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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Sofosbuvir and Ribavirin in HCV genotypes 2 and 3
New England Journal of Medicine, Volume 370, No. 21, Year 2014
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Description
BACKGROUND: In clinical trials, treatment with a combination of the nucleotide polymerase inhibitor sofosbuvir and the antiviral drug ribavirin was associated with high response rates among patients with hepatitis C virus (HCV) genotype 2 infection, with lower response rates among patients with HCV genotype 3 infection. METHODS: We conducted a study involving patients with HCV genotype 2 or 3 infection, some of whom had undergone previous treatment with an interferon-based regimen. We randomly assigned 91 patients with HCV genotype 2 infection and 328 with HCV genotype 3 infection, in a 4:1 ratio, to receive sofosbuvir-ribavirin or placebo for 12 weeks. On the basis of emerging data from phase 3 trials indicating that patients with HCV genotype 3 infection had higher response rates when they were treated for 16 weeks, as compared with 12 weeks, the study was unblinded, treatment for all patients with genotype 3 infection was extended to 24 weeks, the placebo group was terminated, and the goals of the study were redefined to be descriptive and not include hypothesis testing. The primary end point was a sustained virologic response at 12 weeks after the end of therapy. RESULTS: Of the 419 patients who were enrolled and treated, 21% had cirrhosis and 58% had received previous interferon-based treatment. The criterion for a sustained virologic response was met in 68 of 73 patients (93%; 95% confidence interval [CI], 85 to 98) with HCV genotype 2 infection who were treated for 12 weeks and in 213 of 250 patients (85%; 95% CI, 80 to 89) with HCV genotype 3 infection who were treated for 24 weeks. Among patients with HCV genotype 3 infection, response rates were 91% and 68% among those without and those with cirrhosis, respectively. The most common adverse events were headache, fatigue, and pruritus. CONCLUSIONS: Therapy with sofosbuvir-ribavirin for 12 weeks in patients with HCV genotype 2 infection and for 24 weeks in patients with HCV genotype 3 infection resulted in high rates of sustained virologic response. Copyright © 2014 Massachusetts Medical Society.
Authors & Co-Authors
Zeuzem, Stefan S.
Germany, Frankfurt am Main
Universitätsklinikum Frankfurt
Dusheiko, Geoffrey M.
United Kingdom, London
The Royal Free Hospital
Salupere, Riina
Estonia, Tartu
Tartu Ülikooli Kliinikum
Mangia, A.
Italy, San Giovanni Rotondo
Irccs Casa Sollievo Della Sofferenza
Flisiak, Robert
Poland, Bialystok
Uniwersytet Medyczny w Bialymstoku
Brainard, Diana M.
United States, Foster City
Gilead Sciences Incorporated
McHutchison, John G.
United States, Foster City
Gilead Sciences Incorporated
Weiland, Ola
Sweden, Stockholm
Karolinska Institutet
Reésink, Hendrick W.
Netherlands, Amsterdam
Amsterdam Umc - University of Amsterdam
Heźode, Christophe
France, Paris
Ap-hp Assistance Publique - Hopitaux de Paris
Esteban, Rafael
Spain, Barcelona
Hospital Universitari Vall D'hebron
Statistics
Citations: 703
Authors: 11
Affiliations: 11
Identifiers
Doi:
10.1056/NEJMoa1316145
ISSN:
00284793
Research Areas
Genetics And Genomics
Infectious Diseases
Study Design
Cross Sectional Study