Boceprevir-based Triple Therapy Research Articles

Boceprevir-based triple therapy to rescue HCV genotype 1/HBV dually infected patients refractory to peginterferon plus ribavirin combination therapy in Taiwan.

The role of directly-acting antivirals (DAA)-containing regimens in the treatment of patients dually-infected with hepatitis C virus (HCV) and hepatitis B virus (HBV) remains unclear. The pilot study aimed to explore the safety and efficacy of a protease inhibitor, boceprevir, in combination with peginterferon/ribavirin for HCV genotype 1 (HCV-1)/HBV dually-infected patients refractory to prior peginterferon/ribavirin. Twelve peginterferon-experienced patients dually-infected with HCV-1/HBV were assigned to receive boceprevir 800mg, twice a day, plus peginterferon-α 2b 1.5μg/kg/week and ribavirin 800-1400mg/day for 36 or 48 weeks. The primary endpoint was HCV sustained virological response (SVR, HCV RNA undetectable 24 weeks after end-of-treatment). Five patients terminated treatment early due to adverse events (one at week 4, one at week 46), virological failures (one non-response and one breakthrough), and patient request (n=1). Eight patients achieved HCV SVR (66.7% in full-analysis set and 72.7% in modified intention-to-treat population). The HCV SVR rate was 71.4% (5/7) in prior relapsers, 60.0% (3/5) in prior null responder; 75% in non-cirrhotic and 50% in cirrhotic patients. All four patients of prior non-cirrhotic relapsers received 36-week regimen and achieved HCV SVR. There was no HBV-related hepatic flare. All patients experienced at least one adverse event. Two had serious adverse events. Boceprevir plus peginterferon/ribavirin is effective in the treatment of HCV-1/HBV dually infected patients' refractory to prior peginterferon/ribavirin combination therapy.

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

AIMTo evaluate new therapies for hepatitis C virus (HCV), data about real-world outcomes are needed.METHODSOutcomes 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).RESULTSThe 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).CONCLUSIONThe 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.

Efficacy and safety of boceprevir-based triple therapy in HCV cirrhotic patients awaiting liver transplantation (ANRS HC29 BOCEPRETRANSPLANT)

In this French multicentre, open-label study, we analyzed the efficacy, safety and patient-reported outcomes of a boceprevir-based triple therapy in HCV genotype 1 cirrhotic patients awaiting liver transplantation (LT). Patients received PEG-IFN/ribavirin (RBV) for 48 weeks (W) and boceprevir from W4 to W48 or until LT. Fifty-one patients (80% males, median age: 56 years) were included. Fifty-seven percent had hepatocellular carcinoma and 43% end-stage liver disease. At enrolment, the median MELD score was 9 (range: 6-18); the Child-Pugh score was A in 65%, B in 35% and C in 2%. Therapy was discontinued because of severe adverse events (SAEs) in 39% of cases and virological inefficacy in 24%. 16% of patients had undetectable HCV RNA 24 weeks after the end of treatment (SVR24). LT was performed in 18 patients (35%). HCV RNA was undetectable in 16.6% at LT. Seven patients (14%) died and three deaths were attributed to treatment. SAEs (n=129) were observed in 84% of patients. Twenty-four percent of patients developed severe infections. Albumin<35g/L was independently associated with severe infection. Compared with baseline values, a significant decrease (P=0.02) of the physical dimension of health-related quality of life was observed between W4 and W24. The mean (95% CI) number of self-reported symptoms doubled during treatment (from 6.3 [4.8-7.7] to 11.8 [9.3-14.3]; P<0.001). The safety of the PEG-IFN/RBV/boceprevir combination is poor in patients awaiting LT, with a high risk of severe infection. Moreover, the limited efficacy confirms the indication for IFN-free combinations in these patients.

Efficacy and safety of boceprevir based triple therapy in Hungarian patients with hepatitis C genotype 1 infection, advanced stage fibrosis and prior treatment failure

