Effectiveness of Telaprevir and Boceprevir Triple Therapy for Patients with Hepatitis C Virus Infection in a Large Integrated Care Setting

Abstract

Background 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. Methods 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-March 2012. Results Compared to 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). Conclusions 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.

Low SVR Rates in Clinical Practice for Treating Genotype 1 Chronic Hepatitis C with Protease Inhibitors Boceprevir and Telaprevir

“…Our data are consistent with the data presented in this paper [1] and also with the other published reports on SVR in clinical practice including the French Early Access Project (CUPIC)—which had cirrhotic SVR rates of 43 % (boceprevir) and 52 % (telaprevir) [4]; UCSF—which compared SVR rates in compensated (54 %) and mildly decompensated (35 %) cirrhotics [5]; and the national VA experience (SVR of 50 % for boceprevir and 52 % for telaprevir) [6]. …”

“…We read with great interest the research article, ‘‘Effectiveness of Telaprevir and Boceprevir Triple Therapy for Patients with Hepatitis C Virus in a Large Integrated Care Setting’’ by Price et al [1]. To date, there have been few reports on treatment initiation and effectiveness of telaprevir- and boceprevir-based triple regimens in clinical practice.…”

Real‐world effectiveness of ledipasvir/sofosbuvir in 4,365 treatment‐naive, genotype 1 hepatitis C‐infected patients

“…The promise of such results in clinical trials has created similarly high expectations among both providers and patients. However, studies examining real‐world effectiveness with interferon‐based HCV regimens and, more recently, sofosbuvir plus simeprevir regimens revealed differences in outcomes compared to clinical trials . These differences may reflect the wide heterogeneity in clinical practice where patient characteristics, care coordination, and management are not uniform.…”

Mechanisms of Virologic Failure with Direct-Acting Antivirals in Hepatitis C and Strategies for Retreatment

“…The overall SVR for those treated with telaprevir was 56% and 53% for those treated with boceprevir. 11 In a Veterans Affairs population, SVR was achieved in 51.5% of patients, which included those with cirrhosis and a prior relapse or a null response to PEG-IFN and RBV. 12 Those who had relapsed after treatment with PEG-IFN/RBV, had the highest overall success with an SVR of 64%.…”