Differential Utility Losses in Herpes Zoster Cases Between Vaccinated and Unvaccinated Subjects: A Meta-analysis of Three Clinical Trials

• Published in: Clinical drug investigation Vol. 44; no. 5; pp. 293 - 301
• Main Authors: Giannelos, Nikolaos, Francq, Bernard, Curran, Desmond
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.05.2024; Springer Nature B.V
• Subjects: Activities of daily living; Clinical trials; Clinical Trials as Topic; Health economics; Herpes viruses; Herpes Zoster - immunology; Herpes Zoster - prevention & control; Herpes Zoster Vaccine - administration & dosage; Humans; Internal Medicine; Medicine; Medicine & Public Health; Original; Original Research Article; Pain; Patients; Pharmacology/Toxicology; Pharmacotherapy; Quality of life; Quality-Adjusted Life Years; Sensitivity analysis; Unvaccinated Persons; Vaccination - methods; Vaccines; United States > US
• ISSN: 1173-2563; 1179-1918; 1179-1918
• DOI: 10.1007/s40261-024-01355-1

Background and Objective Recombinant zoster vaccine (RZV) is approved in adults for the prevention of herpes zoster. The effect of RZV in moderating the severity of breakthrough cases of herpes zoster has been noted but not explicitly quantified before. In this study, a meta-analysis was undertaken to estimate differential utility losses between unvaccinated (Placebo) and vaccinated (RZV) subjects in breakthrough cases of herpes zoster from three RZV clinical trials. Methods Differential utility losses between the two groups were estimated in units of quality-adjusted life-years (QALYs), leveraging aggregate patient data from the ZOE-50 (NCT01165177), ZOE-70 (NCT01165229), and ZOE-HSCT (NCT01610414) clinical trials. Differential utility losses and the ratio of mean utility losses were analyzed using random-effects and fixed-effects meta-regression models. Results The mean QALY loss differences between the unvaccinated (Placebo) and vaccinated (RZV) groups were 0.008, 0.004, and 0.011 in the ZOE-50, ZOE-70, and ZOE-HSCT studies, respectively, yielding an overall estimated difference of 0.007 (95% confidence interval 0.002–0.012) QALYs. Quality-adjusted life-year loss in the vaccinated group was estimated to be 35.5% of the value in the placebo group. A sensitivity analysis estimated an overall difference of 0.005 (95% confidence interval 0.001–0.009) QALYs, corresponding to 48.6% of the QALY loss value in the placebo group. Conclusions Recombinant zoster vaccine is effective in alleviating disease severity in breakthrough cases of herpes zoster. The results may be useful in distinguishing QALY losses between vaccinated and unvaccinated cohorts in health economics studies, particularly cost-effectiveness analyses. Plain Language Summary Herpes zoster, also known as shingles, may cause painful rashes and persistent pain for months or even years after the initial episode. Recombinant zoster vaccine is approved for the prevention of shingles. Pivotal recombinant zoster vaccine clinical trials have reported data about the impact of shingles episodes on daily activities and overall health-related quality of life. In this work, we combined data from three recombinant zoster vaccine clinical trials and compared the loss in quality of life—measured in quality-adjusted life-years—incurred by vaccinated and unvaccinated subjects who experienced a shingles episode. We found that vaccinated patients experienced lower quality-adjusted life-year losses when they developed shingles compared with unvaccinated patients. Our results may be useful in assessing quality-adjusted life-year losses between vaccinated and unvaccinated cohorts in future herpes zoster vaccination health economics analyses.