2494. Real-World Use of Ibalizumab in Physician Office Infusion Centers (POICs)

BACKGROUND: Ibalizumab-uiyk (IBA) was recently approved for the treatment of multi-drug-resistant HIV-1 infection in patients (pts) failing other antiretroviral regimens. Clinical trial data demonstrated a decrease in HIV-1 viral load in 83% and 43% of patients (n = 40) receiving IBA for 2 and 25 weeks (weeks), respectively. Real-world post marketing data are needed. This pilot study reports the experience of IBA utilization in POICs. METHODS: Medical records of patients receiving intravenous IBA from approval through April 2019 were reviewed. Data collected include demographics, infection and treatment history, IBA regimen and adverse events. Plasma HIV-1 RNA viral load (log(10) copies/mL) and CD4 count (cells/µL) were collected at baseline and as available during therapy. Based on available follow-up (FU) labs, response was assessed at 4–10 weeks (FU 1), 14–22 weeks (FU 2), and 24–37 weeks (FU 3). RESULTS: Nine patients (mean age: 48 ± 11 years, 67% male) from 7 POICs received IBA for a median duration of 33 weeks (range 4–43). Median length of HIV-1 diagnosis was 22 years (range 8–25). Resistance to ≥1 drug in at least 3 drug classes was reported in 56%. All patients received at least one concurrent anti-retroviral agent. IBA was initiated at 2000 mg followed by 800 mg every 2 weeks. All patients received infusions as scheduled (151 total infusions) except for one requiring a second loading dose. Baseline mean CD4 count and viral load were 49 cells/µL and 4.9 log(10) copies/mL, respectively. Labs obtained at FU 1 indicated a decrease in viral load of at least 0.5 log(10) copies/mL in 6/8 patients (75%); a mean reduction of 2.1 ± 1.8 log(10) copies/mL (Table 1). Mean HIV-1 titers available for patients at FU 2 (n = 6) and FU 3 (n = 7) were 3.1 ± 2.0 and 3.2 ± 2.6 log(10) copies/mL, respectively. Mean CD4 counts were 65 ± 57 cells/µL at FU 1, 96 ± 61 cells/µL at FU 2 and 88 ± 82 cells/µL at FU 3. Adverse events were reported in 8 patients (89%), most common itching/rash, diarrhea and abdominal pain. None resulted in discontinuation of IBA. CONCLUSION: This study confirms the antiviral activity of IBA in patients with advanced HIV-1 infection in the real-world setting. We observed well-tolerated therapy with an early reduction in HIV-1 viral load of 75%, followed by a 43% reduction ≥24 weeks, consistent with the clinical trial. [Image: see text] DISCLOSURES: All authors: No reported disclosures.