Emerging Approaches for the Treatment of Hepatitis C Virus

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1 Emerging Approaches for the Treatment of Hepatitis C Virus Gap Analysis 1 Physicians may not be sufficiently familiar with the latest guidelines for chronic HCV treatment, including the initiation and optimization of triple therapy. Physicians are knowledgeable of triple therapy involving direct-acting antiviral agents (DAAs) in combination with the previous standard of care. Physicians do not provide optimal care for patients based on a lack of familiarity of the latest guidelines for treatment of HCV. Implement and optimize the current evidence-based components triple therapy including DAAs in the treatment of chronic HCV. Gap Analysis 2 Physicians may not be knowledgeable of the limitations of triple therapy in certain patient populations. Physicians will be knowledgeable of the limitations of triple therapy in certain populations. Physicians are not sufficiently aware of appropriate treatment for patient populations that were underrepresented in the phase 3 trials documenting the efficacy of triple therapy regimens. Diagnose and integrate the uncertainty of triple therapy regimens in certain patient populations. Gap Analysis 3 Clinicians may not be up to date on the issue of resistant-associated variants (RAVs) after administering triple therapy and of investigational drugs that may help overcome this resistance Physicians will be knowledgeable of the risk of generating RAVs and of emerging therapeutic treatments for hepatitis C. Physicians may not be sufficiently familiar with the increasing risk of RAVs and other DAAs under investigation and may fail to provide optimal ongoing treatment for patients Assess the risk for generation of RAVs with triple therapy and the utility of investigational DAAs in the treatment of hepatitis C.

2 GAP 1: Physicians do not provide optimal care for patients based on a lack of familiarity of the latest guidelines for treatment of HCV Knowledge of the most recent guidelines for HCV subgenotype 1 treatment published in 2011 by the American Association for the Study of Liver Diseases (AASLD) would aid in better management of chronic HCV. Per these guidelines, patients with genotype 1 should receive triple therapy regimen that includes PEG-IFN, weight-based RBV, and a protease inhibitor (boceprevir or telaprevir). Triple therapy has significantly improved SVR rates (70-80%) compared with combination therapy consisting of PEG-IFN/RBV (40-50%). The patient s prior treatment status is an important factor to consider when administering triple therapy. Treatment-naïve patients, prior relapsers (patients who had an undetectable viral load at the end of a prior attempt at treatment but did not achieve a SVR or a negative HCV RNA 24 weeks after completing treatment), partial responders (patients who achieved a 2 log 10 drop in HCV RNA by week 12 of treatment but did not achieve an end of treatment response) and null responders (patients who did not achieve a 2 log 10 drop in HCV RNA by week 12 of treatment) are all candidates for triple therapy. 7 Components of triple therapy 1. Protease Inhibitors Boceprevir and telaprevir mimic the carboxyl-terminal end of the NS3 protease and interfere with formation of the HCV polyprotein resulting in inhibition of HCV replication. 8 Boceprevir and telaprevir have demonstrated potent inhibition of HCV genotype 1 replication and markedly improved SVR rates in treatment-naïve and treatmentexperienced patients in phase 3 trials Telaprevir has also shown activity against HCV genotype 2 but not genotype 3 in limited phase 2 testing. 13 Although similar findings have been observed with boceprevir, neither drug should be used to treat patients with genotype 2 or 3 HCV infections. Both boceprevir and telaprevir administered without PEG-IFN and RBV result in the selection of resistance variants of HCV. However when used in combination with PEG-IFN and RBV, lower resistance associated variants have been observed. 14 Telaprevir and boceprevir have demonstrated similar efficacies in randomized trials. While telaprevir is effective in treatment-naïve patients, relapsers, partial responders, and null responders; boceprevir is effective in treatment-naïve patients, relapsers, partial responders, but it has not been studied in prior null responders Pegylated interferons (PEG-IFN) The licensed pegylated interferons (PEG-IFNs) in the US are PEG-IFN-alfa-2b (Peg-Intron, Schering Plough Corp., Kenilworth, NJ) and PEG-IFN-alfa-2a (Pegasys, Hoffmann-La Roche, Nutley, NJ). While PEG-IFN-alfa-2b has a 12- kd linear polyethylene glycol (PEG) covalently linked to the standard interferon alfa-2b molecule, PEG-IFN-alfa-2a has a 40-kd branched PEG covalently linked to the standard interferon alfa-2a molecule. The doses of these PEG- IFNs differ but both have antiviral and immunomodulatory properties. The linkage of PEG to the interferon molecules enhances its half-life in the body Ribavirin (RBV) RBV is a synthetic guanosine analogue previously used in the treatment of respiratory syncytial virus infection. While the exact mode of action of RBV is unknown, combining RBV with interferon has demonstrated improvements in endof-treatment and SVR rates in HCV-infected patients. 16 Specific guidelines for triple therapy

