Tenofovir (Viread) plus Lamivudine (Epivir-HBV) Appears Effective as Rescue Therapy for Cirrhotic Patients with Resistance to Adefovir (Hepsera)

Tenofovir (Viread) plus Lamivudine (Epivir-HBV) Appears Effective as Rescue Therapy for Cirrhotic Patients with Resistance to Adefovir (Hepsera)

Currently there is no consensus among clinicians regarding the management of patients with hepatitis B virus (HBV) resistant to adefovir (Hepsera).

The aim of the present small study, published the February online edition of Liver International, was to investigate whether tenofovir (Viread) combined with lamivudine (Epivir-HBV) is effective and safe in patients with resistance to or non-responsive to adefovir.

The study included 6 Korean patients with HBV-related cirrhosis, viral breakthrough during lamivudine therapy, and viral breakthrough or non-response during adefovir therapy. Participants were treated daily with tenofovir plus lamivudine for at least 6 months.

HBV DNA level, alanine aminotransferase (ALT) level, Child-Pugh score, and serum creatinine were monitored. Genotypic lamivudine and adefovir resistance mutations were measured in stored blood samples.

Results

• In 5 of the 6 patients, adefovir-resistant mutations at rt181 or rt236 were detected during adefovir therapy.

• Within 6 months of starting tenofovir/lamivudine combination therapy, HBV DNA levels became undetectable (< 400 copies/mL) in 4 of the 6 patients.

• Within 12 months, HBV DNA levels became undetectable in all patients, and ALT levels normalized in 4 of the 6.

• These responses persisted through the end of the observation period (median duration 16.5 months, range 6-21 months).

• Child-Pugh scores improved in 2 of 3 patients with hepatic decompensation.

• No significant changes in serum creatinine were observed.

Conclusion

Based on the findings, the study authors wrote, "Our data demonstrated that tenofovir plus lamivudine safely and markedly suppressed HBV replication in patients with resistance to or non-response to adefovir.'

Further, they stated, "This study suggests that this combination may be a promising rescue therapy for these patients, particularly those with liver cirrhosis or pre-existing lamivudine resistance."

Department of Internal Medicine, Konkuk University School of Medicine, Konkuk University Hospital, Seoul, Korea.

3/21/08

Reference
SY Ko, JE Yeon, KS Byun, and others. Tenofovir plus lamivudine as rescue therapy for adefovir-resistant chronic hepatitis B in hepatitis B e antigen-positive patients with liver cirrhosis. Liver International. February 26, 2008 online edition.