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1rem

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The words HIV or AIDS do not appear in the title of this book, and at first glance, this book appears to be about something else. On the contrary, it is about HIV and much more.

Public Health and Human Rights: Evidence-Based Approaches

A 66-year-old woman had a mildly pruritic rash on the buttocks, lower back, abdomen, and upper posterior thighs. The eruption had been present for approximately 18 months.

A 66-year-old woman had a mildly pruritic rash on the buttocks, lower back, abdomen, and upper posterior thighs. The eruption had been present for approximately 18 months. Your diagnosis?

Clinical Topics

“Swimsuit Area” Rash: Your Dx?

Eli Lilly has shared positive study data from its QWINT clinical trial program evaluating once weekly insulin 

 (efsitora) in adults with type 2 diabetes. Across the QWINT-1 and QWINT-3 Phase III studies, efsitora demonstrated non-inferior A1C reduction compared to other popular daily basal insulins.

Lilly has previously described the novel weekly basal insulin as a “fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain.” The once-weekly subcutaneous formulation's low peak-to-trough ratio allows more stable glucose levels over the 7-day interval, according to Lilly. The company’s QWINT clinical trial program is evaluating efsitora for adults with type 1 and type 2 diabetes.

The QWINT-1 trial was a parallel-design, open-label, treat-to-target, randomized controlled study. It evaluated the efficacy and safety of efsitora compared to once daily insulin glargine for 52 weeks. The trial randomized 796 adults with type 2 diabetes who are insulin naïve to receive either efsitora once weekly in a single-use autoinjector or insulin glargine once daily.

Results from QWINT-1 showed efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine. With this mark, the trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin glargine at week 52.

The second Phase III study, QWINT-3, evaluated efsitora compared to once daily insulin degludec for 78 weeks in adults with type 2 diabetes currently treated with basal insulin. It was a multicenter, randomized, parallel-design, open-label trial. QWINT-3 randomized 986 participants 2:1 to receive either efsitora once weekly or insulin degludec once daily.

Like QWINT-1, QWINT-3 met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 26. Results showed efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec.

"Once weekly insulins, like efsitora, have the potential to transform diabetes care as we know it," Jeff Emmick, MD, PhD, senior vice president, product development, Lilly, said in a press release. "Many patients are reluctant to start insulin because of the burden it places on them. With a simple fixed-dose regimen, once-weekly efsitora could make it easier for people with diabetes to start and manage insulin therapy, while reducing the impact it has on their day-to-day lives."

Lilly plans to share more detailed results from both trials at an upcoming conference and have them published in a peer-reviewed journal.

In May, efsitora alfa met the primary endpoint of HbA1c reduction noninferior to the most commonly used daily basal insulins in another pair of phase 3 studies, QWINT-2 and QWINT-4, that found the antihyperglycemic equally safe and effective in adults naïve to insulin therapy and regardless of GLP-1 mimetic use.

1. In a first-of-its-kind fixed dose study, once weekly insulin efsitora alfa leads to A1C reduction similar to daily insulin. News release. Eli Lilly. September 5, 2024. Accessed September 6, 2024. https://investor.lilly.com/news-releases/news-release-details/first-its-kind-fixed-dose-study-once-weekly-insulin-efsitora

2. With once-a-week dosing, insulin efsitora alfa delivers A1c reduction and safety profile consistent with daily insulin. News release. Lilly. May 16, 2024. Accessed September 6, 2024. https://investor.lilly.com/news-releases/news-release-details/once-week-dosing-insulin-efsitora-alfa-delivers-a1c-reduction

Across two clinical trials in the QWINT program, once-wekly efsitora showed comparable A1C reduction to frequently used daily insulins.

