Skip to main content
Journal cover image

Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection.

Publication ,  Journal Article
Sulkowski, MS; Vargas, HE; Di Bisceglie, AM; Kuo, A; Reddy, KR; Lim, JK; Morelli, G; Darling, JM; Feld, JJ; Brown, RS; Frazier, LM; Fried, MW ...
Published in: Gastroenterology
February 2016

BACKGROUND & AIMS: The interferon-free regimen of simeprevir plus sofosbuvir was recommended by professional guidelines for certain patients with hepatitis C virus (HCV) genotype 1 infection based on the findings of a phase 2 trial. We aimed to evaluate the safety and efficacy of this regimen in clinical practice settings in North America. METHODS: We collected demographic, clinical, and virologic data, as well as reports of adverse outcomes, from sequential participants in HCV-TARGET--a prospective observational cohort study of patients undergoing HCV treatment in routine clinical care settings. From January through October 2014, there were 836 patients with HCV genotype 1 infection who began 12 weeks of treatment with simeprevir plus sofosbuvir (treatment duration of up to 16 weeks); 169 of these patients received ribavirin. Most patients were male (61%), Caucasian (76%), or black (13%); 59% had cirrhosis. Most patients had failed prior treatment with peginterferon and ribavirin without (46%) or with telaprevir or boceprevir (12%). The primary outcome was sustained virologic response (SVR), defined as the level of HCV RNA below quantification at least 64 days after the end of treatment (beginning of week 12 after treatment--a 2-week window). Logistic regression models with inverse probability weights were constructed to adjust for baseline covariates and potential selection bias. RESULTS: The overall SVR rate was 84% (675 of 802 patients, 95% confidence interval, 81%-87%). Model-adjusted estimates indicate patients with cirrhosis, prior decompensation, and previous protease inhibitor treatments were less likely to achieve an SVR. The addition of ribavirin had no detectable effects on SVR. The most common adverse events were fatigue, headache, nausea, rash, and insomnia. Serious adverse events and treatment discontinuation occurred in only 5% and 3% of participants, respectively. CONCLUSIONS: In a large prospective observational cohort study, a 12-week regimen of simeprevir plus sofosbuvir was associated with high rates of SVR and infrequent treatment discontinuation. ClinicalTrials.gov: NCT01474811.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Gastroenterology

DOI

EISSN

1528-0012

Publication Date

February 2016

Volume

150

Issue

2

Start / End Page

419 / 429

Location

United States

Related Subject Headings

  • Young Adult
  • Viral Load
  • Treatment Outcome
  • Time Factors
  • Sofosbuvir
  • Simeprevir
  • Ribavirin
  • RNA, Viral
  • Prospective Studies
  • North America
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Sulkowski, M. S., Vargas, H. E., Di Bisceglie, A. M., Kuo, A., Reddy, K. R., Lim, J. K., … HCV-TARGET Study Group. (2016). Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection. Gastroenterology, 150(2), 419–429. https://doi.org/10.1053/j.gastro.2015.10.013
Sulkowski, Mark S., Hugo E. Vargas, Adrian M. Di Bisceglie, Alexander Kuo, K Rajender Reddy, Joseph K. Lim, Giuseppe Morelli, et al. “Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection.Gastroenterology 150, no. 2 (February 2016): 419–29. https://doi.org/10.1053/j.gastro.2015.10.013.
Sulkowski MS, Vargas HE, Di Bisceglie AM, Kuo A, Reddy KR, Lim JK, et al. Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection. Gastroenterology. 2016 Feb;150(2):419–29.
Sulkowski, Mark S., et al. “Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection.Gastroenterology, vol. 150, no. 2, Feb. 2016, pp. 419–29. Pubmed, doi:10.1053/j.gastro.2015.10.013.
Sulkowski MS, Vargas HE, Di Bisceglie AM, Kuo A, Reddy KR, Lim JK, Morelli G, Darling JM, Feld JJ, Brown RS, Frazier LM, Stewart TG, Fried MW, Nelson DR, Jacobson IM, HCV-TARGET Study Group. Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection. Gastroenterology. 2016 Feb;150(2):419–429.
Journal cover image

Published In

Gastroenterology

DOI

EISSN

1528-0012

Publication Date

February 2016

Volume

150

Issue

2

Start / End Page

419 / 429

Location

United States

Related Subject Headings

  • Young Adult
  • Viral Load
  • Treatment Outcome
  • Time Factors
  • Sofosbuvir
  • Simeprevir
  • Ribavirin
  • RNA, Viral
  • Prospective Studies
  • North America