Standard Deviation 2.3 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypernatremia, Week 24, n= 225, 212 | 0.6 Millimoles per liter | Standard Deviation 2.3 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Sodium, Week 24, n= 225, 212 | 0.6 Millimoles per liter | Standard Deviation 2.3 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Glucose, Week 48, n= 197, 180 | 0.18 Millimoles per liter | Standard Deviation 1.01 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Sodium, Week 36, n= 219, 204 | 0.9 Millimoles per liter | Standard Deviation 2.32 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypernatremia, Week 36, n= 219, 204 | 0.9 Millimoles per liter | Standard Deviation 2.32 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Sodium, Week 48, n= 208, 192 | 0.6 Millimoles per liter | Standard Deviation 2.24 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Chloride, Week 4, n= 245, 237 | 0.6 Millimoles per liter | Standard Deviation 2.42 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Triglycerides, Week 4, n= 1, 3 | -0.18 Millimoles per liter | — |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypernatremia, Week 48, n= 208, 192 | 0.6 Millimoles per liter | Standard Deviation 2.24 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Triglycerides, Week 12, n= 224, 221 | -0.04 Millimoles per liter | Standard Deviation 0.6861 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | HDL CHLS, Direct, Week 4, n= 1, 3 | -0.1 Millimoles per liter | — |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Triglycerides, Week 24, n= 218, 201 | 0.036 Millimoles per liter | Standard Deviation 0.7108 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypoglycaemia, Week 12, n= 226, 224 | 0.3 Millimoles per liter | Standard Deviation 1.359 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Triglycerides, Week 36, n= 205, 191 | 0.037 Millimoles per liter | Standard Deviation 0.6732 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | CHLS, Week 4, n= 1, 3 | -0.1 Millimoles per liter | — |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Triglycerides, Week 48, n= 195, 175 | 0.018 Millimoles per liter | Standard Deviation 0.8158 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypoglycaemia, Week 24, n= 219, 204 | 0.17 Millimoles per liter | Standard Deviation 0.811 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Urea, Week 4, n= 245, 237 | -0.04 Millimoles per liter | Standard Deviation 1.085 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | HDL CHLS, Direct, Week 12, n= 224, 221 | 0.182 Millimoles per liter | Standard Deviation 0.3407 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Urea, Week 12, n= 236, 226 | 0.08 Millimoles per liter | Standard Deviation 1.097 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypoglycaemia, Week 36, n= 211, 196 | 0.17 Millimoles per liter | Standard Deviation 1.24 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Urea, Week 24, n= 225, 212 | 0.03 Millimoles per liter | Standard Deviation 1.187 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Carbon Dioxide, Week 36, n= 219, 204 | 0 Millimoles per liter | Standard Deviation 2.34 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Urea, Week 36, n= 219, 204 | 0.08 Millimoles per liter | Standard Deviation 1.236 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypoglycaemia, Week 48, n= 197, 180 | 0.18 Millimoles per liter | Standard Deviation 1.01 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Urea, Week 48, n= 208, 192 | 0.1 Millimoles per liter | Standard Deviation 1.162 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Carbon Dioxide, Week 4, n= 244, 237 | -0.4 Millimoles per liter | Standard Deviation 2.29 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | HDL CHLS, Direct, Week 24, n= 218, 201 | 0.201 Millimoles per liter | Standard Deviation 0.2962 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Urea, Week 48, n= 208, 192 | 0.02 Millimoles per liter | Standard Deviation 1.179 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Carbon Dioxide, Week 4, n= 244, 237 | 0.6 Millimoles per liter | Standard Deviation 2.2 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Carbon Dioxide, Week 12, n= 236, 226 | 0.8 Millimoles per liter | Standard Deviation 2.19 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Carbon Dioxide, Week 24, n= 224, 212 | 0.3 Millimoles per liter | Standard Deviation 2.38 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Carbon Dioxide, Week 36, n= 219, 204 | 0.6 Millimoles per liter | Standard Deviation 2.5 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Carbon Dioxide, Week 48, n= 208, 192 | 0.4 Millimoles per liter | Standard Deviation 2.46 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Chloride, Week 4, n= 245, 237 | -0.5 Millimoles per liter | Standard Deviation 2.68 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Chloride, Week 12, n= 236, 226 | 0.2 Millimoles per liter | Standard Deviation 2.58 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Chloride, Week 24, n= 225, 212 | -0.1 Millimoles per liter | Standard Deviation 2.58 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Chloride, Week 36, n= 219, 204 | 0 Millimoles per liter | Standard Deviation 2.96 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Chloride, Week 48, n= 208, 192 | 0 Millimoles per liter | Standard Deviation 2.63 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | CHLS, Week 4, n= 1, 3 | -0.017 Millimoles per liter | Standard Deviation 0.446 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | CHLS, Week 12, n= 224, 221 | -0.058 Millimoles per liter | Standard Deviation 0.7137 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | CHLS, Week 24, n= 218, 201 | -0.001 Millimoles per liter | Standard Deviation 0.7456 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | CHLS, Week 36, n= 205, 191 | 0 Millimoles per liter | Standard Deviation 0.7509 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | CHLS, Week 48, n= 195, 175 | 0.109 Millimoles per liter | Standard Deviation 0.7647 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Glucose, Week 12, n= 226, 224 | 0.22 Millimoles per liter | Standard Deviation 1.234 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Glucose, Week 24, n= 219, 204 | 0.26 Millimoles per liter | Standard Deviation 1.248 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Glucose, Week 36, n= 211, 196 | 0.34 Millimoles per liter | Standard Deviation 1.753 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Glucose, Week 48, n= 197, 180 | 0.24 Millimoles per liter | Standard Deviation 1.377 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | HDL CHLS, Direct, Week 4, n= 1, 3 | 0 Millimoles per liter | Standard Deviation 0.0529 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | HDL CHLS, Direct, Week 12, n= 224, 221 | 0.005 Millimoles per liter | Standard Deviation 0.2316 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | HDL CHLS, Direct, Week 24, n= 218, 201 | 0.053 Millimoles per liter | Standard Deviation 0.2819 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | HDL CHLS, Direct, Week 36, n= 205, 191 | 0.036 Millimoles per liter | Standard Deviation 0.2848 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | HDL CHLS, Direct, Week 48, n= 