Hatef Massoumi

Effectiveness of hepatitis C treatment with pegylated interferon and ribavirin in urban minority patients

Randomized controlled trials of hepatitis C virus (HCV) therapy with pegylated interferon and ribavirin have demonstrated sustained viral response rates (SVRs) of 54%‐63% (efficacy). Treatment results in clinical practice (effectiveness) may not be equivalent. The goal of this study was to assess the effectiveness of HCV treatment with pegylated interferon and ribavirin in a treatment‐naïve, human immunodeficiency virus (HIV)‐negative, United States urban population with many ethnic minority patients. We evaluated 2,370 outpatients for HCV therapy from 2001 to 2006 in the Faculty Practice of the Albert Einstein College of Medicine or the attending‐supervised Montefiore Medical Center Liver Clinic. Care was supervised by one experienced physician under conditions of everyday clinical practice, and appropriate ancillary resources were made available to all patients. Two hundred fifty‐five patients were treated with a mean age of 50 years (60% male, 40% female; 58% Hispanic, 20% African American, 9% Caucasian, 13% other; 68% genotype 1, the remainder genotypes 2 or 3). Patients had at least one liver biopsy. Intention‐to‐treat analysis (ITT) showed SVR in 14% of genotype 1 patients and 37% in genotype 2/3 patients (P < 0.001). SVR was significantly higher in faculty practice (27%) than in clinic patients (15%) by intention‐to‐treat (P = 0.01) but not per‐protocol analysis (46% faculty practice, 34% clinic). 3.3% of 1,656 treatment‐naïve, HIV antibody–negative individuals ultimately achieved SVR. Current hepatitis C therapies may sometimes be unavailable to, inappropriate for, and ineffective in United States urban patients. Treatment with pegylated interferon and ribavirin was less effective in this population than is implied by multinational phase III controlled trials. New strategies are needed to care for such patients. (HEPATOLOGY 2010.)

Bile leak after laparoscopic cholecystectomy.

Laparoscopic cholecystectomy is commonly performed as the treatment of choice for symptomatic gallstone diseases. Bile leak is a potential complication of this procedure and the cystic duct stump is the most common site of leakage. Early diagnosis and treatment of bile leak is crucial in decreasing the morbidity and mortality related to this complication. Endoscopic retrograde cholangiopancreatography with stent placement and/or sphincterotomy is highly effective in the diagnosis and treatment of this problem.

An Escalating Dose Regimen of Pegylated Interferon and Ribavirin in HCV Cirrhotic Patients Referred for Liver Transplant

Background. To lessen the severity of recurrent hepatitis C virus (HCV) postliver transplantation (post-LT) by treating HCV patients with cirrhosis, we assessed the safety and efficacy of an escalating dose pegylated interferon (PEG-IFN)/ribavirin protocol in pre-LT patients. Methods. Ninety patients were treated with 90 &mgr;g PEG-IFN alpha-2a and 400 mg ribavirin and advanced to 180 &mgr;g and 800 to 1200 mg, respectively, over 8 weeks. Results. Mean age was 55.3 years. Thirty-four percent of patients received prior interferon treatment, 77% had genotype 1 or 4. Mean Child’s score was 6.7 and model for end-stage liver disease 11.2; 49% reached full-dose PEG-IFN and 85% ribavirin, 18% required dose reduction, 33% stopped treatment because of adverse effects, 9% had deterioration of liver function, and 7% died. Follow-up of 9.6 months showed sustained virological response in 13% of patients. The rate of serious complications was 16.3% in Child’s class A, 48% in B, and 100% in C (P=0.005). Serum albumin was a significant predictor for worsening liver function (P=0.007). Conclusions. Using an escalating dose regimen of PEG-IFN alpha-2a and ribavirin, we achieved only a 13% sustained virological response in HCV cirrhotic pre-LT patients with an accompanying 9% risk of worsening liver function and 7% risk of death.

