COMBINATION THERAPY WITH PEGYLATED INTERFERON-α-2A PLUS RIBAVIRIN IN TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN EGYPTIAN PATIENTS WITH- AND WITHOUT CHRONIC RENAL FAILURE: VIROLOGICAL RESPONSE RATES AND ADVERSE REACTIONS
Essam A. El-Moselhy1*, Ayman Abd El-Aziz2*, Awatif E. Edreis3#, Boshora E. Hussein3#, and Alaa A. Aboulata4*
Departments of Community Medicine1*, Internal Medicine2*, Tropical Medicine3#, and Medical Microbiology & Immunology4* Faculty of Medicine, Al-Azhar* and Tanta# University
Background: Hepatitis C virus (HCV) infection is a major health problem especially in patients with chronic renal failure (CRF) under regular hemodialysis (RHD). CRF patients who have chronic (C) HCV are at increased risk of liver-related mortality. In patients with CHCV infection, genotype (GT)-4, the combination therapy with pegylated interferon (Peg-INF)-α and ribavirin (RBV) remains the currently approved standard of care treatment. Aims: The aims were to determine the response rates and adverse reactions (ADRs) of Peg-INF-α-2a and RBV in treatment of CHCV GT-4 in Egyptian patients with CRF compared to those without. Patients and Methods: A prospective study design was used to conduct this research. The study groups included 60 patients; 30 CRF patients on RHD and had CHCV GT-4 (group I) and 30 patients with only CHCV GT-4 (group II). A base line laboratory evaluation for the patients was done before starting treatment. A scheduled treatment using Peg-INF-α-2a plus RBV with tailored doses was used. Lab evaluations and virological responses (VRs) were regularly done during the therapy at 4, 12, 24, 48 weeks and at week 24 post therapy. The therapy ADRs were monitored throughout the study period. Results: Rapid and sustained VRs (RVR and SVR) were achieved in 46.7% & 43.3% and 70.0% & 63.3% of patients in group I and II, respectively with insignificant differences. Important detected therapy ADRs among patients in group I and II were anemia (20.0% & 13.3%), leucopenia (13.3% & 10.0%), and thrombocytopenia (10.0% & 10.0%) with insignificant differences. Peg-INF dose was lowered in 23.3% and 20.0% of patients in group I and II, respectively. While, RBV dose was lowered in 20.0% and 13.3% of patients in group I and II, respectively. Lastly, there were significant decreases in levels of ALT, AST, AP, and HCV-RNA load in patients in group I and in levels of ALT, AST, bilirubin, AP, and HCV-RNA load in patients in group II. Conclusions and Recommendations: VRs and tolerability of the Peg-INF-α-2a and RBV therapy, with different used doses, were similar in both groups of patients. CHCV GT-4 patients with- and without CRF are candidate to be considered in treatment with this combination therapy. Finally, we recommend conducting more studies on large number of patients with different clinical, pathological stages, and viral loads to better understanding of this research problem.
December 2012