The Relative Efficacy of Boceprevir and Telaprevir in the Treatment of Hepatitis C Virus Genotype 1 (original) (raw)
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Therapeutics and Clinical Risk Management, 2012
The aim of this study was to examine the relative efficacy and safety of boceprevir and telaprevir, when used in combination with pegylated interferon alpha and ribavirin, using an indirect comparison meta-analysis. Methods: Published phase II and phase III randomized placebo-controlled trials examining the efficacy of boceprevir and telaprevir in chronic hepatitis C virus genotype 1 infected adult populations were included. The primary outcomes were sustained virologic response, relapse, and discontinuation of all study drugs. Secondary outcomes included the adverse events of anemia, neutropenia, rash, and pruritus. Results: Four boceprevir trials and six telaprevir trials were included. No significant differences were observed for sustained virologic response among either naïve (relative risk [RR] 1.14, 95% confidence interval [CI] 0.93-1.37, P = 0.20) or experienced patients (RR 0.81, 95% CI 0.52-1.23, P = 0.30). Similarly, for relapse among naïve (RR 0.80, 95% CI 0.18-3.45, P = 0.77) and experienced patients (RR 1.71, 95% CI 0.90-3.24, P = 0.10), or discontinuation of therapy for naïve (RR 0.80, 95% CI 0.28-2.29, P = 0.72) and experienced patients (RR 0.88, 95% CI 0.69-1.12, P = 0.30). Telaprevir was more likely to be associated with rash and pruritus, and boceprevir was more likely to be associated with neutropenia in certain patient populations. Conclusion: Boceprevir and telaprevir appear comparable in terms of sustained virologic response, relapse, or discontinuation of therapy for patients treated with standard-dose therapy durations and response-guided therapy durations.
Clinical Therapeutics, 2013
Background: Telaprevir and boceprevir are protease inhibitors now added to therapy for patients with chronic hepatitis C virus (HCV) genotype 1 infection who either are treatment naive or have a history of relapse or recurrence following a previous course of treatment with pegylated interferon ϩ ribavirin (Peg-IFN ϩ RBV). Because these agents are fairly new to the market, providers may have limited experience with them in the management of chronic HCV.
Gastroenterology, 2014
Background and aims: The efficacy of peginterferon/ribavirin with boceprevir or telaprevir was evaluated in a limited number of selected treatment-experienced cirrhotics with HCV genotype 1 infection. Methods: 511 patients with compensated cirrhosis due to HCV genotype 1 who did not respond to a prior course of peginterferon/ribavirin were treated for 48 weeks with either telaprevir or boceprevir in the framework of the French Early Access Programme (CUPIC cohort). The distribution was the following: 44.3% of relapsers or patients with breakthrough, 44.8% of partial responders and 8.0% of null responders. Virological efficacy (SVR12) and safety were assessed. This was an observational study which did not allow a head-to-head comparison between the 2 treatment regimens. Results: 299 and 212 patients received telaprevir and boceprevir, respectively. With telaprevir, the SVR12 was 74.2% in relapsers, 40.0% in partial responders and 19.4% in null responders. With boceprevir, the SVR12 was 53.9%, 38.3% and 0% in the same groups, respectively. In multivariate analysis, the SVR12 predictors were the prior treatment response, no lead-in phase, the HCV subtype and the baseline platelet count. Severe adverse events occurred in 49.9% of cases, including liver decompensation or severe infections in 10.4% and death in 2.2%. In multivariate analysis, the baseline albumin level and platelet count were the two predictors of severe side effects or death. Conclusions: Relatively high SVR rates can be achieved with a triple combination including telaprevir or boceprevir in real-life non-responders with compensated cirrhosis, at the cost of frequent, often severe side effects. Baseline albumin level and platelet count are useful in guiding treatment decisions. ClinicalTrials.gov number, NCT01514890.
World journal of hepatology, 2017
To evaluate new therapies for hepatitis C virus (HCV), data about real-world outcomes are needed. 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). 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...
