Fig 1.
CONSORT 2025 flow diagram of the progress through the phases of a randomised trial of two groups (that is, enrolment, intervention allocation, follow-up, and data analysis) [8].
Table 1.
Participant demographics and clinical characteristics (n = 29).
Table 2.
Geometric mean (95% CI)[%CV] pharmacokinetic parameters for TFV-DPTAF, FTC-TP (Arm 1) and TFV-DPTDF, 3TC-TP (Arm 2) in HS-C and WM-DBS over 14 days drug intake cessation in healthy volunteers.
Table 3.
Geometric mean (95% CI)[%CV] pharmacokinetic parameters for TFVTAF, FTC, DTG (Arm 1) and TFVTDF, 3TC, DTG (Arm 2) in HS-pL* and L-pL samples over 14 days drug intake cessation in healthy volunteers.
Fig 2.
Geometric mean (95% confidence interval) nucleoside di-/triphosphate concentrations in HS-C and WM-DBS samples for (A) TFV-DPTAF, (B) FTC-TP, (C) TFV-DPTDF and (D) 3TC-TP during the 14-day drug intake cessation period.
HS-C is indicated with a solid black line (circles) and WM with a grey line (triangles). Metabolite concentrations are presented in fmol/sample (HS-C = 12 mm punch; WM-DBS = 6 mm punch). Detectable concentrations below the assay limit of quantification (HS-C = 250 fmol/sample, WM-DBS = 62.5 fmol/sample) are expressed as half LLQ values. Fig 2A displays HS-C data only, as all WM-DBS had undetectable TFV-DPTAF.
Fig 3.
Geometric mean (95% confidence interval) drug concentrations in dried (HS-pL) and liquid plasma (L-pL) for (A) TFVTAF, (B) FTC, (C) TFVTDF (D) 3TC and (E) DTG during the 14-day drug intake cessation period.
HS-pL is indicated with a solid black line (circles) and L-pL with a grey line (squares). Drug concentrations are presented in ng/mL. Concentrations below the assay limit of quantification for HS-pL (TFV – 0.05 ng/50 µL, TAF – 0.025 ng/50 µL, FTC/3TC – 0.25 ng/50 µL) and L-pL (TFV – 1.01ng/mL, TAF – 0.5ng/mL, FTC/3TC – 5ng/mL) are expressed as half LLQ values.
Fig 4.
Bland Altman plots comparing WM-DBS and HS-C for TFV-DPTDF (A), FTC-TP (B) and 3TC-TP (C) as a measure of agreement between the two methods.
Concentration data were log-transformed, and the mean differences and limits of agreement are presented as back-transformed ratios.
Fig 5.
Bland Altman plots comparing L-pL and HS-pL for TFVTAF (A), FTC (B), TFVTDF (C), 3TC (D) and DTG (E) as a measure of agreement between the two methods.
Concentration data were log-transformed, and the mean differences and limits of agreement are presented as back-transformed ratios.