The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic Hepatitis B Virus (HBV) Infection

Ziv Hospital

Status

Unknown

Conditions

Hepatitis B Virus

Treatments

Drug: Peginterferon + Vitamin D

Drug: Sebivo

Drug: entecavir+ vitamin d

Drug: Peginterferon

Study type

Interventional

Funder types

Other

Identifiers

NCT01083251

004-10

Details and patient eligibility

About

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

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients were eligible if they had been HBsAg positive for at least 6 months,
patients were HBeAg positive or negative,
patients had increased serum ALT levels between 1 and 10 times the upper limit of normal (ULN),
patients had serum HBV-DNA levels greater than 1.0 x 10E5 copies/mL (2.0 X 10E4 IUmL), and
patients had findings on a liver biopsy within the preceding 12 months that were consistent with the presence of chronic hepatitis B.

Exclusion criteria

decompensated liver disease,
antiviral therapy within 6 months before randomization,
viral co-infections (hepatitis C virus, hepatitis delta virus, or human immunodeficiency virus), or
pre-existent neutropenia or thrombocytopenia.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 4 patient groups

Peg + Vitamin D

Experimental group

Description:

Treatment arm with vitamin D will be treated first with vitamin D supplement for 3 months before the initiation of antiviral therapy. Vitamin D levels will be measures at baseline and three months after. The serum vitamin D-25-OH levels should be \> 32 ng/ml before the initiation of antiviral treatment). HBV DNA levels will be also measure at baseline and after 3 months of mono therapy with vitamin D

Treatment:

Drug: Peginterferon + Vitamin D

Peginterferon

Active Comparator group

Treatment:

Drug: Peginterferon

Sebivo

Active Comparator group

Description:

Nucleotide Analog Telbivudine 600 mg daily

Treatment:

Drug: Sebivo