Predictors of sustained virological response to a 48-week course of pegylated interferon alfa-2a and ribavirin in patients infected with hepatitis C virus genotype 4.

BACKGROUND AND OBJECTIVES: Knowledge of the predictors of sustained viral response (SVR) to pegylated interferon (PEG-INF) alfa-2a and ribavirin (RBV) therapy in patients with hepatitis C genotype-4 (HCV-4) is crucial for selecting patients who would benefit most from therapy. We assessed the predictors of SVR to this combination therapy in Saudi patients with chronic HCV-4 infection. PATIENTS AND METHODS: This retrospective study included 148 patients with HCV-4 infection who underwent clinical, biochemical and virological assessments before treatment and at 12, 24, 48 and 72 weeks post-treatment. RESULTS: Of the 148 patients, 90 (60.8%) were males. Mean (SD) for age was 48.5 (12.7) years and BMI was 27.9 (7.5) kg/m(2). Seventy-nine of 148 (60.1%) patients were treatment naïve and 110 (74.3%) underwent pre-treatment liver biopsy. Eighteen (12.2%) patients did not complete therapy because of side effects or they were lost to follow up. Early virological response was achieved in 84 of 91 (92.3%) patients. In the 130 (87.8%) patients who completed therapy, 34 (26.2%) were non-responders and 96 (63.8%) achieved end-of-treatment virological response (ETVR). SVR and virological relapse (24 weeks after ETVR) occurred in 66/130 (50.7%) and 30/130 (31.2%) patients, respectively. Compared to relapsers, sustained responders were significantly younger (P=.005), non-diabetic (P=.005), had higher serum albumin (P=.028), lower alpha-fetoprotein level (P=.026), lower aspartate aminotransferase (AST) (P=.04) levels, and were treatment-naïve (P=.008). In a multivariate regression analysis, the independent predictors of SVR were younger age (P=.016), lower serum AST (P=.012), and being treatment naïve (P=.021). CONCLUSION: Approximately half of HCV-4 patients who complete the course of combination therapy achieve an SVR, especially if they are young, treatment naA ve and have lower AST levels.

Wilson disease in 71 patients followed for over two decades in a tertiary center in Saudi Arabia: a retrospective review.

BACKGROUND AND OBJECTIVES: Wilson disease (WD) is a rare autosomal recessive disease. Our objective was to describe the diverse patterns, therapies, and outcomes of this disease. DESIGN AND SETTING: A retrospective study over two decades on WD patients in a tertiary care center in Saudi Arabia. PATIENTS AND METHODS: Clinical and laboratory findings of 71 patients with WD were retrieved from their charts, referral notes and our hospital electronic records and were analyzed. RESULTS: The mean age and standard deviation was 16.8 (10.7) years and 56.5% were males. The main manifestations of WD were hepatic, neurological, and mixed in 39 (54.9%), 12 (16.9%), and 20 (28.2%) patients, respectively, and 11 (15.5%) were asymptomatic cases detected by family screening. A family history of WD was positive in 41 (57.7%) patients, and consanguinity of parents was found in 26 (36.6%) patients. The mean (SD) follow-up period was 92.2 (72.9) (range, 1-320) months. Ten (14.1%) patients died during follow up, while 45 (63.4%) and 16 (22.5%) were still on or lost from follow-up, respectively. The mean (SD) age at the end of follow-up was 25.3 (12) (range, 4-62) years. Hepatoma was discovered in 5 (7.0%) patients. Penicillamine therapy was used by 58 (81.7%) patients, while zinc and trientine were given to 32 (45.1%) and 11 (15.5%) patients, respectively. Sixteen (22.5%) patients underwent liver transplantation and one died (1.4%) on the waiting list. The liver condition remained stable or improved in 35 (49.3%), and the neurological status showed improvement in 11 (34.4%) of the 32 patients who had neurological involvement. CONCLUSIONS: This is the biggest cohort to be reported from the Middle East. WD presentation and outcome of WD are very diverse, and its diagnosis still depends on clinical, laboratory, and radiological evidence of abnormal copper metabolism. WD should be considered in patients of any age with obscure hepatic and/or neurological abnormalities.

Bio-enteric intragastric balloon in obese patients: a retrospective analysis of King Faisal Specialist Hospital experience.

BACKGROUND: Bio-enteric intragastric balloon (BIB) insertion is gaining popularity for weight reduction in obese patients. We evaluated the efficacy, tolerability, and safety of BIB in the treatment of obesity. METHODS: A total of 173 Saudi obese patients [mean+/-SD age 34.5 +/- 11.6 years, 58 (33.5%) were men] who underwent BIB (InaMed Corporation, California, USA) insertion were followed up clinically, biochemically, and endoscopically for 6-12 months. The mean+/-SD baseline body weight, excess weight, and body mass index (BMI) were 123.5 +/- 39.6 and 68.9 +/- 40.0 kg and 46.7 +/- 14.1 kg/m(2), respectively. Associated dietary control, exercise, and medical treatment were used in 67 (38.7%), 60 (34.7%), and 3 (1.7%), respectively. RESULTS: BIBs were safely and successfully inserted in 15.1 +/- 6.2 min, filled with 626.2 +/- 41.7 ml methylene blue solution, removed after a period of 189.7 +/- 68.3 days, within 14.1 +/- 6.3 min. BIB was not tolerated for 6 months in 33 (19.8%) patients. Body weight and BMI at 6 and 12 months postinsertion were significantly reduced to 112.5 +/- 35.7 kg and 43.1 +/- 13.1 kg/m(2), and 110.7 +/- 34.5 kg and 42.3 +/- 12.6 kg/m(2), respectively (p < 0.01 versus baseline by one-way ANOVA). Furthermore, the mean absolute weight loss and mean percentage excess weight reduction (EWR) at 6 and 12 months post-BIB insertion were 13.5 +/- 13.5 kg and 19.5 +/- 21.8, and 14 +/- 18.5 kg and 18.0 +/- 25.8, respectively. No mortality or major complications has occurred. EWR of >or=25% occurred in 24.1% and 30.1% of patients at 6 and 12 months postinsertion, respectively. CONCLUSION: BIB is a safe, simple, and potentially efficient procedure that is well-tolerated by the majority of patients.

