TELBIVUDINE FOR THE TREATMENT OF CHRONIC HEPATITIS B: A CASE SERIES N.K. Gatselis, K. Zachou, E.I. Rigopoulou, G. Papadamou, K. Galanis G.N. Dalekos Department of Medicine & Research Lab of Internal Medicine University of Thessaly Medical School Larissa, Greece
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TELBIVUDINE FOR THE TREATMENT OF CHRONIC HEPATITIS B: A CASE SERIES N.K. Gatselis, K. Zachou, E.I. Rigopoulou, G. Papadamou, K. Galanis G.N. Dalekos Department.
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TELBIVUDINEFOR THE TREATMENT
OF CHRONIC HEPATITIS B:A CASE SERIES
N.K. Gatselis, K. Zachou, E.I. Rigopoulou,G. Papadamou, K. Galanis
G.N. Dalekos
Department of Medicine & Research Lab of Internal Medicine
University of Thessaly Medical SchoolLarissa, Greece
Disclosure
For the current presentation
NONE
Grant/Research Support:
Investigator in International/Greek Protocols: GILEAD,
JANSSEN, BAYERN, ROCHE
Background (I)
• Entecavir (ETV) and Tenofovir (TDF) are potent HBV inhibitors with a high barrier to resistance and therefore, can be used as first-line monotherapies in HBV infection
• Telbivudine (TBV) is a potent inhibitor of HBV replication, but lower barrier to resistance has been observed in patients with high baseline HBV DNA levels and in those with detectable HBV DNA after 6 months of therapy
EASL & KEELPNO CPG 2012
Background (II)
• Resistance rates to TBV are relatively low in patients with low baseline viraemia (<2 X 108 IU/ml in HBeAg-pos & <2 X 106 IU/ml in HBeAg-neg) who achieve undetectable HBV DNA at 6 months of therapy
• Chronic kidney disease is frequent in patients with CHB (15-30%)
• Renal impairment at low percentages with all antivirals except for TBV which seems to improve the creatinine clearance
• After transplantation for CHB, oral antiviral therapy is administered for a long term to prevent HBV recurrence. These patients are at increased risk for CKD due to the concomitant use of calcineurin inhibitors and because of the high prevalence of diabetes and hypertension. TBV appears to be safe and effective in this population.
• Pregnancy: Category Β (with TDF)
• TBV can be used HBV/HIV co-infected not candidates for HIV antiretroviral therapy
• 16 patients are still on TBV treatment with virological and biochemical response
Median (IQR) TBV treatment duration: 25 (26) months
ConclusionsThis uncontrolled real-life study showed that
• TBV administration in HBeAg (-) CHB patients with low baseline viraemia had a safe profile
• Renal function was preserved in all patients
• CK elevations is common AE while myopathy is rare
• So far, treatment efficacy in these patients was excellent as attested by the achievement of virological and biochemical response in almost all compliant patients