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1. High-dose vitamin E supplementation does not diminish ribavirin-associated haemolysis in hepatitis C treatment with combination standard alpha-interferon and ribavirin.

Author

Saeian K, Bajaj JS, Franco J, Knox JF, Daniel J, Peine C, McKee D, Varma RR, and Ho S

Subjects
Adult, Drug Therapy, Combination, Female, Humans, Male, Quality of Life, Antioxidants administration & dosage, Antiviral Agents administration & dosage, Hemolysis drug effects, Hepatitis C, Chronic drug therapy, Ribavirin administration & dosage, Vitamin E administration & dosage
Abstract

Background: Ribavirin is associated with haemolytic anaemia. Antioxidants have been reported to decrease severity of this anaemia., Aim: To determine effect of vitamin E supplementation on ribavirin-associated haemolysis in chronic hepatitis C treated with standard alpha-interferon and ribavirin., Methods: Fifty-one naive chronic hepatitis C patients were randomized to receive either alpha-interferon/ribavirin therapy (control) or therapy plus vitamin E 800 IU b.d. with 24-week follow-up. Alanine aminotransferase ALT, haemoglobin and reticulocyte percentage were monitored. Symptoms and health-related quality of life were also monitored at each visit., Results: Forty-seven subjects were treated (27 vitamin E /20 controls). Thirteen withdrew because of adverse effects or non-compliance. Groups were similar in demographics, genotype and baseline lab indices. Comparison with baseline, treatment and follow-up values showed a significant haemoglobin and ALT reduction in both groups. There was no significant difference in haemoglobin and reticulocyte percentage between groups. Sustained viral response was not significantly different between vitamin E (11/18) and control (6/16) groups. Three patients required ribavirin dose-reduction in the vitamin E group compared with two controls. Health-related quality of life during and end-of-treatment was not different between groups., Conclusions: Vitamin E supplementation alone during standard alpha-interferon and ribavirin therapy does not appear to diminish ribavirin-associated haemolysis.

Published
2004
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2. Effects of Ribavirin Dose Reduction vs Erythropoietin for Boceprevir-Related Anemia in Patients With Chronic Hepatitis C Virus Genotype 1 Infection—A Randomized Trial

Author

Poordad, Fred, Lawitz, Eric, Reddy, K. Rajender, Afdhal, Nezam, Hézode, Christophe, Zeuzem, Stefan, Lee, Samuel, Calleja, Jose Luis, Brown, Robert, Craxi, Antonio, Wedemeyer, Heiner, Nyberg, L. M., Nelson, David, Rossaro, Lorenzo, Balart, Luis, Morgan, Timothy, Bacon, Bruce, Flamm, Steven, Kowdley, Kris, Deng, Weiping, Koury, Kenneth, Pedicone, Lisa, Dutko, Frank, Burroughs, Margaret, Alves, Katia, Wahl, Janice, Brass, Clifford, Albrecht, Janice, Sulkowski, Mark, Bailey, R., Cooper, C., Feinman, S.V., Marotta, P., Tam, E., Wong, F., Bourlière, Marc, Bronowicki, Jean-Pierre, Hezode, Christophe, Tran, A., Goeser, Tobias, Klass, D., Schmid, R., Pirisi, M., Zuin, M., Bennett, M., Bernstein, D., Box, T., Boyer, T., Clain, D., Crippin, J., Davis, M., Felizarta, Franco, Freilich, Bradley, Galati, Joseph, Galler, G., Ghalib, Reem, Gibas, A., Godofsky, E., Gordon, F., Gordon, S., Gross, J., Harrison, S., Herrera, J., Herrine, S., Herring, R., Jacobson, I., Joshi, S., Kilby, A., King, J., Koch, A., Kowdley, Kris V, Kwo, P., Lebovics, E., Lee, W., Levin, J., Li, Xiaojian, Luketic, Velimir, Mailliard, M., Mccone, Jonathan, Mikolich, D., Muir, A., Mullen, K., Nunes, F., Nyberg, A., Pandya, P., Pauly, M., Peine, C., Poleynard, Gary, Poulos, J., Pound, D., Rabinovitz, M., Ravendhran, Natarajan, Reddy, R., Reindollar, Robert, Reuben, A., Riley, T., Rubin, R., Russo, M., Ryan, M., Saab, S., Santoro, J., Schmidt, W., Sepe, T., Sherman, K., Sjögren, Marketa, Slim, J., Smith, C., Stein, L., Strauss, R., Vargas, H., Vierling, John, Witt, D., Wu, G., Younes, Z., Texas Liver Institute [San Antonio], University of Texas Health Science Center, The University of Texas Health Science Center at Houston (UTHealth)- The University of Texas Health Science Center at Houston (UTHealth), Division of Gastroenterology (University of Pennsylvania), University of Pennsylvania [Philadelphia], Beth Israel Deaconess Medical Center, Harvard Medical School, Service d'hépato-gastro-entérologie [APHP Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Johann Wolfgang Goethe University Medical Center, University of Calgary, University Hospital Puerta de Hierro, Madrid, New York Presbyterian Hospital, Università degli studi di Palermo - University of Palermo, Department of Gastroenterology, Hepatology and Endocrinology (MHH), Hannover Medical School [Hannover] (MHH), Kaiser Permanente, University of Florida [Gainesville] (UF), University of California [Davis] (UC Davis), University of California (UC), Tulane University Health Sciences Center, Veterans Affairs Long Beach Healthcare System (VA Long Beach Healthcare System), Saint Louis University School of Medicine [St Louis], Feinberg School of Medicine, Northwestern University [Evanston], Virginia Mason Medical Center, Merck & Co. Inc, Johns Hopkins University School of Medicine [Baltimore], Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), and University of California

