Effectiveness of Telaprevir and Boceprevir Triple Therapy for Patients with Hepatitis C Virus Infection in a Large Integrated Care Setting
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In 2011, the FDA approved telaprevir (TVR) and boceprevir (BOC) for use with pegylated interferon and ribavirin to treat hepatitis C virus (HCV) genotype 1. We aimed to evaluate the real-world application, tolerability, and effectiveness of TVR- and BOC-based HCV treatment in a large integrated care setting.
We utilized Northern California Kaiser Permanente Medical Care Program (KPNC) electronic databases and medical records to study the experience of all KPNC patients who initiated TVR or BOC from June 2011 to March 2012.
Compared with the pool of 5,194 treatment-eligible patients, the 352 treatment initiators were more likely to be cirrhotic (24 vs. 10 %, p < 0.001) and treatment-experienced (44 vs. 22 %, p < 0.001). Among the treatment initiators, 211 received TVR and 141 BOC. Overall, 31 % discontinued treatment prematurely; 16 % of patients stopped treatment early because of side effects. One patient with cirrhosis died of sepsis during treatment. Premature discontinuation was highest among TVR-treated cirrhotic patients (58 %). Sustained virologic response (SVR) was achieved in 55 % overall and was similar comparing the TVR (56 %)- and BOC (53 %)-treated groups. The only independent predictors of treatment failure were cirrhosis at baseline [odds ratio (OR) for SVR 0.44, p = 0.004] and prior partial or null response (OR for SVR 0.57, p = 0.02).
In the initial application of TVR and BOC, patients with cirrhosis and prior treatment failure were prioritized for treatment. In this real-world experience, most patients successfully completed a full treatment course. However, side effect-related premature discontinuations were common, and SVR rates were lower than reported in clinical trials.
KeywordsHCV DAA Antiviral therapy Telaprevir Boceprevir
Hepatitis C virus
Northern California Kaiser Permanente Medical Care Program
Sustained virologic response
Human immunodeficiency virus
Hepatitis B virus
Viral Hepatitis Registry
Pharmacy information management system
Lower limit of detection
Lower limit of quantification
Drug reaction with eosinophilia and systemic symptoms
Body mass index
We thank Dr. Suk Seo for helpful comments on the manuscript.
Conflict of interest
This work was supported by The Permanente Medical Group and was partially funded by Vertex Pharmaceuticals Incorporated. JP discloses serving as an advisor to Gilead and has ownership interest in Bristol-Myers Squibb, Johnson and Johnson, and Abbvie. MPP discloses clinical trial research support from Roche and Merck. MMM discloses research support from Merck, Gilead, and Vertex. RCM and VAS have no conflicts to declare.
- 1.http://www.who.int/mediacentre/factsheets/fs164/en/index.html. Accessed 17 Jan 2014.
- 9.Ridruejo E, Adrover R, Cocozzella D, Reggiardo MV, Fernandez N. Effectiveness of hepatitis C treatment with pegylated interferon and ribavirin in urban minority patients Hepatology. 2010;51:2231; author reply 2231–2232.Google Scholar
- 12.Gordon N. Similarity of the adult Kaiser Permanente membership in northern California to the insured and general population in northern California: statistics from the 2007 California Health Interview Survey. Internal Report: Kaiser Permanente Division of Research. 2012.Google Scholar
- 14.Chen J, Florian J, Carter W, et al. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies. Gastroenterology. 2013;144:e1452.Google Scholar
- 18.Hezode C, Fontaine H, Dorival C et al. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC)—NCT01514890. J Hepatol. 2013;59:434–441.Google Scholar
- 19.Saxena V, Manos MM, Yee H et al. Telaprevir or boceprevir triple therapy in patients with chronic hepatitis C and varying severity of cirrhosis Aliment Pharmacol Ther (in press).Google Scholar
- 20.INCIVEK [package insert]. Cambridge, MA: Vertex Pharmaceuticals Incorporated; 2011.Google Scholar
- 21.VICTRELIS [package insert]. Whitehouse Station, NJ: Schering Corporation, a subsidiary of Merck & Co, INC; 2011.Google Scholar
- 23.Ioannou GN, Beste LA, Green PK. Similar effectiveness of boceprevir and telaprevir treatment regimens for hepatitis C virus infection, based on a nationwide study of veterans Clin Gastroenterol Hepatol. 2014;12:1371–1380.Google Scholar
- 30.Manns M, Marcellin P, Poordad F, et al. Simeprevir (TMC435) with pegylated interferon/ribavirin for the treatment of chronic HCV genotype-1 infection in treatment-naive patients: results from QUEST-2, a phase 3 trial. J Hepatol. 2013, abstract 1413.Google Scholar