Document Detail


Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C.
MedLine Citation:
PMID:  17311621     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The pathogenesis of chronic hepatitis C (CHC) is associated to severe oxidative stress that leads to necro-inflammation and progression of fibrosis. Previous trials suggested that antioxidative therapy may have a beneficial effect. We evaluated the efficacy and safety of Viusid in combination with interferon alpha-2b (IFN alpha-2b) and ribavirin in patients with CHC. METHODS: We randomly assigned 100 patients, between October 2002 and December 2004, in two arms: IFN alpha-2b (5 MU on alternate days), ribavirin at a dose of 13 mg/kg daily and Viusid (three sachets daily) vs. IFN alpha-2b (5 MU on alternate days) and ribavirin at a dose of 13 mg/kg daily. Subjects were treated for 48 weeks and then followed for an additional 24 weeks. The primary end point was the histologic response (reduction of at least two points without fibrosis worsening in the total score on the Histological Activity Index). RESULTS: A significantly high proportion of patients who received combined therapy plus Viusid had a histologic response better than those patients who received IFN alpha-2b and ribavirin (57% vs. 37%, P=0.03). The patients with virologic response achieved the highest percentages of histologic response, irrespective of assigned treatment. Among non-responders, the highest reduction in the mean change from baseline score for necro-inflammatory activity (NA) and fibrosis (F) was reported in patients treated with Viusid [NA, -1.50 (Viusid), -1.20 (without Viusid); F, -0.31 (Viusid), 0.00 (without Viusid)]. Sustained normalization of serum alanine aminotransferase concentration was highest in the Viusid group compared with standard therapy (67% vs. 41%, P=0.009). The overall safety profile was similar in both groups, but interestingly, the anemia was less intense in the group with Viusid (P=0.04). CONCLUSIONS: Our results suggest that triple therapy with Viusid, IFN alpha-2b and ribavirin was well tolerated and may have a beneficial effect on histologic and biochemical variables. The intensity of anemia is reduced in patients treated with Viusid.
Authors:
Eduardo Vilar Gomez; Bienvenido Gra Oramas; EnriqueArus Soler; Raimundo Llanio Navarro; Caridad Ruenes Domech
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Liver international : official journal of the International Association for the Study of the Liver     Volume:  27     ISSN:  1478-3223     ISO Abbreviation:  Liver Int.     Publication Date:  2007 Mar 
Date Detail:
Created Date:  2007-02-21     Completed Date:  2007-04-25     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101160857     Medline TA:  Liver Int     Country:  England    
Other Details:
Languages:  eng     Pagination:  247-59     Citation Subset:  IM    
Affiliation:
Department of Hepatology, National Institute of Gastroenterology, Havana, Cuba. vilar@infomed.sld.cu
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MeSH Terms
Descriptor/Qualifier:
Adult
Alanine Transaminase / blood
Anemia / chemically induced,  etiology
Antiviral Agents / adverse effects,  therapeutic use*
Dietary Supplements* / adverse effects
Drug Therapy, Combination
Female
Hepatitis C, Chronic / blood,  pathology,  therapy*
Humans
Interferon Alfa-2b / adverse effects,  therapeutic use*
Liver / pathology
Male
Middle Aged
Ribavirin / adverse effects,  therapeutic use*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antiviral Agents; 36791-04-5/Ribavirin; 99210-65-8/Interferon Alfa-2b; EC 2.6.1.2/Alanine Transaminase

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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