Frequent dose of peginterferon alfa 2a evaluation in treatment-naive chronic HCV, genotype 4 Egyptian patients

ABSTRACT

More frequent dosing with decreasing time intervals between injections of pegylated interferon in the treatment of HCV genotype 4, to our knowledge, was not tested before. The purpose of reducing the intervals between doses particularly in the first 12 weeks is to decrease the peak/trough ratio of the blood concentration of interferon in order to give no chance for the virus to recover. Therefore, the aim of this study is to explore the effect of such frequent dosing in the first 12 weeks as a trial to increase the response rates of our Egyptian patients with HCV genotype 4. This study includes 28 Egyptian patients, discovered to have chronic hepatitis C genotype 4 infection within 1-11 years before enrolling to study. They include 17 males and 11 females with mean age 41.57. Patients with active HCV infection without any vascular or parenchymatous decompensation were given pegasys 180 micro g every 5 days and ribavirin according the weight [800-1400 mg/day] for the first 4 injections. PCR is then done. Those with RVR [negative PCR after 4[th] injection] were treated in usual way with pegasys given every week. Those with detectable HCV RNA continued in the same way as first month for 12 injections. PCR was then repeated. Those showing EVR continued treatment in the usual way. Those with partial or slow EVR [detected HCV but viral load decreased at least 2 logs] continued as first month for 24 injections. Those with non EVR stopped treatment. All other patients continued treatment till 48 injections. Re-evaluation was done at end of treatment and after 6 and 12 months of end of treatment. Rapid virological response with disappearance of HCV RNA after 4 injections of treatment was detected in 14 cases [50%] in whom treatment in usual way continued till the end of 48 weeks. Additional 8 patients [28.6%] showed disappearance of HCV after 12 weeks of treatment to reach total of 22 cases [78.6%] in whom treatment in usual way continued till the end of 48 weeks. Three patients showed 2 log reduction of viral load continue treatment per protocol while 3 patients showed less viral load reduction were withdrawn from treatment. Additional 2 patients showed disappearance of HCV RNA at 24 weeks of treatment to reach a total of 24 patients [85.7%] the patient showing positive RNA stopped treatment. All those patients continuing treatment to 48 weeks remain negative for HCV RNA at end of treatment. Therefore, the ETR is 85.7% using this frequent dose administration of pegylated interferon. Only one patient relapse at week 72 [after 6 months of end of treatment]. Thus, the SVR occurred in 23/28 patient [82.14%]. Dose reduction was done for Ribavirin in 3 cases during treatment due to clinically significant decrease in the hemoglobin levels, all showed SVR. No reduction of interferon dose was commenced. General side effects were as usual and controlled with paracetamol. It is concluded that the use of more frequent peginterferon is associated with the best SVR in genotype 4, and whenever possible this strategy can be used particularly in patients with early disease as indicated by absence of sever hepatic or hematological abnormalities