Impact of Switch to Fosamprenavir and Addition of Lovaza® for Treatment of Hypertriglyceridemia in HIV-Infected Subjects on Antiretroviral Therapy

Background: Managing hypertriglyceridemia in HIV-infected patients often requires multiple pharmacologic strategies. Many protease inhibitors (PIs), one of 6 classes of drugs used to treat HIV, have been associated with hypercholesterolemia and drug interactions. For this study, we examined a dual strategy to manage hypertriglyceridemia in HIV-infected patient taking PIs: 1) switching patients to fosamprenavir (FPV), a PI with fewer drug interactions, and 2) adding prescription fish oil (LOVAZA?), which has been shown to reduce triglycerides. Methods: This multicenter, 24-week study enrolled 36 patients virologically suppressed (HIV-1 RNA <50 copies/mL) on PI-containing therapy with screening triglyceride levels of 200 - 1200 mg/dL and LDL cholesterol levels ≤160 mg/dL. At baseline, patients were switched to ritonavir (RTV)-boosted fosamprenavir (FPV 1400 mg/RTV 100 mg QD) and any lipid-lowering agents were stopped. At Week 6, LOVAZA 4 g QD was added. Results: Five patients prematurely discontinued due to adverse events (2), non-compliance, lost-to-follow up, and protocol violation. Median triglyceride concentration was 303 mg/dL at screening, 262 mg/dL at baseline, 290 mg/dL at Week 6 (+8% from baseline), and 218 mg/dL at Week 24 (–30% from Week 6). At Week 24, 39% (12/31) of patients had triglycerides <200 mg/dL. Among patients reaching Week 24, 100% (31/31) and 90% (28/31) had HIV-1 RNA <400 and <50 copies/mL, respectively. Conclusions: In this study, a switch to FPV/RTV followed by LOVAZA decreased median triglyceride levels and modestly increased the percentage of patients with triglyceride levels <200 mg/dL while maintaining virologic suppression in HIV-infected subjects with hypertriglyceridemia. Our data suggest that baseline PI may affect the likelihood of achieving triglycerides <200 mg/dL after 18 weeks on study. A larger study would be needed to understand the relative contributions of choice of protease inhibitor and LOVAZA to triglyceride concentrations in HIV-infected patients.