‘Simple’ model predicts PegIFN response in chronic HBV
medwireNews: Chinese researchers have developed a scoring system based on hepatitis B virus (HBV)-related clinical parameters to predict response to pegylated-interferon (PegIFN) in chronic HBV patients.
Their “simple but practical” model could help to determine optimal candidates for PegIFN therapy, which the authors say is an important goal as PegIFN has “suboptimal efficacy, high cost, and multiple adverse events”.
In this study, reported in the Journal of Gastroenterology and Hepatology, 85 treatment-naïve patients were treated with PegIFN alpha-2a for 52 weeks and subsequently followed up for 24 weeks to assess response, defined as hepatitis B e antigen (HBeAg) seroconversion. Clinical parameters were evaluated at baseline, during treatment (at 12, 24 and 52 weeks) and at the end of the follow-up period.
Multivariate analysis showed that the major predictors of response at 76 weeks were levels of alanine aminotransferase (ALT), HBeAg and antibody to hepatitis B core antigen (anti-HBc), and decline in levels of HBeAg and HBV DNA. A scoring system was established using the three most relevant parameters at each timepoint, such that if a parameter met the optimal cutoff, a score of 1 was assigned, otherwise the patient scored 0, giving a total score of up to 3.
For instance, the most meaningful factors at baseline were ALT levels above five times the upper limit of normal, HBeAg levels no higher than 500 S/CO and anti-HBc levels over 10.7 S/CO. Using a prediction model based on these, response rates varied from 6.3% for patients who scored 0 and 90.0% for those who scored 3.
Similarly for scores of 0 versus 3 based on the relevant variables at weeks 12, 24 and 52, response rates were 12.5% versus 83.3%, 0.0% versus 76.9% and 0.0% versus 86.4%, respectively.
The team from Anhui Medical University found that scoring 0 or 1 correlated negatively with response rate at 76 weeks, which decreased with an increase in the number of instances of scoring 0 or 1. Participants who scored 1 or below at three or four timepoints had HBeAg seroconversion rates of 10.5% and 0.0%, respectively. By contrast, those with scores of 2 or above on three or four occasions had response rates ranging from 65.2% to 82.4%.
Zhen-Hua Zhang and colleagues thus propose that patients with a score of 0 at any timepoint or multiple scores of 1 should not receive PegIFN monotherapy, and other options should be considered. However, patients scoring 2 or 3 at baseline or on-treatment should continue and complete PegIFN treatment.
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