Evolocumab safe, effective for LDL lowering in patients living with HIV
In patients living with HIV, the PCSK9 inhibitor evolocumab significantly reduced LDL levels compared with placebo and was well tolerated, according to the results of the BEIJERINCK randomized, double-blind trial.
Additionally, evolocumab (Repatha, Amgen) reduced other atherogenic lipids including non-HDL, apolipoprotein B and lipoprotein(a) compared with placebo, according to findings presented at the virtual American College of Cardiology Scientific Session.
Researchers found that among 464 patients living with HIV (mean age, 56 years; 83% men; 36% with atherosclerotic CVD), those assigned evolocumab 420 mg once per month for dyslipidemia experienced a 56.9% reduction in LDL from baseline to week 24 compared with placebo (95% CI, –61.6 to –52.3). An LDL reduction of at least 50% was reached in 72.5% of the evolocumab cohort compared with 0.7% of placebo group (P < .0001).
Similarly, an LDL level of less than 70 mg/dL was achieved in 73.3% of patients in the evolocumab group compared with 7.9% of the placebo group (P < .0001).
Moreover, patients living with HIV who were treated with evolocumab also experienced reduction in other atherogenic lipid levels, including non-HDL, Lp(a) and ApoB (P for all < .0001).
The findings were simultaneously published in the Journal of the American College of Cardiology.
“Evolocumab therapy resulted in more than 56% reduction in LDL cholesterol from baseline to week 24 compared with placebo in people living with HIV on maximally tolerated statin therapy,” Franck Boccara, MD, PhD, of the cardiology department at the Assistance Publique-Hôpitaux de Paris of Sorbonne University, France, said during a presentation. “Based on the results of the present study, evolocumab use in people living with HIV has a favorable benefit-to-risk profile and effectively reduces LDL cholesterol.”
In other findings, the incidence of treatment-emergent adverse events was similar between the evolocumab and placebo groups (67.5% vs. 61.9%, respectively), as were serious adverse events (5.1% vs. 3.3%, respectively). Researchers reported no occurrences of MI, coronary revascularization or ischemic stroke in either treatment arm.
According to the simultaneous publication, the BEIJERINCK trial is the first randomized controlled study to evaluate the safety of PCSK9 inhibitors in patients living with HIV.
“Dyslipidemia in patients living with HIV is often difficult to manage due to the risk for drug-drug interactions,” Boccara told Healio. “In fact, some statins could not be used with some antiretrovirals. Therefore, patients living with HIV achieved LDL goals less frequently as compared to the general population.
“Is reducing LDL in patients living with HIV in primary prevention clinically relevant? The REPRIEVE study is an ongoing study that will answer this gap,” Boccara said in an interview. – by Scott Buzby
Boccara F, et al. Highlighted Original Research: Prevention and the Year in Review. Presented at: American College of Cardiology Scientific Session; March 28-30, 2020 (virtual meeting).
Disclosures: The BEIJERINCK trial was funded by Amgen. Boccara reports he received research grants from Amgen and lecture fees from Amgen, Gilead, Janssen, Merck Sharpe and Dohme, Sanofi, Servier and ViiV Healthcare. Please see the study for all other authors’ relevant financial disclosures.