3 For treatment-naïve patients the recommended dose of boceprevir is 800 mg with food three times per day (every 7-9 hours) along with PEG-IFN and weight-based RBV for weeks. This regimen is started after 4 weeks of lead-in treatment with PEG-IFN and RBV alone. The recommended dose of telaprevir for treatment naïve patients is 750 mg with food (not low-fat) three times per day (every 7-9 hours) along with PEG-IFN and weight-based RBV for 12 weeks followed by an additional weeks of PEG-IFN and RBV. Patients with virological relapse or partial responders of combination therapy of PEG-IFN/RBV can be re-treated with triple therapy with boceprevir or telaprevir. Triple therapy with telaprevir is also recommended for null-responders of combination therapy. 7 Phase 3 trials with boceprevir and telaprevir have not only provided insights into the benefits of triple therapy but also its associated limitations and toxicities. While both treatment-naïve and -experienced patients have benefited from triple therapy administered for 48 weeks, half to two-thirds of treatment-naïve patients given boceprevir and telaprevir can have reduced duration of treatment, without compromising efficacy. In treatment-experienced patients, prior relapsers have shown the best response while less than one-third of prior null responders have demonstrated an SVR. However, patients with advanced fibrosis or cirrhosis have shown lower rates of SVR. Both telaprevir and boceprevir have adverse effects that need to be effectively managed. Therefore, physicians should be abreast of all the optimization and management options associated with triple therapy. 17 Initiation of Triple Therapy PEG-IFN and RBV remain the backbone of triple therapy and therefore, before initiating triple therapy, contraindications for these agents must be considered. However, most patients with subgenotype 1 HCV are potential candidates for triple therapy. Patients with milder disease (0-1 fibrosis) may also be administered triple therapy regimens. Table 1 describes the dosing and monitoring guidelines for triple therapy. Healthcare professionals should explain the importance of adherence to all the drugs in the triple therapy regimen and the potential barriers to adherence should also be discussed before the initiation of triple therapy. Table 1. Dosing and Monitoring Rules for Boceprevir and Telaprevir 17 Drug Dosing Duration of protease inhibitor HCV RNA monitoring Initial laboratory monitoring Boceprevir 200-mg capsule 800 mg orally 3 times/d (every 7 9 hs) with food Treatment naïve: Baseline and wks 4, 8, 12, and 24 to assess RGT: boceprevir dosed for RGT and futility wks 4 28 CBC: baseline and wks 4, 6, Non-RGT: boceprevir dosed wks 4 36 Must be used in conjunction with PEG-IFN and RBV Treatment experienced: boceprevir dosed wks 4 36 Assess for SVR 6 mos after therapy is completed Serum electrolytes, creatinine, uric acid, LFTs, TSH: baseline and wks 2, 4, Telaprevir 375-mg tablet 750 mg orally 3 times/d (every 7 9 hs) with food Must be used in All patients: telaprevir dosed wks 0 12 for all treatment regimens Baseline and wks 4 and 12 to assess for ervr and futility Assess for SVR 6 mos CBC, serum electrolytes, creatinine, uric acid, LFTs, TSH: baseline and wks 2, 4,

