PCSK9i treatment of dyslipidemic people with HIV reduces LDL-c and is safe
Evolocumab Use in HIV-Infected Patients With Dyslipidemia: Primary Results of the Randomized, Double-blind BEIJERINCK Study
Presented at ACC.20 by Franck Boccara, MD (Paris, France)
Introduction and methods
People living with HIV (PLHIV) have increased risk for CVD, in particular ASCVD events. Prevention and treatment of ASCVD events in PLHIV has become a major concern, and in particular treatment of dyslipidemic PLHIV with lipid-lowering medication has proven difficult.
The objective of the phase 3 Beijerinck study was to evaluate the lipid-lowering efficacy and safety of evolocumab in PLHIV who had had hypercholesterolemia or mixed dyslipidemia and received maximally tolerated statin therapy. Participants (n=467) included both patients with ASCVD (LDL-c ≥70 mg/dL or non-HDL-c ≥100 mg/dL when fasting) and patients without ASCVD (LDL-c ≥100 mg/dL or non-HDL-c ≥130 mg/dL when fasting). They were randomized to receive monthly subcutaneous injections of either 420 mg evolocumab (n=310) or placebo (n=157) over a 24-week treatment period.
Primary endpoint was defined as percentage change in LDL-c from baseline to week 24. Secondary endpoints included (1) achievement of LDL-c <70 mg/dL or LDL-c reduction of ≥50% at week 24, (2) percentage change from baseline in other lipid and lipoprotein levels at week 24 and (3) TEAEs, including maintenance of HIV control.
- Treatment with evolocumab led to a significant reduction of LDL-c as compared to placebo (least squares estimate treatment difference -56.9% [95% CI: -61.6 to -52.3%: p <0.0001]).
- Placebo-corrected percentages of patients achieving an LDL-c <70 mg/dL and an LDL-c reduction of ≥50% at week 24 were 65.4% and 71.9%, respectively.
- Treatment with evolocumab also led to significant reductions of non-HDL-c (LSE treatment difference -50.9% [95% CI: -54.9 to -47.0%; p <0.0001]), ApoB (-47.7% [95% CI: -51.1 to -44.4%; p <0.0001]), total cholesterol (-38.1% [95% CI: -41.3 to -34.9%; p <0.0001]), VLDL-c (-22.2% [95% CI: -30.0 to -14.26%; p <0.0001]), TGs (-22.5% [95% CI: -31.0 to -13.9%; p <0.0001]), Lp(a) (-26.8% [95% CI: -34.2 to -19.4%; p <0.0001]) and a significant increase in HDL-c (8.4% [95% CI: 4.8 to 11.9%; p <0.0001]) as compared to placebo.
- No significant differences were found in TEAEs between evolocumab and placebo groups.
In PLHIV on maximally tolerated statin therapy, treatment with evolocumab resulted in a significant reduction of LDL-c from baseline to week 24 as compared with placebo. In addition, evolocumab therapy achieved significant reductions in TGs, non-HDL-c, ApoB, total cholesterol, VLDL-c and Lp(a), and a significant increase of HDL-c as compared with placebo. Finally, evolocumab treatment was well tolerated and safe in these patients.
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