Use of a human-centered design approach to adapt a nurse-led cardiovascular disease prevention intervention in HIV clinics.

Stakeholder-informed strategies addressing cardiovascular disease (CVD) burden among people living with HIV (PWH) are needed within healthcare settings. This study provides an assessment of how human-centered design (HCD) guided the adaptation of a nurse-led intervention to reduce CVD risk among PWH. Using a HCD approach, research staff guided two multidisciplinary "design teams" in Ohio and North Carolina, with each having five HCD meetings. We conducted acceptability and feasibility testing. Six core recommendations were produced by two design teams of key stakeholders and further developed after the acceptability and feasibility testing to produce a final list of 14 actionable areas of adaptation. Acceptability and feasibility testing revealed areas for adaptation, e.g. patient preferences for communication and the benefit of additional staff to support patient follow-up. In conclusion, along with acceptability and feasibility testing, HCD led to the production of 14 key recommendations to enhance the effectiveness and scalability of an integrated HIV/CVD intervention.

Effect of rosuvastatin on plasma coenzyme Q10 in HIV-infected individuals on antiretroviral therapy.

BACKGROUND: Coenzyme Q10 (CoQ10) deficiency has been associated with statin-induced myopathy, and supplementation with CoQ10 may reduce inflammation markers. The effects of statins on CoQ10 and its anti-inflammatory properties have not been investigated in HIV-positive patients. OBJECTIVE: The objectives of this study were to examine the effect of rosuvastatin on CoQ10 and CoQ10/LDL ratio over 24-week SATURN-HIV trial, explore the associations between CoQ10 levels and markers of vascular disease, inflammation, and immune activation, and assess whether changes in CoQ10 affected the anti-inflammatory effects of statin therapy or were associated with myalgia symptoms. METHODS: This was a secondary analysis of the SATURN-HIV trial, a 96-week randomized clinical trial of 10 mg daily rosuvastatin vs. placebo in HIV-infected patients on antiretroviral therapy. We assessed the statin treatment effect on CoQ10 levels and CoQ10/LDL ratios and whether changes in these markers were related to myalgias. Relationships between CoQ10, subclinical vascular disease, and biomarkers of inflammation and immune activation were explored using Spearman correlations and multivariable regression models. RESULTS: Overall, 147 patients were included. Median age was 46 years; 78% were male and 68% African American. At baseline, CoQ10 levels and CoQ10/LDL ratio were modestly correlated with markers of HIV disease, immune activation, and carotid distensibility. After 24 weeks of statin therapy, CoQ10 levels decreased (p = 0.002 for between group difference) and CoQ10/LDL ratio increased (p = 0.036). In the statin treatment arm, we did not find evidence of a relationship between changes in CoQ10 or CoQ10/LDL ration and changes in markers of inflammation or immune activation. There was a borderline statistically significant association between changes in CoQ10 and myalgia symptoms [OR 4.0 per 0.1 mg/L decrease in CoQ10, p = 0.07]. CONCLUSION: Twenty-four weeks of 10 mg daily rosuvastatin decreases CoQ10 concentration and increases CoQ10/LDL ratio in HIV-infected patients on antiretroviral therapy.

The effect of physical activity on cardiometabolic health and inflammation in treated HIV infection.

BACKGROUND: In HIV-uninfected populations, physical activity decreases mortality and inflammation. Inflammation is a potential cause of comorbidities in HIV+ adults, the evidence examining the effect of physical activity on cardiometabolic health is limited. This analysis examines the relationship between physical activity, cardiometabolic health and inflammation. METHODS: We conducted a nested study within the SATURN-HIV trial in which 147 HIV+ adults were randomized to 10 mg daily rosuvastatin or placebo. Measures of physical activity, cardiometabolic health, inflammation and vascular disease (carotid artery intima media thickness and computed tomography-acquired measures pericardial fat volume) were assessed at baseline and through 96 weeks. Spearman correlations and multivariable analyses were used to explore relationships between physical activity, cardiometabolic health and inflammation. RESULTS: Median age (Q1, Q3) was 46 (40.4, 52.7) years, 80% were male, 69% were African American and 46% were on protease inhibitors. Baseline median physical activity was 44 min per week (0, 150), 24% of participants performed greater than 150 min per week. At baseline, physical activity correlated with several markers of cardiometabolic health and inflammation (all P≤0.05). Over all time points median physical activity was independently associated with carotid distensibility (ß=2.53; P=0.008), pericardial fat volume (ß=-6.13; P=0.001) and interleukin-6 (ß=-0.468; P<0.001). CONCLUSIONS: Physical activity is associated with vascular disease, endothelial function, and may be an adjuvant to decreasing comorbidities in HIV+ adults. Further studies should examine long-term effects of physical activity on cardiometabolic health and inflammation in this population. Clinicaltrials.gov NCT01218802.

