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Pitavastatin showed no difference in health-related quality of life compared with placebo in people with HIVWhy Heart Risk Factors Drag Down Daily Wellbeing for People With HIV

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Key Takeaway
Note that pitavastatin showed no apparent difference in health-related quality of life compared with placebo in this HIV cohort.

This randomized controlled trial enrolled 733 people with HIV aged 40 to 75 years who were on antiretroviral therapy and had low-to-moderate risk for atherosclerotic cardiovascular disease. Participants were randomized to receive pitavastatin or placebo and were followed for 24 months. The primary outcome was health-related quality of life assessed using the Short Form-36-Item Health Survey Version 2 physical and mental component summary scores. Secondary outcomes included cardiometabolic characteristics and coronary atherosclerosis.

At baseline, median physical component summary scores were 54.5 for pitavastatin versus 54.1 for placebo, while median mental component summary scores were 52.9 for pitavastatin versus 52.8 for placebo. Between baseline and month 24, declines in both physical and mental component scores were minimal with no apparent difference by treatment group. Associations with lower physical component scores included older age, Black non-Hispanic race/ethnicity, ART regimen class, elevated BMI, and cigarette smoking.

Safety data, including adverse events, serious adverse events, discontinuations, and tolerability, were not reported in the study. The study authors noted limited evidence concerning the relationship between cardiometabolic characteristics and health-related quality of life, as well as potential effects of statin therapy among people with HIV. Among this cohort of antiretroviral-treated people with HIV, baseline cardiometabolic risk factors were associated with worse self-reported physical health-related quality of life, with no apparent effect of statin therapy on these scores.

The other half of living well with HIV

Modern HIV medicine has made it possible for most people with HIV to live nearly normal lifespans. The conversation has shifted from survival to quality of daily life.

A new analysis from a major heart-prevention trial offers a window into what actually shapes that quality — and what doesn't.

People living with HIV are at higher risk of heart disease than the general population, even when their virus is fully controlled. That's why doctors have been studying whether statin medications, normally used to lower cholesterol, could help prevent heart attacks and strokes in this group.

The REPRIEVE trial answered that core question — yes, the statin lowered heart events. But quality of life is its own measure, and it doesn't always track with what happens inside the arteries.

The old way versus the new way

Quality of life used to be treated as a soft outcome in HIV research. Trials focused on viral counts, CD4 cell numbers, and survival.

Newer studies recognize that how a person feels physically and mentally each day matters just as much. The Short Form-36 questionnaire — used in this analysis — produces two scores: a physical wellbeing summary and a mental wellbeing summary. Tracking those scores alongside biological data gives a fuller picture.

How quality of life and heart risk connect

Imagine the body's blood vessels as the freeway system that supplies every organ. Smoking, high body weight, and cholesterol slowly narrow the lanes.

When the freeway works smoothly, you don't notice it. When it doesn't, climbing stairs feels harder. Walking long distances tires you out. Energy for daily activities drops.

That's the connection this study examined. Are the same risk factors that cause heart attacks down the road already showing up as worse physical wellbeing today?

The study snapshot

Researchers worked with 733 participants enrolled in REPRIEVE's mechanistic substudy. Median age was 51, most were men, about a third were Black non-Hispanic, and the median time living with HIV was 15 years. Participants completed quality-of-life questionnaires at baseline and 24 months. About half were randomly assigned to receive pitavastatin and half a placebo. The team also measured coronary artery plaque using CT scans.

At baseline, several familiar heart risk factors were tied to worse physical wellbeing — older age, higher body weight, smoking, and certain HIV treatment regimens. The connection was specific to physical scores. Mental wellbeing scores didn't show the same clear pattern.

Over the next two years, both physical and mental scores stayed largely stable. There was no clear difference between people who received the statin and those who got a placebo.

In other words, the statin protected the heart — but it didn't make people feel noticeably different in their daily lives over the study window.

This doesn't mean statins don't matter for quality of life.

Where this fits in the bigger picture

Studies measuring quality of life over short time windows often miss longer-term changes. The patients in this analysis were generally well-controlled and didn't have major heart problems at the start. Improvements from a heart-protective drug may take many years to show up in how someone feels day to day.

What this study makes clear is that quality of life in HIV care has more to do with the same modifiable factors that drive risk in the general population — weight, smoking, fitness, sleep — than with any single medication.

If you're living with HIV and your doctor has discussed starting a statin to lower your cardiovascular risk, this study confirms the cardioprotective benefit while putting expectations in perspective. You probably won't feel a difference quickly. The benefit accumulates over years.

The bigger takeaway is on the lifestyle side. Quitting smoking, maintaining a healthy weight, and staying active are likely to have a more noticeable impact on day-to-day physical wellbeing than any single pill.

This was a planned secondary analysis of a larger trial, which limits how strongly the team could test some questions. The study population was 84% male, so results may not fully apply to women living with HIV. The two-year follow-up may also be too short to see how statin therapy eventually shapes wellbeing. And quality-of-life questionnaires capture only what the person chooses to report.

The REPRIEVE team is continuing to track participants over longer periods. As that follow-up grows, we'll learn whether statin treatment eventually translates into better physical wellbeing or whether the benefit truly stays at the level of preventing major cardiovascular events. In the meantime, this study reinforces that cardiometabolic care matters in HIV not just for hearts, but for everyday life.

Study Details

Study typeRct
Sample sizen = 733
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
BACKGROUND: There is limited evidence concerning the relationship between cardiometabolic characteristics and health-related quality of life (HRQoL), and potential effects of statin therapy among people with HIV (PWH). METHODS: The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) enrolled PWH aged 40-75 years on antiretroviral therapy (ART) with low-to-moderate ASCVD risk. Coronary computed tomography angiography assessed coronary plaque among a subset of participants in the REPRIEVE Mechanistic Substudy at baseline and 24 months. The Short Form-36-Item Health Survey Version 2 was collected at baseline, and physical (PCS) and mental (MCS) component summary scores were determined. We explored the relationship of PCS and MCS with cardiometabolic characteristics, coronary atherosclerosis, and assessed change in score by treatment group (pitavastatin vs. placebo). RESULTS: Of 733 participants, median age was 51 years, 84% were male, 34% were Black non-Hispanic, and median years diagnosed with HIV was 15. At baseline, for participants randomized to pitavastatin vs. placebo the median PCS was 54.5 (Q1, Q3: 46.9, 57.7) vs. 54.1 (47.5, 58.0), and the median MCS was 52.9 (44.1, 57.6) vs. 52.8 (44.0, 57.9). In fully adjusted analyses, older age, Black non-Hispanic race/ethnicity, ART regimen class, elevated BMI, and cigarette smoking were associated with lower PCS. No clear trends were apparent with MCS. Between baseline and month 24, declines in PCS and MCS were minimal with no apparent difference by treatment group. CONCLUSIONS: Among this cohort of ART-treated PWH, baseline cardiometabolic risk factors were associated with worse self-reported physical HRQoL, with no apparent effect of statin therapy. TRIAL REGISTRATION: REPRIEVE; NCT02344290; https://clinicaltrials.gov/study/NCT02344290.
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