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Viread, peginterferon alfa-2a more effective in combination for reducing HBsAg

Using the combination of Viread and peginterferon alfa-2a resulted in hepatitis B surface antigen loss more frequently than using either drug alone, according to recent data.

“This study provides direct evidence that combining two agents with different mechanisms of action for a finite treatment duration can result in rates of serum [hepatitis B surface antigen (HBsAg)] loss significantly higher than those obtained with current standard-of-care monotherapy regimens,” Patrick Marcellin, PhD, professor of hepatology at the University of Paris-Diderot, and colleagues wrote. “Our study is the first to provide definitive evidence that patients receiving a potent oral agent can achieve higher rates of HBsAg loss than those receiving monotherapy, with no increase in adverse events compared with peginterferon alone.”

Marcellin and colleagues randomly assigned 740 patients with chronic hepatitis B to either Viread (tenofovir disoproxil fumarate, Gilead Sciences; TDF) and peginterferon alfa-2a for 48 weeks (group A), TDF and peginterferon for 16 weeks before TDF for 32 weeks (group B), TDF for 120 weeks (group C), or peginterferon for 48 weeks (group D).

At 72 weeks, the researchers found HBsAg loss in 9.1% of patients in group A, 2.8% of patients in group B, 0% of patients in group C, and 2.8% of patients in group D. In addition, HBsAg loss in group A occurred in both hepatitis B e antigen-positive and hepatitis B e antigen-negative patients with all major viral genotypes.

The researchers said common adverse events, including headache, alopecia and pyrexia, were comparable across all groups, and treatment discontinuation was similar between all regimens.

“This study provides the proof-of-concept that combination therapy, unlike peginterferon or TDF monotherapies, can induce HBsAg loss at a similar frequency in both HBeAg-positive and HBeAg-negative patients and across all major genotypes,” Marcellin and colleagues wrote. – by Will Offit

Disclosure: The study was supported by Gilead Sciences. Marcellin reports being a speaker and investigator for Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, Roche and Tibotec. Please see the full study for a list of all other authors’ relevant financial disclosures.