Hepatitis B Virus Clinical Trial
Official title:
The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic HBV Viral Infection
Abstract
Telbivudine is a potent inhibitor of HBV but, due to a low genetic barrier to resistance, a
high incidence of resistance has been observed in patients with high baseline levels of
replication and in those with detectable HBV DNA after 24 weeks of therapy (A1). Telbivudine
might be used in patients with good predictors of response (HBV DNA <2 X 106 IU/ ml, i.e.
approximately 107 copies/ ml, or 6.3 log 10 IU/ ml at baseline) with verification of HBV DNA
suppression below detection in real time PCR assay at 24 weeks.(EASL Guidelines for HBV
2009) The therapy of Pegylated-interferon-alpha-2a is considered as the standard of care for
patients with chronic hepatitis b viral infection. However, recent study by Buster et al
showed that a sustained viral response (SVR less than 2000 iu.ml at 6 months after
treatment)) is obtained in 8 % of patients with genotype D, 30% genotype A, and 20-25%
genotypes B or C (47). Vitamin D is a potent immune-modulator; and has been shown to improve
SVR in combination with peg interferone in patients with chronic HCV viral infection (48).
The impact of vitamin D on virologic response rates of interferon-based treatment of CHB is
unknown. The aim of this study therefore was to assess whether Vitamin D, added to the
conventional peg therapy in CHB, or to nucleotide analogues could improve the treatment
efficacy
n/a
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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