195, 175 | 0.081 Millimoles per liter | Standard Deviation 0.2964 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperglycaemia, Week 12, n= 226, 224 | 0.22 Millimoles per liter | Standard Deviation 1.234 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperglycaemia, Week 24, n= 219, 204 | 0.26 Millimoles per liter | Standard Deviation 1.248 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperglycaemia, Week 36, n= 211, 196 | 0.34 Millimoles per liter | Standard Deviation 1.753 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperglycaemia, Week 48, n= 197, 180 | 0.24 Millimoles per liter | Standard Deviation 1.377 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperkalemia, Week 4, n= 244, 237 | 0.12 Millimoles per liter | Standard Deviation 0.367 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperkalemia, Week 12, n= 236, 226 | 0.1 Millimoles per liter | Standard Deviation 0.39 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperkalemia, Week 24, n= 224, 212 | 0.06 Millimoles per liter | Standard Deviation 0.372 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperkalemia, Week 36, n= 219, 204 | 0.13 Millimoles per liter | Standard Deviation 0.387 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyperkalemia, Week 48, n= 208, 192 | 0.04 Millimoles per liter | Standard Deviation 0.372 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypernatremia, Week 4, n= 245, 237 | -0.5 Millimoles per liter | Standard Deviation 2.4 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypernatremia, Week 12, n= 236, 226 | 0.1 Millimoles per liter | Standard Deviation 2.51 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypernatremia, Week 24, n= 225, 212 | 0.2 Millimoles per liter | Standard Deviation 2.11 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypernatremia, Week 36, n= 219, 204 | 0.2 Millimoles per liter | Standard Deviation 2.5 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypernatremia, Week 48, n= 208, 192 | 0.5 Millimoles per liter | Standard Deviation 2.39 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypoglycaemia, Week 12, n= 226, 224 | 0.22 Millimoles per liter | Standard Deviation 1.234 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypoglycaemia, Week 24, n= 219, 204 | 0.26 Millimoles per liter | Standard Deviation 1.248 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypoglycaemia, Week 36, n= 211, 196 | 0.34 Millimoles per liter | Standard Deviation 1.753 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypoglycaemia, Week 48, n= 197, 180 | 0.24 Millimoles per liter | Standard Deviation 1.377 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypokalemia, Week 4, n= 244, 237 | 0.12 Millimoles per liter | Standard Deviation 0.367 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypokalemia, Week 12, n= 236, 226 | 0.1 Millimoles per liter | Standard Deviation 0.39 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypokalemia, Week 24, n= 224, 212 | 0.06 Millimoles per liter | Standard Deviation 0.372 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypokalemia, Week 36, n= 219, 204 | 0.13 Millimoles per liter | Standard Deviation 0.387 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hypokalemia, Week 48, n= 208, 192 | 0.04 Millimoles per liter | Standard Deviation 0.372 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyponatremia, Week 4, n= 245, 237 | -0.5 Millimoles per liter | Standard Deviation 2.4 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyponatremia, Week 12, n= 236, 226 | 0.1 Millimoles per liter | Standard Deviation 2.51 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyponatremia, Week 24, n= 225, 212 | 0.2 Millimoles per liter | Standard Deviation 2.11 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyponatremia, Week 36, n= 219, 204 | 0.2 Millimoles per liter | Standard Deviation 2.5 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Hyponatremia, Week 48, n= 208, 192 | 0.5 Millimoles per liter | Standard Deviation 2.39 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS Calculation, Week 4, n= 1, 3 | -0.123 Millimoles per liter | Standard Deviation 0.5255 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS Calculation, Week 12, n= 221, 219 | -0.14 Millimoles per liter | Standard Deviation 0.6114 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS Calculation, Week 24, n= 213, 201 | -0.111 Millimoles per liter | Standard Deviation 0.6188 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS Calculation, Week 36, n= 201, 188 | -0.099 Millimoles per liter | Standard Deviation 0.6049 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS Calculation, Week 48, n= 190, 175 | -0.021 Millimoles per liter | Standard Deviation 0.6227 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | LDL CHLS, Direct, Week 12, n= 0, 1 | -0.44 Millimoles per liter | — |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Phosphate, Week 4, n= 245, 237 | -0.032 Millimoles per liter | Standard Deviation 0.1726 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Phosphate, Week 12, n= 236, 226 | 0.026 Millimoles per liter | Standard Deviation 0.1634 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Phosphate, Week 24, n= 225, 212 | 0.026 Millimoles per liter | Standard Deviation 0.1701 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Phosphate, Week 36, n= 219, 204 | 0.009 Millimoles per liter | Standard Deviation 0.1675 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Phosphate, Week 48, n= 208, 192 | 0 Millimoles per liter | Standard Deviation 0.1673 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Potassium, Week 4, n= 244, 237 | 0.12 Millimoles per liter | Standard Deviation 0.367 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Potassium, Week 12, n= 236, 226 | 0.1 Millimoles per liter | Standard Deviation 0.39 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Potassium, Week 24, n= 224, 212 | 0.06 Millimoles per liter | Standard Deviation 0.372 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Potassium, Week 36, n= 219, 204 | 0.13 Millimoles per liter | Standard Deviation 0.387 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Potassium, Week 48, n= 208, 192 | 0.04 Millimoles per liter | Standard Deviation 0.372 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Sodium, Week 4, n= 245, 237 | -0.5 Millimoles per liter | Standard Deviation 2.4 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Sodium, Week 12, n= 236, 226 | 0.1 Millimoles per liter | Standard Deviation 2.51 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Sodium, Week 24, n= 225, 212 | 0.2 Millimoles per liter | Standard Deviation 2.11 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Sodium, Week 36, n= 219, 204 | 0.2 Millimoles per liter | Standard Deviation 2.5 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Sodium, Week 48, n= 208, 192 | 0.5 Millimoles per liter | Standard Deviation 2.39 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Triglycerides, Week 4, n= 1, 3 | 0.237 Millimoles per liter | Standard Deviation 0.2491 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Triglycerides, Week 12, n= 224, 221 | 0.167 Millimoles per liter | Standard Deviation 0.7074 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Triglycerides, Week 24, n= 218, 201 | 0.125 Millimoles per liter | Standard Deviation 0.6132 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Triglycerides, Week 36, n= 205, 191 | 0.157 Millimoles per liter | Standard Deviation 0.6785 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Triglycerides, Week 48, n= 195, 175 | 0.107 Millimoles per liter | Standard Deviation 0.5527 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Urea, Week 4, n= 245, 237 | 0.1 Millimoles per liter | Standard Deviation 1.313 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Urea, Week 12, n= 236, 226 | 0.16 Millimoles per liter | Standard Deviation 1.409 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Urea, Week 24, n= 225, 212 | 0.12 Millimoles per liter | Standard Deviation 1.283 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points | Urea, Week 36, n= 219, 204 | -0.03 Millimoles per liter | Standard Deviation 1.256 |
