Less Than Half of People With HIV Who Are Eligible for Statins Receive Them
There is a significant "statin treatment gap" for people living with HIV, with only 47% of people eligible for statins receiving them in 2013, according to an analysis of 86,535 people included in 15 North American cohort studies. The results were presented at the recent Conference on Retroviruses and Opportunistic Infections (CROI 2017) in Seattle, Washington.
According to the study, the gap appears to be narrowing -- in 2001 only 27% received the statins they were eligible for -- but remains of concern. As is well known, rates of cardiovascular disease (CVD) are high in people living with HIV. Alongside behavioral and lifestyle changes, statins are a cornerstone of the prevention of cardiovascular disease. As well as lowering low-density lipoprotein (LDL) cholesterol, statins may protect the heart health of people with HIV through their impact on inflammation and immune activation.
The high prevalence of raised cholesterol and cardiovascular disease in patients with HIV was highlighted in a separate poster at CROI 2017, in this case from the HIV Outpatient Study of participants at eight U.S. clinics. Among those in their forties, 36% had dyslipidemia and 15% had cardiovascular disease. For patients over the age of 60, this rose to 59% and 41%, respectively.
This population frequently has a second or third co-morbidity, as well. Hypertension and chronic kidney disease frequently co-occur with dyslipidemia, as shown in another CROI presentation.
The analysis of the statin treatment gap used data from the NA-ACCORD group of 15 cohort studies. Eligibility for statins was based on the guidelines of the Third Adult Treatment Panel (ATP III) of the National Cholesterol Education Program, published in 2002.
These guidelines are for the general population, rather than being modified for people living with HIV. They recommend statins for primary prevention in the following cases:
- For individuals with LDL cholesterol over 190 mg/dL, but no other major risk factors or just one risk factor.
- For individuals with LDL cholesterol over 130 mg/dL, two or more risk factors, and a 10-year predicted Framingham Risk Score under 20%.
- For individuals with LDL cholesterol over 130 mg/dL, diabetes and a 10-year predicted Framingham Risk Score over 20%.
While the ATP III guidelines were in effect for most of the 2001 to 2013 period of data collection, it's worth noting that that they were superseded in late 2013 by guidelines from the American College of Cardiology and the American Heart Association. The newer guidelines substantially expand eligibility, placing more emphasis on risk scores than current LDL. In particular, statins are recommended to individuals with LDL cholesterol levels over 70 mg/dL who also have diabetes or a 10-year risk of cardiovascular disease of 7.5% or more. Judged against the more recent guidelines, the treatment gap would certainly be wider.
During the study period, statins were prescribed to 10,222 participants for one month or more. Statins were prescribed to 6% of cohort members in 2001, rising to 12% in 2007 and 18% in 2013.
Throughout the study period, the majority of people eligible for statins did not receive them. Of those eligible, 73% did not receive them in 2001, 56% did not receive them in 2007 and 53% did not receive them in 2013.
To put this in a wider context, a study published in the New England Journal of Medicine in 2014 estimated that 25 million Americans aged 40 to 75 were taking lipid-lowering medication, but 43 million were eligible under the ATP III guidelines. In other words, the treatment gap in the general population appears to be narrower.
A number of factors were associated with HIV-positive people not being prescribed statins despite eligibility. After statistical adjustment for confounding factors, these were: being under 40 years of age (adjusted odds ratio 1.61), black (1.22) or male (adjusted odds ratio [AOR] for females 0.79); having a CD4 cell count below 200 (1.26) or protease inhibitor-based therapy (1.26); and being a smoker (AOR for non-smokers 0.60).
Providers should ensure that they assess their patients' cardiovascular risk and discuss statin therapy with them. They should also be attentive to the risk of under-utilizing statins with some demographic groups, such as younger and black patients.
"Although the gap is narrowing, there is still a substantial gap between those indicated and those prescribed statins," Keri Althoff, Ph.D., and colleagues conclude. "Given the increased risk of CVD in HIV-infected adults, further narrowing the statin treatment gap may preserve the health of those aging with HIV."
A large randomized clinical trial is currently recruiting participants to evaluate the benefits of statin therapy for people with HIV aged 40 to 75. Of note, the study is recruiting individuals who have a low to moderate risk of developing heart disease (a ten-year risk of developing atherosclerotic heart disease of less than 10%), not those who would be prescribed statins under ATP III guidelines. Individuals with a history of heart disease are not eligible.
Participants in REPRIEVE are randomized to receive pitavastatin or a placebo. The primary endpoint is major adverse cardiovascular events, with an average follow-up of four years. There's more information about the trial here.