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PEG-IFN a-2b/entecavir does not boost virological response

Combining peginterferon alpha-2b with entecavir for patients with chronic hepatitis B virus did not improve virological response or hepatitis B surface antigen clearance compared with monotherapy, according to study results in the Journal of Viral Hepatitis. The combination, however, did lead to greater HBV DNA suppression.

“The aim of this study was to compare the efficacy of PEG-IFN monotherapy vs. PEG-IFN combined with [entecavir (ETV)] in Thai patients with [hepatitis B e antigen (HBeAg)]-negative [chronic hepatitis B (CHB)],” Pisit Tangkijvanich, MD, from the research unit of hepatitis and liver cancer at Chulalongkorn University in Thailand, and colleagues wrote.

PEG-IFN and nucleoside/nucleotide analogues, such as ETV, are approved as monotherapies for CHB. While studies have assessed combining PEG-IFN with other nucleoside/nucleotide analogues, no study has analyzed combining PEG-IFN with ETV, the investigators wrote.

To determine whether this combination therapy would work better than monotherapy, Tangkijvanich and colleagues performed a prospective trial of 126 treatment-naive patients randomly assigned to monotherapy (n = 63) or combination therapy (n = 63) for 48 weeks. The researchers defined virological response as an HBV DNA level less than 2,000 IU/mL at week 96. They also determined ongoing viral kinetics and any polymorphisms in the IFNL3 (rs12979860) and HLA-DPA1 (rs3077) genes.

At the end of treatment, they found that rates of undetectable HBV DNA were lower among the monotherapy group (41.3% vs 87.3%, P < .001). However, after 96 weeks, no differences in virological response, HBsAg clearance or HBsAg decline were observed between groups. Baseline HBsAg level (OR = 3.14; 95% CI, 1.34-7.69) and rs3077 polymorphism (OR = 2.78; 95% CI, 1.27-6.11) predicted virological response (P = .011). In addition, patients who carried a GG genotype of rs3077 with low baseline HBV, defined as less than 1,000 IU/mL, had a high probability of achieving virological response (76.5%) and HBsAg clearance (29.4%).

These data followed previous studies that did not show any benefit of combining PEG-IFN with other nucleoside/nucleotide analogues, the researchers wrote.

“Our data demonstrated that combination therapy led to greater on-treatment HBV DNA suppression, but did not improve rates of response over PEG-IFN monotherapy,” Tangkijvanich and colleagues wrote. “As the number of patients in this study was limited, further prospective randomized studies with larger sample sizes are required to confirm these observations.” – by Will Offit

Disclosure: The researchers report no relevant financial disclosures.