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Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48
Abstract
BACKGROUND: The present primary analysis of AntiRetroviral Therapy with TMC114 ExaMined In naive Subjects (ARTEMIS) compares the efficacy and safety of once-daily darunavir/ritonavir (DRV/r) with that of lopinavir/ritonavir (LPV/r) in treatment-naive patients. METHODS: Patients with HIV-1 RNA at least 5000 copies/ml were stratified by HIV-1 RNA and CD4 cell count in a phase III, open-label trial, and randomized to receive DRV/r 800/100 mg qd or LPV/r 800/200 mg total daily dose (bid or qd) plus fixed-dose tenofovir and emtricitabine for 192 weeks. The primary objective was to demonstrate non-inferiority of DRV/r as compared with LPV/r in HIV-1 RNA less than 50 copies/ml per-protocol time-to-loss of virologic response at 48 weeks. RESULTS: Six hundred and eighty-nine patients were randomized and treated; mean baseline HIV-1 RNA: 4.85 log10 copies/ml and median CD4 count: 225 cells/microl. At 48 weeks, 84% of DRV/r and 78% of LPV/r patients achieved HIV-1 RNA less than 50 copies/ml (estimated difference = 5.6 [95% confidence interval -0.1-11]%), demonstrating non-inferiority of DRV/r as compared with LPV/r (P < 0.001; per-protocol time-to-loss of virologic response). Patients with HIV-1 RNA at least 100 000 copies/ml had a significantly higher response rate with DRV/r (79%) versus LPV/r (67%; P < 0.05). Median CD4 cell count increases (non-completer = failure; cells/mul) were 137 for DRV/r and 141 for LPV/r. DRV/r had a lower incidence of possibly treatment-related grade 2-4 gastrointestinal-related adverse events (7 versus 14%) and treatment-related moderate-to-severe diarrhea (4 versus 10%) than LPV/r. Adverse events leading to discontinuation were DRV/r: 3% and LPV/r: 7%. CONCLUSION: DRV/r 800/100 mg qd was non-inferior to LPV/r 800/200 mg at 48 weeks, with a more favorable safety profile. Significantly higher response rates were observed with DRV/r in patients with HIV-1 RNA at least 100 000 copies/ml. DRV/r 800/100 mg offers a new effective and well tolerated once-daily, first-line treatment option for treatment-naive patients.
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Cited by
Molina, J.-M., Andrade-Villanueva, J., Echevarria, J., Chetchotisakd, P., Corral, J., David, N., Moyle, G., Mancini, M., Percival, L., Yang, R., et al. (2008) · The Lancet · doi:10.1016/s0140-6736(08)61081-8 · Cited by 486
Self-citationAbacavir–Lamivudine versus Tenofovir–Emtricitabine for Initial HIV-1 Therapy
Sax, P. E., Tierney, C., Collier, A. C., Fischl, M. A., Mollan, K., Peeples, L., Godfrey, C., Jahed, N. C., Myers, L., Katzenstein, D., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0906768 · Cited by 313
Hernandez, A. V., Pasupuleti, V., Deshpande, A., Thota, P., Collins, J. A., & Vidal, J. E. (2013) · PLoS ONE · doi:10.1371/journal.pone.0063272 · Cited by 29
Metadata
- Authors
- Ortiz, R., DeJesus, E., Khanlou, H., Voronin, E., van Lunzen, J., Andrade-Villanueva, J., Fourie, J., De Meyer, S., De Pauw, M., Lefebvre, E., Vangeneugden, T., & Spinosa-Guzman, S.
- Venue
- AIDS
- Published
- 2008-07-31
- Volume
- 22
- Issue
- 12
- Pages
- 1389-1397
- ISSN
- 0269-9370 (ISSN-L)
- OpenAlex
- W2085088518
- Cited by
- 387
- References
- 0
- FWCI
- 34.10
- Type
- journal article
- Language
- en
- Open access
- closed
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- Ortiz, R., DeJesus, E., Khanlou, H., Voronin, E., van Lunzen, J., Andrade-Villanueva, J., Fourie, J., De Meyer, S., De Pauw, M., Lefebvre, E., Vangeneugden, T., & Spinosa-Guzman, S. (2008). Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48. AIDS. https://doi.org/10.1097/qad.0b013e32830285fb
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