During 2011 and 2013, 155 Hungarian hepatitis C genotype 1 infected patients, mostly with advanced liver fibrosis, who did not respond to prior peginterferon + ribavirin dual therapy, started boceprevir based triple therapy in an early access program. Efficacy and safety of the therapy was retrospectively assessed based on sustained virologic responses, as well as on frequency and type of serious adverse events and of those leading to therapy discontinuation. In an intent-to-treat analysis 39.4% patients (61/155) reached sustained virologic response. Amongst pervious relapsers, partial responders and null-responders 59.5%, 41.4 % and 22.9% (p<0.05 compared to the other two categories) reached sustained virologic response, respectively, while amongst non-cirrhotics and cirrhotics 52.5% and 31.3% (p<0.05 compared to the non-cirrhotics) achieved sutained virologic response, respectively. Six out of the 33 most difficult to cure patients (previous null responder and cirrhotic) have reached sustained virologic response (18.2%). Frequency of early discontinuations due to insufficient virologic response was 31.1%, while due to adverse event 10.3%. Reported frequency of serious adverse event was 9.8%. These events represented anemia, diarrhoea, depression, agranulocytosis, elevated aminotransferases, generalized dermatitis and severe gingivitis with loss of teeth, prolonged QT interval on ECG, generalized oedema and severe dyspnoea, uroinfection, exacerbation of Crohn's disease, Campylobacter pylori infection and unacceptable weakness and fatigue. Eight patients received transfusion, 4 patients erythropoietin and 1 granulocyte colony stimulating factor during therapy. No death has been reported. With boceprevir based triple therapy, one of the bests available in 2011-2013 in Hungary, a relevant proportion of hepatitis C infected patients with advanced liver fibrosis achieved sustained viral response. In this cohort, side-effects resembled those reported in registration studies, and resulted in therapy discontinuation with consequent treatment failure in a relevant number of patients. Efficacy and tolerability of boceprevir-based triple therapy are suboptimal, particularly in the most difficult to cure patient population. Orv. Hetil., 2016, 157(34), 1366-1374.

Hepatology topics of special interest from Central Europe (Czech Republic, Hungary, Poland, Slovakia).

This compilation represents abstracts of presentations at the first meeting of the Initiative Group for the Central European Hepatologic Collaboration (CEHC, Warsaw, 19-21 November, 2015) on topics with special interest from four Central European countries and includes a summary of a boceprevir-based triple therapy cohort programme (from Hungary), current trends and challenges in liver diseases (from Poland), acute kidney injury in liver cirrhosis (from Slovakia) and treatment of hepatitis C in haemodialysed patients (from the Czech Republic). All these topics are or have been of high interest during the last several years, and many of them are still not completely resolved with the emergence and availability of the novel interferon-free therapies for hepatitis C and with other advances in the pathophysiology and treatment of liver diseases.

Telaprevir- and Boceprevir-based Triple Therapy for Hepatitis C in Liver Transplant Recipients With Advanced Recurrent Disease: A Multicenter Study.

Antiviral treatment with sustained virologic response (SVR) improves survival in liver transplant (LT) recipients, and is especially relevant to patients with advanced recurrent hepatitis C virus (HCV). We assessed the safety and efficacy of protease inhibitor-based triple therapy in patients with recurrent advanced fibrosis and cholestatic hepatitis. The LT recipients with genotype 1 HCV and advanced fibrosis (F3-4/4) or cholestatic hepatitis treated with telaprevir- or boceprevir-based triple therapy at 6 centers (CRUSH-C consortium) were retrospectively assessed. The primary endpoints were SVR at 12 weeks (SVR12) and safety. Forty-five patients with advanced fibrosis and 9 with cholestatic hepatitis (74% men, 57% genotype 1a, 63% previous nonresponders) were included. SVR12 occurred in 51% with advanced fibrosis and 44% with cholestatic hepatitis. Extended rapid virologic response was highly predictive of SVR12. Hispanic ethnicity (odds ratio, 0.16; P = 0.03), previous null/partial response (0.24; P = 0.02), IL28B genotype CC (7.0; P = 0.02), albumin (3.87; P = 0.03), platelet count (1.01; P = 0.02), and steroid use (0.21; P = 0.03) were associated with SVR12. Six (11%) patients died, and hepatic decompensation occurred in 22% with advanced fibrosis and 33% with cholestatic hepatitis. Albumin (0.02; P = 0.001), encephalopathy (12.0; P = 0.04) and Hispanic ethnicity (odds ratio, 6.17; P = 0.01) were associated with death or decompensation. For LT recipients with recurrent advanced HCV and at greatest need of cure, protease inhibitor-based triple therapy achieved approximately 50% SVR12. However, there is significant risk of serious adverse events, arguing for earlier intervention. The availability of treatments with better efficacy and safety is of particular importance for posttransplant patients with advanced disease.

