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. 2017 Apr 18;9(11):551-561.
doi: 10.4254/wjh.v9.i11.551.

Factors associated with success of telaprevir- and boceprevir-based triple therapy for hepatitis C virus infection

Kian Bichoupan  1 , Neeta Tandon  1 , Valerie Martel-Laferriere  1 , Neal M Patel  1 , David Sachs  1 , Michel Ng  1 , Emily A Schonfeld  1 , Alexis Pappas  1 , James Crismale  1 , Alicia Stivala  1 , Viktoriya Khaitova  1 , Donald Gardenier  1 , Michael Linderman  1 , William Olson  1 , Ponni V Perumalswami  1 , Thomas D Schiano  1 , Joseph A Odin  1 , Lawrence U Liu  1 , Douglas T Dieterich  1 , Andrea D Branch  1
Affiliations

Factors associated with success of telaprevir- and boceprevir-based triple therapy for hepatitis C virus infection

Kian Bichoupan et al. World J Hepatol. .

Abstract

Aim: To evaluate new therapies for hepatitis C virus (HCV), data about real-world outcomes are needed.

Methods: Outcomes of 223 patients with genotype 1 HCV who started telaprevir- or boceprevir-based triple therapy (May 2011-March 2012) at the Mount Sinai Medical Center were analyzed. Human immunodeficiency virus-positive patients and patients who received a liver transplant were excluded. Factors associated with sustained virological response (SVR24) and relapse were analyzed by univariable and multivariable logistic regression as well as classification and regression trees. Fast virological response (FVR) was defined as undetectable HCV RNA at week-4 (telaprevir) or week-8 (boceprevir).

Results: The median age was 57 years, 18% were black, 44% had advanced fibrosis/cirrhosis (FIB-4 ≥ 3.25). Only 42% (94/223) of patients achieved SVR24 on an intention-to-treat basis. In a model that included platelets, SVR24 was associated with white race [odds ratio (OR) = 5.92, 95% confidence interval (CI): 2.34-14.96], HCV sub-genotype 1b (OR = 2.81, 95%CI: 1.45-5.44), platelet count (OR = 1.10, per x 104 cells/μL, 95%CI: 1.05-1.16), and IL28B CC genotype (OR = 3.54, 95%CI: 1.19-10.53). Platelet counts > 135 x 103/μL were the strongest predictor of SVR by classification and regression tree. Relapse occurred in 25% (27/104) of patients with an end-of-treatment response and was associated with non-FVR (OR = 4.77, 95%CI: 1.68-13.56), HCV sub-genotype 1a (OR = 5.20; 95%CI: 1.40-18.97), and FIB-4 ≥ 3.25 (OR = 2.77; 95%CI: 1.07-7.22).

Conclusion: The SVR rate was 42% with telaprevir- or boceprevir-based triple therapy in real-world practice. Low platelets and advanced fibrosis were associated with treatment failure and relapse.

Keywords: Adverse event; Boceprevir; Classification and regression; Hepatitis C virus; Real-world; Relapse; Sustained virologic response; Telaprevir; Triple-therapy.

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Conflict of interest statement

Conflict-of-interest statement: Kian Bichoupan is a paid consultant for Gilead Sciences and Janssen Pharmaceuticals, Inc. Dr. Andrea D Branch is a paid consultant for Gilead Sciences and Janssen Pharmaceuticals, Inc. Dr. Douglas T Dieterich serves as a paid lecturer, consultant and is a member on scientific advisory boards of companies which either develop or assess medicines used for the treatment of viral hepatitis. These companies include Gilead Sciences, Abbvie, Achillion, Bristol-Myers Squibb, Merck, and Janssen Pharmaceuticals, Inc. Dr. Thomas D Schiano is a paid consultant for Salix, Merck, Gilead, BMS, Novartis and Janssen and received research support from Mass biologics, Gilead, Merck, Biotest and Genentech. Michel Ng is a paid member of AbbVie’s Speakers bureau. Viktoriya Khaitova is a paid member of a scientific advisory board for Abbvie, and Johnson & Johnson. Dr. Valerie Martel-Lafferiere, Dr. Emily A Schonfeld, Dr. James Crismale, Alicia Stivala, Donald Gardenier, Dr. David Sachs, Dr. Joseph A. Odin, Dr. Lawrence Liu, Dr. Neal M Patel, and Dr. Ponni V Perumalswami do not have any disclosures.

Figures

Figure 1
Figure 1
Outcomes of 223 patients inititating telaprevir- or boceprevir-based triple therapy. SVR: Sustained virological response.
Figure 2
Figure 2
Classification and regression trees analysis of baseline factors associated with sustained virologic response. SVR: Sustained virologic response; HCV: Hepatitis C virus.
Figure 3
Figure 3
Treatment outcome stratified by low and high baseline platelet count. Treatment outcomes of patients with platelets ≤ 13.5 × 104/μL and > 13.5 × 104/μL are shown in a stacked column graph. The SVR rate in the low platelet group was 28% vs 53% in the high platelet group. SVR: Sustained virologic response.
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