Archive for June 1, 2006

A Study of Low Dose Peginterferon Alpha-2b with Ribavirin for the Initial Treatment of Chronic Hepatitis C

Am J Gastroenterol Jun 2006 Vol.101 N.6 p.1268–1273

Edward L. Krawitt, M.D.1,2, Stuart R. Gordon, M.D.2, Norman D. Grace, M.D.3, Takamaru Ashikaga, Ph.D.4, Mary Ann Ray, B.S.N.1, Melissa Palmer, M.D.5, Joseph C. Yarze, M.D.6, Sam Moskowitz, M.D.7 for the New York New England Study Team

1Department of Medicine, University of Vermont, Burlington, Vermont; 2Department of Medicine, Dartmouth Medical School, Hanover, New Hampshire; 3Department of Medicine, Brigham and Women's Hospital, Harvard Medical College, Boston, Massachusetts; 4Department of Medical Biostatistics, University of Vermont, Burlington, Vermont; 5Liver Center of Long Island, Plainview, New York; 6Gastroenterology Associates of Northern New York, Glens Falls, New York; and 7Gastro-Biliary Associates, Forest Hills, New York
Reprint requests and correspondence: Edward L. Krawitt, M.D., University of Vermont, Given C-246, Burlington, VA 05405–0068.

PURPOSE:  A prospective randomized trial was undertaken to test the efficacy of low and standard doses of pegylated interferon alpha-2b in combination with ribavirin for the initial treatment of chronic hepatitis C. By nature of its design the study also provided data on response to therapy over a spectrum of doses of both pegylated interferon alpha-2b and ribavirin calculated on a body weight basis.

SUBJECTS AND METHODS:  Fifty micrograms of pegylated interferon alpha-2b or 100 μg for patients weighing <75 kg or 150 μg for patients ≥75 kg were administered weekly with 1000 mg ribavirin daily for 48 wk if serum hepatitis C virus (HCV) RNA was undetectable after the first 24 wk of therapy.

RESULTS:  Overall sustained viral response (SVR) was 45% for standard dose and 33% for low dose, p= 0.02. For genotypes 2 and 3 SVR was 65% for standard dose, and 56% for low dose, p= 0.51. For genotype 1 SVR was 38% for standard dose, and 24% for low dose, p= 0.03. For genotype 1 patients whose doses exceeded the 1-2-5 threshold, that is ≥1.25 μg/kg body weight pegylated interferon alpha-2b weekly and ≥12.5 mg/kg body weight ribavirin daily, SVR was 51%.

CONCLUSION:  The results of this study underscore the importance of adequate dosing of ribavirin as well as pegylated interferons in achieving an SVR when treating genotype 1 chronic hepatitis C patients with combination therapy.

Clic ver abstract

June 1, 2006 at 12:37 am Leave a comment

SPECIAL ARTICLE – Hepatitis C in 6,865 Patients 65 yr or Older: A Severe and Neglected Curable Disease?

Am J Gastroenterol Jun 2006 Vol.101 N.6 p.1260–1267

Dominique Thabut, M.D.1, Sophie Le Calvez, M.D.1, Vincent Thibault, M.D., Ph.D.2, Julien Massard, M.D.1, Mona Munteanu, M.D.1, Vincent Di Martino, M.D., Ph.D.1, Vlad Ratziu, M.D.1, and Thierry Poynard, M.D., Ph.D.1

1Services d'Hépato-Gastroentérologie; 2de Virologie, Groupe Hospitalier Pitié-Salpêtrière, Paris, France
Reprint requests and correspondance: Dominique Thabut, Service d'Hépato-Gastroentérologie, 47–83 Bld de l'Hôpital 75013 Paris, France.

BACKGROUND:  Few data are available on chronic hepatitis C (CHC) in elderly patients. The aim of this study was to compare the features and severity of CHC and the efficacy/safety of antiviral therapy in patients <65, between 65 and 80, and >80 yr old, and to determine the usefulness of biochemical markers (Fibrotest-Fibrosure/ActiTest [FT-AT]) in aged patients.