Acquired spherocytic like anemia combined with ineffective erythropoiesis sustains anemia in patients with chronic hepatitis C infection receiving telaprevir or boceprevir-based triple therapy

Background and aims: The addition of protease inhibitors, boceprevir (BOC) or telaprevir (TVR), to peg-interferon and ribavirin (PR) increases the incidence of anemia. Although genetic variants in ITPA gene have been linked to the hemolytic anemia induced by PR, the mechanism sustaining the severe anemia during triple therapy is still unknown.

Hepatitis C virus reinfection after liver transplant: New chances and new challenges in the era of direct-acting antiviral agents.

The first interferon-free regimens have been approved for the treatment of patients with chronic hepatitis C virus (HCV). In the liver transplant (LT) setting, these regimens are expected to have an important effect, because graft loss due to HCV recurrence is a serious problem after LT. The response to the hitherto conventional treatment with pegylated interferon and ribavirin is poor. The significantly better response rates achieved with boceprevir-based and telaprevir-based triple therapy have led to better graft and patient survival rates, but severe drug interactions with immunosuppressants limit the feasibility of this therapy for LT patients. With the approval of sofosbuvir in January 2014, of simeprevir in May 2014, and of daclatasvir in August 2014, three antiviral agents are now available and promise to be applicable without relevant adverse effects or negative interactions with immunosuppressants. Thus, 2014 marks the beginning of a new era of treatment options for HCV recurrence after LT. Although safety and efficacy studies of several interferon-free regimens for patients with HCV recurrence after LT have achieved good preliminary results, reports of clinical experiences with LT patients are scarce. The lack of randomized studies, the small number of enrolled and carefully selected patients, and the heterogeneity of these studies make the results questionable. Real-life experiences are eagerly awaited so that clinicians can estimate the usefulness and the pitfalls of these new regimens. Additionally, the high costs of these agents may limit their accessibility for many patients. The aim of this review is to summarize the current experience with and the expectations of the new direct-acting antiviral agents for LT patients.

Response-guided boceprevir-based triple therapy in HIV/HCV-coinfected patients: the HIVCOBOC-RGT study.

The HIVCOBOC-RGT study (NCT01925183) was the first study to evaluate response-guided shortening of the duration of boceprevir (BOC)-based triple therapy in human immunodeficiency virus (HIV)/hepatitis C virus genotype 1-coinfected patients (HIV/HCV-GT1). After 4 weeks of pegylated interferon-α-2a/ribavirin (PEGIFN/RBV) lead-in, patients with target-not-detectable HCV-RNA at week 8 (rapid virologic response; LI4W-W8UTND) received 24 weeks of BOC/PEGIFN/RBV (total: 28 weeks [W28]). Patients with target-detectable HCV-RNA at week 8 received 44 weeks of BOC/PEGIFN/RBV (total: 48 weeks [W48]). Fourteen patients (67%) had LI4W-W8UTND and were eligible for the shortened W28 arm, while 7 (33%) patients were allocated to the W48 arm. No breakthrough or relapse occurred in the W28 arm, resulting in a sustained virologic response (SVR12TND) rate of 100% (12/12). In the W48 arm, the SVR12TND was 50% (3/6), with 3 patients meeting the futility rule at treatment week 12. The preliminary overall SVR12TND rate was 83% (15/18). Serious adverse events were observed in 5 (24%) patients, with 2 (10%) patients requiring surgical treatment of abscesses. The majority of HIV/HCV-GT1 were eligible for response-guided shortening of treatment duration to W28 and all of these patients had a SVR12TND. If second-generation direct-acting antivirals are not available, W28 of BOC-based triple therapy may be recommended.

Personalized cost-effectiveness of boceprevir-based triple therapy for untreated patients with genotype 1 chronic hepatitis C

BackgroundWe assessed the cost-effectiveness of boceprevir-based triple therapy compared to peginterferon alpha and ribavirin dual therapy in untreated patients with genotype 1 chronic hepatitis C; patients were discriminated according to the combination of baseline plus on-treatment predictors of boceprevir-based triple therapy. MethodsCost-effectiveness analysis performed according to data from the available published literature. The target population was composed of untreated Caucasian patients, aged 50 years, with genotype 1 chronic hepatitis C, and these were evaluated over a lifetime horizon by Markov model. The study was carried out from the perspective of the Italian National Health Service. Outcomes included discounted costs (in euro, at 2013 value), life-years gained, quality-adjusted life year, and incremental cost-effectiveness ratio. The robustness of the results was evaluated by multivariable probabilistic sensitivity analyses. ResultsAccording to the baseline predictors of sustained virological response (genotype 1b, low viral load, fibrosis F0-F3, and body mass index) and the 1Log drop of HCV-RNA after the dual therapy lead-in period, boceprevir was cost-effective in different patient profiles. ConclusionsIn untreated genotype 1b chronic hepatitis C patients, the cost-effectiveness of boceprevir-based triple therapy widely ranges according to different profiles of sustained virological response predictors, allowing optimization and personalization of triple therapy.

