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Impact of Hyperbilirubinemia on Persistence and Adherence of Atazanavir among HIV Patients

Session: Poster Abstract Session: HIV Treatment: Outcomes, Adherence, and Toxicities
Saturday, October 11, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Background: Despite a favorable tolerability profile among the protease inhibitors, atazanavir (ATV) has been associated with hyperbilirubinemia (HBR). HBR is reversible upon ATV discontinuation and often asymptomatic but may sometimes lead to jaundice or scleral icterus. The goal of this study was to examine ATV persistence and adherence during the first year of therapy among HIV patients with and without HBR.

Methods: This retrospective analysis used medical and pharmacy claims and lab data from 7/1/03-8/31/12 for commercial members from a large US managed care database. Included patients had ≥1 pharmacy claims for ATV (first claim = index date), were age 18+, had ≥6 months of continuous enrollment prior to (baseline period, or b/l) and 12 months after (follow-up period, or f/u) the index date, and no b/l ATV use. HBR was defined by total bilirubin of ≥Grade 3 (>2.5x ULN) within 90 days of index; Non-HBR was defined as ≤Grade 2 (>1.5-2.5x ULN) in the 12-month f/u. Adherence was assessed using a medication possession ratio (MPR). Persistence was defined as the days on ATV until the earliest of discontinuation or end of the study period.

Results: Approximately one-third of the 3,268 ATV patients who met criteria had lab data available (131 HBR and 1,061 non-HBR). Mean age was 43.1 years, 82.6% were male, and 36.3% were treatment-naive. Patients in the HBR cohort were more likely to be male, have a bachelor degree or higher and be Caucasian compared to patients in the non-HBR cohort. Mean (SD) MPR (0.93 (0.10) vs. 0.92 (0.11); p=0.22) and persistence on ATV therapy (260 days (133) vs. 241 (143); p=0.15) in the f/u period were similar in the HBR and non-HBR cohorts.  After controlling for demographics, socioeconomic status, b/l Charlson comorbidity index, and concomitant HIV medications while receiving ATV in multivariate analyses, differences in adherence and persistence between the two cohorts remained non-significant.

Conclusion: In this large US managed care database analysis of approximately 1,200 HIV-infected patients on ATV, patients with HBR ≥Grade 3 did not show significant differences in adherence or persistence of ATV in the first year of therapy versus those who developed ≤Grade 2 HBR. HBR does not appear to influence persistence with ATV in a real-world setting.

Lisa Rosenblatt, MD1, Helene Hardy1, Teresita Grasso1, Ying Fan2 and James Burke, PhD2, (1)Health Economics and Outcomes Research, Bristol-Myers Squibb, Plainsboro, NJ, (2)Health Economics and Outcomes Research, Optum, Eden Prairie, MN


L. Rosenblatt, Bristol-Myers Squibb: Employee, Salary

H. Hardy, Bristol Myers Squibb: Employee, Salary

T. Grasso, Bristol Myers Squibb: Employee, Salary

Y. Fan, None

J. Burke, None

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