Some of the data in this paper were presented as a poster at the 10th International Congress on Drug Therapy in HIV Infection, Glasgow, UK, 7-11 November 2010: C. Orkin, E. DeJesus, H. Khanlou, A. Stoehr, K. Supparatpinyo, T. Van de Casteele, E. Lathouwers, S. Spinosa-Guzman. ARTEMIS: 192-week efficacy and safety of once-daily darunavir/ritonavir (DRV/r) versus lopinavir/r (LPV/r) in treatment-naïve HIV-1-infected adults. Journal of the International AIDS Society 2010 13(Suppl 4):P3.
Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naïve patients in the ARTEMIS trial†
Article first published online: 23 OCT 2012
© 2012 British HIV Association
Volume 14, Issue 1, pages 49–59, January 2013
How to Cite
Orkin, C., DeJesus, E., Khanlou, H., Stoehr, A., Supparatpinyo, K., Lathouwers, E., Lefebvre, E., Opsomer, M., Van de Casteele, T. and Tomaka, F. (2013), Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naïve patients in the ARTEMIS trial. HIV Medicine, 14: 49–59. doi: 10.1111/j.1468-1293.2012.01060.x
- Issue published online: 3 DEC 2012
- Article first published online: 23 OCT 2012
- Manuscript Accepted: 20 SEP 2012
This paper presents the final analysis of once-daily darunavir/ritonavir (DRV/r) vs. lopinavir/ritonavir (LPV/r) in treatment-naïve HIV-1-infected adults.
ARTEMIS (AntiRetroviral Therapy with TMC114 ExaMined In naïve Subjects; NCT00258557) was a randomized, open-label, phase-III, 192-week trial. Patients were stratified by baseline HIV-1 RNA and CD4 count, and randomized to once-daily DRV/r 800/100 mg or LPV/r 800/200 mg total daily dose (either once or twice daily) plus tenofovir/emtricitabine.
Of 689 randomized patients receiving treatment (DRV/r: 343; LPV/r: 346), 85 and 114 patients in the DRV/r and LPV/r arms, respectively, had discontinued by week 192. Noninferiority was shown in the primary endpoint of virological response (HIV-1 RNA < 50 copies/mL) [DRV/r: 68.8%; LPV/r: 57.2%; P < 0.001; intent to treat (ITT)/time to loss of virological response; estimated difference in response 11.6% (95% confidence interval 4.4–18.8%)]. Statistical superiority in virological response of DRV/r over LPV/r was demonstrated for the primary endpoint (P = 0.002) and for the ITT non-virological-failure-censored analysis (87.4% vs. 80.8%, respectively; P = 0.040). No protease inhibitor (PI) primary mutations developed and only low levels of nucleoside reverse transcriptase inhibitor (NRTI) resistance developed in virological failures in both groups. Significantly fewer discontinuations because of adverse events were observed with DRV/r (4.7%) than with LPV/r (12.7%; P = 0.005). Grade 2–4 treatment-related diarrhoea was significantly less frequent with DRV/r than with LPV/r (5.0% vs. 11.3%, respectively; P = 0.003). DRV/r was associated with smaller median increases in total cholesterol and triglyceride levels than LPV/r. Changes in low- and high-density lipoprotein cholesterol were similar between groups. Similar increases in aspartate aminotransferase and alanine aminotransferase for DRV/r and LPV/r were observed.
Over 192 weeks, once-daily DRV/r was noninferior and statistically superior in virological response to LPV/r, with a more favourable gastrointestinal profile, demonstrating its suitability for long-term use in treatment-naïve patients.