Nanomedicines in the treatment of hepatitis C virus infection in Asian patients: optimizing use of peginterferon alfa.

Asia is endemic for hepatitis C virus (HCV) infection, which is the leading cause of cirrhosis, hepatic decompensation, hepatocellular carcinoma, and liver transplantation worldwide. HCV has six major genotypes and each HCV genotype has its specific geographic distribution. HCV genotypes 1, 2, 3, and 6 are common in Asia. The aim of HCV treatment is to eradicate the virus by effective therapeutic agents; viral clearance is durable after long-term post-treatment follow-up. In most Asian countries, peginterferon alfa (PEG-IFN α) in combination with ribavirin remains the standard of care, and the overall sustained viral response (SVR) rate in Asian HCV patients is higher than that in Western patients. The differences are most significant in patients with HCV genotype 1 (HCV-1) infection, which is attributed to the higher frequency of IFN-responsive or favorable interleukin-28B (IL-28B) genotype in Asian populations than in other ethnic populations. In addition, the introduction of response-guided therapy, where the optimized treatment duration is based on the early viral kinetics during the first 12 weeks of treatment, increases the SVR rate. Recently, telaprevir or boceprevir-based triple therapy was found to further improve the SVR rate in treated and untreated HCV-1 patients and has become the new standard of care in Western and some Asian countries. Many novel direct-acting antiviral agents, either in combination with PEG-IFN α plus ribavirin or used as IFN-free regimens are under active investigation. At the time of this writing, simeprevir and sofosbuvir have been approved in the US. Because the SVR rates in Asian HCV patients receiving PEG-IFN α plus ribavirin therapy are high, health care providers should judiciously determine the clinical usefulness of these novel agents on the basis of treatment duration, anticipated viral responses, patient tolerance, financial burdens, and drug accessibility.

Boceprevir is highly effective in treatment-experienced hepatitis C virus-positive genotype-1 menopausal women.

To investigate the safety/efficacy of Boceprevir-based triple therapy in hepatitis C virus (HCV)-G1 menopausal women who were historic relapsers, partial-responders and null-responders. In this single-assignment, unblinded study, we treated fifty-six menopausal women with HCV-G1, 46% F3-F4, and previous PEG-α/RBV failure (7% null, 41% non-responder, and 52% relapser) with 4 wk lead-in with PEG-IFNα2b/RBV followed by PEG-IFNα2b/RBV+Boceprevir for 32 wk, with an additional 12 wk of PEG-IFN-α-2b/RBV if patients were HCV-RNA-positive by week 8. In previous null-responders, 44 wk of triple therapy was used. The primary objective of retreatment was to verify whether a sustained virological response (SVR) (HCV RNA undetectable at 24 wk of follow-up) rate of at least 20% could be obtained. The secondary objective was the evaluation of the percent of patients with negative HCV RNA at week 4 (RVR), 8 (RVR BOC), 12 (EVR), or at the end-of-treatment (ETR) that reached SVR. To assess the relationship between SVR and clinical and biochemical parameters, multiple logistic regression analysis was used. After lead-in, only two patients had RVR; HCV-RNA was unchanged in all but 62% who had ≤ 1 log10 decrease. After Boceprevir, HCV RNA became undetectable at week 8 in 32/56 (57.1%) and at week 12 in 41/56 (73.2%). Of these, 53.8% and 52.0%, respectively, achieved SVR. Overall, SVR was obtained in 25/56 (44.6%). SVR was achieved in 55% previous relapsers vs. 41% non-responders (P = 0.250), in 44% F0-F2 vs 54% F3-F4 (P = 0.488), and in 11/19 (57.9%) of patients with cirrhosis. At univariate analysis for baseline predictors of SVR, only previous response to antiviral therapy (OR = 2.662, 95%CI: 0.957-6.881, P = 0.043), was related with SVR. When considering "on treatment" factors, 1 log10 HCV RNA decline at week 4 (3.733, 95%CI: 1.676-12.658, P = 0.034) and achievement of RVR BOC (7.347, 95%CI: 2.156-25.035, P = 0.001) were significantly related with the SVR, although RVR BOC only (6.794, 95%CI: 1.596-21.644, P = 0.010) maintained significance at multivariate logistic regression analysis. Anemia and neutropenia were managed with Erythropoietin and Filgrastim supplementation, respectively. Only six patients discontinued therapy. Boceprevir obtained high SVR response independent of previous response, RVR or baseline fibrosis or cirrhosis. RVR BOC was the only independent predictor of SVR.

