Dataset Information

Duration of Antiviral Prophylaxis and Risk of Herpes Zoster among Patients Receiving Autologous Hematopoietic Stem Cell Transplants: A Retrospective, Observational Study.

ABSTRACT:

Introduction

There are no real-world data on antiviral prophylaxis (AP) duration and risk of herpes zoster (HZ) given AP duration in patients receiving autologous hematopoietic stem cell transplants (auto-HSCT). The objectives of this study are to describe the duration of AP and to compare incidence of HZ by AP duration in auto-HSCT patients.

Methods

This is a retrospective, observational database (Marketscan^®) study. This study included patients ≥18 years old who had auto-HSCT during 2009-2013, had chemotherapy within 60 days prior to auto-HSCT (latest chemotherapy date within the 60 days was the study enrollment date), and had continuous health plan enrollment for at least 365 days before and after the study enrollment date. AP duration was the sum of days supply of all AP prescriptions from 30 days before to 365 days after the study enrollment date. Patients were followed from the study enrollment date to the end of continuous health plan enrollment, death, or December 31, 2014 to assess HZ incidence. The Cox proportional hazards model was used to examine the association between the risk of HZ and AP duration.

Results

This study identified 1959 eligible auto-HSCT patients, of whom 93.0% were prescribed AP. Average AP duration was 220 days (SD = 122), while 200 (11%) patients had AP for ≥1 year. HZ incidence was 42.4/1000 person-years (PY) (95% CI 36.5, 49.0) for the overall auto-HSCT cohort. Among patients who received AP, duration of AP prescriptions and HZ incidence were inversely related. Compared with patients who were on AP for 1-89 days, patients with AP duration of 180-269 days [hazard ratio (HR) = 0.576, p = 0.019], 270-359 days (HR = 0.594, p = 0.023), and ≥360 days (HR = 0.309, p < 0.001) had significantly lower risk of HZ.

Conclusion

Auto-HSCT patients are at increased risk for HZ, even when prescribed AP. A safe and effective vaccine against HZ for auto-HSCT patients could be a useful adjunctive prevention strategy.

SUBMITTER: Zhang D

PROVIDER: S-EPMC5504229 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundMultiple myeloma (MM) is known for its immune disturbance and patients suffering from MM are thus vulnerable to opportunistic infections, including herpes zoster (HZ). As HZ infection remarkably affects patients' quality of life and poses huge economic burdens on the health system, we aim to identify the risk factors of HZ infection and evaluate the effects of different dosages, types, and durations of anti-HZ prophylaxis drugs to prevent HZ infection.Methods551 MM patients at Taipei Veterans General Hospital in Taiwan between January 1, 2009 and August 31, 2021 were restrospectively analyzed. The patients' baseline characteristics were recorded. The primary endpoint of the study was the incidence of HZ infection among the studied patient population. Due to the lack of cost coverage from Taiwanese public health insurance on HZ prophylaxis drugs, the use of anti-HZ drugs mainly depends on physicians' preferences and patients' choices.ResultsIn our study, prophylaxis was given to 283 of the patients. In the multivariate analysis, we included non-prophylaxis, age ≥ 60, corrected serum calcium ≥12 mg/dl, serum creatinine ≥2 mg/dl, serum β2-microglobulin ≥5500 mg/L, autologous stem cell transplant (SCT), and allogeneic SCT for analysis. Our results demonstrated that the non-prophylaxis group (HR: 2.37, 95% CI 1.57-3.57) and patients receiving autologous SCT (HR: 2.22, 95% CI 1.28-3.86) and allogeneic SCT (HR: 5.12, 95% CI 1.13-23.22) had higher risk of HZ infection. The difference in dosage and types of anti-HZ drugs showed similar protective effects. In patients who stopped anti-HZ prophylaxis before active cancer-related treatment, a higher risk of getting HZ infection compared to the corresponding group was also observed (adjusted HR 3.09, 95% CI 1.35-7.07, p = 0.008).ConclusionsWe concluded that MM patients should receive HZ prophylaxis drugs while receiving active cancer-related treatment. Patients receiving SCT are also at high risk of getting HZ infection, even under prophylaxis.

Project description:ImportanceHerpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster.ObjectiveTo assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients.Design, setting, and participantsPhase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT.InterventionsParticipants were randomized to receive 2 doses of either recombinant zoster vaccine (n = 922) or placebo (n = 924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter.Main outcomes and measuresThe primary end point was occurrence of confirmed herpes zoster cases.ResultsAmong 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P < .001), equivalent to 68.2% vaccine efficacy. Of 8 secondary end points, 3 showed significant reductions in incidence of postherpetic neuralgia (vaccine, n=1; placebo, n=9; IRR, 0.1; 95% CI, 0.00-0.78; P = .02) and of other prespecified herpes zoster-related complications (vaccine, n=3; placebo, n=13; IRR, 0.22; 95% CI, 0.04-0.81; P = .02) and in duration of severe worst herpes zoster-associated pain (vaccine, 892.0 days; placebo, 6275.0 days; hazard ratio, 0.62; 95% CI, 0.42-0.89; P = .01). Five secondary objectives were descriptive. Injection site reactions were recorded in 86% of vaccine and 10% of placebo recipients, of which pain was the most common, occurring in 84% of vaccine recipients (grade 3: 11%). Unsolicited and serious adverse events, potentially immune-mediated diseases, and underlying disease relapses were similar between groups at all time points.Conclusions and relevanceAmong adults who had undergone autologous HSCT, a 2-dose course of recombinant zoster vaccine compared with placebo significantly reduced the incidence of herpes zoster over a median follow-up of 21 months.Trial registrationClinicalTrials.gov Identifier: NCT01610414.