Secondary
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 96, Week 432
Population: ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase | Week 96, n=99 | 286.5 Cells per cubic millimeter | Standard Deviation 196.77 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase | Week 432, n=3 | 254.7 Cells per cubic millimeter | Standard Deviation 342.31 |
Secondary
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
Change from Baseline in cluster of differentiation 4 (CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 12, n=236, 224 | 143.8 Cells per cubic millimeter | Standard Deviation 142.19 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 36, n=219, 204 | 230.7 Cells per cubic millimeter | Standard Deviation 163.61 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 24, n=226, 210 | 200.6 Cells per cubic millimeter | Standard Deviation 162.37 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 48, n=208, 191 | 248.8 Cells per cubic millimeter | Standard Deviation 172.01 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 4, n=245, 237 | 94.9 Cells per cubic millimeter | Standard Deviation 140.02 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 48, n=208, 191 | 230.7 Cells per cubic millimeter | Standard Deviation 189.59 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 4, n=245, 237 | 73.7 Cells per cubic millimeter | Standard Deviation 108.15 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 12, n=236, 224 | 124.4 Cells per cubic millimeter | Standard Deviation 133.6 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 24, n=226, 210 | 163.0 Cells per cubic millimeter | Standard Deviation 126.67 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase | Week 36, n=219, 204 | 191.4 Cells per cubic millimeter | Standard Deviation 167.24 |
Secondary
Change From Baseline in Creatinine Clearance at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Creatinine Clearance at Indicated Time Points | Week 12, n= 236, 226 | -17.3 Milliliter per minute | Standard Deviation 17.01 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Creatinine Clearance at Indicated Time Points | Week 36, n= 219, 204 | -16.8 Milliliter per minute | Standard Deviation 22.35 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Creatinine Clearance at Indicated Time Points | Week 24, n= 225, 212 | -16.2 Milliliter per minute | Standard Deviation 20.36 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Creatinine Clearance at Indicated Time Points | Week 48, n= 208, 192 | -15.9 Milliliter per minute | Standard Deviation 19.62 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Creatinine Clearance at Indicated Time Points | Week 4, n= 245, 237 | -16.3 Milliliter per minute | Standard Deviation 15.03 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Creatinine Clearance at Indicated Time Points | Week 48, n= 208, 192 | -7.7 Milliliter per minute | Standard Deviation 18.42 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Creatinine Clearance at Indicated Time Points | Week 4, n= 245, 237 | -7.5 Milliliter per minute | Standard Deviation 12.91 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Creatinine Clearance at Indicated Time Points | Week 12, n= 236, 226 | -7 Milliliter per minute | Standard Deviation 23.14 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Creatinine Clearance at Indicated Time Points | Week 24, n= 225, 212 | -9.1 Milliliter per minute | Standard Deviation 16.88 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Creatinine Clearance at Indicated Time Points | Week 36, n= 219, 204 | -7.5 Milliliter per minute | Standard Deviation 17.67 |
Secondary
Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points | Week 12, n= 233, 220 | 3.4 Femtoliter | Standard Deviation 2.98 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points | Week 36, n= 218, 203 | 6.0 Femtoliter | Standard Deviation 4.04 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points | Week 24, n= 225, 211 | 5.5 Femtoliter | Standard Deviation 4.03 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points | Week 48, n= 207, 190 | 7.1 Femtoliter | Standard Deviation 4.31 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points | Week 4, n= 243, 234 | 0.9 Femtoliter | Standard Deviation 1.81 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points | Week 48, n= 207, 190 | 3.7 Femtoliter | Standard Deviation 5.15 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points | Week 4, n= 243, 234 | 0.5 Femtoliter | Standard Deviation 1.83 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points | Week 12, n= 233, 220 | 1.9 Femtoliter | Standard Deviation 2.94 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points | Week 24, n= 225, 211 | 3.1 Femtoliter | Standard Deviation 4.33 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points | Week 36, n= 218, 203 | 3.1 Femtoliter | Standard Deviation 5.22 |
Secondary
Change From Baseline in Erythrocytes at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Erythrocytes at Indicated Time Points | Week 12, n= 233, 220 | -0.07 10^12 cells per liter | Standard Deviation 0.351 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Erythrocytes at Indicated Time Points | Week 36, n= 218, 203 | -0.10 10^12 cells per liter | Standard Deviation 0.384 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Erythrocytes at Indicated Time Points | Week 24, n= 225, 211 | -0.08 10^12 cells per liter | Standard Deviation 0.373 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Erythrocytes at Indicated Time Points | Week 48, n= 207, 190 | -0.10 10^12 cells per liter | Standard Deviation 0.365 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Erythrocytes at Indicated Time Points | Week 4, n= 243, 234 | -0.04 10^12 cells per liter | Standard Deviation 0.244 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Erythrocytes at Indicated Time Points | Week 48, n= 207, 190 | -0.05 10^12 cells per liter | Standard Deviation 0.318 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Erythrocytes at Indicated Time Points | Week 4, n= 243, 234 | -0.07 10^12 cells per liter | Standard Deviation 0.239 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Erythrocytes at Indicated Time Points | Week 12, n= 233, 220 | -0.09 10^12 cells per liter | Standard Deviation 0.308 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Erythrocytes at Indicated Time Points | Week 24, n= 225, 211 | -0.09 10^12 cells per liter | Standard Deviation 0.329 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Erythrocytes at Indicated Time Points | Week 36, n= 218, 203 | -0.08 10^12 cells per liter | Standard Deviation 0.358 |
