Efficacy and safety of Sildenafil daily use in HCV positive men with erectile dysfunction

Background: Sildenafil citrate is a specific phosphodiesterase-5 (PDE-5) inhibitor, which has been approved for treatment of erectile dysfunction (ED) in men. Men with liver diseases have higher rate of ED. Objective: To evaluate the efficacy and safety of sildenafil citrate daily use on hepatic functions and ED in normal and chronic hepatitis C patients. Patients and Methods: The study enrolled 60 males with ED they were divided into 30 patients (HCV negative) and 30 patients (HCV positive). The degree of ED was assessed before and after treatment using International Index of Erectile Function (IIEF-5) questionnaire. They received sildenafil citrate 25 mg daily for 8 weeks. Liver function tests [serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum albumin (ALB), serum total bilirubin (BIL)] were done before start of treatment, 2 weeks after start of treatment and at the end of the study. Results: Biochemical parameters including ALT, AST, and BIL were significantly higher in hepatitis C positive group before and after sildenafil therapy than the other group. The mean values of ALB were approximately similar in both groups. After treatment with sildenafil, control group had insignificant differences as regard serum ALT, AST, BIL, and ALB. On the other hand, hepatitis group had significant decrease in serum levels of AST and significant increase in serum albumin, whereas, there was insignificant change in serum levels of ALT and BIL. In addition, there was significant increase in IIEF-5 score after treatment with improvement of erectile state. Conclusion: PDE5-Is can be administered in patients with mild or moderate hepatic impairment, provided that an individual benefit/risk evaluation has been considered prior to their use.