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An Analysis of the Correlation between the Severity of Injection Site Reactions and the Amount of Subcutaneous Fat in the Alliance Cohort
David Cooper and On behalf of the Alliance Investigator Group
Univ of New South Wales, Sydney, Australia
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Background: Enfuvirtide (EDF) is
a fusion inhibitor, ART medication administered by twice daily subcutaneous
injection. Injection site reactions (ISR) have been reported as occurring in
98% of patients using EDF with varying severity. The etiology
of these reactions is unknown. The aim of this analysis was to assess whether
the severity of ISR was correlated with the amount of subcutaneous fat.
Methods: We recruited 59 patients into a 48-week, open-label,
multicenter, nucleoside reverse transcriptase inhibitor-sparing
study of EDF plus optimized background therapy. Limb fat was assessed at
baseline, week 24 and 48 by dual energy X ray
absorptiometry (DEXA). ISR were assessed at every visit using standardized
questions. ISR were graded for severity from 1 to 4 (4 being the most severe).
In these analyses ISR were categorized as < or ≥ grade 3. The
association between ISR and limb fat mass (categorized as tertiles:
< 2.70, 2.70 to 4.29, ≥ 4.30 kg) was assessed by general estimating
equation modelling, accounting for repeated measures within individuals. The
relationship between limb fat percentage (categorized as tertiles: < 10.5, 10.5 to 16.5, > 16.5%) and ISR
tested by logistic regression at weeks 24 and 48.
Results: Baseline limb fat mass of > 4.3 kg was
strongly protective against grade 3 or 4 ISR reactions during the study (OR 0.40,
p = 0.014). Peripheral fat percent
greater than 16.5 was also protective against grade 3 or 4 ISR at week 24 and
48 (OR = 0.17, p = 0.027 and OR =
0.21, p = 0.031, respectively).
Conclusions: Increased peripheral fat is associated with a
decreased incidence of grade 3 or 4 ISR in this study group. This may be
because a patient’s ability to inject subcutaneously is likely to be increased
when there is a greater amount of peripheral fat.
Keywords: HIV; Anti retroviral; Injection site reactions
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