Secondary
Change From Baseline in Hematocrit Count at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Hematocrit Count at Indicated Time Points | Week 12, n= 233, 220 | 0.0081 Proportion of red blood cells in blood | Standard Deviation 0.03157 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Hematocrit Count at Indicated Time Points | Week 36, n= 218, 203 | 0.0167 Proportion of red blood cells in blood | Standard Deviation 0.03451 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Hematocrit Count at Indicated Time Points | Week 24, n= 225, 211 | 0.0157 Proportion of red blood cells in blood | Standard Deviation 0.03209 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Hematocrit Count at Indicated Time Points | Week 48, n= 207, 190 | 0.0212 Proportion of red blood cells in blood | Standard Deviation 0.03293 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Hematocrit Count at Indicated Time Points | Week 4, n= 243, 234 | 0.0003 Proportion of red blood cells in blood | Standard Deviation 0.02176 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Hematocrit Count at Indicated Time Points | Week 48, n= 207, 190 | 0.0107 Proportion of red blood cells in blood | Standard Deviation 0.032 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Hematocrit Count at Indicated Time Points | Week 4, n= 243, 234 | -0.0042 Proportion of red blood cells in blood | Standard Deviation 0.02238 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Hematocrit Count at Indicated Time Points | Week 12, n= 233, 220 | 0.0000 Proportion of red blood cells in blood | Standard Deviation 0.02646 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Hematocrit Count at Indicated Time Points | Week 24, n= 225, 211 | 0.0051 Proportion of red blood cells in blood | Standard Deviation 0.03083 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Hematocrit Count at Indicated Time Points | Week 36, n= 218, 203 | 0.0062 Proportion of red blood cells in blood | Standard Deviation 0.03379 |
Secondary
Change From Baseline in Lipase at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Lipase at Indicated Timepoints | Week 4, n= 245, 237 | -1.2 Units per liter | Standard Deviation 15.06 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Lipase at Indicated Timepoints | Week 36, n= 219, 204 | -6.3 Units per liter | Standard Deviation 25.62 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Lipase at Indicated Timepoints | Week 12, n= 236, 226 | -2.2 Units per liter | Standard Deviation 22.74 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Lipase at Indicated Timepoints | Week 48, n= 208, 192 | -6.5 Units per liter | Standard Deviation 29.63 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Lipase at Indicated Timepoints | Week 24, n= 225, 212 | -6 Units per liter | Standard Deviation 21.05 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Lipase at Indicated Timepoints | Week 48, n= 208, 192 | -7.8 Units per liter | Standard Deviation 20.72 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Lipase at Indicated Timepoints | Week 24, n= 225, 212 | -6 Units per liter | Standard Deviation 18.57 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Lipase at Indicated Timepoints | Week 4, n= 245, 237 | -1.3 Units per liter | Standard Deviation 15.81 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Lipase at Indicated Timepoints | Week 12, n= 236, 226 | -2.1 Units per liter | Standard Deviation 29 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Lipase at Indicated Timepoints | Week 36, n= 219, 204 | -6.3 Units per liter | Standard Deviation 21.36 |
Secondary
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 96 and Week 432
Population: ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase | Week 96, n=99 | -2.911 Log10 copies/mL | Standard Deviation 0.797 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase | Week 432, n=3 | -3.107 Log10 copies/mL | Standard Deviation 0.7659 |
Secondary
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 12, n=236, 226 | -2.756 Log10 copies/mL | Standard Deviation 0.892 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 36, n=221, 204 | -2.838 Log10 copies/mL | Standard Deviation 0.8589 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 24, n=225, 212 | -2.789 Log10 copies/mL | Standard Deviation 0.916 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 48, n=207, 192 | -2.874 Log10 copies/mL | Standard Deviation 0.8035 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 4, n=245, 238 | -2.591 Log10 copies/mL | Standard Deviation 0.8015 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 48, n=207, 192 | -2.752 Log10 copies/mL | Standard Deviation 0.8433 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 4, n=245, 238 | -1.923 Log10 copies/mL | Standard Deviation 0.533 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 12, n=236, 226 | -2.541 Log10 copies/mL | Standard Deviation 0.7373 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 24, n=225, 212 | -2.726 Log10 copies/mL | Standard Deviation 0.889 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase | Week 36, n=221, 204 | -2.772 Log10 copies/mL | Standard Deviation 0.8451 |
Secondary
Change From Baseline in TC/HDL Ratio at Week 48
Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.
Time frame: Baseline (Day 1) and Week 48
Population: Safety Population. Participants on lipid lowering therapy at Baseline were excluded from analysis. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in TC/HDL Ratio at Week 48 | -0.264 Ratio | Standard Error 0.0707 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in TC/HDL Ratio at Week 48 | -0.158 Ratio | Standard Error 0.0784 |
p-value: 0.316595% CI: [-0.313, 0.101]Multiple Imputed Dataset - MAR
Secondary
Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints | Week 12, n= 233, 223 | -0.2736 Ratio | Standard Deviation 1.0283 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints | Week 36, n= 212, 198 | -0.3286 Ratio | Standard Deviation 1.01181 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints | Week 24, n= 224, 209 | -0.3098 Ratio | Standard Deviation 1.11093 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints | Week 48, n= 207, 186 | -0.2886 Ratio | Standard Deviation 1.01415 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints | Week 4, n= 1, 4 | 0.1264 Ratio | — |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints | Week 48, n= 207, 186 | -0.1444 Ratio | Standard Deviation 1.23362 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints | Week 4, n= 1, 4 | 0.2159 Ratio | Standard Deviation 0.60727 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints | Week 12, n= 233, 223 | -0.1092 Ratio | Standard Deviation 0.73776 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints | Week 24, n= 224, 209 | -0.1922 Ratio | Standard Deviation 0.79848 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints | Week 36, n= 212, 198 | -0.1433 Ratio | Standard Deviation 0.79498 |
Secondary
Change From Baseline in Triglycerides at Week 48
Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.
