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Fig 1.

Participant flow diagram.

B/F/TAF, bictegravir/emtricitabine/tenofovir alafenamide; TE, treatment-experienced; TN, treatment-naïve.

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Table 1.

Baseline demographics and disease characteristics by ART status.

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Fig 2.

Virologic outcomes at 3, 6, and 12 months (M = E analysis).

(A) TN and (B) TE participants. At 12 months, of the 26 participants with no virologic data, 1 TN participant discontinued B/F/TAF before the 12-month time window (but remained in the study), 7 (6 TN and 1 TE) participants withdrew from the study before the 12-month time window (but remained on B/F/TAF), 1 TN participant discontinued B/F/TAF and withdrew from the study before the 12-month time window and 17 (10 TN and 7 TE) remained on B/F/TAF before the 12-month time window and had their last visit ≥275 days from B/F/TAF initiation. M = E, missing-as-excluded; TE, treatment-experienced; TN, treatment-naïve.

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Fig 3.

Change in CD4 count in (A) TN and (B) TE participants and change in CD4/CD8 ratio in (C) TN and (D) TE participants from baseline to 12 months.

a In participants with data available at baseline and at 12 months. b p-values calculated using the Signed Rank test. c p-values calculated using the Sign test. CD, cluster of differentiation; M, months; Q, quartile; TE, treatment-experienced; TN, treatment-naïve.

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Table 2.

Adverse events reported through 12 months overall and by ART status.

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Table 2 Expand

Fig 4.

Change in weight in (A) TN and (B) TE participants and change in BMI in (C) TN and (D) TE participants from baseline to 12 monthsa.

a In participants with data available at baseline and 12 months. b p-values calculated using the Sign test. BMI, body mass index; M, months; Q, quartile; TE, treatment-experienced; TN, treatment-naïve.

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Fig 5.

Changes in lipid levels from baseline to 12 months in (A) TN and (B) TE participantsa.

a In participants with data available at baseline and 12 months. b p-values calculated using the Student t-test. c p-values calculated using the Sign test. HDL, high-density lipoprotein; LDL, low-density lipoprotein; Q, quartile; TE, treatment-experienced; TN, treatment-naïve.

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Fig 6.

Change in eGFR levels from baseline to 12 months in (A) TN and (B) TE participants.

p-values calculated using the Sign test. eGFR, estimated glomerular filtration rate; Q, quartile; TE, treatment-experienced; TN, treatment-naïve.

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