Raltegravir 1200 mg Once Daily vs 400 mg Twice Daily, With Emtricitabine and Tenofovir Disoproxil Fumarate, for Previously Untreated HIV-1 Infection: Week 96 Results From ONCEMRK, a Randomized, Double-Blind, Noninferiority Trial

Journal of Acquired Immune Deficiency Syndromes : JAIDS
Pedro CahnONCEMRK Study Group

Abstract

Raltegravir 1200mg (2×600mg tablets) once daily (QD) demonstrated noninferior efficacy and similar safety to raltegravir 400mg twice daily (BID) at week 48 of the ONCEMRK trial. Here, we report the week 96 results from this study. ONCEMRK is a phase 3, multicenter, double-blind, noninferiority trial comparing raltegravir 1200mg QD with raltegravir 400mg BID in treatment-naive HIV-1-infected adults. Participants were assigned (2:1) to raltegravir 2×600mg QD or 400mg BID, both with emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) for 96 weeks. Randomization was stratified by screening HIV-1 RNA and hepatitis B/C status. Efficacy was assessed as the proportion of participants with HIV-1 RNA <40 copies per milliliter (Food and Drug Administration Snapshot approach); the noninferiority margin was 10 percentage points. Of the 797 participants who received study therapy (84.6% were men, 59.3% were white, and mean age was 35.9 years), 694 completed 96 weeks of treatment (87.6% QD; 84.4% BID), with few discontinuations because of lack of efficacy (1.1% for both groups) or adverse events (1.3% QD; 2.3% BID). At week 96, 81.5% (433/531) of QD recipients and 80.1% (213/266) of BID recipients achieved HIV-1 RNA <40 copies per milli...Continue Reading

References

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Citations

Dec 5, 2018·Expert Review of Clinical Pharmacology·Giovanni Di PerriStefano Bonora
Dec 7, 2018·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Huldrych F GünthardDouglas D Richman
Jan 31, 2019·The Journal of Antimicrobial Chemotherapy·Antonella d'Arminio MonforteUNKNOWN ICONA Foundation Study Group
Aug 30, 2020·Drugs·Kimberly K ScarsiCourtney V Fletcher
Mar 21, 2018·Expert Opinion on Pharmacotherapy·Margaret R CaplanKatya C Corado
Dec 29, 2020·CPT: Pharmacometrics & Systems Pharmacology·Vera E BukkemsElin M Svensson
Dec 22, 2020·Therapeutic Advances in Drug Safety·Michael WohlfeilerGregory Fusco
Aug 19, 2021·Infection & chemotherapy·UNKNOWN Korean Society for AIDS

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Methods Mentioned

BETA
Assay

Clinical Trials Mentioned

NCT02131233

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