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Tenofovir comparable to combination therapy for chronic hepatitis B patients
CHICAGO — Monotherapy with tenofovir achieved viral suppression comparable to tenofovir plus entecavir combination as rescue therapy for patients with chronic hepatitis B who partially responded to entecavir, according to research presented here at Digestive Disease Week.
“Long-term studies of entecavir monotherapy have shown that more than 90% of patients achieve undetectable DNA levels,” Louis Lu, a medical student at the University of Michigan, said during his presentation. “However, some patients have suboptimal response to entecavir. Current guidelines recommend considering treatment modification in patients with suboptimal response at 24 to 48 weeks.”
Lu and colleagues conducted a retrospective cohort study of patients with partial response to entecavir (Baraclude, Bristol-Myers Squibb) therapy, who had a detectable HBV DNA of more than 60 IU/mL after 12 months or more of entecavir therapy. The study included 25 patients who switched to tenofovir (Viread, Gilead Sciences) monotherapy and 43 patients who switched to tenofovir/entecavir combination therapy. They analyzed the rates of viral suppression between the two groups.
The patients were similar in age, sex and hepatitis B e antigen (HBeAg) status, and most patients were Asian. Patients in the tenofovir group spent a median of 26 months on entecavir therapy, and patients in the combination therapy group spent a median 25 months on entecavir therapy. The two groups had differences in HBV DNA levels before entecavir therapy (6.69 log10 IU/mL for tenofovir group vs. 7.71 log10 IU/mL for the combination therapy group) and at the start of rescue therapy (3.10 log10 IU/mL vs. 3.57 log10 IU/mL).
After 6 months of rescue therapy, the viral suppression rate for tenofovir monotherapy was 71%, and for the combination therapy, the viral suppression rate was 83% (P=0.23). After 12 months of therapy, the viral suppression rates were 86% and 84% (P=0.85), respectively. On a multivariate analysis that controlled for HBV DNA before entecavir therapy and rescue therapy, the combination therapy was not an independent predictor for viral suppression.
“Further studies with a larger number of entecavir partial responder patients receiving tenofovir rescue therapy are needed to evaluate how to treat this group of patients,” Lu said. “Tenofovir monotherapy would be a more convenient option than the combination therapy and would also be a more cost-effective option.”
For more information:
Lu L. #701. Presented at: Digestive Disease Week 2014; May 3-6, 2014; Chicago.
Disclosure: Lu reports no relevant financial disclosures. Five of the researchers report various financial ties with Bayer, Bristol-Myers Squibb, Dynavax, Gilead Sciences, Hoffmann-La Roche, Janssen, Merck, Novartis, Onyx, Roche and Vertex.