Patients with HCV may not benefit from HAV vaccination

Rowe IA. Hepatology. 2012;doi:10.1002/hep.25683.

July 24 2012

Routine HAV vaccination in patients with HCV may not be cost-effective or beneficial to patients, according to recent study results.

In a meta-analysis of 10 studies, researchers evaluated the mortality risk from HAV superinfection among 22,371 patients with HCV who were vaccinated against HAV. Incorporated data included the type of study, data collection methods, diagnostic criteria, study length, the number of patients involved and the number of deaths attributed to HAV.

Investigators established a pooled OR of 7.23 (95% CI, 1.24-42.12) for mortality risk from HAV superinfection, which was equated with 1.4 deaths for every one million susceptible patients with HCV annually. Heterogeneity between studies was determined (I²=56%, P=.03), and this analysis excluded three studies reporting zero deaths. A subsequent analysis that incorporated all 10 studies and used a random effects model and continuity correction resulted in an OR of 6.88 (95% CI, 1.32-36.01).

Publication bias toward increased mortality risk was observed, with studies submitted as original articles reporting a higher mortality risk (OR=38.75; 95% CI, 7.33-204.84) while those published as correspondence suggested rates similar to the population risk (OR=0.86; 95% CI, 0.15-4.90).

Assuming an incidence rate of five cases of HAV superinfection for every 100,000 patients with HCV, researchers calculated the number needed to vaccinate (NNV) patients with HCV against HAV was 23,565 to prevent one case. The NNV to prevent one death annually was calculated at 814,849, with an estimated cost of $162 million for the vaccine, or $80.1 million per death prevented. Both calculations assumed a 94.3% efficacy rate and 90% uptake for the vaccine.

“These data challenge the use of routine HAV vaccination in HCV-infected persons and its incorporation into clinical practice guidelines,” the researchers wrote. “These findings highlight several key issues in the development of both guidelines and quality measures. Firstly, the assessment of the evidence and the benefit of interventions need occur in light of relevant prevalence data. Secondly, changes in prevalence need to be considered when guidelines or quality measures are revised or reassessed. Physicians otherwise run the risk of exposing many patients to interventions that are ultimately of no benefit to them.”

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