Background incidence rates of health outcomes of interest for COVID-19 vaccine safety monitoring in a US population: a claims database analysis.

OBJECTIVE: To evaluate background incidence rates of 59 health outcomes of interest (HOI) in a diverse population, including important subpopulations, during the pre-COVID-19 era (1 January 2017-31 December 2019) and the COVID-19 era (1 March 2020-31 December 2020), before the introduction of COVID-19 vaccines. DESIGN: Observational retrospective cohort study. Annual incidence rates and 95% confidence intervals (CIs) of HOIs were estimated for each population of interest, stratified by: age, sex, age and sex and seasonality. DATA SOURCE: Optum's de-identified Clinformatics Data Mart Database (CDM). PARTICIPANTS: Individuals from the US general population and four subgroups of interest: influenza-vaccinated, paediatric (<18 years of age), elderly (≥65 years of age) and pregnant women. RESULTS: During the COVID-19 era, the incidence of several cardiac conditions, coagulation disorders and acute liver injury increased across all populations assessed while the rates of some dermatological and neurological HOIs decreased relative to the pre-COVID-19 era. The incidence of acute respiratory distress syndrome (ARDS) varied considerably by subgroup: among the elderly, it decreased annually during the pre-COVID-19 era but peaked during the COVID-19 era; among pregnant women, it slightly increased annually during the pre-COVID-19 era and substantially increased during the COVID-19 era; among paediatrics, it decreased annually over the entire study. The incidence of the majority of HOIs increased with age, but were generally comparable between sexes with few exceptions. Cardiac, gastrointestinal, neurological and haematological HOIs, along with acute kidney injury and ARDS, were more common in males, whereas several immunological HOIs and chilblain-like lesions were more common in females. Pregnancy-related HOIs did not increase during the COVID-19 era, except for spontaneous abortions which increased annually over the entire study. CONCLUSION: These observations help contextualise fluctuations in background rates of adverse events noted during the COVID-19 era, and provide insight on how their use may impact safety surveillance for other vaccines.

Prevalence of Diagnosed Genital Herpes and Antiviral Treatment in the United States.

BACKGROUND: Genital herpes is a common sexually transmitted infection caused by the herpes simplex virus. Contemporary United States (US) population-based epidemiologic data on genital herpes are limited. This study aimed to provide nationally representative estimates of genital herpes prevalence and treatment using a large US health insurance claims database. METHODS: This observational cohort study used administrative claims data from HealthVerity. Crude and age- and sex-standardized prevalence rates of genital herpes and recurrent genital herpes were calculated for the years 2019 to 2021. The distribution of patients with prevalent genital herpes who received episodic or suppressive antiviral therapy was also estimated. RESULTS: From 2019 to 2021, the standardized prevalence of genital herpes and recurrent genital herpes ranged from 236 to 280 cases per 100,000 person-years and 81 to 98 cases per 100,000 person-years, respectively. The prevalence of genital herpes was highest among those aged 25-29 years (prevalence range: 497 to 582), female patients (prevalence range: 348 to 404), and those with a history of HIV infection (prevalence range: 1608 to 2080). The prevalence of recurrent genital herpes was also highest in these groups. From 2019 to 2021, two-thirds of patients (65% to 68%) with prevalent genital herpes received antiviral medications; the majority received episodic therapy (80%) rather than suppressive therapy (20%). CONCLUSIONS: The burden of genital herpes and recurrent genital herpes in the US is substantial, with the highest rates observed in young adults, women, and immunocompromised individuals. About two-thirds receive antiviral treatment each year.

Incidence of Herpes Zoster and Postherpetic Neuralgia and Herpes Zoster Vaccination Uptake in a US Administrative Claims Database.

Background: The objective of this study was to estimate the annual incidence rates of herpes zoster (HZ) and postherpetic neuralgia (PHN) among individuals aged ≥19 years and the proportion who received HZ vaccination among those aged ≥50 years. Methods: This observational cohort study was conducted with administrative claims data from HealthVerity and included insured individuals across the US. Crude and US age- and sex-standardized incidence rates of HZ and PHN were calculated from 1 January 2019 to 31 May 2022 by calendar year in persons aged ≥19 years. Outcomes were defined as ≥1 ICD-10 diagnosis code for HZ or PHN. Analyses were stratified by age, sex, and immunocompromised status. Among those aged ≥50 years, the proportion who received 1 or 2 doses of recombinant zoster vaccine (Shingrix) or 1 dose of Zostavax was calculated. Results: Standardized annual incidence rates from 2019 to 2021 were 542 to 685 per 100 000 person-years for HZ and 35 to 38 per 100 000 person-years for PHN. Rates were highest among females, older adults, and individuals who were immunocompromised. From 1 January 2019 to 31 May 2022, 4.3% and 9.0% of persons aged ≥50 years received 1 and 2 doses of Shingrix, respectively, and 0.2% received 1 dose of Zostavax. Conclusions: In this US claims database analysis, HZ and PHN were more frequent among older adults, females, and individuals who were immunocompromised. Between 1 January 2019 and 31 May 2022, 9% of persons aged ≥50 years received 2 doses of the Shingrix vaccine. Greater efforts are needed to increase vaccine uptake against HZ, especially for those at highest risk.

Statin Use and Severe Acute Liver Injury Among Patients with Elevated Alanine Aminotransferase.

Introduction: While serious liver injury among statin users is extremely rare, baseline liver enzyme testing is still recommended prior to initiating therapy. The benefit of such screening should be reevaluated based on empirical evidence. This study compared the risk of severe acute liver injury (SALI) between statin initiators with an elevated ALT (>35U/L) matched to statin initiators with a normal ALT level (≤35U/L). Statin initiators with an elevated ALT were additionally compared against matched non-users. Methods: The study created cohorts from Optum and MarketScan claims data. Exposed and comparison cohorts were propensity score (PS) matched in each dataset and findings were pooled using meta-analysis. Proportional hazards regression was used to estimate hazard ratios (HRs), and a prespecified non-inferiority margin for SALI was set at a HR of 1.8. Results: 232,889 patients with elevated ALT were PS-matched to 232,889 with normal ALT level. The overall incidence rate of SALI was about 19/100,000 person-years among statin initiators. Statin initiators with elevated ALT had no meaningfully increased risk of SALI compared to those with normal ALT (HR=1.15; 95% CI 0.75 to 1.75). Comparing statin initiators with non-initiators with elevated ALT values equally yielded no increased risk (HR=0.76; 95% CI 0.52 to 1.11). Conclusion: In this large population-based study, SALI in statin users was rare. Importantly, the results showed no evidence that baseline ALT status is a reliable indicator for an increased risk of severe liver injury among statin initiators.