Efsitora Alfa, Eli Lilly’s Once Weekly Insulin, Has Positive Topline Results in Two Trials

 (LCS) criteria had higher sensitivity and specificity for identifying people who would benefit most from the low-dose CT (LDCT) scan than criteria recommended by the United States Preventive Services Task Force (USPSTF), according to research published online August 19 in the 

Specifically, the alternative criteria had 91% sensitivity vs USPSTF sensitivity of 78%, and specificity of 86% vs 84%, respectively, (both 

 <.001). For racial and ethnic minority groups, the alternative screening criteria provided more significant gains in sensitivity vs the USPSTF criteria at similar specificity (

Further, according to study authors the alternative criteria identified high-risk, high benefit groups excluded by current USPSTF criteria, ie, Black and other racial/ethnic minorities, individuals at high benefit, those with long duration of smoking (≥40 years ) but at lower intensity (<20 pack years) and those who smoked heavily but quit more than 15 years before the study.

Screening for lung cancer with LDCT has been shown to reduce mortality rates among individuals at high risk for the disease. Lead author Lauren Kearney, MD, of Boston University’s Chobanian & Avedisian School of Medicine in Massachusetts, and colleagues, cite updated LCS screening guidelines issued by the 

 that reduced the starting age for screening from age 55 to 50 years and adjusted duration of smoking history from 30 pack years to 20 pack years. The revisions aimed to help identify lung cancer in earlier stages when it is more treatable and also to help reduce racial and ethnic disparities in eligibility compared with the 2013 USPSTF statement.

Currently, USPSTF recommends LCS for individuals who meet all of 3 criteria: age 50 to 80 years, a smoking history of at least 20 pack-years, and currently smoking or having quit within the previous 15 years. Uptake of the early detection screening continues to be low, however, and modeling studies reviewed by the research team suggest that “the USPSTF criteria may not be optimally effective, efficient, or cost-effective because many people who would derive high benefit from LCS [are still] ineligible."

Uptake of the early detection screening continues to be low, however, and modeling studies reviewed by the research team suggest that “the USPSTF criteria may not be optimally effective, efficient, or cost-effective because many people who would derive high benefit from LCS [are still] ineligible."

Kearny et al used model-based projections to explore whether the use of alternative and simplified LCS criteria could identify a greater proportion of individuals who would derive "high benefit" from regular cancer screening. “High benefit” was defined for the study as “gaining an average of at least 16.2 days of life from 3 annual screenings.” The selected alternative criteria expanded the duration and amount of smoking, to include people who smoked any amount every year for at least 40 years and people aged 60 to 80 years with a history of at least 40 pack-years of smoking.

Investigators tapped data for from the 1997-2014 National Health Interview Survey (NHIS) for development of potential alternative screening criteria, and from the 2014-2018 NHIS and the 2022 Behavioral Risk Factor Surveillance System to compare the USPSTF criteria to the selected alternative criteria for sensitivity and specificity for identifying individuals with greatest eligibility for LCS. The final evaluation set numbered 31,975, a group authors said matched the trends in recent years for older adults who have lower pack-year history and more quit-years.  

The team found, based on model projections, that use of the alternative criteria significantly increased the number of people eligible for LCS with higher sensitivity and specificity compared with the USPSTF guidelines, particularly among racial and ethnic groups, as noted.

According to the study findings, the simple criteria compared with the USPSTF criteria, were also more specific in identifying individuals not considered high benefit in both the NHIS (88% vs. 86%; 

< .001) and the BRFSS 2022 (83% vs. 81%; 

To be clear, no simple criteria will have “perfect specificity” for identifying individuals with potential for high benefit from LCS, Kearney and colleagues wrote, adding that the alternative criteria explored in this study did outperform the USPSTF. However, “By definition, only the full prediction model has perfect specificity.” Assessing individualized risks and benefits requires shared clinical decision making as well as a prediction model, they said.

“The [simple alternative lung cancer screening criteria] we identified would result in more effective screening, lead to better support of the ethical principle of ‘equal management for equal risk,’ and substantially reduce racial disparities,” Kearney and colleagues wrote. “These…easy-to-remember criteria that use information already routinely collected for LCS decisions represent a way to improve or augment current eligibility criteria.”

Simple criteria for lung cancer screening identified more people who would highly benefit, including more from racial/ethnic minority groups.  
 

Alternative Lung Cancer Screening Criteria Expand Eligible Population vs USPSTF Guidance 

H. F. Pizer, eds

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