13th Conference on Retroviruses and Opportunistic Infections Denver, Colorado - February 5-8, 2006

Conf Retrovir Opportunistic Infect 2006 Feb 5-8;13:abstract no. 772

Mark Hull^1,2, E Phillips^1,3, M Harris^2,3, G Bondy⁴, P Leong⁴, J Toy⁴, R Hogg^1,3, J Singer^1,2, and J Montaner^1,2,3
1Univ of British Columbia, Vancouver, Canada; ²Canadian HIV Trials Network, Vancouver, Canada; ³BC Ctr for Excellence in HIV/AIDS, Vancouver, Canada; and ⁴St. Paul's Hosp, Vancouver, BC, Canada

BACKGROUND: Case reports of exogenous steroid excess and adrenal insufficiency in patients on inhaled or nasal fluticasone propionate (FP)- and ritonavir (RTV)-containing protease inhibitor (PI) regimens have underscored the potential for this interaction.

METHODS: To determine whether unsuspected adrenal suppression occurs in HIV+ patients using RTV/FP in a clinic setting, fasting morning cortisol screening was done on sequential unselected patients undergoing routine HIV follow-up at St Paul’s Hospital Immunodeficiency Clinic, Vancouver, British Columbia, between July and October 2005. Cases, defined as those with a cortisol value <100 nmol/L were assessed for symptoms of either adrenal suppression or exogenous steroid excess. Controls were those with a normal fasting serum cortisol (175 to 685 nmol/L). All patients who underwent cortisol screening had their medication records abstracted from both the provincial ART and prescription drug databases (Pharmanet); p values were calculated for the comparison between cases and the unmatched control group for the RTV/FP pharmacologic interaction as a cause of a suppressed fasting cortisol.

RESULTS: We screened 50 patients. The average age was 49 years and 88% were male; 92% were on ART, and 87% of the ART regimens contained RTV-boosted PI; 7 patients had suppressed fasting cortisols (<28 nmol/L in all 7), and 43 patients (controls) were unsuppressed. All 7 were on RTV-containing PI regimens and FP (inhaled = 6, nasal = 1) vs only 1 control (p <0.0001, Fishers exact test). Of 7 cases, 6 were virologically suppressed, with a median CD4 of 340/mm³ (240 to 430). The median time on ART regimens was 8 months (range 2 to 15months) and 6 of the 7 had been on FP >10 months. Of the 7 adrenally suppressed patients, 3 were asymptomatic and 4 were symptomatic: 2 had Cushingoid features, 1 had easy bruising, and 1 experienced loss of diabetic control.

CONCLUSIONS: A high proportion of RTV/FP-exposed patients were identified with suppressed fasting cortisols (7 of 8; 88%), including 57% with associated but unrecognized symptoms, highlighting the need for increased clinical vigilance. RTV/FP combinations should be avoided where alternatives exist, and routine fasting cortisol screening applied in patients on this combination.

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2006-02-05
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