Patients with advanced cancer treated with immune checkpoint inhibitors (ICIs) have a lower risk of hepatitis B virus reactivation (HBVr), according to a study published in The Journal of Cancer The epidemic of poverty.
As immunotherapy becomes increasingly used to treat cancer, patient concerns about potential complications of HBVr following checkpoint blockade immunotherapy have increased, the researchers explained. More ICI clinical trials enable diverse patient groups to receive treatment. On the other hand, the researchers noted that most trials excluded patients with hepatitis B, resulting in a lack of efficacy and safety data.
Therefore, researchers conducted a study to assess the risk of HBVr in patients receiving ICIs for advanced cancer, with the primary outcome being the incidence of HBVr in patients with previous HBV infection or chronic hepatitis B receiving ICIs. . To this end, the researchers searched for relevant studies published before April 30, 2023, through a comprehensive search across multiple databases. The Newcastle-Ottawa Scale (NOS) was used to assess the quality of each study based on patient selection, comparability between groups, and outcome assessment. The researchers noted that “studies with less than 6 stars were considered to be of relatively low quality and were therefore excluded.”
Hepatitis B virus | Image source: Destina – stock.adobe.com.
They first searched 12,384 articles, and the researchers narrowed the scope to 34 studies published between 2018 and 2023, analyzing 7126 patients. Of these, 25 studies were conducted in Asia, 5 in the United States, 2 in Australia, 1 in New Zealand, and 1 in Italy. HBVr events occurred in 16 studies, with reactivation cases occurring in 123 patients. Therefore, the pooled HBVr rate was 1.3%, with risk estimates ranging from 0% to 30.0%, indicating considerable heterogeneity among included studies (95% CI, 0.2%-2.9%; I2 = 90.44%; ask < .001).
“ICI therapy can be considered close to low risk based on the thresholds recommended by the AGA (American Gastroenterological Association) Guidelines for the Prevention and Management of HBVr, which define an expected incidence of (less than) 1% of cases as low risk,” ” the author wrote.
The researchers also performed subgroup analyzes to identify sources of heterogeneity and examine how various factors influence HBVr risk in cancer patients receiving ICIs. They first performed a subgroup analysis to compare the incidence of HBVr between hepatocellular carcinoma (HCC) patients and non-HCC patients. The researchers found a response rate of 1.9% in patients with HCC and 1.9% in patients without HCC (95% CI, 0%-5.7%; I2 = 92.52%; ask < .001) and 0.5% (95% CI, 0%-2.2%; I2 = 72.37%; ask < .001), respectively.
Additionally, the researchers found a reactivation rate of 1.3% (95% CI, 0%-4.5%; I2 = 87.44%; ask < .001) and 0% (95% CI, 0%-0%; I2 = 0; ask = 0.796, respectively. This suggests that patients with positive HBsAg status are at higher risk for HBVr infection than patients with negative HBsAg status.
Finally, they analyzed the study according to regional economic development levels classified by the International Monetary Fund (IMF), comparing HBVr rates in developing and developed regions. A meta-analysis of 14 studies from developing regions showed a pooled HBVr rate of 2.9% (95% CI, 0.2%-7.5%; I2 = 91.85%; ask < .001), the reactivation rate in 20 studies from developed countries was 0.2% (95% CI, 0%-1.0%; I2 = 72.91%; ask < .001). The researchers learned that reported reactivation rates varied widely from region to region.
They acknowledged the study’s limitations, one of which is that it did not cover all ICIs or cancer types, meaning the findings may not be generalizable to all populations. Furthermore, since most of the included studies were retrospective, they noted that this could lead to a high degree of selection bias. Despite these limitations, the researchers explain that such a meta-analysis is necessary given the critical situation in hepatitis B prevention and control and the urgent need for evidence-based information. Therefore, they call for further research based on their findings.
“Further research is needed to extend these findings and better understand the risks associated with ICI-based treatment of advanced cancer in patients with hepatitis B,” the authors concluded.
refer to
Xia Z, Zhang J, Chen W, et al. Hepatitis B reactivation in cancer patients receiving immune checkpoint inhibitors: a systematic review and meta-analysis. infectious disease poverty. 2023;12(1):87. Number: 10.1186/s40249-023-01128-6