Pharmacokinetics of dolutegravir in HIV-seronegative subjects with severe renal impairment View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2014-01

AUTHORS

Stephen Weller, Julie Borland, Shuguang Chen, Mark Johnson, Paul Savina, Brian Wynne, Toshihiro Wajima, Amanda F. Peppercorn, Stephen C. Piscitelli

ABSTRACT

PURPOSE: Dolutegravir (DTG), an unboosted HIV integrase inhibitor (INI), is metabolized by UGT1A1 and to a minor extent by CYP3A. Renal elimination of unchanged DTG is very low (< 1 %). As renal impairment may affect pharmacokinetics (PK), even for drugs primarily metabolized or secreted in bile, this study investigated the effect of renal impairment on the PK of DTG. METHODS: This was an open-label, single-dose study of oral DTG 50 mg administered to subjects with severe renal impairment (creatinine clearance [CLcr] <30 mL/min; not on dialysis) and to healthy controls (CLcr >90 mL/min) matched for gender, age and body mass index (8 subjects per group). Serial PK samples were collected up to 72 h post-dose for determination of DTG and DTG-glucuronide (DTG-Gluc) concentrations in plasma. DTG unbound fraction in plasma was determined at 3 and 24 h. PK parameters were determined by non-compartmental methods and compared between groups by analysis of covariance. RESULTS: DTG was well tolerated with a low incidence of Grade 1 adverse events. DTG PK parameters showed significant overlap between groups. DTG mean exposure was lower in subjects with severe renal impairment compared to healthy, matched subjects: AUC(0-∞) and Cmax were 40 % and 23 % lower, while mean DTG-Gluc was increased. Renal impairment did not affect DTG fraction unbound in plasma. CONCLUSIONS: The modest reductions in mean PK exposures for DTG and increases for DTG-Gluc in the severe renal impairment group are not considered clinically significant. DTG does not require dose adjustment in patients with renal impairment. More... »

PAGES

29-35

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00228-013-1590-9

DOI

http://dx.doi.org/10.1007/s00228-013-1590-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1033324527

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/24096683


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