Is there still a role for PEG IFN+RBV therapy in patients with HCV genotype 1?

Boceprevir and telaprevir-based triple therapy is now the standard of care for the treatment of genotype 1 patients. However, dual therapy with pegylated interferon and ribavirin should be discussed in treatment-naïve patients with good predictors of response. A recent published trial has shown in non-cirrhotic patients with low viral load at baseline, similar efficacy of a 24-week course of dual therapy vs a 24-week course of boceprevir-based triple therapy in case of rapid virological response. Accordingly, addition of protease inhibitor should be discussed after 4weeks of dual therapy in this easy-to-treat population.

Salvage Treatment with Boceprevir-based Triple Therapy after Failed Treatment of Acute Hepatitis C with Dual Therapy: Presidential Poster

Purpose: Acute hepatitis C virus (HCV) infection is usually defined by the presence of signs or symptoms of hepatitis within six months of presumed HCV exposure. While the majority of patients with acute HCV infection are asymptomatic, some do present with symptoms. Treatment of acute HCV infection with interferon is recommended in patients who do not spontaneously clear the virus within 12 weeks of diagnosis, and the vast majority of patients (>80%) who are treated will have a sustained virologic response (SVR) with interferon alone. Recommendations are lacking, however, for patients who do not respond well to standard treatment of acute hepatitis C, and at this time, the use of protease inhibitors in the treatment of acute HCV infection is not widely advocated. We present a case of acute HCV infection that was treated with boceprevir-based triple therapy after failure of treatment with combined pegylated interferon and ribavarin. A 24-year-old female was admitted to the hospital with abdominal pain, vomiting and jaundice. Her transaminases were elevated, with ALT 673 and AST 971. Work-up revealed positive HCV antibodies, with HCV RNA viral load of 3.1 million copies and genotype 1b. The patient had been hospitalized one month prior, and HCV antibodies were negative at the time, indicating a recent infection consistent with acute hepatitis C. Follow-up eight weeks after diagnosis revealed HCV RNA of 5760 copies, with hopes that the patient would spontaneously clear the virus by 12 weeks. However, the HCV RNA viral load increased to 165,160 copies at 12 weeks, and the patient was started on treatment with combined pegylated interferon and ribavarin. The patient failed to respond, however, and after 12 weeks of dual therapy, her HCV RNA had actually increased to 327,000 copies. At this point, given the evident lack of response to combined pegylated interferon and ribavirin, it was decided to add a protease inhibitor, and boceprevir was added without an interruption in therapy, with plans to treat with triple therapy for an additional 44 weeks. Four weeks after the addition of boceprevir, the patient's HCV RNA viral load was undetectable and has remained undetectable at end of treatment (pending SVR). As this case illustrates, immediate initiation of protease inhibitor-based triple therapy may be a reasonable treatment option in patients with acute genotype 1 HCV infection who do not respond to standard therapy. Studies are needed to better determine the efficacy and optimal duration of treatment in this patient population.

Early Treatment Response and Discontinuation Rates with Telaprevir and Boceprevir-based Triple Therapy in a Tertiary Care Liver Center

Early Treatment Response and Discontinuation Rates with Telaprevir and Boceprevir-based Triple Therapy in a Tertiary Care Liver Center

Personalized cost-effectiveness of boceprevir-based triple therapy for untreated patients with genotype 1 chronic hepatitis C

Personalized cost-effectiveness of boceprevir-based triple therapy for untreated patients with genotype 1 chronic hepatitis C

Optimizing DAA management in daily practice

Despite the incontestable benefits of telaprevir and boceprevir-based triple therapy in patients infected with genotype 1, the practitioner faces a number of new challenges. In daily clinical practice, a checklist approach may facilitate the management of triple therapy. Before initiation, several specific issues should be reviewed with the patient in order to optimize adherence and treatment outcome: potential drug to drug interaction, treatment duration and stopping rules, possible treatment outcomes, side effects, dose and administration with food advice, management of side effects. Because treatment failure is associated with the emergence of resistance-associated variants with reduced sensitivity to protease inhibitors, adherence is of major importance. In this setting, the role of educational nurse should be emphasized for the management of triple therapy in daily clinical practice.