Time frame: Baseline (Day 1) and Week 48
Population: Safety Population. Participants on lipid lowering therapy at Baseline were excluded from analysis. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Triglycerides at Week 48 | 0.045 Millimoles per liter | Standard Error 0.0477 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Triglycerides at Week 48 | 0.070 Millimoles per liter | Standard Error 0.0477 |
p-value: 0.705395% CI: [-0.159, 0.107]Multiple Imputed Dataset - MAR
Secondary
Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints | Week 24, n=221, 207 | 89.8 Nanograms per liter | Standard Deviation 173.09 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints | Week 48, n=202, 185 | 75.9 Nanograms per liter | Standard Deviation 173.73 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints | Week 24, n=221, 207 | 272.4 Nanograms per liter | Standard Deviation 205.22 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints | Week 48, n=202, 185 | 267.9 Nanograms per liter | Standard Deviation 200.82 |
Secondary
Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points
Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 24 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points | Week 24, n= 179, 186 | -1.15 milligrams per millimole | Standard Deviation 16.557 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points | Week 48, n= 170, 164 | -0.68 milligrams per millimole | Standard Deviation 20.597 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points | Week 24, n= 179, 186 | -1.03 milligrams per millimole | Standard Deviation 9.091 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points | Week 48, n= 170, 164 | -0.10 milligrams per millimole | Standard Deviation 9.393 |
Secondary
Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Weeks 24 and 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Vitamin D, Week 24, n=223, 208 | 1.8 Nanomoles per liter | Standard Deviation 24.95 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Vitamin D, Week 48, n=206, 186 | -1.9 Nanomoles per liter | Standard Deviation 20.63 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Vitamin D2, Week 24, n=223, 208 | 0.3 Nanomoles per liter | Standard Deviation 6.04 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Vitamin D2, Week 48, n=206, 186 | 0.1 Nanomoles per liter | Standard Deviation 4.71 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Vitamin D3, Week 24, n=223, 208 | 1.5 Nanomoles per liter | Standard Deviation 24.33 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Vitamin D3, Week 48, n=206, 186 | -1.9 Nanomoles per liter | Standard Deviation 20.56 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Vitamin D3, Week 24, n=223, 208 | 15.2 Nanomoles per liter | Standard Deviation 31.39 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Vitamin D, Week 24, n=223, 208 | 16.3 Nanomoles per liter | Standard Deviation 31.66 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Vitamin D2, Week 48, n=206, 186 | 0.9 Nanomoles per liter | Standard Deviation 11 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Vitamin D, Week 48, n=206, 186 | 8.9 Nanomoles per liter | Standard Deviation 23.78 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Vitamin D3, Week 48, n=206, 186 | 7.9 Nanomoles per liter | Standard Deviation 21.72 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 | Vitamin D2, Week 24, n=223, 208 | 1.0 Nanomoles per liter | Standard Deviation 7.88 |
Secondary
HIVTSQs Total Score at Indicated Timepoints
The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test.
Time frame: Weeks 4, 12, 24 and 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | HIVTSQs Total Score at Indicated Timepoints | Week 4, n=243, 239 | 54.0 Score on a scale | Standard Deviation 6.37 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | HIVTSQs Total Score at Indicated Timepoints | Week 12, n=236, 226 | 56.1 Score on a scale | Standard Deviation 5.38 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | HIVTSQs Total Score at Indicated Timepoints | Week 24, n=225, 211 | 56.8 Score on a scale | Standard Deviation 4.55 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | HIVTSQs Total Score at Indicated Timepoints | Week 48, n=206, 191 | 57.0 Score on a scale | Standard Deviation 4.38 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | HIVTSQs Total Score at Indicated Timepoints | Week 48, n=206, 191 | 55.4 Score on a scale | Standard Deviation 6 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | HIVTSQs Total Score at Indicated Timepoints | Week 4, n=243, 239 | 51.9 Score on a scale | Standard Deviation 8.53 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | HIVTSQs Total Score at Indicated Timepoints | Week 24, n=225, 211 | 54.3 Score on a scale | Standard Deviation 7.27 |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | HIVTSQs Total Score at Indicated Timepoints | Week 12, n=236, 226 | 53.6 Score on a scale | Standard Deviation 7.67 |
p-value: 0.016Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: 0.002Wilcoxon (Mann-Whitney)
p-value: 0.007Wilcoxon (Mann-Whitney)
Secondary
Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.
Time frame: From Weeks 48 to 432
Population: Safety - Continuation Phase Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase | 4 Participants |
Secondary
Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.
Time frame: Up to Week 48
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase | 10 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase | 17 Participants |
Secondary
Number of Participants With AEs by Maximum Toxicity-Continuation Phase
Number of participants with Grade 1-4 AEs were assessed in Continuation Phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.
Time frame: From Weeks 48 to 432
Population: Safety - Continuation Phase Population comprised of all participants in the DTG/ABC/3TC group who received at least 1 dose of study treatment after entering the Continuation Phase
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With AEs by Maximum Toxicity-Continuation Phase | Grade 4 | 6 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With AEs by Maximum Toxicity-Continuation Phase | Grade 1 | 32 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With AEs by Maximum Toxicity-Continuation Phase | Grade 2 | 48 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With AEs by Maximum Toxicity-Continuation Phase | Grade 3 | 7 Participants |
Secondary
Number of Participants With AEs by Maximum Toxicity-Randomized Phase
Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.
Time frame: Up to Week 48
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With AEs by Maximum Toxicity-Randomized Phase | Grade 1 | 79 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With AEs by Maximum Toxicity-Randomized Phase | Grade 2 | 94 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With AEs by Maximum Toxicity-Randomized Phase | Grade 3 | 18 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With AEs by Maximum Toxicity-Randomized Phase | Grade 4 | 3 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With AEs by Maximum Toxicity-Randomized Phase | Grade 4 | 9 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With AEs by Maximum Toxicity-Randomized Phase | Grade 1 | 60 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With AEs by Maximum Toxicity-Randomized Phase | Grade 3 | 37 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With AEs by Maximum Toxicity-Randomized Phase | Grade 2 | 91 Participants |
Secondary
Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.
Time frame: Up to Week 48
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase | Any AEs | 195 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase | Any SAEs | 12 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase | Any AEs | 197 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase | Any SAEs | 20 Participants |
Secondary
Number of Participants With Any AEs, and SAEs in Continuation Phase
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.
Time frame: From Weeks 48 to 432
Population: Safety-Continuation Phase Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Any AEs, and SAEs in Continuation Phase | Any AEs | 93 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Any AEs, and SAEs in Continuation Phase | Any SAEs | 13 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase
Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.
