NEW ORLEANS, LA—The investigational anti-HIV integrase inhibitor cabotegravir (CAB) is well-tolerated, according to findings from a meta-analysis of data from clinical trials reported at IDWeek 2016. CAB is being developed to treat and prevent HIV-1 infection.
“CAB given orally, intramuscularly [IM] or subcutaneously was well tolerated, and supports continued development of both oral and parenteral CAB formulations,” reported Yu Lou, MS, of Parexel International in Durham, NC, and coauthors of a poster presentation. “There were no clinically relevant changes in the existing oral or LA safety profile with the addition of 6 new Phase 1 studies of oral or IM CAB.”
The findings “support continued development of both oral and parenteral CAB formulations,” Lou said.
CAB is dosed orally (5–150mg, once-daily, for up to 28 days) or parenteral injection (LA; 100–800mg intramuscular or 100–400mg subcutaneous injection). The authors pooled data from 14 Phase 1 and 2a trials to summarize injection-site reactions (ISRs) and non-ISR adverse events. In all, 423 adult participants had received CAB.
The team reported no drug-related Grade 3+ adverse events. Drug-related Grade 1–2 adverse events in the oral CAB group included headache and nausea.
“There were no clinically-significant changes in vitals, ECGs, or key lab parameters,” Lou said.