Successful management of multifactorial colitis in a recipient of hematopoietic stem cell transplant: a case report.

Recipients of allogeneic hematopoietic stem cell transplant can develop life-threatening complications at any time following their transplants. These complications require repeated clinical assessment, appropriate and thorough screening as well as a comprehensive management approach. We report a young adult male who received a sibling allograft in the second complete remission of his acute lymphoblastic leukemia at King Faisal Specialist Hospital and Research Centre in Riyadh. The patient developed severe colitis which was caused by: acute exacerbation of chronic graft versus host disease of the lower gastrointestinal tract, cytomegalovirus disease of the colon and a superadded Salmonella infection caused by food poisoning. The multifactorial colitis was properly investigated and successfully managed. To our knowledge, this is the first case of multifactorial colitis in a recipient of hematopoietic stem cell transplant.

Sustained virologic response to peginterferon alpha-2a and ribavirin in 335 patients with chronic hepatitis C: a tertiary care center experience.

BACKGROUND/AIM: This retrospective study assessed the efficacy, safety, and the predictors of sustained viral response (SVR) to a 48-week-course of peginterferon alpha-2a (Pegasys) and ribavirin combination therapy in 335 consecutive Saudi patients with chronic hepatitis C virus (HCV) infection. MATERIALS AND METHODS: Clinical, biochemical, and virological parameters were collected at time 0 (pretreatment) and at 12, 24, 48, and 72 weeks posttreatment. The mean +/- SD age was 49.1 +/- 13.0 years; 229 (68.4%) were males, mean +/- SD body mass index was 27.8 +/- 7.4, 85 (25.4%) were diabetic, 25 (7.5%) had renal impairment, 136 (40.6%) had previously received interferon +/- ribavirin therapy, and 247 (73.7%) underwent pretreatment liver biopsy. Patients with genotypes 1, 2 or 3, 4 and mixed genotype were 60 (22.15%), 30 (11.0%), 148 (54.4%), and 34 (12.5%), respectively. RESULTS: Early viral response (>or=2-log10 HCV-RNA decline 12 weeks posttreatment) was achieved in 253 (75.3%). Patients who completed 48 weeks of treatment were 292 (87.1%); of these, 121 (75.6%) achieved ETVR, 161 (55.1%) continued to have SVR and 60 (20.5%) had a viral relapse following end-of-treatment response, that is 48.1 and 17.9% of all patients (n = 335), respectively. Nonresponders (NR) were 71 (24.3%) patients and 43 (12.8%) were unable to complete treatment (due to side effects or loss to follow up). Compared to the relapsers, patients with SVR were significantly younger (P = 0.000), nondiabetics (P = 0.015), had higher serum albumin (P = 0.007), had less pretreatment inflammatory grade (P = 0.011), infected with genotypes 2 or 3 (P = 0.014), and treatment-naïve patients (P = 0.001). However, in stepwise multivariate logistic regression analysis, only treatment naiveté and low pretreatment inflammatory score were the independent predictors of SVR (P = 0.005 and P = 0.018, respectively). CONCLUSION: Combination therapy, if tolerated and completed, is effective in treating chronic HCV patients, especially those with no previous interferon therapy and lower pretreatment inflammatory grade.

A pilot trial of combination cisplatin, 5-fluorouracil and interferon-alpha in the treatment of advanced esophageal carcinoma.

BACKGROUND/OBJECTIVES: Based on the synergistic effect between cisplatin and 5-fluorouracil (5-FU), and between 5-FU and interferon-alpha, we conducted a trial to assess the response rate and toxicity of the combination of cisplatin, 5-FU and interferon-alpha in patients with advanced esophageal cancer. METHODS: Patients with locally advanced or metastatic squamous cell or adenocarcinoma of the esophagus were eligible. No prior chemotherapy or interferon were allowed. Patients received cisplatin 80 mg/m(2) on day 1, 5-FU 750 mg/m(2)/day by continuous intravenous infusion for 5 days, and interferon-alpha 5 x 10(6) units/m(2)/day by subcutaneous injection on days 1-5 of each cycle. Cycles were repeated every 21 days for a total of 6 cycles. RESULTS: Forty patients were enrolled. Median age was 57.5 years (range 30-70). 33 had squamous carcinoma and 7 adenocarcinoma; 15 were male; the locoregional metastatic ratio was 1:39; median ECOG performance status was 2 (range 1-3). Grade 3-4 toxicities were: leukopenia (9 cases), thrombocytopenia (4), electrolyte imbalance (11), febrile neutropenia (11), vomiting (5), diarrhea (4), and mucositis (11). There were 3 early deaths, most probably related to therapy. Five patients (13%) achieved a complete response and 17 (42%) achieved a partial response, yielding an overall response rate of 55%. Response rates for squamous and adeno histology were 61% and 29%, respectively. Median survival was 6.4 months. CONCLUSION: The combination of cisplatin, 5-FU and interferon-alpha produces a high response rate in advanced squamous cell esophageal carcinoma, but with considerable toxicity. A modified combination of the above agents is presently being evaluated at our institution.