Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 Chronic Hepatitis C Patients?

Ziv Hospital

Status: Unknown

Conditions: Chronic Hepatitis C

Treatments: Drug: Peg + Vitamin D + Ribavirin; Drug: Peg + Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT01151397

Genotype 2,3 HCV +Vitamin D

Details and patient eligibility

About

Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines

1. Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
2. whether Vitamin D levels predicts negative treatment outcome.

Full description

Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2, 3. Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D, a potent immunomodulator, for 3 months therapy could improve viral response. The working hypothesis is that 3 months therapy with Vitamin D + Peg + Ribavirin significantly improves RVR, EVR, and SVR.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 65 years of age
• chronic genotype 2,3 HCV infection
• treatment Naive negative sero for HBV, HDV and HIV viral infections
• absolute neutrophil count of >1500 per cubic millimeter
• a platelet count of >90,000 per cubic millimeter normal hemoglobin level

Exclusion criteria

• decompensated liver disease (cirrhosis with CP score >9)
• another cause of clinically significant liver disease hepato cellular carcinoma
• psychiatric Disorder
• chronic heart failure
• pregnant women
• uncontrolled diabetes with retinopathy Arrhythmia Active CAD
• positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Peg + Vitamin D + Ribavirin

Active Comparator group

Description:

Peg + Vitamin D + Ribavirin for 3 months

Treatment:

Drug: Peg + Vitamin D + Ribavirin

Peg + Ribavirin

Active Comparator group

Description:

Peg + Ribavirin for 6 months

Treatment:

Drug: Peg + Ribavirin