Darunavir Outcomes Study: Comparative Effectiveness of Virologic Suppression, Regimen Durability, and Discontinuation Reasons for Three-Class Experienced Patients at 48 Weeks

Abstract

Several new antiretroviral (ARV) agents for treatment experienced HIV-infected patients have been approved since June 2006, including darunavir (DRV) and raltegravir (RAL). While efficacious in clinical trials, the effectiveness, durability, and tolerability of these new ARVs remains understudied in the context of routine clinical care. The Darunavir Outcomes Study is a prospective cohort study of three-class ARV-experienced patients changing regimens at the 1917 Clinic after 1/7/2006. All treatment decisions were at the discretion of primary providers. Multivariate (MV) logistic regression for 48 week VL <400c/ml and Cox models for regimen durability were completed. Propensity score methods controlled for sociodemographics. Among 108 patients, mean age of 46, 48% were white, 80% male, with prior exposure to a mean 10.5 ARVs. Overall, 64% of patients achieved 48-week VL <400 c/ml. In MV modeling DRV/r (OR ¼5.77;95%CI ¼ 1.62-20.58) and RAL (OR ¼ 3.84;95%CI ¼ 1.23-11.95) use increased odds of 48-week suppression. Use of these agents exhibited a trend towards prolonged regimen durability in Cox models. Among those highly ARV-experienced, regimens containing DRV/r and/or RAL were more likely to achieve 48-week VL <400 c/ml and exhibited a trend towards prolonged durability. New agents have transformed the treatment landscape for ARV-experienced patients, with effectiveness in routine clinical care mirroring efficacy in clinical trials.

Rural Residence and Adoption of a Novel HIV Therapy in a National, Equal-Access Healthcare System

“…On October 12, 2007 the Food and Drug Administration (FDA) approved raltegravir—the first HIV integrase inhibitor—for use in treatment-experienced persons with HIV. Raltegravir has improved outcomes for persons with HIV infection resistant to previously available therapies [5, 19]. …”

Long-Term Efficacy and Safety of Atazanavir/Ritonavir Treatment in a Real-Life Cohort of Treatment-Experienced Patients with HIV Type 1 Infection

“…[11][12][13][14] However, information about these long-term real-life outcomes is sparse in patients receiving ATV/r [11][12][13] and in patients receiving boosted PI-based therapy in general, 15 especially in the case of treatment-experienced patients. 16,17 Therefore, the aim of the current study was to evaluate the long-term outcomes of ATV/r-based regimens in a large sample of ARV-experienced patients in a real-life European clinical setting. To our knowledge this represents the largest cohort to date evaluating long-term outcomes of a boosted PI-based regimen in ARV-experienced patients.…”

Virologic Effectiveness of Abacavir/Lamivudine with Darunavir/Ritonavir Versus Other Protease Inhibitors in Treatment-Experienced HIV-Infected Patients in Clinical Practice

“…However, the backbone components of these PI-based regimens were not taken into account for this analysis. Reviewing these studies individually, none separately evaluated the different NRTI backbones, and several excluded use of abacavir altogether [8–10, 15–22]. …”

“…Darunavir also offers superior potency and better short- and long-term tolerability, making its use more clinically practical than many first-generation PIs. Clinical trial data have indicated that treatment-experienced patients receiving DRV/r are more likely to reach and maintain treatment response when compared with antiretroviral-experienced patients receiving other ritonavir-boosted PIs [8–10]. …”