ViiV Healthcare has reported positive results from its 41-week Phase IIa Eclair trial of an investigational, long-acting, injectable cabotegravir for pre-exposure prophylaxis (PrEP) in healthy adult males.
The trial evaluated the safety, tolerability, dosing and satisfaction of injectable cabotegravir in HIV-uninfected males who were at a low risk of contracting HIV.
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Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and analogue of dolutegravir.
The results support the advancement of cabotegravir as a potential drug for HIV prevention.
The company noted that in the trial, adverse events (AEs) during the injection phase occurred in 98% and 90% of cabotegravir and placebo group participants, respectively.
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A total of 127 patients were randomised to cabotegravir or placebo in a 5:1 ratio. The trial began with a four-week safety assessment, which administered patients with an oral cabotegravir 30mg or matching placebo tablet.
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By GlobalDataThis was followed by intramuscular injections of 800mg cabotegravir or placebo once every 12 weeks for three cycles.
ViiV Healthcare chief scientific and medical officer John C Pottage Jr said: "There are more than 36 million people worldwide living with HIV today and, despite considerable progress made in the fight against HIV, infections are still increasing in parts of the world.
"Preventative measures like PrEP could play an important role in reducing the number of new infections and help contribute to the goal of ending the global AIDS epidemic.
"We are encouraged by these first results from the Eclair study and look forward to understanding the potential efficacy and broader safety profile of cabotegravir in the PrEP setting as we move into phase III development later this year."
The Eclair trial also collected cabotegravir exposure data throughout each 12-week dosing interval. The results showed that concentrations were lower than expected at the end of dosing in about two-thirds of participants.
