Real-world effectiveness of Simeprevir-containing regimens among patients with chronic hepatitis C virus: The SONET study

Imtiaz Alam, Kimberley Brown, Cynthia Donovan, Jamie Forlenza, Kris Lauwers, Mitchell A. Mah'moud, Richard Manch, Smruti R. Mohanty, Avinash Prabhakar, Robert Reindollar, Ralph DeMasi, Jihad Slim, Neeta Tandon, Shirley Villadiego, Susanna Naggie

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6 Citations (Scopus)

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.

Original languageEnglish (US)
JournalOpen Forum Infectious Diseases
Volume4
Issue number1
DOIs
StatePublished - Jan 1 2017

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Chronic Hepatitis C
Hepacivirus
Fibrosis
Ribavirin
Genotype
Virus Diseases
Therapeutics
Simeprevir
Age Factors
Hispanic Americans
Population
RNA
Recurrence

Keywords

  • Hepatitis C virus
  • Real-world
  • Simeprevir

ASJC Scopus subject areas

  • Oncology
  • Clinical Neurology

Cite this

Real-world effectiveness of Simeprevir-containing regimens among patients with chronic hepatitis C virus : The SONET study. / Alam, Imtiaz; Brown, Kimberley; Donovan, Cynthia; Forlenza, Jamie; Lauwers, Kris; Mah'moud, Mitchell A.; Manch, Richard; Mohanty, Smruti R.; Prabhakar, Avinash; Reindollar, Robert; DeMasi, Ralph; Slim, Jihad; Tandon, Neeta; Villadiego, Shirley; Naggie, Susanna.

In: Open Forum Infectious Diseases, Vol. 4, No. 1, 01.01.2017.

Research output: Contribution to journalArticle

Alam, I, Brown, K, Donovan, C, Forlenza, J, Lauwers, K, Mah'moud, MA, Manch, R, Mohanty, SR, Prabhakar, A, Reindollar, R, DeMasi, R, Slim, J, Tandon, N, Villadiego, S & Naggie, S 2017, 'Real-world effectiveness of Simeprevir-containing regimens among patients with chronic hepatitis C virus: The SONET study', Open Forum Infectious Diseases, vol. 4, no. 1. https://doi.org/10.1093/ofid/ofw258
Alam, Imtiaz ; Brown, Kimberley ; Donovan, Cynthia ; Forlenza, Jamie ; Lauwers, Kris ; Mah'moud, Mitchell A. ; Manch, Richard ; Mohanty, Smruti R. ; Prabhakar, Avinash ; Reindollar, Robert ; DeMasi, Ralph ; Slim, Jihad ; Tandon, Neeta ; Villadiego, Shirley ; Naggie, Susanna. / Real-world effectiveness of Simeprevir-containing regimens among patients with chronic hepatitis C virus : The SONET study. In: Open Forum Infectious Diseases. 2017 ; Vol. 4, No. 1.
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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.",
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AU - Donovan, Cynthia

AU - Forlenza, Jamie

AU - Lauwers, Kris

AU - Mah'moud, Mitchell A.

AU - Manch, Richard

AU - Mohanty, Smruti R.

AU - Prabhakar, Avinash

AU - Reindollar, Robert

AU - DeMasi, Ralph

AU - Slim, Jihad

AU - Tandon, Neeta

AU - Villadiego, Shirley

AU - Naggie, Susanna

PY - 2017/1/1

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N2 - 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.

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