Rilpivirine (TMC278) could become a new treatment option for treatment-naïve patients infected with HIV-1, according to a study published in The Lancet.
The non-nucleoside reverse transcriptase inhibitor (NNRTI) showed a favourable safety profile and non-inferior efficacy to efavirenz in a phase 3, randomised, double-blind, double-dummy, non-inferiority trial led by Dr Calvin Cohen, Director of Research at the Community Research Initiative of New England.
The study took place at 98 hospitals in 21 countries over a 96-week period, involving adults recently diagnosed with HIV, who had not been given antiretroviral therapy before and had screening plasma viral loads of at least 5000 copies/mL.
Participants were divided equally into groups to receive oral rilpivirine (25mg) or efavirenz (600mg) once daily.
Of the 340 participants in the rilpivirine group, 291 (86%) responded, compared to 276 (82%) of those receiving efavirenz.
Increases in CD4 cell counts were similar between groups, with a slight increase in virological failure (7% compared to 5%) in the group receiving rilpivirine but more patient forced to discontinue treatment in the efavirenz group (7% versus 4%) due to adverse events.
Rashes and dizziness were less common in the rilpivirine group, while increases in lipid levels were also significantly lower.
Cohen et al concluded:
“Despite a slightly increased incidence of virological failures, a favourable safety profile and non-inferior efficacy compared with efavirenz means that rilpivirine could be a new treatment option for treatment-naive patients infected with HIV-1.”