Subjects
Male, viruses, [SDV]Life Sciences [q-bio], Hepacivirus, medicine.disease_cause, Gastroenterology, Polyethylene Glycols, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Erythropoiesis, Incidence, Disease Management, virus diseases, Anemia, Middle Aged, Recombinant Proteins, 3. Good health, Treatment Outcome, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Algorithms, medicine.drug, medicine.medical_specialty, Genotype, Proline, Side effect, Hepatitis C virus, Interferon alpha-2, Antiviral Agents, 03 medical and health sciences, Internal medicine, Boceprevir, Ribavirin, medicine, Humans, Erythropoietin, DAA, Dose-Response Relationship, Drug, Hepatology, business.industry, Interferon-alpha, Hepatitis C, Chronic, biochemical phenomena, metabolism, and nutrition, medicine.disease, digestive system diseases, Side Effect, Logistic Models, chemistry, Immunology, Hemoglobin, business, EPO
Abstract

International audience; Background & AimsTreatment of hepatitis C virus (HCV) infection with boceprevir, peginterferon, and ribavirin can lead to anemia, which has been managed by reducing ribavirin dose and/or erythropoietin therapy. We assessed the effects of these anemia management strategies on rates of sustained virologic response (SVR) and safety.MethodsPatients (n = 687) received 4 weeks of peginterferon and ribavirin followed by 24 or 44 weeks of boceprevir (800 mg, 3 times each day) plus peginterferon and ribavirin. Patients who became anemic (levels of hemoglobin approximately ≤10 g/dL) during the study treatment period (n = 500) were assigned to groups that were managed by ribavirin dosage reduction (n = 249) or erythropoietin therapy (n = 251).ResultsRates of SVR were comparable between patients whose anemia was managed by ribavirin dosage reduction (71.5%) vs erythropoietin therapy (70.9%), regardless of the timing of the first intervention to manage anemia or the magnitude of ribavirin dosage reduction. There was a threshold for the effect on rate of SVR: patients who received

Published
2013
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3. High-dose vitamin E supplementation does not diminish ribavirin-associated haemolysis in hepatitis C treatment with combination standardα-interferon and ribavirin.

Author

Saeian, K., Bajaj, J. S., Franco, J., Knox, J. F., Daniel, J., Peine, C., McKee, D., Varma, R. R., and Ho, S.

Subjects
VITAMIN E, RIBAVIRIN, DRUG dosage, HEMOLYSIS & hemolysins, HEPATITIS C, THERAPEUTICS, INTERFERONS
Abstract

Background: Ribavirin is associated with haemolytic anaemia. Antioxidants have been reported to decrease severity of this anaemia. Aim: To determine effect of vitamin E supplementation on ribavirin-associated haemolysis in chronic hepatitis C treated with standard α-interferon and ribavirin. Methods: Fifty-one naive chronic hepatitis C patients were randomized to receive either α-interferon/ribavirin therapy (control) or therapy plus vitamin E 800 IU b.d. with 24-week follow-up. Alanine aminotransferase ALT, haemoglobin and reticulocyte percentage were monitored. Symptoms and health-related quality of life were also monitored at each visit. Results: Forty-seven subjects were treated (27 vitamin E /20 controls). Thirteen withdrew because of adverse effects or non-compliance. Groups were similar in demographics, genotype and baseline lab indices. Comparison with baseline, treatment and follow-up values showed a significant haemoglobin and ALT reduction in both groups. There was no significant difference in haemoglobin and reticulocyte percentage between groups. Sustained viral response was not significantly different between vitamin E (11/18) and control (6/16) groups. Three patients required ribavirin dose-reduction in the vitamin E group compared with two controls. Health-related quality of life during and end-of-treatment was not different between groups. Conclusions: Vitamin E supplementation alone during standard α-interferon and ribavirin therapy does not appear to diminish ribavirin-associated haemolysis. [ABSTRACT FROM AUTHOR]

Published
2004
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