Scott Sutton S, Magagnoli Joseph, Hardin James W
Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, South Carolina College of Pharmacy, Columbia, South Carolina.
Health and Demographics, South Carolina Revenue and Fiscal Affairs Office, Columbia, South Carolina.
Pharmacotherapy. 2016 Apr;36(4):385-401. doi: 10.1002/phar.1728. Epub 2016 Apr 13.
To evaluate the impact of pill burden on outcomes in patients with human immunodeficiency virus (HIV) infection and acquired immune deficiency syndrome (AIDS) receiving antiretroviral therapy (ART) as a single-tablet regimen (STR) or multiple-tablet regimen (MTR).
Retrospective cohort study.
South Carolina Medicaid medical and pharmacy paid claims data were obtained from the South Carolina Revenue and Fiscal Affairs Office; laboratory data were obtained from the South Carolina Department of Health and Environmental Control.
A total of 2174 patients covered by South Carolina Medicaid who were dispensed a complete ART STR (580 patients) or MTR (1594 patients) lasting at least 60 days between January 1, 2006, and December 31, 2013.
Outcomes were ART adherence; risk of, time to, and total number of hospitalizations; and viral load suppression. Patients were followed from the index date (start date of their complete ART regimen) until the earliest date of one of the following: treatment discontinuation; treatment switch from MTR to STR, or vice versa; end of study period; last date of Medicaid eligibility; or death. Differences in outcomes were evaluated by using bivariate χ(2) and Wilcoxon rank sum tests, as well as multivariate regression models controlling for covariates measured during a 6-month baseline period. The STR and MTR cohorts were, on average, similar in terms of age at index date, Charlson Comorbidity Index score, sex, drug abuse, and mental health diagnoses, but they differed significantly in racial composition, index year of regimen, previous treatment, baseline viral load, and CD4 measures. The bivariate analysis revealed that the STR cohort was more adherent (p<0.0001), had a lower risk of hospitalization (p=0.0076), and had a higher proportion of patients with viral suppression (64.5% vs 49.5%, p<0.0001). In addition, multivariate regression models revealed that the STR cohort was more adherent and was associated with a lower risk of hospitalization (hazard ratio 0.71, 95% confidence interval 0.59-0.86), but no significant difference in viral load suppression was noted between the STR and MTR cohorts.
The STR was associated with higher adherence rates and a lower risk of hospitalization (both in the adjusted and unadjusted analyses) in South Carolina Medicaid patients with HIV infection and AIDS. A higher proportion of patients in the STR cohort had viral suppression during the follow-up period in the unadjusted analysis compared with the MTR cohort; however, no significant difference in viral suppression was observed when controlling for adherence.
评估药丸负担对接受抗逆转录病毒治疗(ART)的人类免疫缺陷病毒(HIV)感染和获得性免疫缺陷综合征(AIDS)患者采用单片复方制剂(STR)或多片复方制剂(MTR)治疗结局的影响。
回顾性队列研究。
南卡罗来纳医疗补助计划的医疗和药房付费索赔数据来自南卡罗来纳州税收和财政事务办公室;实验室数据来自南卡罗来纳州卫生与环境控制部。
共有2174名参加南卡罗来纳医疗补助计划的患者,他们在2006年1月1日至2013年12月31日期间接受了至少60天的完整ART STR(580例患者)或MTR(1594例患者)治疗。
结局指标为ART依从性;住院风险、住院时间及住院总次数;以及病毒载量抑制情况。从索引日期(完整ART治疗方案开始日期)开始对患者进行随访,直至以下最早日期之一:治疗中断;从MTR转换为STR或反之的治疗转换;研究期结束;医疗补助资格的最后日期;或死亡。通过双变量χ²检验和Wilcoxon秩和检验以及控制6个月基线期测量的协变量的多变量回归模型评估结局差异。STR组和MTR组在索引日期的年龄、Charlson合并症指数评分、性别、药物滥用和心理健康诊断方面平均相似,但在种族构成、治疗方案的索引年份、既往治疗、基线病毒载量和CD4测量方面存在显著差异。双变量分析显示,STR组的依从性更高(p<0.0001),住院风险更低(p=0.0076),病毒抑制患者的比例更高(64.5%对49.5%,p<0.0001)。此外,多变量回归模型显示,STR组的依从性更高,且与较低的住院风险相关(风险比0.71,95%置信区间0.59-0.86),但STR组和MTR组在病毒载量抑制方面未观察到显著差异。
在南卡罗来纳州感染HIV和AIDS的医疗补助患者中,STR与更高的依从率和更低的住院风险相关(在调整和未调整分析中均如此)。在未调整分析中,与MTR组相比,STR组在随访期间有更高比例的患者实现病毒抑制;然而,在控制依从性后,未观察到病毒抑制方面的显著差异。