Cabotegravir is a long-acting integrase inhibitor being tested both for HIV treatment and as pre-exposure prophylaxis (PrEP). At IDWeek, two new pharmacokinetics studies shed light on the safety of this drug in special populations.
One study, presented as a poster on Oct. 6 by Jafar Sadik Shaik, Ph.D., of GlaxoSmithKline, evaluated oral cabotegravir in people with moderate hepatic impairment and found that the blood plasma exposure of cabotegravir in these participants was similar to that in matched healthy people. The study, which evaluated 16 people with Child Pugh scores in the range of 7-9, concluded that the dose of cabotegravir would not need to be adjusted for people with mild to moderate hepatic impairment.
Another study, also presented as a poster on Oct. 6 by Ridhi Parasrampuria, Ph.D., of GlaxoSmithKline, evaluated the effect of cabotegravir in people with renal impairment, and concluded that the plasma exposure levels in people with sever renal impairment were similar those in healthy subjects, and so, once again, people with renal impairment would not need dose adjustments. Specifically, among the 16 subjects that completed the study, the pharmacokinetic parameters were similar for people with severe renal impairment and healthy subjects, although one person with renal impairment experienced a drug-related, grade-3 lipase elevation.
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