Time frame: From Weeks 48 to 432
Population: Safety - Continuation Phase Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hypernatremia, Grade 4, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hypoglycaemia, Grade 1, n=143 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hypoglycaemia, Grade 2, n=143 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hypoglycaemia, Grade 4, n=143 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hypokalemia, Grade 1, n=146 | 13 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hypokalemia, Grade 3, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hypokalemia, Grade 4, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hyponatremia, Grade 1, n=146 | 36 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hyponatremia, Grade 2, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hyponatremia, Grade 4, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Alanine aminotransferase, Grade 1, n=146 | 7 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Alanine aminotransferase, Grade 2, n=146 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Alanine aminotransferase, Grade 3, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Alanine aminotransferase, Grade 4, n=146 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Alkaline phosphatase, Grade 1, n=146 | 5 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Alkaline phosphatase, Grade 2, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Alkaline phosphatase, Grade 3, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Alkaline phosphatase, Grade 4, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Aspartate aminotransferase, Grade 1, n=146 | 10 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Aspartate aminotransferase, Grade 2, n=146 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Aspartate aminotransferase, Grade 3, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Aspartate aminotransferase, Grade 4, n=146 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Bilirubin, Grade 2, n=146 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Bilirubin, Grade 3, n=146 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Bilirubin, Grade 4, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Carbon dioxide, Grade 1, n=146 | 58 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Carbon dioxide, Grade 2, n=146 | 7 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Cholesterol, Grade 1, n=71 | 9 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Cholesterol, Grade 3, n=71 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Cholesterol, Grade 4, n=71 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Creatine kinase, Grade 2, n=146 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Creatine kinase, Grade 4, n=146 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Creatinine, Grade 1, n=146 | 5 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Creatinine, Grade 2, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Creatinine, Grade 3, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Creatinine, Grade 4, n=146 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | LDL cholesterol calculation, Grade 1, n=70 | 5 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | LDL cholesterol calculation, Grade 4, n=70 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | LDL cholesterol direct, Grade 2, n=2 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | LDL cholesterol direct, Grade 4, n=2 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Lipase, Grade 1, n=146 | 9 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Lipase, Grade 2, n=146 | 6 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Lipase, Grade 3, n=146 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Lipase, Grade 4, n=146 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Phosphate, Grade 1, n=146 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Phosphate, Grade 2, n=146 | 15 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Phosphate, Grade 3, n=146 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Phosphate, Grade 4, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Potassium, Grade 1, n=146 | 13 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Potassium, Grade 2, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Potassium, Grade 3, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Potassium, Grade 4, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Sodium, Grade 1, n=146 | 37 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Sodium, Grade 2, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Sodium, Grade 3, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Sodium, Grade 4, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Triglycerides, Grade 1, n=71 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Triglycerides, Grade 2, n=71 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Triglycerides, Grade 3, n=71 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Triglycerides, Grade 4, n=71 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Glucose, Grade 2, n=143 | 9 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Glucose, Grade 3, n=143 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Glucose, Grade 4, n=143 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hyperglycaemia, Grade 1, n=143 | 24 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hyperglycaemia, Grade 2, n=143 | 9 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hyperglycaemia, Grade 3, n=143 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hyperglycaemia, Grade 4, n=143 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hypernatremia, Grade 1, n=146 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hypernatremia, Grade 2, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hypernatremia, Grade 3, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hypoglycaemia, Grade 3, n=143 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hypokalemia, Grade 2, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Hyponatremia, Grade 3, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Bilirubin, Grade 1, n=146 | 4 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Carbon dioxide, Grade 3, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Carbon dioxide, Grade 4, n=146 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Cholesterol, Grade 2, n=71 | 9 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Creatine kinase, Grade 1, n=146 | 6 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Creatine kinase, Grade 3, n=146 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | LDL cholesterol calculation, Grade 2, n=70 | 8 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | LDL cholesterol calculation, Grade 3, n=70 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | LDL cholesterol direct, Grade 1, n=2 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | LDL cholesterol direct, Grade 3, n=2 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase | Glucose, Grade 1, n=143 | 24 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase
Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.
Time frame: Up to Week 48
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Phosphate, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyponatremia, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Triglycerides, Grade 1 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Triglycerides, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypernatremia, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Glucose, Grade 4 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperglycaemia, Grade 1 | 17 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Aspartate aminotransferase, Grade 1 | 12 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperglycaemia, Grade 2 | 16 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypokalemia, Grade 1 | 17 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperglycaemia, Grade 3 | 4 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Aspartate aminotransferase, Grade 2 | 4 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperglycaemia, Grade 4 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alanine aminotransferase, Grade 1 | 5 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperkalemia, Grade 1 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Aspartate aminotransferase, Grade 3 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperkalemia, Grade 2 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypoglycaemia, Grade 2 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperkalemia, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alanine aminotransferase, Grade 2 | 6 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperkalemia, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Bilirubin, Grade 1 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypernatremia, Grade 1 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypokalemia, Grade 2 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Bilirubin, Grade 2 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyponatremia, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Albumin, Grade 2 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alkaline phosphatase, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Aspartate aminotransferase, Grade 4 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Bilirubin, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Carbon dioxide, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alanine aminotransferase, Grade 3 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Bilirubin, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatine kinase, Grade 3 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypernatremia, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatinine, Grade 1 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Carbon dioxide, Grade 1 | 65 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatinine, Grade 3 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol calculation, Grade 2 | 13 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alanine aminotransferase, Grade 4 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol calculation, Grade 3 | 7 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Carbon dioxide, Grade 2 | 4 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol calculation, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypokalemia, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol direct, Grade 1 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Carbon dioxide, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol direct, Grade 2 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Albumin, Grade 1 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol direct, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypoglycaemia, Grade 3 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol direct, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Cholesterol, Grade 1 | 52 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Lipase, Grade 1 | 12 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Cholesterol, Grade 2 | 28 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypokalemia, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Lipase, Grade 3 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Cholesterol, Grade 3 | 4 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Lipase, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Albumin, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Phosphate, Grade 1 | 5 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Cholesterol, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Phosphate, Grade 2 | 7 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatine kinase, Grade 1 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Phosphate, Grade 3 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyponatremia, Grade 1 | 44 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Potassium, Grade 1 | 18 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatine kinase, Grade 2 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Potassium, Grade 2 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Albumin, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Potassium, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypoglycaemia, Grade 1 | 6 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Potassium, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Sodium, Grade 1 | 45 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatine kinase, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Sodium, Grade 2 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alkaline phosphatase, Grade 1 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Sodium, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatinine, Grade 2 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Sodium, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyponatremia, Grade 2 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatinine, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Triglycerides, Grade 2 | 5 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alkaline