Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir
- Conditions
- HIV/AIDS
- Registration Number
- NCT02532673
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine whether HIV patients on Atazanavir who have Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
- Diagnosis of Human immunodeficiency virus
- Treatment with Atazanavir
- 18 yrs and older
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Atazanavir compliance among treated patients who develop hyperbilirubinemia compared with Atazanavir-treated patients without evidence of hyperbilirubinemia One year after starting Atazanavir Discontinuation rate, defined as proportion of patients having discontinued Atazanavir at 1 year, of HBR vs. non-HBR patients. Persistence, defined as mean days to Atazanavir discontinuation, of HBR vs non-HBR patients. Compliance defined as mean medication-possession ratio of HBR vs non-HBR patients
Atazanavir persistence among treated patients who develop hyperbilirubinemia compared with Atazanavir-treated patients without evidence of hyperbilirubinemia One year after starting Atazanavir Discontinuation rate, defined as proportion of patients having discontinued Atazanavir at 1 year, of HBR vs. non-HBR patients. Persistence, defined as mean days to Atazanavir discontinuation, of HBR vs non-HBR patients. Compliance defined as mean medication-possession ratio of HBR vs non-HBR patients
- Secondary Outcome Measures
Name Time Method Rate of Human immunodeficiency virus viral suppression among patients treated with Atazanavir who develop hyperbilirubinemia compared with patients without evidence of hyperbilirubinemia 1 year Health care resource utilization for HBR vs non-HBR patients 1 year Health care resource utilization:
Binary indicators and counts of mean number of ambulatory visits (office and outpatient), ER visits, and inpatient admissions over 12 months will be calculated. Total number of inpatient days and mean length of inpatient stay will also will be captured.Liver function based on Alanine aminotransferase and Aspartate aminotransferase test results among patients treated with Atazanavir who develop hyperbilirubinemia compared with patients without evidence of hyperbilirubinemia 1 year Changes (increase, decrease, no change) in the grade of bilirubin laboratory test results during follow-up among Atazanavir-treated patients who develop hyperbilirubinemia 1 year Grade of the bilirubin test result will be captured and defined as follows: Grade 0 = normal; Grade 1 ≥ 1.0 to 1.5 times the upper limit of normal (x ULN), Grade 2 ≥1.5 to 2.5 x ULN; Grade 3 ≥ 2.5 to 5 x ULN; Grade 4 ≥ 5 x ULN
The upper limit of normal range was used to standardize the laboratory results across different lab systems. Each laboratory vendor provides a normal range for their results. These results were then transformed based on the normal ranges provided. The ranges below were used to categorize the patients:
=0, if result in normal rage
=1, if result \> 1.0-1.5 times the upper limit of normal (x ULN)
=2, if result \> 1.5-2.5 x ULN
=3, if result \> 2.5-5 x ULN
=4, if result \> 5 x ULNHealthcare costs for HBR vs non-HBR patients 1 year Health care costs:
Health care costs will be computed as the combined health plan and patient paid amounts for all claims in the 12-month post-index period. Mean costs will be calculated for total costs, medical costs, pharmacy costs, ambulatory costs, emergency services costs, inpatient costs, and other costs.
* Costs will be adjusted into 2013 US dollars using the annual medical care component of the Consumer Price Index (CPI) to reflect inflation between 2003 and 2013