Interventions Can Reduce CVD Risk Factors in HIV Patients, Studies Show

DENVER — Efforts aimed at lowering blood pressure (BP) and cholesterol in people with HIV can succeed, two randomized trials presented here demonstrated.

In the first, prehypertensive Haitians on stable antiretroviral therapy (ART) who received early treatment with a calcium channel blocker experienced significantly greater reductions in systolic and diastolic BP compared with those who received standard care, reported Lily Yan, MD, of Weill Cornell Medicine in New York City.

And in the EXTRA-CVD trial involving U.S. patients with established hypertension and hypercholesterolemia, a multicomponent nurse-led strategy that included guidance on home BP monitoring and management of cardiovascular disease risk factors helped lower systolic BP and non-HDL cholesterol, according to Christopher Longenecker, MD, of the University of Washington in Seattle.

“HIV increases cardiovascular disease by twofold,” Yan told attendees at the Conference on Retroviruses and Opportunistic Infections, where the two studies were presented. He added that 10-year mortality has more than doubled among patients with hypertension at the time of ART initiation.

Longenecker emphasized that in order to preserve lifespan gains achieved by ART in people with HIV, clinicians must now focus on managing non-AIDS comorbidities as well.

“We’ve done the clinical epidemiology, we’ve done the clinical trials, and we even have guidelines,” for managing cardiovascular risk factors in this population, he said. “But what we need now are implementation strategies [for] evidence-based cardiovascular prevention care for people living with HIV.”

Treating Prehypertension

Data presented by Yan showed that early treatment with the calcium channel blocker amlodipine led to greater mean decreases in systolic and diastolic BP compared with standard of care (treatment only if patients developed hypertension):

• Systolic BP: -5.8 mm Hg (95% CI -8.77 to -3.01)
• Diastolic BP: -5.5 mm Hg (95% CI -7.92 to -3.16)

Early treatment of prehypertension also lowered the risk of incident hypertension by 57% in the early treatment group (HR 0.43, 95% CI 0.26-0.70) over a 12-month period. Among people being treated for prehypertension, 39.5% developed hypertension over the study period versus 64.2% in the standard-care group.

“Lowering the blood pressure threshold for antihypertensive initiation among people living with HIV — similar to diabetes or kidney disease — may be an important tool for CVD [cardiovascular disease] prevention,” Yan said. Currently, the World Health Organization recommends initiation of antihypertensive treatment for people with HIV at a BP target of 140/90 mm Hg, the same threshold as for the general population.

The study enrolled 250 adults ages 18-65 with prehypertension from the GHESKIO HIV clinic in Port-au-Prince, Haiti. Prehypertension was defined as a BP of 120-139/80-90 mm Hg. Other inclusion criteria included current use of ART for a minimum of 1 year, a viral load of less than 1,000 copies/mL, and no current use of antihypertensive medications.

Participants were randomized 1:1 to either amlodipine 5 mg (the standard treatment for hypertension in Haiti) or no treatment. In the intervention group, amlodipine was increased to 10 mg if systolic BP was >130 mm Hg at a follow-up visit. If a person in the control group developed hypertension during the study, they received amlodipine as treatment.

The average age of participants was 47-50 years. There were few smokers or drinkers in either group, but all participants consumed fewer than five servings of fruits or vegetables daily.

In the early treatment arm, the mean change in systolic BP was -10.52 mm Hg (95% CI -12.55 to -8.48), the mean change in diastolic BP was -8.87 mm Hg (95% CI -10.55 to -7.19), with BP control (<120/80 mm Hg) attained by 57.4% of this cohort.

For the standard-care arm, mean BP changes were -4.63 mm Hg (95% CI -6.67 to -2.59) and -3.33 mm Hg (95% CI -5.01 to -1.65), respectively, while BP control was attained by 36.7%.

There were 26 adverse events in the study, with dizziness and edema being the most common. No serious adverse events were related to amlodipine and treatment did not affect viral load suppression. Participants and study staff reported high acceptability of amlodipine, Yan said.

Nurse-Led Strategy for Hypertension and High Cholesterol

EXTRA-CVD enrolled 297 adult patients from three academic HIV clinics in the U.S. who were taking ART and had comorbid hypertension and high cholesterol.

The year-long nurse-led strategy helped patients lower their systolic BP by 4.2 mm Hg (95% CI 0.3-8.2, P=0.04) and their non-HDL cholesterol by 16.9 mg/dL (95% CI 8.6-25.2, P<0.001), according to the findings reported by Longenecker, which were also published in JAMA Network Open.

The nurse-led intervention included four key components: nurse-led coordination, nurse-managed medication protocols and adherence support, home BP monitoring, and electronic health records support tools. Nurses met with participants in the intervention group every 4 months over the course of a year. Participants received additional telephone check-ins as necessary to adjust medications and coordinate clinical care. All nurses received education, ongoing feedback, and coaching. Participants in the control group received general prevention education sessions at each of the visits.

Overall, the nurse-led intervention led to a nearly threefold increase in the odds of reaching the BP treatment goal of systolic BP lower than 130 mm Hg (OR 2.9, 95% CI 1.0-8.3, P=0.05) and a sevenfold increase in reaching the non-HDL cholesterol goals of <100 mg/dL for high-risk individuals and <130 mg/dL for others (OR 7.3, 95% CI 2.3-23.3, P<0.001).

The change in non-HDL cholesterol was driven primarily by a 29.5 mg/dL reduction in triglycerides (95% CI -53.7 to -5.3, P=0.02), rather than the 9.6 mg/dL reduction in LDL levels, which was not statistically significant (95% CI -25.5 to 6.3 mg/dL, P=0.24).

There was some evidence that the systolic BP effect was greater in women compared with men, Longenecker pointed out. Women had an 11.8 mm Hg greater reduction in systolic BP at 4 months, 9.6 mm Hg at 8 months, and 5.9 mm Hg at 12 months. However, the difference was not statistically significant (overall joint test P=0.06).

All participants in the study had suppressed HIV-1 viral loads and normal or near-normal CD4 T-cell counts. Their mean age was 59 years, 79% were male, and 66% were of non-white race.

At baseline, mean systolic BP was 135 mm Hg and mean baseline non-HDL cholesterol was 139.9 mg/dL. At baseline, half of participants were currently prescribed two or more antihypertensive medications and two-thirds were taking a statin.

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