Abstract
Introduction: Hepatitis C virus (HCV) infection affects almost 180 million people around the world. Even though the development of direct acting antivirals (DAAs) has significantly improved the treatment responses to HCV infection, treatment with pegylated interferon (PegIFN) in combination with ribavirin is considered the standard of care (SOC) for chronic HCV infection treatment in countries with limited medical resources. Considering the inhibitory effect of vitamin B12 on HCV replication, we have evaluated the effect of vitamin B12 supplementation along with SOC on treatment outcomes in patients with chronic HCV infection, who were antiviral treatment-naive.
 Methods: In this regard, seventy-four HCV-infected patients, naïve to antiviral therapy, were randomly assigned to receive SOC or SOC in addition to vitamin B12 (SOC + B12). Viral response was evaluated at 4, 12, 24 and 48 weeks following the initiation of viral treatment and at 24 weeks after completing the treatment. Genotyping of the interleukin 28B (IL28B) polymorphisms was also performed. Demographic characteristics, clinical findings, fibroscan results and drug adverse effects were recorded.
 Results: Our findings showed that rapid viral response was not significantly different between the two groups; however, the rates of complete early viral response (cEVR) (p=0.033), end-of-treatment viral response (ETVR) (p=0.001) and sustained virologic response (SVR) (p=0.0001) were significantly higher in SOC + B12 patients compared to SOC patients. Besides, in SOC + B12 patients, those with a higher baseline viral load and carriers of IL28B CC genotype showed significantly higher rate of SVR.
 Conclusion: In conclusion, the addition of vitamin B12 significantly improved the rate of SVR in HCV-infected patients, who were naïve to antiviral therapy. As this treatment regimen is safe and inexpensive, it proposes an option for improving the effectiveness of the HCV treatment with SOC, particularly in resource-limited settings.
Highlights
Hepatitis C virus (HCV) infection affects almost 180 million people around the world
Our findings showed that rapid viral response was not significantly different between the two groups; the rates of complete early viral response (p=0.033), end-of-treatment viral response (ETVR) (p=0.001) and sustained virologic response (SVR) (p=0.0001) were significantly higher in standard of care (SOC) + B12 patients compared to SOC patients
Of the 90 chronically infected patients that referred to our hepatology clinic, 16 were excluded from the study for the following reasons: having the history of treatment with interferon ± ribavirin (n=6), concomitant hepatitis B virus infection (n=2), heavy alcohol consumption (n=1), hepatocellular carcinoma (HCC) (n=1), severe depression (n=3), poorly controlled diabetes (n=1), and refused treatment (n=2)
Summary
Hepatitis C virus (HCV) infection affects almost 180 million people around the world. In SOC + B12 patients, those with a higher baseline viral load and carriers of IL28B CC genotype showed significantly higher rate of SVR. Conclusion: In conclusion, the addition of vitamin B12 significantly improved the rate of SVR in HCV-infected patients, who were naïve to antiviral therapy. As this treatment regimen is safe and inexpensive, it proposes an option for improving the effectiveness of the HCV treatment with SOC, in resource-limited settings. On a global scale, chronic HCV infection is responsible for approximately 250 000 to 350 000 deaths annually, which are mostly related to the decompensation of cirrhosis, end-stage liver disease, and HCC 4–6. Based on sequence homology analysis, at least seven major HCV genotypes and numerous distinct sub-
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