The study found that long-acting, once-monthly rilpivirine and cabotegravir had comparable efficacy to GlaxoSmithKline‘s (NYSE:GSK) oral Triumeq product. Janssen and ViiV Healthcare also reported that virologic response and drug resistance results for the injectable regimen were consistent with data from previous Phase II trials.
The Phase III Flair study was intended to demonstrate whether or not adults with HIV-1, whose virus is suppressed after 20 weeks on Triumeq, remained suppressed at a similar rate after switching to the injectable, two-drug regimen of rilpivirine and cabotegravir.
“These results offer further evidence to suggest that this investigational, two-drug, once a month dosing regimen may reduce the impact of treatment on people’s lives,” Dr. Wim Parys, head of R&D for Janssen’s global public health unit, said in prepared remarks. “This novel approach would signify a much-needed treatment evolution for people living with HIV, moving from dosing 365 to just 12 times per year.”
At a meeting in Scotland, researchers also reported three-year results from a Phase IIb study of the injectable, two-drug regimen, demonstrating high rates of virologic response, good overall tolerability and long-term durability of virologic response.
At 160 weeks, 90% of people receiving the injectable regimen every eight weeks and 83% of people receiving it every four weeks remained virally suppressed, according to Janssen.