Pharmacokinetic parameters and weight change in HIV patients newly switched to dolutegravir-based regimens in SIMPL’HIV clinical trial. British Journal of Clinical Pharmacology
Courlet et al. aimed to evaluate the association between dolutegravir (DTG) pharmacokinetic parameters and weight changes in treatment-experienced people with HIV (PWHIV) from the Simpl’HIV study newly switched to a dual DTG-based regimen.
They used multivariable linear regressions to evaluate the association between DTG pharmacokinetic parameters at week 48 and weight change between week 0 and week 48 and adjusted their model for potential confounders including CD4 nadir, female sex, African origin, age, weight at week 0 and presence of a non-nucleoside reverse transcriptase inhibitor-based regimen before switch to DTG.
The analysis included data from 39 PWHIV. An average significant weight gain of 2.4 kg was observed between baseline and week 48. DTG plasma exposure was not significantly associated with weight gain, even after adjusting for potential confounders (P = .9).
In conclusion, the study did not find evidence for an association between DTG pharmacokinetic parameters and weight gain within a particular population of people living with HIV newly switched to DTG in the context of a randomized clinical trial. This might arise from the moderate between-subject variability in DTG concentration–time profile, compromising the power to detect an effect of pharmacokinetic parameters on weight gain.