Good adherence predicts lipodystrophy in Italian cohort

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Italian researchers have shown that people who adhered better to their antiretroviral therapy were at much higher risk of developing body fat alterations than people who did not always take their medication at the prescribed intervals, in a study published online this week by the Journal of Acquired Immune Deficiency Syndromes in a special supplement on adherence to anti-HIV therapy.

The LipoICONA cohort enrolled 207 patients receiving antiretroviral therapy and assessed adherence at baseline, and evaluated adipose tissue alterations and adherence every six months thereafter. Adherence was assessed by asking patients whether they had missed doses on the previous day, in the previous week, two weeks previously or three to four weeks previously. Adipose tissue alterations were assessed by patient questionnaire and by physician evaluation of fat distribution. Plasma drug concentrations were also measured.

All patients were receiving highly active antiretroviral therapy (HAART) and 74% were receiving a PI-containing regimen. The median prior duration of therapy was 89 weeks, with 37 weeks on the current HAART regimen.

Glossary

p-value

The result of a statistical test which tells us whether the results of a study are likely to be due to chance and would not be confirmed if the study was repeated. All p-values are between 0 and 1; the most reliable studies have p-values very close to 0. A p-value of 0.001 means that there is a 1 in 1000 probability that the results are due to chance and do not reflect a real difference. A p-value of 0.05 means there is a 1 in 20 probability that the results are due to chance. When a p-value is 0.05 or below, the result is considered to be ‘statistically significant’. Confidence intervals give similar information to p-values but are easier to interpret. 

plasma

The fluid portion of the blood.

cholesterol

A waxy substance, mostly made by the body and used to produce steroid hormones. High levels can be associated with atherosclerosis. There are two main types of cholesterol: low-density lipoprotein (LDL) or ‘bad’ cholesterol (which may put people at risk for heart disease and other serious conditions), and high-density lipoprotein (HDL) or ‘good’ cholesterol (which helps get rid of LDL).

hazard

Expresses the risk that, during one very short moment in time, a person will experience an event, given that they have not already done so.

lipodystrophy

A disruption to the way the body produces, uses and distributes fat. Different forms of lipodystrophy include lipoatrophy (loss of subcutaneous fat from an area) and lipohypertrophy (accumulation of fat in an area), which may occur in the same person.

Sixty two per cent of patients reported non-adherence in the previous month, and 25% had a clinical diagnosis of adipose tissue alteration at baseline.

During a median follow-up of 45 weeks, a significantly larger proportion of patients who were adherent at baseline developed adipose tissue alterations when compared to non-adherent patients (43% vs 18%, p=0.007), an adjusted hazard ratio of 2.58 (p=0.03).

“The median time to the development of adipose tissue alterations was five times shorter in those with good adherence”, the authors reported.

Even after controlling for gender, age, mode of HIV transmission, duration of exposure to every antiretroviral drug, ever having an HIV RNA level below 500 copies/ml, plasma concentration score for PIs or NNRTIs and most recent cholesterol and triglyceride score, the relationship persisted.

Men who acquired HIV through sex with other men were significantly more likely than injecting drug users to develop adipose tissue alterations (HR 4.30, p=0.02), and those whose viral load decreased below 500 copies/ml were also significantly more likely to develop adipose tissue alterations (HR 18.49, p=0.02).

However, this study did not adjust for CD4 cell nadir or baseline CD4 count in the regression analysis, even though another analysis of the LipoICONA cohort has shown that the risk of fat loss (although not of a mixed syndrome of fat accumulation and fat loss) was significantly greater in individuals with baseline CD4 cell counts below 200 cells/mm3.

The study also found that fat accumulation (but not the mixed form of lipodystrophy) was associated with an increased risk of non-adherence (odds ratio 4.67), and that duration of therapy was associated with non-adherence (OR 1.84 per year of therapy).

References

Ammassari A et al. Relationship between HAART adherence and adipose tissue alterations. Journal of Acquired Immune Deficiency Syndromes 31: S140-S144, 2002.