Table 1.
Baseline demographics and clinical characteristics of study participants, stratified by treatment group.
Fig 1.
Proportions of individuals with composite treatment outcome (cTO) success, on-treatment success, or favorable immunologic response after 12±3 months.
Error bars and numbers in the 3rd row in the table indicate 95% confidence intervals. * cTO failure was defined as ≥1 of VL ≥200 cp/mL, unknown VL, any ART regimen change, AIDS events, or death. ** Individuals with known VL at 12±3 months without ART regimen change in the periods (N = INSTI 4513; PI/b 1721; NNRTI 2263). *** Persons with known CD4 counts at 12±3 months (N = INSTI 5823; PI/b 2550; NNRTI 2882). ****Persons with known CD4 counts at 12±3 months, excluding those with ≥750 CD4 cells/μL at baseline (N = INSTI 4297; PI/b 2160; NNRTI 2253).
Fig 2.
Adjusted odds ratios (aOR) of composite treatment outcome (cTO) success and on-treatment success at 12±3 months.
Forest plots showing the aOR of cTO success (A) or on-treatment success (B). A controlled viral load was defined as <200 cp/mL. The multivariable models were adjusted for: Age (per ten years older), ethnicity, mode of transmission, baseline date (per year later), baseline smoking status, hypertension, diabetes, HBV and HCV status, prior AIDS event, cardiovascular disease, chronic kidney disease, end stage liver disease, non-AIDS-defining malignancies and prior fractures, viral load(<200 cp/mL, ≥200 cp/mL at baseline) and treatment status, CD4 count (nadir and baseline; both per 100 cells higher), treatment regimen and number of drugs in regimen. * cTO failure was defined as ≥1 of VL ≥200 cp/mL, unknown VL, any ART regimen change, AIDS events, or death. ** Individuals with known VL at 12±3 months without ART regimen change in the period.
Fig 3.
Reasons for cTO failure at 12±3 months.
Error bars and 3rd row in the table indicate 95% confidence intervals. Total numbers with cTO failure: INSTI: 2749/7147; PI/b: 1396/3102; NNRTI 1253/3454. *cTO failure: ≥1 of: VL ≥200 cp/mL, unknown VL, any antiretroviral treatment (ART)-regimen change, AIDS, or death (note it was possible to fail more than one parameter).
Fig 4.
Adjusted odds ratios (aOR) of a favorable immunologic response at 12±3 months.
Immunologic response was defined as a 25% increase in CD4 cell counts (A) or reaching a CD4 cell count ≥750 cells/μL (B). Models were adjusted for age (per ten years older), ethnicity, mode of transmission, baseline date (per year later), baseline smoking status, hypertension, diabetes, HBV and HCV status, prior AIDS event, cardiovascular disease, chronic kidney disease, end stage liver disease, non-AIDS-defining malignancies and prior fractures, viral load (<200 cp/mL, ≥200 cp/mL at baseline) and treatment status, CD4 count (nadir and baseline; both per 100 cells higher), treatment regimen and number of drugs in regimen. *Excluding individuals with a CD4 cell count ≥750 cells/μL at baseline.
Fig 5.
Sensitivity analysis: Adjusted odds ratios (aOR) of cTO and on-treatment analysis with VL cut-off <50 cp/mL at 12±3 months.
Multivariable models were adjusted for age (per ten years older), ethnicity, mode of transmission, baseline date (per year later), smoking status, hypertension, diabetes, prior AIDS event- cardiovascular disease, chronic kidney disease, end stage liver disease, non-AIDS-defining malignancies and fractures, HBV and HCV status, viral load (<200 cp/mL, ≥200 cp/mL at baseline), CD4 count (nadir and baseline; both per 100 cells higher), treatment regimen and number of drugs in regimen. * cTO failure was defined as ≥1 of VL ≥50 cp/mL, unknown VL, any ART regimen change, AIDS events, or death. ** Individuals with known VL at 12±3 months without ART regimen change in the period.
Fig 6.
Adjusted odds ratios of cTO success, on-treatment success and favorable immunologic outcomes at 12 ± 3 months for ART-naïve individuals initiating treatment after 16th January 2014.
Forest plots showing the aOR of cTO success, on-treatment success, and immunologic response as a 25% increase in CD4 cell counts or reaching a CD4 cell count ≥750 cells/μL. A controlled viral load was defined as <200 cp/mL. Multivariable models were adjusted for age (per ten years older), ethnicity, mode of transmission, baseline date (per year later), baseline smoking status, hypertension, diabetes, HBV and HCV status, prior AIDS event, cardiovascular disease, chronic kidney disease, end stage liver disease, non-AIDS-defining malignancies and prior fractures, viral load (<200 cp/mL, ≥200 cp/mL at baseline), CD4 count (nadir and baseline; both per 100 cells higher, treatment regimen and number of drugs in regimen. *cTO failure was defined as ≥1 either of VL ≥200 cp/mL, unknown VL, ART regimen change, AIDS events, or death. ** Individuals with known VL at 12±3 months without ART regimen change in the period. ***Excluding individuals with ≥750 CD4 cells/μL at baseline.