A pilot study to assess the efficacy and safety of folic acid and/or vitamin B complex on hepatitis C infected patients treated with pegylated interferon and ribavirin

Abstract

Egypt has the highest prevalence of hepatitis C virus (HCV) infection in the world. The prevalence of HCV viremia was estimated to be 7.3% for the year 2013 on the basis of data from the 2008 Egypt Demographic and Health Survey. Egypt also has the greatest number of patients with genotype 4 HCV – more than 90% of those infected or approximately 6 million people. Over the past few years, new medicines for HCV infection have begun to transform the treatment landscape, and, just in the past few months alone, the development of new regimens has been so successful that disease experts are heralding an era where all patients can be cured, even debating whether eradication is possible. The main drawback of these new agents is the huge price tag, which will make treatment out of reach for people in the developed and developing world. In Egypt, the huge price is certainly a burden on the government and individuals, despite the continuous effort to cut the prices down. Furthermore, clinical experiences regarding the efficacy and safety of the new regimen on Egyptian HCV patients still in its early phases. Indeed preliminary results showed that sofosbuvir, when used in Egyptian patients in combination with peginterferon and ribavirin has resulted in high rates of sustained virological response (SVR) of 82% to 96%. Sofosbuvir has a favorable safety profile, and most adverse reactions reaction reported in clinical studies with sofosbuvir has been attributable to concurrent use of peginterferon or ribavirin. Ribavirin has been used in combination with pegylated interferon (PIFN/RBV) as the most effective antiviral therapy. Although this PIFN/RBV Summary 158 therapy seems effective and safe for hepatitis C, several side effects such as anemia, neutropenia, leukopenia, thrombocytopenia, depression, and flu-like syndrome from this anti-hepatitis C virus therapy have been reported. Hepatitis C virus (HCV) patients commonly experience fatigue, anxiety, and depression. These symptoms negatively affect patients’ health related quality of life (HRQL) and well-being. In addition to well-known side effects of interferon, one important determinant of HRQL during anti-viral therapy for HCV is development of ribavirin-induced anemia. There is some evidence that HCV patients who experience poorer HRQL are more likely to discontinue treatment prematurely with its negative impact on virologic response. Treatment of anemia improves HRQL, potentially impacting adherence to antiviral regimen and improving virologic response. Hepatitis C virus infection and PIFN/RBV led to the decline of B vitamins including vitamin B1, B6, vitamin B12 and folic acid. It has been documented that B vitamins could exhibit antioxidant activity via scavenging oxygen radicals and organic radicals. Thus, the decrease in B vitamins diminished their antioxidant defense. On the other hand, the depletion of B vitamins also favored the occurrence of anemia in HCV patients with PIFN/RBV therapy. It was speculated that the antioxidant effect of B vitamins could protect the erythrocyte membrane from the RBV-induced hemolysis and would promote erythropoiesis in response to the RBV-induced anemia.