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Pegylated interferon lowers HDV RNA after 24 weeks
Keskin O, et al. Clin Gastroenterol Hepatol. 2015;doi:10.1016/j.cgh.2015.05.029.
December 3, 2015
Analysis of data from the Hep-Net-International Delta Hepatitis Intervention Trial showed that pegylated interferon lowered hepatitis D virus RNA, with or without adefovir, and predicted clearance rate 24 weeks post-treatment.
Data of 50 patients with compensated liver disease and positive for anti-HDV and HDV RNA were treated with pegylated interferon alpha 2a and adefovir, adefovir alone or placebo for 48 weeks. Of these patients, 41 were evaluated for various parameters 24 weeks after treatment, including measurement of HDV RNA level, liver enzymes, and hepatitis B surface antigen (HBsAg).
According to univariate and multivariate analyses, the researchers found that HDV RNA serum at 24 weeks of therapy was associated more closely with a response to therapy than other factors. HBsAg serum at 24 weeks was found to be associated with a response to treatment only in univariate analysis.
Univariate analysis also showed that patients with an end of treatment virologic response had a greater baseline histology activity score compared with patients who did not experience virologic response. The patients who reached a viroloigc response had lower mean HDV RNA serum levels at 24 weeks compared with nonresponders, as well as had a greater likelihood to have a decrease in HBsAg serum compared with patients who did not reach an end of treatment virologic response.
Using the area under receiver operating characteristic curve (AUROC) for predictive analysis, the AUC for HDV RNA levels at 24 weeks of treatment was 0.862 for predicting a virologic response 24 weeks after the end of treatment.
Positive predictors for the absence of HDV RNA at 24 weeks of therapy (71%) and end of treatment (100%) were also identified using AUROC.
At 24 weeks post-treatment, a decrease in HDV RNA serum of less than 1 log with no decrease in HBsAg serum showed null responders with a positive predictive value of 83%. In addition, a decrease in HDV RNA level greater than 2 log at 24 weeks of therapy “identified null responders with a negative predictive value of 95%,” according to the data.
“The main finding of this analysis was that on-treatment week 24 HDV RNA is suited for treatment outcome prediction,” the researchers wrote.
The researchers concluded: “We believe that these findings, short of providing solid prediction rules, nevertheless can help physicians treating [chronic delta hepatitis] patients for better orientation regarding when to decide to continue or stop pegylated interferon treatment.” – by Melinda Stevens
Disclosures: Keskin reports no relevant financial disclosures. Please see the study for a full list of all other authors’ relevant financial disclosures.
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