The impact of an educational program on HCV patient outcomes using boceprevir in community practices (OPTIMAL trial)

Objectives: Although effective, direct acting antiviral (DAA) therapies for genotype 1 (GT 1) hepatitis C virus (HCV) have been associated with compliance challenges. Additionally, treatment at predominantly community-based centers has been associated with low retention of patients on treatment and higher dropout rates. The OPTIMAL Phase IV interventional trial (ClinicalTrials.gov Identifier: NCT01405027) was designed to evaluate the impact of an education program for community investigator (CI) sites participating in a Chronic Liver Disease Foundation study treating chronic GT 1 HCV patients. Methods: This physician educational program was administered by 22 Hepatology Centers of Educational Expertise (HCEE) academic sites to 33 CI sites asked to participate from December 2011 to July 2012. The HCEE mentors from DAA-experienced academic sites educated those at CI sites on therapeutic management, practice, and patient outcomes through a series of four standardized educational sequence visits regarding the use of first generation HCV protease inhibitors and the overall treatment of HCV. Results: Treatment duration compliance rates for patients treated at CI sites versus those treated at HCEE academic sites were evaluable in 77 of 84 HCEE academic site patients, 102 of 113 patients treated at CI sites, and 179 of 197 overall patients. The treatment duration compliance rates for patients treated at HCEE academic sites, CI sites and overall were 85.4 ± 25.39%, 83.8 ± 27.37%, and 84.5 ± 26.48%, respectively, and did not differ statistically between the groups (p = 0.49). Almost half (47%) of the patients in the study achieved a sustained virological response for 24 weeks (SVR24) regardless of the type of site (p = 0.64). Safety profiles were similar at both HCEE and CI sites. Conclusions: These results demonstrated that education of CI sites unfamiliar with DAAs resulted in patient outcomes consistent with those observed at DAA-experienced academic sites.

Portal hypertensive vaginal bleeding

A 44-year-old woman with hepatitis C cirrhosis presented with a week of heavy vaginal bleeding. Her obstetric history was significant for three cesarean sections. Her gynecologist made an initial diagnosis of menometrorrhagia exacerbated by thrombocytopenia and coagulopathy. Computed tomography (CT) angiography revealed splenic vein thrombosis and engorged pelvic veins which arose as collaterals from the splenic vein (Fig. 1). Hysteroscopy could not identify a culprit lesion due to the rapidity of bleeding. A transjugular intrahepatic portosystemic shunt (TIPS) was created and thrombectomy of the splenic vein was performed and the residual partially occlusive thrombus was then stented. Hepatopedal flow was then noted from splenic vein to portal vein and through the TIPS. Hysteroscopy showed persistently engorged varices. Venous embolization of the varices was performed with a combination of embolization coils and a vascular plug (Fig. 2). Recovery was uneventful, and she was followed for 2 years in our clinic without further vaginal bleeding.

Laboratory Parameters May Help Predict In-Hospital Mortality After Percutaneous Endoscopic Gastrostomy (PEG)

Laboratory Parameters May Help Predict In-Hospital Mortality After Percutaneous Endoscopic Gastrostomy (PEG) Uma Kantamneni, Ajit Kokkat, Mario Ricci, Hatef Massoumi, Edward Norkus, Nejat Kiyici, Hilary Hertan Background: Although PEG has been touted as a safe procedure, given the seriously ill population the procedure is performed on,mortality prior to discharge is not uncommon. Aim: To identify laboratory parameters predicting the inhospital mortality after PEG. Methods: A retrospective chart review was conducted of 96 patients undergoing PEG in a university teaching hospital over six months. Multiple factors were studied in patients who were discharged and those who died in the hospital. Results were obtained using student t-tests and logistic regression. Results: The study group had 40 men and 56 women, and average age was 82 + 13. Five out of ninety-six (5.21%) patients died in the hospital after PEG prior to discharge. Conclusion: Laboratory studies should guide patient selection for PEG and the above-mentioned factors may predict inhospital mortality after PEG.

Ibrutinib-induced severe liver injury

Ibrutinib, an inhibitor of the Brutons tyrosine kinase of the B‐cell receptor pathway, is an effective therapeutic agent for B‐cell lymphomas. As these drugs are novel, long‐term or rare adverse events are not yet known. We report the first case of ibrutinib‐induced severe liver injury in a patient with relapsed/refractory CLL.

Drug-Induced Liver Injury

Drug-induced liver injury (DILI) is a common health disorder that is unpredictable and often poorly understood in pathogenesis. DILI may result in serious, sometimes fatal liver injury in older adults. Recognizing the relationship of medications to hepatic injury and prompt cessation of the responsible drug may result in spontaneous resolution in most, although a return to normal liver function may take months. Antimicrobials and acetaminophen account for a large proportion of DILI. Detailed history and exclusion of competing causes help make the diagnosis. DILI may also result from herbal and dietary supplements, emphasizing the need to enquire about all prescribed and over-the-counter medications, including supplements.