An Open Labelled, Active Controlled, Three-Arm, Parallel- Group study of the safety and efficacy of the oral formulation of Oral Iodine Complex (RENESSANS) administered alone and in combination with standard interferon therapy in patients suffering from Chronic HCV Hepatitis.

Iodine has strong antimicrobial properties and has been used in topical applications as antiseptic. Its systemic use in form of iodine complexes derived from dried seaweed extract is beneficial in treating various disorders. Hepatitis C Virus (HCV) chronic infection is present in 6-10% of the Pakistani population and is a major healthcare burden that could benefit from innovative therapeutic regimens. Objective: A pilot study has shown the safety and efficacy of iodine complexes in chronic Hepatitis C virus infection. and this clinical study is aimed to further explore the previous findings. Methods: This is an open-labeled, active-controlled, three-arm, parallel-group study including 90 patients of chronic HCV infection with each arm having 30 patients. The patient groups received 15mg/day iodine complex only, the standard of care therapy interferon+ribavirin, and iodine complex in combination with interferon+ribavirin regimen for 6 months. Efficacy assessment will base upon post-treatment Rapid Virological Response (RVR) at 4 weeks, Early Virological Response (EVR) at 12 weeks, and End of Treatment Viral Response (ETR) at 24/48 weeks. Results: As only 3.33% of patients showed at the ETR with iodine complex alone, combination with interferon+ribavirin showed significant improvement in comparison to interferon+ribavirin alone. Iodine complex+ interferon+ribavirin showed 80% RVR and 90% ETR while the standard of care therapy showed 66.7% RVR and 76.67% ETR, respectively. No additional adverse events of iodine complex were observed. Conclusion: Iodine complex showed a significant synergistic effect when combined interferon+ribavirin regimen and could be useful in relapsers and non-responders.