Cabotegravir Combined With Broadly Neutralizing Antibodies Maintains Undetectable HIV
In a long-acting dose regimen, an investigational antibodies treatment is a potent antiviral that can function as a component of a complete antiretroviral regimen.
ViiV Healthcare presented results today at this week's CROI conference from its EMBRACE study demonstrating further evidence the combination of its broadly neutralizing antibodies (bNAb) N6LS, (VH3810109 or VH109), administered every 4 months, effectively maintained undetectable viral load when combined with long-acting cabotegravir.
Results from the phase 2b study, EMBRACE, demonstrate that 96% of participants receiving VH109 60 mg/kg intravenously (IV) and 88% receiving N6LS 3000 mg subcutaneously (SC) with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL, compared to 96% in the standard-of-care group. N6LS was administered in both arms every 4 months, combined with monthly CAB-LA. Confirmed virologic failure was observed in 2 participants from each VH109 group. The results were evaluated at 6 months.
“The participants were able to maintain or to keep the HIV level suppressed throughout the period of observation, which was up to 6 months, and we saw this in both the arm that was given intravenously and the 1 that was given also subcutaneously under the skin,” said study investigator Babafemi Taiwo, MBBS, head of Early Development, ViiV Healthcare.
Overall, 4% of the IV group and 6% of the SC group had HIV-1 RNA levels of 50 copies/mL or higher, compared to none in the standard-of-care group when measured at month 6.
VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration. Adverse events specific to the use of study medication were reported in 64% of the IV group and 65% of the SC group, with 16% of participants in the SC group experiencing grade 3-4 adverse events (erythema). No participants in the IV group experienced a grade 3-4 adverse event.
Taiwo says they are at the very beginning of understanding how broadly neutralizing antibodies for HIV treatment work and the possibility of utilizing them for viral supression.
“One of the things that the field is trying to understand is whether these antibodies, in addition to essentially binding to HIV, killing it, and preventing from infecting new cells, that maybe it can actually kill cells that are infected with HIV, which will be very unique in that it might have the ability to do what traditional HIV treatment cannot do in terms of reducing the HIV that's in the reservoir or that is hiding in different parts of the body," Taiwo said. "Now, how well these antibodies can or will do that is a subject of intense interest, because one of the things we're trying to get closer and closer to is to reduce the amount of HIV that people have. Even when they're on good treatment, HIV is hiding in reservoirs. So can these broadly neutralizing antibodies help to kill cells that are infected with HIV and reduce the level of the reservoir in the body?"
