Real-world utilization and outcomes of systemic therapy among patients with advanced or recurrent endometrial cancer in the United States

OBJECTIVE: Evaluate systemic therapy utilization patterns and outcomes by line of therapy among patients with advanced/recurrent endometrial cancer (EC) treated in the United States. METHODS: This retrospective observational study used the Optum Clinformatics Extended Data Mart Date of Death database (1 January 2004-31 December 2019) and included de-identified data from adult patients with advanced/recurrent EC who were treated with first-line (1L) platinum-based chemotherapy and initiated second-line (2L) anti-neoplastic therapy. The index date was the date of 1L therapy initiation. The number and sequence of treatments received and the proportion of patients who received each type of treatment for each line of therapy were evaluated. To account for new drug approvals, patients first treated in 2018 or 2019 were also assessed separately. RESULTS: Among the 1317 patients who met all eligibility criteria, 520 (39.5%) and 235 (17.8%) patients received 3 or 4+ lines of treatment, respectively, during a median total follow-up time of 25.2 months (range, 2.5-173.3 months) following the index date. Chemotherapy, including platinum- and non-platinum-based regimens, was the most common treatment across all lines of therapy: 2L, 80.0%; 3L, 66.2%; 4L+, 80.4%. Overall, 2.5%, 2.3%, and 8.9% of 2L, 3L, and 4L + patients, respectively, received anti-program death 1 (anti-PD-1) immunotherapies. In patients first treated in 2018 and 2019 ( CONCLUSIONS: Among patients with advanced/recurrent EC treated with 1L platinum-based therapy in clinical practice, chemotherapy was the most common treatment choice across all lines of therapy. Immunotherapy use was low overall but increased in patients who started treatment in 2018 or 2019. Overall, median TTNT decreased as lines of therapy increased

Medication-Taking Practices of Patients on Antiretroviral HIV Therapy: Control, Power, and Intentionality

Among people living with HIV (PLWH), adherence to antiretroviral therapy (ART) is crucial for health, but patients face numerous challenges achieving sustained lifetime adherence. We conducted six focus groups with 56 PLWH regarding ART adherence barriers and collected sociodemographics and ART histories. Participants were recruited through clinics and AIDS service organizations in North Carolina. Dedoose software was used to support thematic analysis. Participants were 59% male, 77% black, aged 23–67 years, and living with HIV 4–20 years. Discussions reflected the fluid, complex nature of ART adherence. Maintaining adherence required participants to indefinitely assert consistent control across multiple areas including: their HIV disease, their own bodies, health care providers, and social systems (e.g., criminal justice, hospitals, drug assistance programs). Participants described limited control over treatment options, ART's impact on their body, and inconsistent access to ART and subsequent inability to take ART as prescribed. When participants felt they had more decision-making power, intentionally choosing whether and how to take ART was not exclusively a decision about best treating HIV. Instead, through these decisions, participants tried to regain some amount of power and control in their lives. Supportive provider relationships assuaged these struggles, while perceived side-effects and multiple co-morbidities further complicated adherence. Adherence interventions need to better convey adherence as a continuous, changing process, not a fixed state. A perspective shift among care providers could also help address negative consequences of the perceived power struggles and pressures that may drive patients to exert control via intentional medication taking practices

Brief Report: Factors Associated With the Selection of Initial Antiretroviral Therapy From 2009 to 2012

We examined factors associated with selection of initial antiretroviral regimen in the CNICS cohort. Patients initiating antiretroviral therapy (ART) between July 2009 and Dec 2012 were classified as receiving an NNRTI, boosted-PI, or raltegravir-based regimen. Among 873 patients initiating ART, 488 regimens contained an NNRTI, 319 a boosted-PI, and 66 raltegravir. Patients with depression and women were less likely to receive an NNRTI, while those with underlying cardiovascular disease, liver disease, and those co-infected with hepatitis C were more likely to receive raltegravir. Those with baseline viral load > 100,000 c/ml and those with substance use were more likely to receive a boosted PI. Thus, in the ‘real world’ ARV regimen choices appear to take into account adverse effects and patient baseline characteristics. Factors that impact initial regimen selection will likely become more heterogeneous over time as more choices for HIV therapy become available

Quality of life of HIV-infected patients who switch antiretroviral medication due to side effects or other reasons

<p><b>Objective: </b>The objective of this study was to investigate changes in health-related quality of life (HRQOL) among HIV patients following switch from a first- to second-line antiretroviral therapy (ART) regimen.</p> <p><b>Research design and methods:</b> This was an observational study of adult HIV patients in the US at 35 academic and community health centers. Patients were required to be switching an antiretroviral regimen for the first time at the enrollment visit. Patients were assigned to a study cohort based on whether the switch was due to treatment-related side effects or for any other reason as reported by their physician. Patients completed the Medical Outcomes Study–Human Immunodeficiency Virus (MOS-HIV) health survey, the Depression, Anxiety, and Stress Scale Short Form (DASS-21), and the Human Immunodeficiency Virus Treatment Satisfaction Questionnaire–status (HIVTSQs) at the enrollment visit (baseline) and a follow-up survey was completed approximately 4 weeks later. The within cohort change in survey measures from baseline to follow-up was assessed by two-sample paired <i>t</i>-test.</p> <p><b>Results:</b> Patients who switched their ART regimen due to treatment-related side effects (<i>n</i> = 50) had statistically significant improvements (<i>p</i> < .05, baseline to follow-up) in mean Physical and Mental Health Summary scores (MOS-HIV scale) and in all three HIVTSQ summary scores. Patients who switched for other reasons (<i>n</i> = 44) did not experience statistically significant improvements in these same measures.</p> <p><b>Conclusions:</b> HIV patients whose regimen was switched due to treatment-related side effects experienced an improvement in QOL following the switch. Physicians should take the potential impact on QOL into consideration when deciding on a switch in ART regimen, particularly when patients are intolerant of their current treatment. The results are based on a patient survey and may have been influenced by recall and response bias.</p

Economic Burden of HIV Antiretroviral Therapy Adverse Events in the United States

Objective: To estimate health care costs associated with medical events identified as antiretroviral therapy (ART)-attributable adverse events (AEs). Methods: During September 2006 to June 2012, adults with ≥1 HIV International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code (042/V08), ≥1 claim for ART prescription (March 2007-June 2011; index date), and continuous health plan enrollment for ≥6 months pre- and ≥12 months postindex were included (IMS’ PharMetrics Plus Health Plan Claims Database). Patients with events of interest/ART claim during preindex period or with pregnancy/hepatitis C virus diagnosis/hepatitis B virus/cancer/tuberculosis during the study period were excluded. Postindex medical events were defined as first diagnosis code of event with ART claim ≤60 days prior to start of the event. Results: Differences in median total all-cause health care costs observed for diabetes/insulin resistance management (US$14 547 median all-cause health care costs during time periods identified as diabetes/insulin resistance medical events versus US$11 237 without diabetes/insulin resistance events; P = .0021), lipid disorders (US$12 825 versus US$10 033; P = .0004), and renal disorders (US$1389 versus US$0; P < .0001). Discussion/Conclusion: Health care costs of ART AEs should be key consideration for payers/providers in HIV management