METHODS:  This was a retrospective study with two groups of patients: Group 1: prospective cohort including all hepatitis C virus patients from our institution (N = 4,182); Group 2: all consecutive patients who had FT-AT performed in France between 2002 and 2004 (N = 33,738).

RESULTS:  A total of 6,865 patients ≥65 yr old was included (Group 1 = 881, Group 2 = 5,984). Group 1: patients ≥65 had a longer duration of and a higher age at infection, more genotype 1, and a history of transfusion ( p< 0.001). Among the 2,169 patients who underwent liver biopsy, bridging fibrosis (F2,F3,F4) was more frequent in patients ≥65 yr old, regardless of the duration of infection. In multivariate analysis, ages at biopsy and at infection were associated with F2,F3,F4. Discovery of CHC by a complication was more frequent in patients ≥65 yr ( p< 0.001). One hundred seventy patients ≥65 yr received antiviral therapy. A sustained virologic response was obtained in 45% of patients ≥65 yr treated with pegylated interferon/ribavirin. Group 2: At FT, 58% of patients >80 yr, 37% of patients between 65 and 80 yr, and 14% of patients <65 yr ( p< 0.001) had cirrhosis. Patients >80 yr (43%) with cirrhosis had nonelevated alanine amino transferase (ALT), compared with 31% of patients <65 yr ( p< 0.001).

CONCLUSION:  In patients ≥65 yr, CHC is more severe and presents with lower ALT than in younger patients. Treatment is effective. Biochemical markers seem particularly useful as a noninvasive alternative to liver biopsy in this population.

Clic ver abstract

June 1, 2006 at 12:36 am Leave a comment

Sexual Dysfunction is Highly Prevalent Among Men with Chronic Hepatitis C Virus Infection and Negatively Impacts Health-Related Quality of Life

Am J Gastroenterol Jun 2006 Vol.101 N.6 p.1235-1243

Ann Danoff, M.D.1,4,5, Oona Khan, M.D.1,5, David W. Wan, M.D.5, Lainie Hurst, M.D.1,5, Daniel Cohen, M.D.5, Craig T. Tenner, M.D.2,4,5, and Edmund J. Bini, M.D., M.P.H.3,4,5

1Division of Endocrinology,2Division of General Internal Medicine, and 3Division of Gastroenterology, 4VA New York Harbor Healthcare System, and 5NYU School of Medicine, New York, New York
Reprint requests and correspondence: Edmund J. Bini, M.D., M.P.H., Division of Gastroenterology, VA New York Harbor Healthcare System, 423 East 23rd Street, New York, New York 10010.

OBJECTIVES:  Although sexual dysfunction has been reported in patients with hepatitis C virus (HCV) infection, little is known about this association. The aims of this study were to determine the prevalence of sexual dysfunction among men with chronic HCV infection and to evaluate the impact of sexual dysfunction on health-related quality of life (HRQOL).

METHODS:  We prospectively enrolled 112 HCV positive men and 239 HCV negative controls, and all patients completed validated questionnaires to assess sexual function (Brief Male Sexual Function Inventory [BMSFI]), depression (Beck Depression Inventory), and HRQOL (Medical Outcomes Study Short Form-36). The BMSFI assessed sexual drive, erection, ejaculation, sexual problem assessment, and overall sexual satisfaction.

RESULTS:  HCV positive men had significantly more sexual dysfunction than control subjects across all five domains of the BMFSI. In addition, HCV-infected men were significantly more likely than controls to not be sexually satisfied (53.6%vs 28.9%, p< 0.001) and this remained statistically significant after adjusting for age, race, and other potential confounding variables (OR = 3.36; 95% CI, 1.59–7.13). In the 241 individuals without depression, HCV positive men were significantly more likely to not be sexually satisfied as compared with control subjects (47.5%vs 11.0%, p< 0.001). HCV-infected men who were not sexually satisfied scored significantly worse in six of eight domains of HRQOL as compared with HCV-infected men who were sexually satisfied.

CONCLUSIONS:  Sexual dysfunction is highly prevalent in men with chronic HCV infection, is independent of depression, and is associated with a marked reduction in HRQOL.

Clic ver abstract:

June 1, 2006 at 12:34 am Leave a comment


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