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This study examined the plasma concentration, clinical efficacy, and safety of dolutegravir (DTG) in Chinese people with HIV (PWH). In this observational study, HIV-positive individuals on DTG-based regimens for at least 6 months were included. Plasma DTG concentrations were measured 1 month after initiating treatment. Viral loads (VL) and CD4+ T cell counts were evaluated at baseline and after 1 and 6 months of therapy. High-performance liquid chromatography was used for measuring DTG concentrations, polymerase chain reaction for VL, and flow cytometry for CD4+ T cell counts. Safety assessments included monitoring liver enzymes, serum creatinine estimated glomerular filtration rate, and adverse reactions. Eighty-two Chinese PWH were enrolled. Average VL decreased significantly from baseline by 3.1 log at 1 month and 3.5 log at 6 months. CD4+ T cell counts increased from 273 cells/mm3 at baseline to 378 cells/mm3 and 446 cells/mm3 after 1 and 6 months, respectively. Seventy-five percent achieved undetectable VLs (<20 copies/mL) by 6 months. Cmax and Cτ were 4.63 and 1.98 μg/mL, respectively. The safety profile was favorable with only 4.88% experiencing transient dizziness. Preliminary findings suggest higher DTG plasma concentrations in Chinese PWH compared to Western populations, with promising short-term efficacy and safety. [ABSTRACT FROM AUTHOR]

AbstractMultiple-use calibration using regression is an important statistical tool. Confidence sets for the x-values associated with all future y-values should guarantee a key property, which can be satisfied by simultaneous tolerance intervals (STI’s), and so multiple-use calibration requires the construction of STI’s. In this article, exact two-sided STI’s have been constructed for polynomial regression over any given covariate interval. There is a misconception that two-sided pointwise tolerance intervals (PTI’s) can be employed for multiple-use calibration. This article shows that the confidence sets based on the two-sided PTI’s do not satisfy the key property and so should not be used. Real-world data examples are given in this article for illustration. Supplementary materials for this article are available online. [ABSTRACT FROM AUTHOR]