2024-03-04 03:04:39
▲Image source: Getty Image Bank.
[메디칼업저버 박선혜 기자] The U.S. Department of Health and Human Services (HHS) recommended statins as a treatment for primary prevention of cardiovascular disease in people infected with human immunodeficiency virus (HIV).
In the REPRIEVE phase 3 clinical trial announced last year, pitavastatin was found to significantly lower the risk of major cardiovascular events (MACE) in HIV-infected people, and this was reflected in the guidelines.
The ‘Guidelines for the use of antiretroviral drugs in HIV-infected adults and children and adolescents’, which contains statin recommendations for primary prevention of atherosclerotic cardiovascular disease (ASCVD) in HIV-infected people, was released on the website on the 27th of last month.
The U.S. HHS developed this recommendation in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), and the Human Immunodeficiency Virus Association (HIVMA).
REPRIEVE provides evidence for why HIV-infected people should take statins
It is reported that HIV-infected people have up to twice the risk of ASCVD, such as myocardial infarction and stroke, compared to the general population, and that it occurs regarding 10 years earlier.
Until now, HIV-infected people have focused on correcting traditional cardiovascular disease risk factors such as diet, exercise, smoking cessation, and blood pressure control for primary prevention of cardiovascular disease. There have been no large-scale randomized studies evaluating treatment strategies for primary prevention of cardiovascular disease in HIV-infected people, and no recommendations have been prepared.
However, the mood changed last year when the results of REPRIEVE, a multinational, double-blind, placebo-controlled randomized study, were announced. Approximately 7,800 HIV-infected people aged 40 to 75 years old, at mild to moderate risk of cardiovascular disease, who were receiving antiretroviral treatment were recruited for the study.
The entire patient group was randomly assigned to a group taking 4 mg of pitavastatin per day (pitavastatin group) or a placebo group. As a result of 5.1-year follow-up, the risk of MACE was significantly lower in the pitavastatin group by 35% than in the placebo group. Additionally, the risk of MACE was reduced to a similar level regardless of LDL-cholesterol level at the time of enrollment.
In the safety evaluation, non-fatal serious adverse reactions were similar in both groups, but the incidence of diabetes and muscle-related symptoms was higher in the pitavastatin group.
REPRIEVE presented evidence that HIV-infected people with mild to moderate cardiovascular disease risk who are receiving antirestoviral treatment should take statins for primary prevention of cardiovascular disease.
ASCVD risk 5-20%;
Pitavastatin, atorvastatin, rosuvastatin recommended
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This guideline provides recommendations based on 10-year ASCVD risk. In the REPRIEVE sub-analysis, it was found that if the 10-year ASCVD risk was 5% or more, the absolute reduction in MACE risk due to taking partyvastatin was greater. Therefore, recommendations were developed dividing the ASCVD risk into 5-20% and less than 5%, and the recommendation grade and The level of evidence was also included differently.
First, HIV-infected people aged 40 to 75 years and with a 10-year ASCVD risk of 5 to 20% were recommended with the strongest recommendation and highest level of evidence to start at least moderate-intensity statins (recommendation grade: A, evidence level: I).
Recommended medium-intensity statins include △pitavastatin 4 mg once daily (AI) △ atorvastatin 20 mg once daily (AII) △ rosuvastatin 10 mg once daily (AII). The recommendation levels are all the same, but pitavastatin has the highest level of evidence based on the results of randomized controlled trials.
They then ordered a weak recommendation grade, saying that if the 10-year ASCVD risk is less than 5%, it may be preferable to start at least moderate-intensity statins (CI). Because the absolute benefit of statins is minimal in these people, statin treatment was decided upon considering whether there were HIV-related factors that might increase the risk of ASCVD.
HIV-related factors that may increase the risk of ASCVD include longer duration of HIV infection, delayed initiation of antiretroviral treatment, prolonged HIV viral infection and poor treatment compliance, and low current or nadir CD4 T lymphocyte cell count (less than 350 cells/mm3). ), exposure to old antiretroviral treatment associated with cardiometabolic toxicity, and co-infection with hepatitis C. The recommended moderate-intensity statins are the same for patients with a 10-year ASCVD risk of 5 to 20%.
They stated that there is insufficient evidence to recommend or contraindicate statins for primary prevention of ASCVD in HIV-infected people younger than 40 years of age.
In addition, based on AHA·ACC and multi-society guidelines, high-intensity statin treatment was recommended for patients aged 40 to 75 years and with a 10-year ASCVD risk of 20% or higher. Patients aged 20 to 75 years and with LDL-cholesterol of 190 mg/dL or higher were ordered to take high-intensity statin at the maximum tolerated dose.
Additionally, if you are 40 to 75 years old and have diabetes, you should start treatment with at least a moderate-intensity statin, and if you consider a high-intensity statin, conduct an additional risk assessment.
Precautions to be considered during statin treatment are also included. Caution was cautioned that combining certain statins with antiretroviral treatment might cause serious drug interactions.
Specifically, it was stated that antiretroviral treatment boosted with ritonavir and cobicistat is prone to drug interactions with statins. When antiretroviral treatment augmented with ritonavir and cobicistat is used in combination with atorvastatin or rosuvastatin, it may be necessary to reduce the statin dose, change to another statin, or strengthen monitoring of statin-related adverse reactions.
Additionally, lovastatin and simvastatin are contraindicated in antiretroviral treatment that requires pharmacokinetic enhancement with cobicistat or ritonavir.
In addition, pregnant women with a mild to moderate 10-year ASCVD risk should postpone statin treatment until following giving birth, and if pregnant with HIV infection, statins should be discontinued immediately. Additionally, breastfeeding is not recommended while taking statins.
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