Once-Daily Raltegravir Safe, Effective for Initial HIV Treatment
Few serious treatment-related adverse events were reported for both once-daily and twice-daily raltegravir formulations.
A once-daily, 1200-mg dose of raltegravir was equally effective as the standard twice-daily, 400-mg dose for treatment of HIV-1, as reported in a recent study published in The Lancet HIV.
In a phase 3, noninferiority study (ONCEMRK; ClinicalTrials.gov identifier: NCT02131233), 802 participants ≥18 years of age with HIV-1 RNA of ≥1000 copies/mL and no prior antiretroviral treatment were randomly assigned into groups treated either once daily with a 1200-mg oral dose (n=533) or twice daily with 400-mg oral doses (n=269) of raltegravir in combination with tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg. A total of 797 (531 once daily and 266 twice daily) participants ultimately received treatment.
The primary end point was reached at 48 weeks with 89% of once-daily participants and 88% of twice-daily participants achieving HIV-1 RNA <40 copies/mL (treatment difference 0.5%; 95% CI: -4.2 to 5.2). Antiretroviral efficacy was also similar in both groups irrespective of demographic or prognostic factors.
The proportion of patients with drug-related and serious drug-related adverse clinical effects was similar in both groups with only 2 patients, both from the twice-daily group, discontinued from the trial. Common drug-related adverse effects in both groups were headache, nausea, and dizziness.
“This study provides strong evidence that a new formulation of raltegravir administered as 1200 mg once daily in a combination regimen provides equivalent efficacy and similar safety to the raltegravir 400 mg tablet administered twice daily,” concluded the researchers.
The authors also note that a once-daily formation is “a more convenient treatment option” and is preferred “to facilitate adherence and improve quality of life.”
Disclosures: The study sponsor (Merck & Co, Inc.) provided study drugs and participated in study design, study management, data collection, data analysis, data interpretation, and writing of the report.
Cahn P, Kaplan R, Sax PE, et al; for the ONCEMRK Study Group. Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial [published online September 11, 2017]. Lancet HIV. doi: 10.1016/S2352-3018(17)30128-5