Background: Therapeutic vancomycin trough levels correlate with therapeutic success and the development of renal failure. In this study, we aimed to describe the safety and outcome of pharmacy-led vancomycin dosing and monitoring. Methods: We included adults requiring vancomycin for >48 h and who had a vancomycin trough level drawn near steady state. The primary outcome of the comparison was the achievement of therapeutic trough levels, defined as 10-20 µg/ml. Secondary outcome included acute renal failure. We compared these outcomes before and after the implementation of pharmacy-led vancomycin dosing and monitoring. Result: During the study period, a total of 278 patients were in the preimplementation phase and 286 were in the postintervention phase. There was a clear increase in the percentage of patients achieving the therapeutic range (50.5 vs. 79.7%, p = 0.0001) and an increase in the percentage of levels within the therapeutic range (31.6 vs. 59.1%; p = 0.0001). The number of cases receiving vancomycin increased by 5% and the duration of therapy decreased by 19.5%. More patients attained a therapeutic range of 10-20 µg/ml (i.e. the level was 31.6% in the preintervention and 59.1% in the postintervention phase). Conclusions: A higher percentage of patients achieved a therapeutic range and less nephrotoxicity when using a pharmacy-led protocol for vancomycin dosing.
Background Third line antiretroviral regimens have been associated with suboptimal virologic suppression, due to drug cross-resistance and regimen complexity. Yet, in treatment-experienced (TE) HIV patients, ART durability is essential for preventing further resistance and decreasing HIV-associated morbidity and mortality. Ibalizumab (IBA), the first long-acting, post-attachment inhibitor approved to treat multi-drug resistant (MDR) HIV, may support regimen durability given its directly observed administration. We analyzed the safety, efficacy, and durability of response in 12 patients who started IBA in a Phase 2b study. Methods In TMB-202, 113 patients with MDR HIV received either 2000 mg IBA every 4 weeks (n=54) or 800 mg IBA every 2 weeks (n=59) for 24 weeks with an optimized background regimen (OBR). Of 96 patients who completed TMB-202, 56 transferred into an investigator-sponsored investigational new drug protocol and 12 later moved onto an expanded access protocol, TMB-311, where efficacy and safety were monitored until IBA was commercially available (approval 2018). Results Baseline median viral load (VL) and CD4 count for the 12 patients were 4.4 log10 copies/mL (c/mL) and 135 cells/mL, respectively. The median duration of HIV infection was 22 years (range 18-25). At the completion of TMB-202 11/12 achieved virologic suppression (VL < 200 c/mL) and 8/12 had VL < 50 c/mL. All 12 patients were suppressed (VL < 50 c/mL) at their last TMB-311 visit. Patients gained an average of 99 CD4 cells/mL relative to baseline. There were no treatment-emergent adverse events (TEAE) or therapy discontinuations related to IBA during follow-up. Two patients died from unrelated causes. Overall, the 12 patients remained on IBA for an average of 8.9 years (range 8-9.5), during which 8/12 did not require addition of new ARVs to their OBR to maintain suppression. Figure 1: duration of ibalizumab-based regimen is displayed for the 12 patients. Grey bars represent patients with no addition of new ARVs to OBR. Black bars represent patients with an addition to OBR. Asterisks represent addition of ritonavir only. Conclusion Data from 12 patients who received IBA for an average of 9 years validate the long-term efficacy and safety of IBA in TE patients. Importantly, for most patients, the durability of virologic response was maintained with minimal adjustments to the OBR. Altogether, these data demonstrate the contribution of IBA towards durable viral suppression in TE HIV patients with limited therapeutic options. Disclosures William Towner, MD, Dynavax (Research Grant or Support)Gilead (Grant/Research Support)Merck (Research Grant or Support)Tai Med (Research Grant or Support)ViiV (Research Grant or Support) Edwin DeJesus, MD, Gilead Sciences (Advisor or Review Panel member) Colleen McGary, PhD, Theratechnologies (Employee) Mohammed Zogheib, PharmD, MPH, Theratechnologies (Employee) Steven Weinheimer, PhD, TaiMed Biologics USA (Employee) Pedro Mesquita, PhD, Theratechnologies, Inc. (Employee)
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