| Autor: |
Yazdanpanah, Y., Fagard, C., Descamps, D., Taburet, A. M., Colin, C., Roquebert, B., Katlama, C., Pialoux, G., Jacomet, C., Piketty, C., Bollens, D., Molina, J. M., Chêne, G. |
| Předmět: |
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| Zdroj: |
Clinical Infectious Diseases; 11/1/2009, Vol. 49 Issue 9, p1441-1449, 9p, 3 Charts, 3 Graphs |
| Abstrakt: |
Background. The introduction of 2 or 3 fully active drugs in human immunodeficiency virus (HIV)-infected patients receiving failing antiretroviral therapy is a key determinant of subsequent treatment efficacy. The aim of this study was to assess the safety and efficacy of a regimen containing raltegravir, etravirine, and darunavir/ ritonavir for treatment-experienced patients infected with multidrug-resistant HIV. Methods. Patients enrolled in this phase II, noncomparative, multicenter trial were naive to the investigational drugs and had plasma HIV RNA levels 11000 copies/mL, a history of virologic failure while receiving nonnucleoside reverse-transcriptase inhibitors (NNRTI), ⩾3 primary protease inhibitor and nucleoside reverse transcriptase inhibitor (NRTI) mutations, and ⩽3 darunavir and NNRTI mutations. The primary end point was the proportion of patients with plasma HIV RNA levels <50 copies/mL at 24 weeks. Results. A total of 103 patients enrolled in the study. At baseline, genotypic resistance profiles showed a median of 4 primary protease inhibitor mutations, 1 NNRTI mutation, and 6 NRTI mutations. In addition to the investigational drugs, 90 patients (87%) received optimized background therapy that included NRTIs (86 patients) or enfuvirtide (12 patients). At week 24, 90% of patients (95% confidence interval, 85%-96%) had an HIV RNA level <50 copies/mL. At week 48, 86% (95% confidence interval, 80%-93%) had an HIV RNA level <50 copies/ mL. The median CD4 cell count increase was 108 cells/mm3. Grade 3 or 4 clinical adverse events were reported in 15 patients (14.6%). Only 1 patient discontinued the investigational antiretroviral regimen, because of an adverse event. Conclusion. In patients infected with multidrug-resistant virus who have few remaining treatment options, the combination of raltegravir, etravirine, and darunavir/ritonavir is well tolerated and is associated with a rate of virologic suppression similar to that expected in treatment-naive patients. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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