Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience (original) (raw)
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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.
The Relative Efficacy of Boceprevir and Telaprevir in the Treatment of Hepatitis C Virus Genotype 1
Clinical Infectious Diseases, 2012
Background. The licensing of direct-acting antivirals heralds a new era in the treatment of hepatitis C virus (HCV) genotype 1. We undertook a mixed treatment comparison to examine the relative efficacy among current treatments for HCV. Methods. A systematic literature review identified relevant studies. Meta-analyses were planned in treatmentnaive and treatment-experienced patients. Study arms that evaluated telaprevir or boceprevir for unlicensed durations or without both pegylated interferon and ribavirin at standard doses were excluded. A Bayesian mixed treatment comparison model was fitted for each patient population. Results. Four hundred ninety-nine studies were identified. Ten met inclusion criteria. In the subgroup of prior treatment "relapsers," telaprevir had greater relative efficacy than boceprevir (odds ratio [OR], 2.61 [95% confidence interval {CI}, 1.24-5.52]). There were no statistically significant differences detected in relative efficacy for other patient categories. Treatment-naive patients: boceprevir vs standard of care (n = 1417) (OR, 3.06 [95% CI, 2.43-3.87]); telaprevir vs standard of care (n = 1309) (OR, 3.24 [95% CI, 2.56-4.10]); telaprevir vs boceprevir (OR, 1.06 [95% CI, 0.75-1.47]). Total treatment-experienced population: boceprevir vs standard of care (n = 604) (OR, 6.53 [95% CI, 4.20-10.32]); telaprevir vs standard of care (n = 891) (OR, 8.32 [5.69-12.36]); telaprevir vs boceprevir (OR, 1.27 [95% CI, .71-2.30]). Conclusions. Telaprevir had greater relative efficacy than boceprevir in patients who had previously relapsed. There was insufficient evidence to detect a difference in treatment outcomes between the 2 agents in the overall population. It was not possible to determine relative efficacy for subgroups such as patients with cirrhosis owing to small numbers.
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.
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.
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...
Boceprevir and personalized medicine in hepatitis C virus infection
Pharmacogenomics and personalized medicine, 2012
Boceprevir was the first agent, along with telaprevir, of a novel class of direct-acting antivirals that entered clinical practice for the treatment of chronic hepatitis C. Boceprevir is an antiprotease that directly blocks hepatitis C virus (HCV) replication. Two studies in patients with HCV genotype 1 infection have shown that addition of boceprevir to the standard of care, ie, pegylated interferon-alfa (PEG-IFN-α) and ribavirin, markedly increased the rate of sustained virological response. A sustained virological response was obtained in about 70% of patients who had never been treated, as well as in 69%-75% and 40% of previous relapsers and nonresponders to PEG-IFN-α-ribavirin, respectively. Side effects were observed in almost all treated patients. Anemia, the most frequent adverse event related to administration of boceprevir, occurred in about 50% of patients. The decision to add boceprevir to the standard of care is made on an individual basis, and takes into account the pr...
Boceprevir in the treatment of hepatitis C infection: rationale and clinical data
Clinical Investigation, 2011
An estimated 1.8% of the population in the USA is infected with the hepatitis C virus (HCV). The standard of care treatment for HCV consists of pegIFN and ribavirin. Genotype is considered a strong predictor determining response rates to treatment. Patients infected with genotype 1 are more resistant to treatment with an estimated response rate of approximately 40-50%. The recent discovery of polymorphisms in the IL28-B gene has given new insight into response rates and is now being considered the strongest pretreatment predictor of response. Recent insights into the HCV lifecycle and structure have led to the development of drugs that inhibit the NS3 protease in the HCV virus molecule, thereby preventing viral replication and increased degradation, and thus increasing chances of achieving a sustained viral response to therapy. Two drugs-boceprevir and telaprevir-have recently been approved by the US FDA and have been shown to have increased efficacy for genotype 1 patients, increasing the sustained virologic response rates to 75%. These drugs will be the biggest advance in the field since the introduction of pegIFN and ribavirin.
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). ...