Specialty pharmacy: An individualized and agile patient care approach

Pharmacy has historically prided itself on its ability to pioneer innovative patient care as drug development and delivery systems have become more advanced. True advancement in our industry has traditionally been driven by the science behind the drugs. Specialty medications challenge us in providing patient-centric strategies, as specialty pharmaceuticals represent the single most explosive prescription medications market in terms of growth, high cost, and management complexities. Pharmacists must be agile in delivering patient care approaches that meet the needs of patients, prescribers, and payors from a population-based perspective, yet meet and support patients' individual challenges with their disease and medication regimens. The benefits of an agile system, considering the potential of FDA approvals of new drug molecules and the expansion of FDA-approved indications of currently approved medications, are as follows:■As the needs of patients change as new therapies are introduced, pharmacists in agile systems can readily reconfigure or upgrade their services as well as demonstrate adaptability in coping with new and varied situations.■Reprogrammable and reconfigurable service systems, integrated into an information-intensive network, allow an agile pharmacy system to produce patient-specific results.■An agile system allows for a patient-centric system designed to produce specific services for individual patients, not just broad categories of services designed to fit the average person.■An agile system is totally integrated. Ideally, information flows seamlessly from different areas of practice (e.g., community, hospital, specialty pharmacy), from different areas of responsibility (e.g., physician, nurse, pharmacist), and from all of these areas to the manufacturers of the medication to provide seamless pharmaceutical care. This integration ensures that the patient-specific knowledge collected by each health professional is transferred to the others to obtain the optimum patient outcome. The treatment of hepatitis C virus (HCV) infection is an example where specialty pharmacy must be agile in both treatment approach and patient care management as regimens continue to change. Until 2011, the historically accepted standard therapy for chronic genotype 1 HCV infection was dual therapy with a pegylated interferon and ribavirin for 48 weeks. The standard of care for treatment of HCV genotype 1 changed dramatically with the approval of two new direct acting antiviral (DAA) drugs—telaprevir and boceprevir—for use in pegylated interferon-based and ribavirin-based triple therapy. Boceprevir-based and telaprevir-based triple therapy with pe- gylated interferon and ribavirin marked the beginning of a new era in HCV therapy for genotype 1 patients. It began the era of response-guided therapy (RGT), suggesting that a shortened duration of therapy was acceptable for patients meeting certain criteria. Many new drugs are currently under investigation (i.e., next generation protease inhibitors [DDA drugs], polymerase inhibitors, and NS5A inhibitors) that will continue to change current therapy and patient care approaches in addition to interferon-free regimens. The agile approach optimizes patient management as the continuum of care changes and creates continuity to provide a model of seamless pharmaceutical care. The patient-centric approach necessitates that the patient remains a crucial and active link throughout the process. Patients are asked to report to the pharmacist data such as adherence levels, problems with therapy such as adverse effects, and other applicable outcomes. Pharmacists follow up with those patients who may be experiencing adverse effects or failing to respond to treatment. The flow of information and the care of the patient therefore circulate seamlessly among the many players within the agile pharmacy system and provide the decision makers with the proper quality and quantity of pertinent data. The agile approach benefits specialty pharmacy especially as it has grown from a small niche in the marketplace to a significant presence in the practice of pharmacy based on a rich pipeline of complex therapies and regimens. Gary W. Kadlec, BSPharm, MBA, ScD, President, Diplomat Specialty Pharmacy, Flint, MI Gary Rice, BSPharm, MS, MBA, Vice President, Clinical Services, Diplomat Specialty Pharmacy, Flint, MI

On-treatment and projected sustained viral responses with boceprevir-based triple therapy in previous treatment-failure HCV patients with advanced fibrosis or cirrhosis. Interim analysis of the Hungarian named patient program cohort

Background and Aims: Efficacy and safety of boceprevir+peginterferon/ribavirin (B+PR) therapy in pervious treatment failure HCV genotype 1 pts with advanced liver fibrosis (F3) or cirrhosis (F4) have been analyzed, with special attention to previous null-responder cirrhotics.

Boceprevir-based triple therapy for belgian liver transplant patients infected with hepatitis C virus: A preliminary experience

Boceprevir-based triple therapy for belgian liver transplant patients infected with hepatitis C virus: A preliminary experience