Entecavir Reduces HBV-Related Hepatitis and HBV Reactivation vs Lamivudine in Lymphoma Patients Receiving R-CHOP
In a Chinese study reported in JAMA, Huang et al found that treatment with entecavir (guanosine analog reverse transcriptase inhibitor) reduced hepatitis B virus (HBV)-related hepatitis and HBV reactivation compared with lamivudine (cytidine analog reverse transcriptase inhibitor) in HBV-positive patients with untreated diffuse large B-cell lymphoma receiving R-CHOP (rituximab [Rituxan], cyclophosphamide, doxorubicin, vincristine, and prednisone).
Study Details
In this open-label phase III study, 121 patients from 10 Chinese centers were randomly assigned between February 2008 and December 2012 to receive entecavir at 0.5 mg/d (n = 61) or lamivudine at 100 mg/d (n = 60) beginning 1 week before the start of R-CHOP through 6 months after completion of chemotherapy. The primary endpoint was occurrence of HBV-related hepatitis.
For the entecavir and lamivudine groups, median age was 41 and 44.5 years, 51% and 62% were male, 62% and 60% had Ann Arbor stage III or IV disease, 87% and 87% had International Prognostic Index scores of 0 to 2, 8% and 3% had liver involvement, and 2% and 3% had cirrhosis.
Efficacy
HBV-related hepatitis occurred in 0% of the entecavir group vs 13.3% of the lamivudine group (P = .003), HBV reactivation occurred in 6.6% vs 30% (P = .001), and chemotherapy was disrupted due to hepatitis in 1.6% vs 18.3% (P = .002).
Adverse Events
Treatment-related adverse events occurred in 24.6% of entecavir patients, including nausea (10%), dizziness (7%), headache (5%), and fatigue (3%), vs 30% of lamivudine patients (P = .50), including nausea (10%), fatigue (8%), headache (7%), and dizziness (5%). All adverse events were grade 1 or 2.
The investigators concluded: “Among patients seropositive for the hepatitis B surface antigen with diffuse large B-cell lymphoma undergoing R-CHOP chemotherapy, the addition of entecavir compared with lamivudine resulted in a lower incidence of HBV-related hepatitis and HBV reactivation. If replicated, these findings support the use of entecavir in these patients.”
Tongyu Lin, MD, PhD, of Sun Yat-sen University Cancer Center, is the corresponding author for the JAMA article.
The study was supported by a grant from the Foundation of 5010 Clinical Trials of Sun Yat-sen University.
The authors reported no potential conflicts of interest.
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