4 Drug Dosing Duration of protease inhibitor HCV RNA monitoring Initial laboratory monitoring conjunction with PEG-IFN and RBV after therapy is completed CBC, complete blood count; ervr, extended rapid virologic response; LFTs, liver function tests; RGT, responseguided therapy; TSH, thyroid-stimulating hormone. Evaluation of Drug Interactions Like other common medications, boceprevir and telaprevir are metabolized via the cytochrome p450 pathway. In addition, boceprevir and telaprevir inhibit and/or serve as substrates for p-glycoprotein. Therefore, boceprevir and telaprevir administration could alter efficacy and/or toxicities of drugs that are metabolized by the same pathway or vice versa. Hence, several drugs are contraindicated for use with boceprevir and telaprevir and a review of medications used by patients must be conducted to avoid potentially harmful drug interactions. Additionally, careful monitoring of therapeutic dose and efficacy of all drugs administered to the patients should be performed. Boceprevir and telaprevir could also affect systemic hormonal therapies and metabolism of cholesterol-lowering agents (statins) and antidepressant medications such as escitalopram. Product information brochures for boceprevir and telaprevir and on-line resources (such as and would be useful in assisting clinicians with the management of drug interactions. 17,18 Monitoring response to treatment For telaprevir, patients must be monitored for HCV RNA levels at weeks 4 and 12 after treatment initiation. Patients with an SVR at weeks 4 and 12 can be considered for 24 weeks of total therapy and only need an additional 12 weeks of treatment with PEG-IFN and RBV. In the absence of an SVR at weeks 4 and 12, 48 weeks of the recommended triple therapy regimen for telaprevir must be followed. Partial and null responders are also recommended a total of 48 weeks of therapy. In contrast to telaprevir, triple therapy including boceprevir follows a different routine, wherein boceprevir is administered after 4 weeks of lead-in combination therapy with PEG-IFN and RBV and then triple therapy is continued through at least week 28. Treatment naïve patients demonstrating an SVR at weeks 8 and 24 can discontinue treatment at week 28. However, patients with detectable levels of HCV RNA at week 8 but undetectable levels at week 24 should continue treatment through week 48. Prior partial responders and relapsers who have undetectable levels of HCV RNA at both 8 and 24 week time points can continue triple therapy until week 36. Prior partial responders and relapsers showing detectable HCV RNA at week 8 but not at week 24 should follow guidelines for boceprevir triple therapy through week 48. Since strict adherence to the treatment guidelines is essential for optimal outcome, regular clinic visits should be encouraged to monitor adherence. Assays for HCV RNA vary in accuracy and sensitivity of detection. 19 Therefore, ensuring that the HCV RNA assay matches the accuracy and detection levels of the assays from the clinical trials would be of importance. 17,20,21 Adverse event management For successful triple therapy outcomes, physicians administering triple therapy should not only be knowledgeable of the reported adverse events but also be prepared for the management of those adverse events. For telaprevir triple therapy regimens, rash (56%), anemia (36%), and anorectal complaints (29% in aggregate) were some of the significant adverse events. 11,12,22 Boceprevir triple therapy adverse events were anemia (45% 50%) and dysgeusia (35% 44%). 9,10

5 Anemia: Anemia should be regularly monitored (every 2 weeks) and can be managed by reducing the dose of RBV in both telaprevir and boceprevir regimens. Reduction in the dose of RBV is indicated when hemoglobin decreases by 1.5 g/dl within a 2-week period. 23 Severe (persistently 10 g/dl), symptomatic, or progressive anemia even upon reduction of RBV dose can be managed by administration of growth factors such as epoeitin-α. 24 Notably, doses of protease inhibitors should not be reduced. Rash: Mild to moderate rashes can be managed by administration of oral antihistamine and a topical corticosteroid with triple therapy. However, in case of severe rash, telaprevir therapy should be stopped, but treatment with PEG- IFN and RBV can be continued. Serious cutaneous adverse reactions, such as Stevens Johnson syndrome or drug rash with eosinophillia and systemic symptoms, such as fever or edema (also known as DRESS), although rare require urgent medical evaluation and cessation of all treatment. 21 Gastrointestinal Adverse Effects: Telaprevir therapy has been associated with hemorrhoids, anal pruritis, anorectal discomfort and anal burning which can be managed with topical corticosteroids, analgesics, over-the-counter hemorrhoid preparations and antidiarrheal agents. 21 Boceprevir was associated with dysgeusia (altered taste sensations or unpleasant taste in the mouth) but significant weight loss from dysgeusia was not observed in the phase 3 trials. 20

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