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Xagena Newsletter

Risk of peripheral neuropathy with Sebivo

Telbivudine ( Sebivo ) is a new nucleoside analogue that is indicated for treatment of chronic hepatitis B in adults with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase ( ALT ), and histological evidence of active inflammation or fibrosis ( or both ).

The risk of peripheral neuropathy with Telbivudine has been under review since the time of licensing.

Up to the end of January 2008, six cases of peripheral neuropathy have been reported in association with Telbivudine monotherapy.

In an ongoing multicentre trial comparing Telbivudine monotherapy with Telbivudine and Pegylated interferon alfa 2a ( Pegasys ) combination therapy, eight cases of peripheral neuropathy have been reported in 48 patients. The combination arm of this trial was suspended in January 2008. These cases were serious, occurred in relatively young patients within 3 months of starting treatment, and required treatment discontinuation.

Patients who take Telbivudine and Pegylated Interferon are at increased risk of peripheral neuropathy. Patients who develop symptoms of peripheral neuropathy should stop taking both medicines.

Advice for healthcare professionals

• The combination of Telbivudine and Interferon cannot be recommended;

• All patients who take Telbivudine should be monitored for occurrence of peripheral neuropathy;

• Patients who are taking Telbivudine and Pegylated Interferon who develop peripheral neuropathy should stop taking both medicines;

• For patients who are taking Telbivudine alone who develop peripheral neuropathy, consideration should be given to stopping this medicine.

Source: Medicines and Healthcare product Regulatory Agency – MHRA, 2008