Real-World Effectiveness of Simeprevir-containing Regimens Among Patients With Chronic Hepatitis C Virus: The SONET Study.
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2017-01
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Abstract
Background
The Simeprevir ObservatioNal Effectiveness across practice seTtings (SONET) study evaluated the real-world effectiveness of simeprevir-based treatment for hepatitis C virus (HCV) infection.Methods
The SONET study was a phase 4, prospective, observational, United States-based study enrolling patients ≥18 years of age with chronic genotype 1 HCV infection. The primary endpoint was the proportion of patients who achieved sustained virologic response 12 weeks after the end of treatment (SVR12), defined as HCV ribonucleic acid undetectable ≥12 weeks after the end of all HCV treatments.Results
Of 315 patients (intent-to-treat [ITT] population), 275 (87.3%) completed the study. Overall, 291 were treated with simeprevir + sofosbuvir, 17 with simeprevir + sofosbuvir + ribavirin, and 7 with simeprevir + peginterferon + ribavirin. The majority of patients were male (63.2%) and white (60.6%); median age was 58 years, 71.7% had genotype/subtype 1a, and 39.4% had cirrhosis. The SVR12 was achieved by 81.2% (255 of 314) of ITT patients (analysis excluded 1 patient who completed the study but was missing SVR12 data); 2 had viral breakthrough and 18 had viral relapse. The SVR12 was achieved by 92.4% (255 of 276) of patients in the modified ITT (mITT) population, which excluded patients who discontinued treatment for nonvirologic reasons before the SVR12 time point or were missing SVR12 assessment data. Among mITT patients, higher SVR12 rates were associated with factors including age ≥65 years, non-Hispanic/Latino ethnicity, and employment status, but not genotype/subtype nor presence of cirrhosis. Simeprevir-based treatment was well tolerated; no serious adverse events were considered related to simeprevir.Conclusions
In the real-world setting, simeprevir + sofosbuvir treatment was common and 92% of mITT patients achieved SVR12. Simeprevir-based treatment was effective and well tolerated in this cohort, including patients with cirrhosis.Type
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Alam, Imtiaz, Kimberley Brown, Cynthia Donovan, Jamie Forlenza, Kris Lauwers, Mitchell A Mah'moud, Richard Manch, Smruti R Mohanty, et al. (2017). Real-World Effectiveness of Simeprevir-containing Regimens Among Patients With Chronic Hepatitis C Virus: The SONET Study. Open forum infectious diseases, 4(1). p. ofw258. 10.1093/ofid/ofw258 Retrieved from https://hdl.handle.net/10161/26711.
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Mitchell Amuda Mah'moud
My research focuses on Hepatitis C management including new treatment options and possible complications. In addition, I am also interested in studying NAFLD including risk factors, new treatment modalities and economic impact on the society. As a member of the African Liver Cancer Consortium, I am involved in investigating the etiological factors and treatment options of hepatoma in Africa in the context of limited resources.
In addition to my research activities, I have been involved in teaching and mentoring the GI fellows. Nationally, I have served on several society committees including the Annual Meeting Educational Committee of AASLD, Professional Issues Committee of ACG and the Ethics Committee of the AGA. I was a founding member of the Executive Management Board of the AGA Center for GI Innovation and Technology.
Susanna Naggie
Dr. Susanna Naggie completed her undergraduate degrees in chemical engineering and biochemistry at the University of Maryland, College Park, and her medical education at Johns Hopkins School of Medicine. She conducted her internal medicine and infectious diseases fellowship training at Duke University Medical Center, where she also served as Chief Resident. She joined the faculty in the Duke School of Medicine in 2009. She is a Professor of Medicine and currently holds appointments at the Duke University School of Medicine, at the Duke Clinical Research Institute, and at the Durham Veterans Affairs Medical Center. Dr. Naggie is a clinical investigator with a focus in clinical trials in infectious diseases and translational research in HIV and liver disease. She is a standing member of the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents and the CDC/NIH/IDSA-HIVMA Opportunistic Infections Guideline. She is the Vice Dean for Clinical and Translational Research and Director for the Duke Clinical and Translational Sciences Institute.
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