Randomized Trial to Prevent Vascular Events in HIV - REPRIEVE
Contribution To Literature:
Highlighted text has been updated as of November 12, 2023.
The REPRIEVE trial showed that pitavastatin treatment lowers the risk of adverse cardiovascular events among individuals with HIV and low-to-moderate risk of cardiovascular disease.
The goal of the trial was to evaluate pitavastatin compared with placebo among individuals with human immunodeficiency virus (HIV) infection and low-to-moderate risk of cardiovascular disease.
Individuals with HIV and low-to-moderate risk of cardiovascular disease were randomized to pitavastatin 4 mg daily (n = 3,888) vs. placebo (n = 3,881).
- Total number of enrollees: 7,769
- Duration of follow-up: median 5.1 years
- Mean patient age: 50 years
- Percentage female: 31%
- Individuals with HIV infection 40-75 years of age
- Stable anti-retroviral therapy
- Statin use within the last 90 days
- Known atherosclerotic cardiovascular disease
Other salient features/characteristics:
- Median screening low-density lipoprotein cholesterol (LDL-C): 108 mg/dL
- Median CD4 count: 621 cells/mm3
- HIV RNA value below quantification: 5,250 of 5,997 participants (87.5%)
The primary outcome, incidence of major adverse cardiovascular events, occurred in 4.81 per 1,000 person-years in the pitavastatin group vs. 7.32 per 1,000 person-years in the placebo group (p = 0.002).
- Cardiovascular death: 0.64 per 1,000 person-years in the pitavastatin group vs. 0.85 per 1,000 person-years in the placebo group (p = not significant [NS])
- Nonfatal serious adverse event: 4.16 per 1,000 person-years in the pitavastatin group vs. 4.13 per 1,000 person-years in the placebo group (p = NS)
- Myalgia, muscle weakness, or myopathy grade ≥3, or treatment-limiting: 0.49 per 1,000 person-years in the pitavastatin group vs. 0.28 per 1,000 person-years in the placebo group (p < 0.05)
Mechanistic substudy (n = 804):
- Change in noncalcified plaque volume at 2 years: -1.7 mm3 with pitavastatin vs. 2.6 mm3 with placebo (p = 0.044)
- Change in LDL-C: -29 mg/dL with pitavastatin vs. 0 with placebo
- Change in Lp-PLA2: -10.1 ng/dL with pitavastatin vs. 19.3 with placebo (p < 0.001)
- Change in oxLDL: -14.9 U/L with pitavastatin vs. -6.45 with placebo (p < 0.001)
- Change in hs-CRP: -0.1 mg/L with pitavastatin vs. 0.1 with placebo (p = 0.09)
Among individuals with HIV infection and low-to-moderate risk of cardiovascular disease, pitavastatin treatment was beneficial. Pitavastatin vs. placebo was associated with a reduction in major adverse cardiovascular events. This benefit may be mediated by decreased risk of plaque progression, decreased lipid oxidation, and decreased arterial inflammation. The results were the same in various tested subgroups (gender, geographic region, CD4 level, etc.). The benefit observed with pitavastatin was more than predicted by the degree of LDL-C lowering. Pitavastatin treatment was safe with similar incidence of nonfatal serious adverse events; however, muscle-related symptoms were more common vs. placebo.
Presented by Dr. Michael Lu at the American Heart Association Scientific Sessions, Philadelphia, PA, November 12, 2023.
Presented at the 2023 International AIDS Society Meeting on July 23 in Brisbane, Australia.
Keywords: Biomarkers, HIV, Vascular Diseases, AHA23
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