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Clinical Trial
. 2015 Apr;41(7):671-85.
doi: 10.1111/apt.13095. Epub 2015 Jan 28.

Virological Outcomes and Treatment Algorithms Utilisation in Observational Study of Patients With Chronic Hepatitis C Treated With Boceprevir or Telaprevir

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Free PMC article
Clinical Trial

Virological Outcomes and Treatment Algorithms Utilisation in Observational Study of Patients With Chronic Hepatitis C Treated With Boceprevir or Telaprevir

R K Sterling et al. Aliment Pharmacol Ther. .
Free PMC article

Abstract

Background: HCV-TARGET is a longitudinal observational study of chronic hepatitis C virus (HCV) patients treated with direct-acting anti-viral agents (DAAs) in a US consortium of 90 academic and community medical centres.

Aim: To assess utilisation of response-guided therapy (RGT) and sustained virological response (SVR) of a large cohort of patients.

Methods: Patients received peginterferon (PEG-IFN), ribavirin and either telaprevir or boceprevir. Demographical, clinical and virological data were collected during treatment and follow-up. RGT and treatment futility stopping rules was assessed at key time points.

Results: Of 2084 patients, 38% had cirrhosis and 56% had received prior treatment for HCV. SVR rates were 31% (95% CI: 24-40) and 50% (95% CI: 44-56) in boceprevir patients with and without cirrhosis, respectively. SVR rates were 46% (95% CI: 42-50) and 60% (95% CI: 57-64) in telaprevir patients with and without cirrhosis, respectively. Early clearance of virus, IL28B genotype, platelet counts and diabetes were identified as predictors of SVR among boceprevir patients, while early clearance of virus, IL28B, cirrhosis, HCV subtype, age, haemoglobin, bilirubin and albumin levels were identified as predictors of SVR for telaprevir patients.

Conclusions: In academic and community centres, triple therapy including boceprevir or telaprevir led to SVR rates somewhat lower than those noted in large phase 3 clinical trials. Response rates were consistently higher among patients without cirrhosis compared to those with cirrhosis regardless of DAA used and prior treatment response. Trial registration clinicaltrials.gov NCT01474811.

Conflict of interest statement

Declaration of interest: Richard K. Sterling has received research grants from AbbVie, Gilead, BMS, Merck, Vertex, Bayer, Boehringer Ingelheim, and Roche/Genentech and has received honoraria for consulting from AbbVie, Gilead, Vertex, Roche/Genentech, Merck, Bayer, Salix, and Bristol-Myers Squibb. Alexander Kuo has received research grants from AbbVie, BMS, Gilead, Roche/Genentech, Merck, and Vertex. Vinod K Rustgi has received grant/research support from Abbott Laboratories, Anadys Pharmaceuticals, Inc, Bristol-Myers Squibb, Gilead Sciences, and Novartis Pharmaceuticals Corporation; is a consultant for and has received honoraria from Genentech, Inc, Gilead Sciences, Inc, and Merck; and is on the advisory boards of Merck, Novartis Pharmaceuticals Corporation, and Tibotec. Mark S. Sulkowski has received funds for research support paid to Johns Hopkins University from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, and Vertex and consulting fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, and Tobira. Thomas G. Stewart has nothing to disclose. Jonathan M. Fenkel has received honoraria for consulting from Bristol-Myers Squibb, Gilead, Idenix, Janssen, and Vertex. Hisham El-Genaidi has nothing to disclose. Mitchell A. Mah’moud has received research grants from Roche/Genentech, Merck and Janssen and also honoraria for speaking or consulting from AbbVie, Merck and Salix. George M. Abraham has received research grants from Gilead, Merck, Vertex and Roche/Genentech and has received honoraria for consulting from AbbVie, Gilead, Vertex, Roche/Genentech, Merck and Kadmon. Paul W. Stewart has nothing to disclose Lucy Akushevich has nothing to disclose. David R Nelson has received grant/research support from Abbott, Achillion, Boehringer-Ingelheim, Bristol-Myers Squibb, Janssen, Kadmon, Genentech, Gilead, Merck, and Vertex. Michael W. Fried has received research grants from AbbVie, Bristol-Myers Squibb, Genentech, Gilead, Janssen, Merck, and Vertex and has received honoraria for speaking or consulting from AbbVie, Bristol-Myers Squibb, Genentech, Gilead, GlaxoSmithKline, Janssen, Merck, Vertex. Adrian M. Di Bisceglie serves on the advisory boards of Bristol-Myers Squibb, Merck, Pharmasset, Roche/Genentech, Salix, Tibotec, and Vertex, serves on the Data Safety Monitoring Board for Bayer, and has received grant and research support from Abbott, Anadys, Bristol-Myers Squibb, Gilead, GlobeImmune, Idenix, Pharmasset, Roche/Genentech, Transgene, Tibotec, and Vertex.

Figures

Figure 1
Figure 1
Disposition of Patients from Enrollment to Treatment Initiation.
Figure 2
Figure 2
Sustained virologic responses and 95% CI in total population and in various subpopulations of chronic hepatitis C patients with genotype 1, treated with boceprevir and stratified by treatment experienced (254 patients) vs. treatment naïve (201 patients).
Figure 3
Figure 3
Sustained virologic responses and 95% CI in total population and in various subpopulations of chronic hepatitis C patients with genotype 1, treated with boceprevir and stratified by cirrhosis (140 patients) vs. no cirrhosis (310 patients).
Figure 4
Figure 4
Age- and gender- adjusted odd ratio estimates and 95% CI for the association of various predictors and SVR to antiviral therapy with boceprevir (A) or telaprevir (B) in chronic hepatitis C patients. Black dots indicate point estimate for OR.
Figure 5
Figure 5
Sustained virologic responses and 95% CI in various subpopulations of chronic hepatitis C patients with genotype 1, treated with telaprevir and stratified by treatment experienced (925 patients) vs. treatment naïve (701 patients).
Figure 6
Figure 6
Sustained virologic responses and 95% CI in various subpopulations of chronic hepatitis C patients with genotype 1, treated with telaprevir and stratified by cirrhosis (648 patients) vs. no cirrhosis (947 patients).

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