phosphatase, Grade 2 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Triglycerides, Grade 3 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol calculation, Grade 1 | 38 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypoglycaemia, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Glucose, Grade 1 | 22 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Lipase, Grade 2 | 5 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Glucose, Grade 2 | 19 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Glucose, Grade 3 | 4 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alkaline phosphatase, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypernatremia, Grade 2 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Glucose, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypernatremia, Grade 2 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypernatremia, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypernatremia, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypoglycaemia, Grade 1 | 5 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypoglycaemia, Grade 2 | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypoglycaemia, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypoglycaemia, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypokalemia, Grade 1 | 19 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypokalemia, Grade 2 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypokalemia, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyponatremia, Grade 1 | 57 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyponatremia, Grade 2 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyponatremia, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyponatremia, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alanine aminotransferase, Grade 1 | 7 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alanine aminotransferase, Grade 2 | 4 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alanine aminotransferase, Grade 3 | 2 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alanine aminotransferase, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Albumin, Grade 1 | 2 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Albumin, Grade 2 | 2 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Albumin, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Albumin, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alkaline phosphatase, Grade 1 | 14 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alkaline phosphatase, Grade 2 | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alkaline phosphatase, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Alkaline phosphatase, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Aspartate aminotransferase, Grade 1 | 7 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Aspartate aminotransferase, Grade 2 | 4 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Aspartate aminotransferase, Grade 3 | 2 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Aspartate aminotransferase, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Bilirubin, Grade 1 | 52 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Bilirubin, Grade 3 | 57 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Bilirubin, Grade 4 | 5 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Carbon dioxide, Grade 1 | 54 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Carbon dioxide, Grade 2 | 3 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Carbon dioxide, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Carbon dioxide, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Cholesterol, Grade 2 | 9 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Cholesterol, Grade 3 | 2 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatine kinase, Grade 1 | 5 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatine kinase, Grade 2 | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatine kinase, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatinine, Grade 1 | 7 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatinine, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatinine, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol calculation, Grade 1 | 21 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Phosphate, Grade 3 | 2 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Potassium, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Glucose, Grade 2 | 10 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperglycaemia, Grade 1 | 11 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperglycaemia, Grade 2 | 9 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperglycaemia, Grade 3 | 3 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperglycaemia, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperkalemia, Grade 1 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperkalemia, Grade 2 | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperkalemia, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hyperkalemia, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypernatremia, Grade 1 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Hypokalemia, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Bilirubin, Grade 2 | 86 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Cholesterol, Grade 1 | 31 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Cholesterol, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatine kinase, Grade 4 | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Creatinine, Grade 2 | 3 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol calculation, Grade 2 | 9 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol calculation, Grade 3 | 2 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol calculation, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol direct, Grade 1 | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol direct, Grade 2 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol direct, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | LDL cholesterol direct, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Lipase, Grade 1 | 7 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Lipase, Grade 2 | 3 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Lipase, Grade 3 | 2 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Lipase, Grade 4 | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Phosphate, Grade 1 | 11 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Phosphate, Grade 2 | 9 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Phosphate, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Potassium, Grade 1 | 19 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Potassium, Grade 2 | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Potassium, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Sodium, Grade 1 | 57 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Sodium, Grade 2 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Sodium, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Sodium, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Triglycerides, Grade 1 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Triglycerides, Grade 2 | 2 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Triglycerides, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Triglycerides, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Glucose, Grade 1 | 15 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase | Glucose, Grade 3 | 3 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase
Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.
Time frame: From Weeks 48 to 432
Population: Safety - Continuation Phase Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Hemoglobin, Grade 1 | 5 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Hemoglobin, Grade 2 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Hemoglobin, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Hemoglobin, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Leukocytes, Grade 1 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Leukocytes, Grade 2 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Leukocytes, Grade 3 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Neutrophils, Grade 4 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Platelets, Grade 1 | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Platelets, Grade 2 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Platelets, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Platelets, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Leukocytes, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Neutrophils, Grade 1 | 10 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Neutrophils, Grade 2 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase | Neutrophils, Grade 3 | 1 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase
Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and end of Randomized Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.
Time frame: Up to Week 48
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Hemoglobin, Grade 1 | 7 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Hemoglobin, Grade 2 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Hemoglobin, Grade 3 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Hemoglobin, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Leukocytes, Grade 1 | 5 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Leukocytes, Grade 2 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Leukocytes, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Leukocytes, Grade 4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Neutrophils, Grade 1 | 15 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Neutrophils, Grade 2 | 7 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Neutrophils, Grade 3 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Neutrophils, Grade 4 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Platelets, Grade 1 | 6 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Platelets, Grade 2 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Platelets, Grade 3 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Platelets, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Platelets, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Hemoglobin, Grade 1 | 21 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Neutrophils, Grade 1 | 12 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Hemoglobin, Grade 2 | 3 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Platelets, Grade 1 | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Hemoglobin, Grade 3 | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Neutrophils, Grade 2 | 9 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Hemoglobin, Grade 4 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Platelets, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Leukocytes, Grade 1 | 6 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Neutrophils, Grade 3 | 2 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Leukocytes, Grade 2 | 2 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Platelets, Grade 2 | 2 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Leukocytes, Grade 3 | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Neutrophils, Grade 4 | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase | Leukocytes, Grade 4 | 0 Participants |
Secondary
Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)
Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
Time frame: Up to week 432
Population: ITT-E Population, only those participants who experienced a disease progression to CDC Class C or death were analyzed
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) | CDC Class A to CDC Class C | 6 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) | CDC Class C to new CDC Class C | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) | CDC Class A, B or C to Death | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) | CDC Class B to CDC Class C | 1 Participants |
Secondary
Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase
Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
Time frame: Up to week 48
Population: ITT-E Population, only those participants who experienced a disease progression to CDC Class C or death were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase | CDC Class A to CDC Class C | 5 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase | CDC Class B to CDC Class C | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase | CDC Class C to new CDC Class C | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase | CDC Class A, B or C to Death | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase | CDC Class A, B or C to Death | 1 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase | CDC Class A to CDC Class C | 4 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase | CDC Class C to new CDC Class C | 0 Participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase | CDC Class B to CDC Class C | 2 Participants |
Secondary
Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)
Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.
