Rilpivirine Has Non-Inferior Efficacy to Efavirenz for HIV-1
Slightly increased incidence of virological failures, but good safety profile for rilpivirine
FRIDAY, July 15 (HealthDay News) -- Rilpivirine offers a safe profile and non-inferior efficacy to efavirenz in treatment-naive patients infected with HIV-1, according to a study published in the July 16 HIV special issue of the The Lancet.
Calvin J. Cohen, M.D., from the Community Research Initiative of New England in Boston, and colleagues investigated the non-inferiority of rilpivirine to efavirenz when given with standard background therapy of two nucleoside or nucleotide reverse transcriptase inhibitors (N[t]RTIs) in 678 treatment-naive patients with HIV-1. Participants, aged 18 years or older, with plasma viral load of 5000 copies per mL or more, and viral sensitivity to N(t)RTIs, were randomly allocated to receive oral rilpivirine 25 mg or efavirenz 600 mg once daily (1:1), combined with selected N(t)RTIs. Non-inferiority of rilpivirine, compared with efavirenz was defined as a 12 percent margin on logistic regression analysis, in terms of the percentage of patients with confirmed response (viral load less than 50 copies per mL) at 48 weeks.
The investigators found that the patients receiving rilpivirine and efavirenz had a response rate of 86 and 82 percent, respectively, and virological failure of 7 percent and 5 percent. Discontinuation of treatment due to adverse effects was found in 4 percent of patients receiving rilpivirine, and in 7 percent receiving efavirenz. Rilpivirine was associated with significantly fewer cases of rash, dizziness, and grade 2 to 4 treatment-related adverse events than efavirenz (16 versus 31 percent). Increases in lipid levels were significantly lower with rilpivirine than with efavirenz.
"Despite a slightly increased incidence of virological failures, a favorable 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," the authors write.
Several of the study authors disclosed financial ties to the pharmaceutical industry, including Tibotec, which funded the study.