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Efficacy in clinical trials:
- 256 patients with a viral load of < 50 HIV-1 RNA currently on HAART for at least 6 months were switched to either DRV/r monotherapy or DRV/r plus two NRTI’s. At 144 weeks DRV/r monotherapy showed noninferior efficacy to DRV/r plus two NRTI’s in a strict ITT analysis (2012).
- In the MONOI-ANRS 136 trial of maintenance monotherapy in patients with suppressed HIV RNA viremia 225 patients were randomized to receive DRV/r monotherapy or DRV/r triple drug regimen. Three patients experienced virological failure on DRV/r monotherapy and none on the triple drug regimen. No resistance emerged to protease inhibitors and the two groups did not differ in the number of serious adverse events (2010).
- Arribas, J. R., et al. "The MONET trial: week 144 analysis of the efficacy of darunavir/ritonavir (DRV/r) monotherapy versus DRV/r plus two nucleoside reverse transcriptase inhibitors, for patients with viral load < 50 HIV‐1 RNA copies/mL at baseline." HIV medicine 13.7 (2012): 398-405.
- Katlama, Christine, et al. "Efficacy of darunavir/ritonavir maintenance monotherapy in patients with HIV-1 viral suppression: a randomized open-label, noninferiority trial, MONOI-ANRS 136." Aids 24.15 (2010): 2365-2374.