Time frame: Up to week 48
Population: On-treatment Genotypic Resistance Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase) | INSTI; n= 3 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase) | NNRTI; n=4 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase) | NRTI; n=4 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase) | PI; n=4 | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)
Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.
Time frame: Up to week 432
Population: On-treatment Genotypic Resistance Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) | INSTI; n= 6 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) | NNRTI; n=8 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) | NRTI; n=8 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) | PI; n=8 | 0 Participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase
Percentage of participants with plasma HIV-1 RNA \<50 and \<400 c/mL were assessed at Baseline, Weeks 4, 12, 24 , 36 and 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Percentage values are rounded off.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Population: ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <50 c/mL, Baseline (Day 1) | 0 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <50 c/mL, Week 4 | 64 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <50 c/mL, Week 12 | 81 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <50 c/mL, Week 24 | 85 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <50 c/mL, Week 36 | 85 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <50 c/mL, Week 48 | 82 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <400 c/mL, Baseline (Day 1) | 1 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <400 c/mL, Week 4 | 90 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <400 c/mL, Week 12 | 91 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <400 c/mL, Week 24 | 88 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <400 c/mL, Week 36 | 86 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <400 c/mL, Week 48 | 83 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <400 c/mL, Week 36 | 81 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <50 c/mL, Baseline (Day 1) | 0 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <400 c/mL, Baseline (Day 1) | 1 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <50 c/mL, Week 4 | 13 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <400 c/mL, Week 24 | 82 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <50 c/mL, Week 12 | 49 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <400 c/mL, Week 4 | 54 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <50 c/mL, Week 24 | 77 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <400 c/mL, Week 48 | 76 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <50 c/mL, Week 36 | 77 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <400 c/mL, Week 12 | 84 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase | HIV-1 RNA <50 c/mL, Week 48 | 71 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \<50 c/mL were reported. Percentage values are rounded off.
Time frame: Week 96 and Week 432
Population: ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase | Week 96, n=99 | 100 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase | Week 432, n=3 | 100 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups
Percentage of participants with plasma HIV-1 RNA \<50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA \[BPHR\], Baseline CD4+ cell count \[BCCC\], Baseline Centers for Disease Control and Prevention \[CDC\] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =\<versus \[vs\]. \>100,000 c/mL) and CD4+ cell count (=\<350 cells/mm\^3 or \>350 cells/mm\^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off.
Time frame: Week 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Age, <50 Years, n=212, 212 | 80 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Age, >=50 Years, n=36, 35 | 92 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Race, White, n=115, 107 | 86 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Race, Non-White, n=133,140 | 78 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Non-African-American/African Heritage, n=146, 139 | 88 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BPHR, 1000 to <10,000, n=66, 62 | 83 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BPHR, 10,000 to <50,000, n=83, 81 | 84 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BPHR, 50,000 to <=100,000, n=25, 28 | 80 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BPHR, >100,000, n=69, 66 | 80 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, <200, n=64, 49 | 81 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, >=200, n=184, 198 | 82 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, <50, n=9, 15 | 67 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, 50 to <200, n=55, 34 | 84 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, 200 to <350, n=66, 74 | 89 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, 350 to <500, n=56, 65 | 79 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, >=500, n=62, 59 | 77 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | CDC category, A, n=210, 208 | 81 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | CDC category, B, n=27, 30 | 81 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | CDC category, C, n=11, 9 | 91 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | HIV-1 subtype: B vs Non-B, B, n=95, 111 | 80 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | HIV-1 subtype: B vs Non-B, non-B, n=140, 131 | 84 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Argentina, n=24, 20 | 92 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Canada, n=11, 9 | 91 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Italy, n=17, 11 | 88 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Mexico, n=6, 5 | 100 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Portugal, n=4, 5 | 75 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Russia, n=28, 22 | 89 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | South Africa, n=33, 33 | 67 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Spain, n=23, 31 | 70 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Thailand, n=19, 21 | 95 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | USA, n=62, 69 | 74 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | United Kingdom, n=14, 11 | 93 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | France, n=7, 8 | 100 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Race, African-American/African Heritage, n=102,108 | 74 Percentage of participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BPHR, <1000, n=5, 10 | 60 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Portugal, n=4, 5 | 60 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | CDC category, B, n=27, 30 | 77 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Age, <50 Years, n=212, 212 | 71 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Puerto Rico, n=0, 2 | 100 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Age, >=50 Years, n=36, 35 | 74 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | CDC category, C, n=11, 9 | 56 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Race, White, n=115, 107 | 80 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Thailand, n=19, 21 | 52 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Race, African-American/African Heritage, n=102,108 | 67 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | HIV-1 subtype: B vs Non-B, B, n=95, 111 | 69 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Non-African-American/African Heritage, n=146, 139 | 75 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BPHR, <1000, n=5, 10 | 80 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Russia, n=28, 22 | 82 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BPHR, 1000 to <10,000, n=66, 62 | 77 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | HIV-1 subtype: B vs Non-B, non-B, n=140, 131 | 73 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BPHR, 10,000 to <50,000, n=83, 81 | 74 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | United Kingdom, n=14, 11 | 64 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BPHR, 50,000 to <=100,000, n=25, 28 | 64 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Argentina, n=24, 20 | 80 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BPHR, >100,000, n=69, 66 | 64 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | South Africa, n=33, 33 | 76 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, <200, n=64, 49 | 69 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Canada, n=11, 9 | 89 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, >=200, n=184, 198 | 72 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | France, n=7, 8 | 75 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, <50, n=9, 15 | 60 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | USA, n=62, 69 | 67 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, 50 to <200, n=55, 34 | 74 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Italy, n=17, 11 | 64 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, 200 to <350, n=66, 74 | 73 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Spain, n=23, 31 | 77 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, 350 to <500, n=56, 65 | 74 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Mexico, n=6, 5 | 60 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | BCCC, >=500, n=62, 59 | 68 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | Race, Non-White, n=133,140 | 64 Percentage of participants |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups | CDC category, A, n=210, 208 | 71 Percentage of participants |