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• W2124509162 abstract "<h3>Importance</h3> Treatment of hepatitis C virus (HCV) infection in patients also infected with human immunodeficiency virus (HIV) has been limited due to drug interactions with antiretroviral therapies (ARTs) and the need to use interferon. <h3>Objective</h3> To determine the rates of HCV eradication (sustained virologic response [SVR]) and adverse events in patients with HCV-HIV coinfection receiving sofosbuvir and ribavirin treatment. <h3>Design, Setting, and Participants</h3> Open-label, nonrandomized, uncontrolled phase 3 trial conducted at 34 treatment centers in the United States and Puerto Rico (August 2012-November 2013) evaluating treatment with sofosbuvir and ribavirin among patients with HCV genotypes 1, 2, or 3 and concurrent HIV. Patients were required to be receiving ART with HIV RNA values of 50 copies/mL or less and a CD4 T-cell count of more than 200 cells/μL or to have untreated HIV infection with a CD4 T-cell count of more than 500 cells/μL. Of the treatment-naive patients, 114 had HCV genotype 1 and 68 had HCV genotype 2 or 3, and 41 treatment experienced participants who had been treated with peginterferon-ribavirin had HCV genotype 2 or 3, for a total of 223 participants. <h3>Interventions</h3> Treatment-naive patients with HCV genotype 2 or 3 received 400 mg of sofosbuvir and weight-based ribavirin for 12 weeks and treatment-naive patients with HCV genotype 1 and treatment-experienced patients with HCV genotype 2 or 3 received the same treatment for 24 weeks. <h3>Main Outcomes and Measures</h3> The primary study outcome was the proportion of patients with SVR (serum HCV <25 copies/mL) 12 weeks (SVR₁₂) after cessation of HCV therapy. <h3>Results</h3> Among treatment-naive participants, 87 patients (76%) of 114 (95% CI, 67%-84%) with genotype 1, 23 patients (88%) of 26 with genotype 2 (95% CI, 70%-98%), and 28 patients (67%) of 42 with genotype 3 (95% CI, 51%-80%) achieved SVR₁₂. Among treatment-experienced participants, 22 patients (92%) of 24 with genotype 2 (95% CI, 73%-99%) and 16 patients (94%) of 17 (95% CI, 71%-100%) achieved SVR₁₂. The most common adverse events were fatigue, insomnia, headache, and nausea. Seven patients (3%) discontinued HCV treatment due to adverse events. No adverse effect on HIV disease or its treatment was observed. <h3>Conclusions and Relevance</h3> In this open-label, nonrandomized, uncontrolled study, patients with HIV who were coinfected with HCV genotype 1, 2, or 3 who received the oral, interferon-free combination of sofosbuvir and ribavirin for 12 or 24 weeks had high rates of SVR₁₂. Further studies of this oral regimen in diverse populations of coinfected patients are warranted. <h3>Trial Registration</h3> clinicaltrials.gov Identifier:NCT01667731." @default.
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• W2124509162 date "2014-07-23" @default.
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• W2124509162 title "Sofosbuvir and Ribavirin for Hepatitis C in Patients With HIV Coinfection" @default.
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• W2124509162 doi "https://doi.org/10.1001/jama.2014.7734" @default.
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