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Lamivudine less safe, effective than tenofovir, entecavir for cirrhotic patients with HBV

Treatment with tenofovir or entecavir had better long-term outcomes than lamivudine therapy for patients with cirrhosis and chronic hepatitis B in a recent study.

Researchers performed a retrospective analysis on data from 227 cirrhotic adults with chronic hepatitis B. Participants were treated with tenofovir (n=72, with a follow-up of 21.4 ± 9.7 months), entecavir (n=77, with follow-up over 24 ±13.3 months) or lamivudine (n=74, with follow-up over 36.5 ± 24.1 months). Clinical outcomes, lab results and incidence of adverse events were observed across groups. Most participants (86.3%) were treatment-naive before enrollment.

After follow-up, HBV DNA levels below 400 copies/mL occurred in 91.5% of tenofovir recipients, 92.5% of those receiving entecavir and 77% receiving lamivudine (P=.01). These results were similar to those observed after 1 year of treatment (92.2% of tenofovir recipients, 92.6% for entecavir and 71.4% for lamivudine). Patients in all three groups also experienced ALT normalization at 1 year (83.6% for tenofovir, 84.7% for entecavir and 64.5% for lamivudine, P=.01) and upon completion of follow-up (86.8% of tenofovir recipients, 92.1% for entecavir and 71.8% lamivudine, P=.01).

More participants in the lamivudine group (27.4%) indicated increases to Child-Turcotte-Pugh scores during follow-up than either the entecavir (15.6%) or tenofovir groups (8.5%) (P=.01), but the change to mean score per year was similar between groups (P=.35).

Incidence of mortality, hepatocellular carcinoma, hepatic encephalopathy and variceal bleeding was similar across groups, as was mean survival and complications-free times. Investigators noted that 32.4% of patients who received lamivudine required switching to another drug (21 patients to tenofovir and three to entecavir), while only two patients each in the tenofovir and entecavir groups had their medications switched to the other.

“Tenofovir and entecavir are similarly effective and safe agents for long-term use in patients with HBV-related cirrhosis,” the researchers concluded. “Lamivudine monotherapy still may be preferred, even in advanced liver disease, but only if those patients are monitored regularly. Available antivirals may provide improvement of liver function or at least stabilize or even prevent deterioration of cirrhosis outcomes.”