| Title | High Rate of Virologic Suppression with Raltegravir Plus Etravirine and Darunavir/Ritonavir among Treatment-Experienced Patients Infected with Multidrug-Resistant HIV: Results of the ANRS 139 TRIO Trial. | | Author(s) | Yazdanpanah Y, Fagard C, Descamps D, Taburet AM, Colin C, Roquebert B, Katlama C, Pialoux G, Jacomet C, Piketty C, Bollens D, Molina JM, Chêne G | | Institution | Hôpital Tourcoing, Lille School of Medicine, Lille, 2INSERM U897, Bordeaux, 3Hôpital Bichat-Claude Bernard, 4Hôpital Bicetre, Le Kremlin Bicetre, 5Hôpital Pitie-Salpetriere, 6Hôpital Tenon, 7Hôpital Georges Pompidou, 8Hôpital Saint Antoine, and 9Hôpital Saint Louis and Université de Paris Diderot Paris 7, Paris, and 10Hôpital Clermont-Ferrand, Clermont-Ferrand, France. | | Source | Clin Infect Dis 2009 Oct 8. | | Abstract | 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 >1000 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/mm(3). 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. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19814627 |
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