A Real Life Study on Treatment of Egyptian Patients with HCV Genotype IV with Simeprevir and Sofosbuvir

Abstract

Background and Aims: Treatment with a combination of the nucleotide polymerase inhibitor sofosbuvir and NS3A (non-structural protein 3A) protease inhibitor simeprevir resulted in high rates of sustained virological response in chronic hepatitis C Genotype 4. Methods: We conducted a real life study on Egyptian patients coming to tropical medicine department clinic at El Mery main university hospital from February 2015 to February 2016 for treatment naive and treatment experienced patients with chronic HCV genotype 4, including cirrhotics and non cirrhotics. Naive (cir-rhotics and non cirrhotics) and relapsers (non cirrhotics) received nucleotide polymerase inhibitor sofosbuvir and NS3A inhibitor simeprevir once daily for 12 weeks and 24 weeks for relapser cirrhotic patients. The primary end point was a sustained virologic response at 12 weeks after end of treatment. An informed consent was obtained from each patient at the beginning of the study (Real life study: a study on Egyptian patients when the drug was available in the market). Results: 30 naive patients with HCV genotype 4 and 20 relapsers (10 non cirrhotic and 10 cirrhotic patients) were enrolled. Patient inclusion criteria: Naive patients are those who tested positive for HCV RNA by PCR and had no experience to HCV treatment; Relapsers are those who tested positive for HCV RNA by PCR and had a previous treatment for HCV. Cirrhosis was diagnosed on ultrasound basis. Mean age was 53.57 ± 10.682 years old in naive patients and 48.30 ± 5.100 years old in relapsers. Median baseline HCV RNA was 360,069 IU/mL for naive patients and 1,245,000 IU/mL for relapsers; using Fib4 20% of naive patients were F3-F4, while 40% of relapsers were F3-F4. Degree of fibrosis was confirmed by fibrotest in relapsers. Upon treatment of patients with sofosbuvir and semiprevir once daily for 12 weeks and 24 weeks only to cirrhotic relapsers, end of treatment PCR was negative in 100% in all groups including cirrhotics and non cirrhotics. Primary end point (SVR 12) was achieved in 100% of all patients. Second end point (SVR 24) was achieved in 96.6% of naive pa-ients; SVR 24 for non-cirrhotic relapsers was achieved in 100% of patients and in 90% of cirrhotic relapsers. One patient had transient total bilirubin elevations without increased ALT (alanine aminotransferase) or AST (aspartate aminotransferase). One patient developed cutaneous rash. Conclusion: Once daily sofosbuvir and simeprevir for 12 weeks provided high rate of sustained virological response among treatment naive and treatment experienced patients with HCV genotype IV.