Treatment of chronic hepatitis C with peginterferon alfa-2b, plus ribavirin in end stage renal disease patients treated by hemodialysis: single Saudi center experience.
BACKGROUND
Hepatitis C virus (HCV) infection is a global health problem, common worldwide, leading to acute and chronic hepatitis and its consequences of hepatic cirrhosis and hepatocellular carcinoma. Antiviral therapy of HCV+ in dialysis patients with interferon-α (INF-α) gives slightly better results than in the general population, but is poorly tolerated and associated with side effects. Although, Ribavirin in not recommended for dialysis patients, the addition of small doses of this medication to pegylated INF is discussed.


OBJECTIVE
The aim of this study is to assess the efficacy and safety of peginterferon alfa-2b (12 kDa) plus Ribavirin in hemodialysis chronic HCV patients.


METHODS
Fourteen end-stage renal disease patients (ESRD) on regular hemodialysis (HD) in Prince Salman Center for Kidney Diseases (PSCKD), ten males (71.4%) and four females (28.6) were enrolled in a prospective study. All the patients have Hepatitis C Virus infection; were treated by pegylated interferon alpha-2b (peginterferon alfa-2b) 1 mcg/kg/week subcutaneously with Ribavirin 200 mg three times weekly; for 48 weeks. Two patients were non responsive to previous course of 24 weeks peginterferon alfa-2a. HCV -RNA PCR qualitative and quantitative were tested before, 12, 48 weeks of treatment and 24 weeks after for sustained virologic response (SVR) results. α-fetoprotein level was measured in all the 14 patients before starting treatment to exclude any evidence of hepatocellular carcinoma.


RESULTS
One patient (7.1%) refused to complete the treatment because he could not tolerate the side effects and treatment was stopped after the third dose. After 12 weeks, three of 14 patients (21.4%) were still HCV-RNA PCR positive and there were not two log decrees in quantitative PCR, so treatment was stopped in this group of patients. One patient of the remaining had more than two log decrees in quantitative PCR, while nine were seroconverted to HCV-RNA PCR negative, so the treatment was completed for 48 weeks in 10 patients. After 48 weeks of treatment, qualitative and quantitative HCV-RNA PCR were done for 10 patients and the results were still negative (71.4%). Results of qualitative and quantitative HCV-RNA PCR done 24 weeks later showed that 10 patients still negative and SVR was (64%). Their mean ALT and AST dropped from 54.36 ± 36.79 IU/dL and 31.52 ± 17.02 IU/dL before starting therapy to 37.26 ± 36.53 IU/dL and 25.37 ± 23.72 IU/dL, respectively, after termination. Their mean hemoglobin (Hb) level dropped from 11.31 ± 0.86 to 10.06 ± 1.06 g/dL; (p < 0.001), and white blood cell count (WBC) dropped from 6.14 ± 0.65 × 10(3)/mm(3) to 4.51 ± 0.95 × 10(3)/mm(3); (p < 0.001). Platelet count fell from 130.11 ± 48.06 × 10(3)/mm(3) to 63.03 ± 23.19 × 10(3)/mm(3); (p < 0.001), also erythropoietin dose increased from 182.14 ± 39.30 IU/kg/w to 253.93 ± 83.07 IU/kg/w, (p = 0.776).


CONCLUSIONS
Peginterferon alfa-2b (12 kDa) plus Ribavirin therapy in hemodialysis chronic HCV patients is safe, well tolerated and effective with accepted rates of sustained virological response up to 64%.
Prince Salman Center for Kidney Diseases , Riyadh , Kingdom of Saudi Arabia and.
Khalid
K
Alsaran
Alaa
A
Sabry
Azeb
A
Molhem
D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004921:Erythropoietin / Q000008:administration & dosage; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D006435:Renal Dialysis; D012254:Ribavirin / Q000627:therapeutic use*; D012529:Saudi Arabia
D000998:Antiviral Agents; D006454:Hemoglobins; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D004921:Erythropoietin; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b