Clinical trial NCT01083251: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B Virus
Keywords: HBV
VITAMIN D
PEGITERFERON
Telbivudine
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2010-03-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: treatment efficacy
timeFrame: 120 weeks
measure: histologic response
timeFrame: 120 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
city: Safed, Israel
country: Israel
facility: Ziv medical center liver unit
city: Safed
country: Israel
facility: Liver clinic
Study officials:
References: