Abstract
Background
There are limited data analyzing the effectiveness of boceprevir (BOC) or telaprevir (TVR) in combination with pegylated interferon (PEG-IFN) plus ribavirin (RBV) in a real-life patient cohort.
Aims
In clinical trials, patients with chronic hepatitis C (CHC) treated with BOC or TVR plus PEG-IFN and RBV achieved sustained virological response (SVR) rates of 70 %. However, it is not clear whether similar results can be realized in routine practice. Our goal is to examine SVR rates of these triple regimens for CHC in a multicenter real-life patient cohort.
Methods
We retrospectively studied 200 consecutive CHC genotype 1 patients who were initiated on PEG-IFN, RBV, and either TVR (n = 113) or BOC (n = 87) from July 2011 to February 2014 at two US academic liver clinics, a Veterans Affairs liver clinic and a community gastroenterology clinic.
Results
Both BOC and TVR treatment groups were similar in regard to comorbidities, BMI, and HCV RNA levels. BOC patients were more likely to have cirrhosis than TVR patients (47 vs. 24 %, P = 0.001). SVR rates were low in both cohorts (40 % for BOC, 53 % for TVR, P = 0.05). On multivariate logistic regression, treatment adherence by the “80/80/80 rule,” diagnosis of cirrhosis, and use of erythropoietin were statistically significant predictors for SVR. Of these, treatment adherence was the strongest predictor (OR 4.43, 95 % CI 2.8–6.06, P < 0.001).
Conclusion
SVR was much lower in a real-life patient cohort than in clinical trials (53 % for TVR and 40 % for BOC, compared to 66–75 % in clinical trials).
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Abbreviations
- HCV:
-
Hepatitis C virus
- SVR:
-
Sustained virological response
- PEG-IFN + RBV:
-
Pegylated interferon and ribavirin
- RCT:
-
Randomized controlled trial
- ITT:
-
Intention-to-treat
- EVR:
-
Early virological response
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Conflict of interest
Kevin P. Vo, Philip Vutien, Matthew J. Akiyama, Vinh D. Vu, Nghiem B. Ha, Joy I. Piotrowski, and James Wantuck have none to declare. Marina M. Roytman is on Gilead speakers’ bureau and advisory board. Naoky Tsai discloses research grants with AbbVie, Janssen, Gilead Sciences, BMS, and Beckman. Naoky Tsai discloses he is on the Speaker’s bureau for AbbVie, Janssen, Gilead Sciences, BMS, Salix, and Bayer, and is also on the advisory board for Gilead Sciences and AbbVie. Ramsey Cheung discloses research grants with Gilead Sciences. Jiayi Li discloses he is a speaker for Gilead Sciences. Mindie H. Nguyen discloses she has received honoraria and research support from Bristol-Myers Squibb, Gilead Sciences, and Janssen Pharmaceuticals.
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Vo, K.P., Vutien, P., Akiyama, M.J. et al. Poor Sustained Virological Response in a Multicenter Real-Life Cohort of Chronic Hepatitis C Patients Treated with Pegylated Interferon and Ribavirin plus Telaprevir or Boceprevir. Dig Dis Sci 60, 1045–1051 (2015). https://doi.org/10.1007/s10620-015-3621-0
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DOI: https://doi.org/10.1007/s10620-015-3621-0