Pharmacokinetic and Virologic Outcomes of Bictegravir-Containing ART

Pharmacokinetic parameters were estimated by performing a non-compartmental analysis (NCA) using Phoenix WinNonlin Build 8 (Certara), using all PK data available starting with the time point after the last infusion of 10–1074 from either TZM-bl assay (using the X2088_c9 pseudovirus to determine 10–1074 levels) or ELISA, and compared by a two-tailed unpaired t-test. CD4⁺ T cell counts on day 0 and at the time of viral rebound were compared by two-tailed paired t-test. IUPM determined at week −2 and week 12 compared using a two-tailed paired t-test. Time to rebound in current trial participants (combination therapy with 3BNC117 + 10–1074), participants receiving 3BNC117 monotherapy^{9 (link)} and participants in previous non-interventional ATI studies conducted by ACTG^{10 (link)} were plotted using Kaplan-Meier survival curves. Potential correlation between IUPM and time to rebound was analyzed by two-tailed Pearson correlation test.

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Mendoza P., Gruell H., Nogueira L., Pai J.A., Butler A.L., Millard K., Lehmann C., Suárez I., Oliveira T.Y., Lorenzi J.C., Cohen Y.Z., Wyen C., Kümmerle T., Karagounis T., Lu C.L., Handl L., Unson-O’Brien C., Patel R., Ruping C., Schlotz M., Witmer-Pack M., Shimeliovich I., Kremer G., Thomas E., Seaton K.E., Horowitz J., West AP J.r., Bjorkman P.J., Tomaras G.D., Gulick R.M., Pfeifer N., Fätkenheuer G., Seaman M.S., Klein F., Caskey M, & Nussenzweig M.C. (2018). Combination therapy with anti-HIV-1 antibodies maintains viral suppression. Nature, 561(7724), 479-484.

Publication 2018

Phoenix WinNonlin Build 8

Assay Cd4 t cell Combination therapy Elisa

Corresponding Organization : Howard Hughes Medical Institute

Other organizations : University Hospital Cologne, University of Tübingen, Duke University, California Institute of Technology, Cornell University, German Center for Infection Research, Beth Israel Deaconess Medical Center

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Variable analysis

independent variables

Treatment: Combination therapy with 3BNC117 + 10–1074
Treatment: 3BNC117 monotherapy
Treatment: Previous non-interventional ATI studies conducted by ACTG

dependent variables

Pharmacokinetic parameters of 10–1074
CD4+ T cell counts on day 0 and at the time of viral rebound
IUPM determined at week -2 and week 12
Time to rebound

control variables

Pharmacokinetic parameters of 10–1074 determined by either TZM-bl assay (using the X2088_c9 pseudovirus) or ELISA
Comparison of CD4+ T cell counts and IUPM using two-tailed paired t-test

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