Purpose : Antiretroviral therapy (ART) adverse effects (AEs) can have a substantial impact on HIV patients' quality of life, healthcare resource utilization and adherence and persistence to ART. Atazanavir and darunavir are currently the only protease inhibitors preferred in first-line ART regimens in the Department of Health and Human Services (DHHS) antiretroviral treatment guidelines.� To date, atazanavir has not been compared to darunavir in either a clinical trial or the �real world� setting of routine care. This study is the first to compare the healthcare costs of medically-attended AEs in atazanavir- and darunavir-based ART among U.S. Medicaid patients receiving routine care. ��
Method : Retrospective study using Medicaid administrative healthcare claims from 15 States. Subjects were HIV patients aged 18�64 years initiating atazanavir- or darunavir-based ART from 1/1/2003�7/1/2010, with continuous enrollment for 6 months before (baseline) and 6 months after (evaluation period) ART initiation, and ≥1 evaluation period medical claim. Outcomes were per-patient-per-month (PPPM) healthcare costs of medically-attended (ICD-9-CM-coded or treated) AEs during the evaluation period. Five AEs were chosen for study from those listed within the DHHS antiretroviral treatment guidelines as being specific to atazanavir and darunavir: gastrointestinal; lipid abnormalities; diabetes/hyperglycemia; rash; jaundice.� All-cause healthcare costs were also examined. Atazanavir and darunavir patients were propensity score matched (ratio=3:1, nearest neighbor with calipers technique) using demographic and clinical covariates. Multivariable models adjusted for covariates lacking post-match statistical balance. ��
Result : Propensity-matched study sample included 1,848 atazanavir and 616 darunavir patients; mean age 41 years, 50% female, 69% black. Table displays unadjusted PPPM healthcare costs and adjusted PPPM healthcare cost differences (darunavir minus atazanavir). Jaundice occurred too infrequently to support multivariable modeling (11 instances in atazanavir, 1 in darunavir). ��
Conclusion : Compared to atazanavir patients, patients treated with darunavir incurred higher adjusted healthcare costs for medically-attended AEs as well as higher all-cause healthcare costs, the difference being statistically significant in the latter case.
Atazanavir unadjusted | Darunavir unadjusted | Adjusted difference (Darunavir minus Atazanavir) | ||
PPPM healthcare costs $, Mean [SD] |
|
| ||
� Gastrointestinal | $38 [$387] | $73 [$382] | $43 | p=0.132 |
� Lipid abnormalities | $14 [$544] | $0 [$4] | $3 | p=0.879 |
� Diabetes/hyperglycemia | $28 [$396] | $27 [$297] | $13 | p=0.693 |
� Rash | $96 [$1,253] | $62 [$518] | $0 | p=0.760 |
� Jaundice | $6 [$80] | $5 [$25] | n/a | n/a |
� All-cause healthcare | $3,879 [$6,635] | $5,354 [$8,127] | $1,086 | p<0.001 |
See more of: The 34th Annual Meeting of the Society for Medical Decision Making