Sofosbuvir and Simeprevir Combination Therapy for HCV Genotype 1 Infection: Results of a Single-Center VA Experience.

Treatment of chronic hepatitis C virus (HCV) infection remains a priority in the veterans affairs (VA) health care system nationwide, as there is a high burden of liver disease due to HCV infection among US veterans. The combination of sofosbuvir and simeprevir was the first all-oral antiviral regimen used in clinical practice to treat veterans with HCV infection. In this study, we report a single-center experience showing both the feasibility and effectiveness of this all-oral combination to treat HCV genotype 1 infection.

Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data.

Unlabelled: Black patients chronically infected with genotype 1 hepatitis C virus (HCV) have historically had lower rates of response to interferon-based treatment than patients of other races. In the phase 3 ION program, the single-tablet regimen of the NS5A inhibitor ledipasvir and NS5B nucleotide polymerase inhibitor sofosbuvir was shown to be safe and highly effective in the general population. The aim of this study was to evaluate the safety and efficacy of ledipasvir/sofosbuvir in black patients using data from the three open-label ION clinical trials, which evaluated the safety and efficacy of 8, 12, and 24 weeks of ledipasvir/sofosbuvir with or without ribavirin for the treatment of treatment-naïve and treatment-experienced patients with genotype 1 HCV, including those with compensated cirrhosis.

Peginterferon alfa-2a and ribavirin in Latino and non-Latino whites with hepatitis C.

Background: Race has been shown to be a factor in the response to therapy for hepatitis C virus (HCV) infection, and limited data suggest that ethnic group may be as well; however, Latinos and other ethnic subpopulations have been underrepresented in clinical trials. We evaluated the effect of Latino ethnic background on the response to treatment with peginterferon alfa-2a and ribavirin in patients infected with HCV genotype 1 who had not been treated previously.

Methods: In a multicenter, open-label, nonrandomized, prospective study, 269 Latino and 300 non-Latino whites with HCV infection received peginterferon alfa-2a, at a dose of 180 microg per week, and ribavirin, at a dose of 1000 or 1200 mg per day, for 48 weeks, and were followed through 72 weeks.

Correlation of Laparoscopic Liver Biopsy to Elasticity Measurements (FibroScan) in Patients With Chronic Liver Disease.

Background: Elastography is a noninvasive method to assess liver fibrosis by measuring liver stiffness. Studies have compared elas-tography to percutaneous biopsy. Laparoscopic biopsy is associated with decreased sampling error compared to percutaneous biopsy, as laparoscopic biopsies are obtained from both liver lobes and gross nodu-larity can be visualized.

Prospective Evaluation of FIBROSpect II for Fibrosis Detection in Hepatitis C and B Patients Undergoing Laparoscopic Biopsy.

Serum markers of liver fibrosis are difficult to validate, due to the sampling error and observer variability associated with percutaneous liver biopsies. Laparoscopic biopsy decreases sampling error and increases the reliability of histopathologic assessment. We prospectively evaluated the FIBROSpect(SM) II serum marker test for viral liver fibrosis against laparoscopic biopsies by studying 145 patients with chronic hepatitis B or C who underwent laparoscopy in a tertiary care setting.

Treating hepatitis C in African Americans.

Background: The epidemiology, natural history and response to therapy of chronic hepatitis C differs significantly between African Americans and other ethnic populations. The reasons for these differences are not entirely clear but include mode of transmission, viral kinetics, immune responsiveness, and demographics.

Objective: Review of the peer-reviewed literature and expert opinion from 1990 to 2005 regarding features of hepatitis C virus (HCV) infection in African Americans, differences in presentation and response to therapy, and treatment recommendations.

Modeling hepatic fibrosis in African American and Caucasian American patients with chronic hepatitis C virus infection.

Assessment of histological stage is an integral part of disease management in patients infected with the hepatitis C virus (HCV). The aim of this study was to develop a model incorporating objective clinical and laboratory parameters to estimate the probability of severe fibrosis (i.e.

Peginterferon and ribavirin treatment in African American and Caucasian American patients with hepatitis C genotype 1.

Background & Aims: Compared with Caucasian Americans (CA), African Americans (AA) with chronic hepatitis C are less likely to respond to interferon-based antiviral therapy.

Methods: In a multicenter treatment trial, 196 AA and 205 CA treatment-naive patients with hepatitis C virus (HCV) genotype 1 infection were treated with peginterferon alfa-2a (180 microg/wk) and ribavirin (1000-1200 mg/day) for up to 48 weeks. The primary end point was sustained virologic response (SVR).

Distal splenorenal shunt versus transjugular intrahepatic portal systematic shunt for variceal bleeding: a randomized trial.

Background & Aims: Variceal bleeding refractory to medical treatment with beta-blockers and endoscopic therapy can be managed by variceal decompression with either surgical shunts or transjugular intrahepatic portal systemic shunts (TIPS). This prospective randomized trial tested the hypothesis that patients receiving distal splenorenal shunts (DSRS) would have significantly lower rebleeding and encephalopathy rates than TIPS in management of refractory variceal bleeding.

Methods: A prospective randomized controlled clinical trial at 5 centers was conducted.

Budd-Chiari-like presentation of hepatic adenoma.

Hepatic adenoma is a benign tumor characterized by its hypervascularity. Hepatic adenoma tends to occur more frequently in women and is related to the use of contraceptive hormones, androgenic/anabolic steroids, pregnancy, glycogen storage diseases and hemochromatosis. Hepatic venous obstruction, or Budd-Chiari syndrome, is a condition of hepatic vein occlusion that has many causes.

Peginterferon alfa-2a (40 kd) and ribavirin for black American patients with chronic HCV genotype 1.

Black Americans (blacks) have a high prevalence of chronic hepatitis C virus (HCV) infection and respond poorly to therapy with interferon alfa-based regimens, but they have been underrepresented in clinical trials. The aim of this study was to assess the rate of sustained virological response (SVR) to peginterferon alfa-2a (40 kd) in combination with ribavirin in black patients chronically infected with HCV genotype 1. In a prospective, multicenter, open-label trial, 78 black and 28 white American interferon-naïve patients were enrolled to receive once weekly subcutaneous injections of 180 microg peginterferon alfa-2a plus oral ribavirin (1000 mg/d for patients weighing less than 75 kg and 1200 mg/d for patients weighing 75 kg or more) for 48 weeks.

Pretreatment laparoscopic appearance of the liver can predict response to combination therapy with interferon alpha 2B and ribavirin in chronic hepatitis C.

Background: The aim of this study was to determine whether the pretreatment laparoscopic appearance of the liver is an additional predictor of response to combination therapy with interferon and ribavirin in patients with hepatitis C.

Methods: A retrospective review was performed of 112 patients (61 men, 51 women [ratio 1.3:1]; mean age 50 [10] years, range 15-73 years) with untreated hepatitis C, without other causes of liver disease, who underwent diagnostic laparoscopy before combination therapy with interferon and ribavirin for at least 24 weeks with a 24-week post-treatment follow-up.

Sampling error and intraobserver variation in liver biopsy in patients with chronic HCV infection.

Objectives: Needle liver biopsy has been shown to have a high rate of sampling error in patients with diffuse parenchymal liver diseases. In these cases, the sample of liver tissue does not reflect the true degree of inflammation, fibrosis, or cirrhosis, despite an adequate sample size. The aim of this study was to determine the rate and extent of sampling error in patients with chronic hepatitis C virus infection, and to assess the intraobserver variation with the commonly used scoring system proposed by Scheuer and modified by Batts and Ludwig.