Statins to improve cardiovascular outcomes in treated HIV infection.

PURPOSE OF REVIEW: To evaluate evidence that statins reduce cardiovascular risk in patients living with HIV. RECENT FINDINGS: Moderate to high-dose atorvastatin and rosuvastatin appear to reduce noncalcified coronary plaque volume and slow progression of carotid intima-media thickness in patients with treated HIV infection. Expected lipoprotein changes with statins on the background of modern antiretroviral therapy are similar to the general population. In addition to lipids, the statin benefit may be mediated in part by improvements in vascular inflammation and levels of T-cell and monocyte activation. One concern is the potential for rosuvastatin to cause insulin resistance. Decisions to prescribe statins must be done in the context of global risk assessment, but traditional risk calculators such as the Framingham Risk Score or the American College of Cardiology/American Heart Association pooled-risk equations underestimate risk in this population. Furthermore, many patients with subclinical disease would not be recommended for statins according to the most recent American College of Cardiology/American Heart Association guidelines. SUMMARY: Statins are likely to improve cardiovascular outcomes for patients with HIV, but results of the first outcome study are not expected until 2020. In the meantime, clinicians should individualize statin prescriptions, and should consider using more potent statins (rosuvastatin, atorvastatin, and pitavastatin) when possible.

Vitamin D supplementation and endothelial function in vitamin D deficient HIV-infected patients: a randomized placebo-controlled trial.

BACKGROUND: Studies suggest that vitamin D deficiency is a risk factor for cardiovascular disease and diabetes. Vitamin D deficiency is prevalent in HIV patients but the effect of vitamin D supplementation on cardiovascular risk in this population is unknown. METHODS: We conducted a randomized, double-blind, placebo-controlled trial among 45 HIV-infected adults in Cleveland (OH, USA) on stable antiretroviral therapy with durable virological suppression and a baseline serum 25-hydroxyvitamin D level of ≤20 ng/ml. Participants were randomized 2:1 to vitamin D3 4,000 IU daily or placebo for 12 weeks. The primary outcome was a change in flow-mediated brachial artery dilation (FMD). RESULTS: Baseline demographics were similar except for age (vitamin D versus placebo, mean ±sd 47 ±8 versus 40 ±10 years; P=0.009). Both groups had reduced FMD at baseline (median values 2.9% [IQR 1.6-4.8] for vitamin D versus 2.5% [IQR 1.7-6.4] for placebo; P=0.819). Despite an increase in the concentration of serum 25-hydroxyvitamin D from baseline to 12 weeks (5.0 ng/ml [IQR -0.9-7.4] versus -1.9 ng/ml [IQR -4.0-0.1] for vitamin D versus placebo, respectively; P=0.003), there was no difference in FMD change (0.55% [IQR -1.05-2.13] versus 0.29% [IQR -1.61-1.77]; P=0.748). Vitamin D supplementation was associated with a decrease in total and non-high-density lipoprotein cholesterol, and an increase in indices of insulin resistance. CONCLUSIONS: Among HIV-infected individuals with vitamin D deficiency, supplementation with 4,000 IU vitamin D3 daily for 12 weeks modestly improved vitamin D status and cholesterol but worsened insulin resistance without change in endothelial function. The mechanisms of resistance to standard doses of vitamin D and the complex role of vitamin D in glucose metabolism in this population require further investigation.