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Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection.
- Source :
-
Gastroenterology [Gastroenterology] 2016 Feb; Vol. 150 (2), pp. 419-29. Date of Electronic Publication: 2015 Oct 21. - Publication Year :
- 2016
-
Abstract
- 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.<br />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.<br />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.<br />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.<br /> (Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Antiviral Agents adverse effects
Biomarkers blood
Drug Therapy, Combination
Female
Genotype
Hepacivirus genetics
Hepatitis C diagnosis
Hepatitis C virology
Humans
Male
Middle Aged
North America
Prospective Studies
RNA, Viral blood
Ribavirin adverse effects
Simeprevir adverse effects
Sofosbuvir adverse effects
Time Factors
Treatment Outcome
Viral Load
Young Adult
Antiviral Agents therapeutic use
Hepacivirus drug effects
Hepatitis C drug therapy
Ribavirin therapeutic use
Simeprevir therapeutic use
Sofosbuvir therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1528-0012
- Volume :
- 150
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 26497081
- Full Text :
- https://doi.org/10.1053/j.gastro.2015.10.013