Alimentary pharmacology & therapeutics, 2015
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. To assess utilisation of response-guided therapy (RGT) and sustained virological response (SVR) of a large cohort of patients. 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. 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 we...
Journal of Hepatology, 2015
Background & Aims: The safety profiles of boceprevir and telaprevir in the treatment of chronic hepatitis C, administered in academic and community centres across the United States, were evaluated. Methods: In 90 medical centres, patients with chronic HCV received pegylated interferon, ribavirin, and either telaprevir or boceprevir per local standard of care. Demographic, adverse event, clinical, and virological data were collected during treatment and follow-up. Results: A total of 2084 patients (97% HCV genotype 1) received at least one dose of a protease inhibitor. At baseline, 38% of patients had cirrhosis, and 57% had received at least one prior treatment for hepatitis C. Serious adverse events occurred in 12% of patients receiving protease inhibitor therapy. Overall, 66% of patients experienced anaemia, leading to frequent ribavirin dose reductions (42%) and erythropoietin use (37%); 11% received blood transfusion. More than 90% of patients had adverse events that led to a prescription, treatment, or dosage change, and 39% of patients discontinued treatment early, most commonly because of adverse events (18%) or lack of efficacy (16%). Hepatic decompensation events occurred in 3% of all patients. Age, female gender, cirrhosis, HCV genotype 1 subtype, creatinine clearance, platelet levels, albumin levels and haemo-globin levels were independent predictors of anaemia. Five deaths occurred. Overall, 52% of all patients achieved a sustained virologic response. Conclusions: In academic and community centres, where chronic hepatitis C patients commonly have advanced liver disease, triple therapy was associated with a high rate of adverse events and involved frequent treatment modifications and adverse event management.
Alimentary Pharmacology & Therapeutics, 2014
SummaryBackgroundRisks and benefits of protease inhibitor (PI) (telaprevir or boceprevir) triple therapy in hepatitis C virus (HCV)‐infected patients with mildly decompensated cirrhosis, including those wait‐listed for liver transplantation (LT), are incompletely known.AimTo assess virological responses and safety of PI triple therapy in patients with mildly decompensated Child‐Pugh (CP) CP ≥6 vs. compensated (CP = 5) cirrhosis.MethodsMulticentre cohort of 160 adults with cirrhosis treated with peginterferon/ribavirin (peg‐IFN/RBV) plus telaprevir (69%) or boceprevir (31%), comparing outcomes between those with CP = 5 and CP ≥6.ResultsPatients, 47% with CP ≥6 cirrhosis (CP range 6–10), received PI triple therapy for a targeted duration of 48 weeks. The cohort was median age 59 years, 32% female, 59% genotype 1a, 35% previous null/partial responders. Sustained virological response at 12 weeks (SVR12) was achieved by 35% of patients with CP ≥6 vs. 54% of those with CP = 5 (P = 0.02). ...
European journal of gastroenterology & hepatology, 2015
Hepatitis C virus (HCV) treatment in patients coinfected with HIV has historically been limited by poor efficacy and medication toxicities. Direct-acting antivirals (e.g. boceprevir and telaprevir) improve treatment results in clinical trials, but little is known about the outcomes in community-based coinfected populations. This project aimed to describe the real-world effectiveness of boceprevir-based or telaprevir-based therapies in HIV/HCV coinfected patients. We identified HIV/HCV coinfected patients of all genotypes in the Veterans Affairs healthcare system who initiated pegylated interferon and ribavirin with or without boceprevir or telaprevir from June 2011 to November 2012 (n=134). Sustained virologic response (SVR) was higher in genotype 1 patients receiving boceprevir or telaprevir [n=62, SVR=50.0%, 95% confidence interval (CI) 37-63] versus pegylated interferon/ribavirin alone (n=48, SVR=33.3%, 95% CI 20-47). Patients with genotypes 2/3 treated with pegylated interferon/...