Treatment of chronic hepatitis C with peginterferon alfa-2b, plus ribavirin in end stage renal disease patients treated by hemodialysis: single Saudi center experience.

INTRODUCTION: 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. PURPOSE: 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). CONCLUSION: 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%.

Nutritional assessment of patients on hemodialysis in a large dialysis center.

Management of the nutritional aspects of chronic kidney disease (CKD) presents a number of challenges. This study was performed to assess the nutritional status among patients on maintenance hemodialysis at the Prince Salman Center for Kidney Diseases, Riyadh, Saudi Arabia. The study included 200 patients with a mean age of 50 ± 16 years; there were 108 males (54%) and 92 females (46%). Nutritional assessment was made by the Subjective Global Assessment (SGA) score. In the present study, 4% of the patients were found to be underweight, 49% had average weight, 27.5% were overweight, 14% were obese, and 5.5% had morbid obesity. Severe malnutrition by SGA significantly correlated with duration on dialysis, functional capacity, and associated co-morbid diseases. The number of patients included in this study was small and we recommend multi-center studies with a larger number of patients for better evaluation. Also, we recommend a survival trial to evaluate the relationship between low serum albumin and patient survival in the Saudi population.

Superior vena cava syndrome in hemodialysis patient.

Obstruction of blood flow in the superior vena cava (SVC) results in symptoms and signs of SVC syndrome. SVC obstruction can be caused either by invasion or external compression of the SVC by contagious pathologic processes involving the right lung, lymph nodes, and other mediastinal structures, or by thrombosis of blood within the SVC. Occasionally, both mechanisms co-exist. We hereby report a case of a 28-year-old male, Saudi patient who was diagnosed with end-stage renal disease and was maintained on regular hemodiaysis via right jugular vein dual lumen catheter for ten months. Three years later, the patient presented with signs and symptoms suggestive of SVC obstruction that was successfully managed with SVC stenting.

Cinacalcet effect on severe hyperparathyroidism.

To determine the efficacy and safety of cinacalcet, a calcimimetic drug that suppress parathyroid hormone (PTH) production, we studied its effect on 20 patients (13 males) on maintenance hemodialysis (HD), 80% of them have persistent high PTH levels (i.e. more than 80 pmol/L), the remaining patients had PTH levels more than 60 pmol/L. Five of 20 (25%) patients dropped out from the study (2 because of severe GIT upset, one showed severe myalgia and arthralgia, one patient due to non compliance and one died at home due to cardiac arrest). The remaining 15 patients (10 males) had a mean age of 40 ± 12.86 years and dialysis duration of 29.13 ± 18.27 months. The follow-up period on cinacalcet was 4 months with a single daily oral dose started with 30 mg/day and increased gradually according to the PTH levels. Nine (60%) patients were on concomitant active vitamin D during the study period with a mean dose of 7.33 ± 3.39 µg/week. There was a significant decrease in the serum PTH levels at the end the study compared to that at the start (46.4 ± 4.7 pmol/L versus 93.3 ± 25.6 pmol/L, respectively, P< 0.000), and the target PTH level (< 31.6 pmol/L) was achieved in 54% of patients. No significant changes in serum Ca and phosphorous levels were observed. We conclude that cinacalcet is an effective therapy to suppress the serum PTH levels and allows favorable management of the serum calcium and phosphorus levels in HD patients. The drug was well tolerated; however, GIT discomfort is a significant side effect that may necessitate drug withdrawal in some patients.

Nutritional assessment of patients in a large Saudi dialysis center.

OBJECTIVE: To examine interventions used to manage malnutrition, and obesity, and to share experiences, concerns, and solutions to these problems for management of nutritional disorders in Saudi patients on maintenance hemodialysis. METHODS: The subjects included in this cross-sectional study were chronic hemodialysis patients in the Prince Salman Center for Kidney Diseases (PSCKD), Riyadh, Kingdom of Saudi Arabia during the period from September 2007 to September 2008. Medical history, examination, baseline laboratory tests, and the nutritional status was assessed using the subjective global assessment score (SGA). RESULTS: Subjects in the study had a mean age of 50+/-16 years, 108 (54%) were males and 92 (46%) were females with a mean single pooled Kt/v of 1.4+/-0.15, and a mean normalized protein catabolic ratio of 1.130.2. Regarding body mass index, 4% of patients were underweight, 49% had average weight, 27.5% were overweight, 14% were obese, and 5.5% had morbid obesity. The SGA classified patients into 68% normal, 24% mild to moderately malnourished, and 8% with severe malnutrition. CONCLUSION: Using different parameters for individualization of metabolic needs to each patient's own metabolic status, and for detection of the coexisting nutritional conditions is essential for optimal care for hemodialysis patients.