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Specialty Pharmacy Continuum • Winter 2012
PATIENT EDUCATION
Hopes About New HCV Drugs Often Unrealistic Careful patient selection, preparation and education is key to successful treatment San Francisco—Soon after the FDA approved two direct-acting antiviral agents (DAAs) last spring for treating infection with hepatitis C virus (HCV), a 57-year-old black man came to see gastroenterologist Andrew Muir, MD. The man had been diagnosed with hepatitis C in 2001. A liver biopsy one year later revealed he had stage II fibrosis. At that time, the patient declined treatment, saying the duration was too long and offered too few benefits. But recently, he came back to Dr. Muir, wanting to try one of the new protease inhibitors. Based on information he had read, the man believed he could avoid interferon (IFN) and ribavirin (RBV), take a protease inhibitor as monotherapy for 24 weeks and expect a 75% chance of achieving a sustained viralogic response (SVR). Unfortunately, the patient’s expectations were unrealistic on all counts. The new protease inhibitors can only
be given in conjunction with IFN and RBV, and the treatment duration varies. For black patients, therapy usually lasts a full 48 weeks, and in clinical trials, only 30% of black patients achieved an SVR with 28 weeks of therapy. Moreover, among black patients in the Phase III trials, SVR rates fell short of the 75% that the patient expected, and in treatment-naive blacks, only 62% of those taking telaprevir (Incivek, Vertex) and 53% of those taking boceprevir (Victrelis, Schering-Plough) achieved an SVR.
Educate To Encourage Adherence Unrealistic expectations are com-
mon among patients with HCV infection who, after years of waiting for better therapies, are eager to try treatment with the new DAAs, said Dr. Muir, clinical director of hepatology at Duke University Medical Center, Durham, N.C. But, the DAAs on the market today are complex, with varied stoppage rules, monitoring points and some serious adverse events and drug–drug interactions. In a presentation at the 2011 annual meeting of the American Association for the Study of Liver Diseases, Dr. Muir stressed that for patients to achieve optimal benefits from DAA therapy, they need to be prepared through clear, detailed discussions prior to and throughout treatment. “The major challenges are preparing patients for the rigors of therapy, checking in frequently to make decisions about the duration of treatment and managing any issues as the patient goes along,” he said.
Comparative Effectiveness Guides Hepatitis C Therapy Steve Burman, RPh President, CEO Burman’s Specialty Pharmacy Brookhaven, Pennsylvania
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onfusion and inappropriate expectations about new therapies are common among patients with hepatitis C, as reported above. The available regimens differ with respect to efficacy, side effects, etc. Comparative effective research (CER)—a method of gathering and comparing evidence on the efficacy, benefits and hazards of diagnostic methods and treatment options—is an important tool for health care providers as they seek to provide optimal therapy for their patients with hepatitis C. Based on the premises of the American Recovery and Reinvestment Act, the U.S. Department of Health and Human Services approved and allocated $1.1 billion to the Federal Coordinating Council for CER, the efforts of which guide research investments. Clinicians, patients, policymakers, health insurance companies and other payers also use the results of CER to make health care decisions. Furthermore, CER data must accompany arguments by pharmaceutical companies for FDA approval of treatments in addition to safety and efficacy data from clinical trials. The emerging emphasis on CER impacts the management of hepatitis C on many levels. Hepatitis C is a complex disease state that demands complex therapeutic regimens and extensive monitoring to facilitate successful outcomes. Laboratory values that need to be monitored and measured as hepatitis C virus (HCV) intermediate outcome criteria using the CER method include early viral response, sustained viral response, histologic changes, biochemical response, alanine transaminase and drug resistance. Other essential data to consider include static patient characteristics, such as age, gender, ethnicity and HCV genotype; historical patient data, such as whether the patient is treatment-naive or being retreated, previous and/or failed treatment regimens, and possible reasons for treatment failure or relapse; and “real-world” patient situation factors, such as education level, comorbidities, drug interactions, presence of mental illness and a variety of other adherence deterrents. Additionally, the following final outcomes should be measured: morbidity, mortality, quality of life, transmission of HCV, liver transplantation, development of cirrhosis, disease relapse and development of hepatocellular carcinoma.1 Specialty pharmacy is an ideal support resource for educational programs that are required to manage the increasingly complex HCV treatment regimens as well as patients’ expectations about those regimens. The specialty pharmacy can provide the necessary staff to assess and comment on patient laboratory values and to send out provider and patient reminders to promote medication adherence and appropriate laboratory visits. Some specialty pharmacies use software that can store relevant clinical data and provide reports for patient clinical management and outcome and trend analysis purposes. Specialty pharmacists also can help manage drug interactions and adverse effects. Innovative thinking is still necessary to address the current and future challenges posed by drug treatment of hepatitis C. Clinical, service and cost outcomes of specialty pharmacy products will become increasingly important in health care, and there is an emerging need to evaluate outcomes as more and more high-cost specialty pharmaceuticals are used for the treatment of hepatitis C.2
References 1. Agency for Healthcare Research and Quality AHRQ Effective Health Care Program. Comparative effectiveness of hepatitis C treatment adherence interventions. http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction= displayproduct&productid=839. Accessed January 18, 2012. 2. Stern D, Reissman D. Specialty pharmacy cost management strategies of private health care payers. J Manag Care Pharm. 2006;12(9):736-744. http://www.amcp.org/data/jmcp/736-744.pdf.
To clarify a patient’s expectations, Dr. Muir outlines the complex prescribing rules, contraindications, life style changes and duration of treatment related to DAA therapy. He cautions patients that the lifestyle changes can be significant. Both telaprevir and boceprevir must be taken three times a day, and always with a meal. It is very challenging, agreed Raymond Chung, MD, chief of hepatology and vice-chief of gastroenterology at Massachusetts General Hospital, in Boston. “Patients must adhere to that regimen because lapses in the concentration of telaprevir and boceprevir have historically been the risk period for breakthrough variants on therapy,” said. He noted that many of his patients limit or reschedule their work hours while on DAA therapy to help with adherence. The key to getting patients through DAA treatment successfully is to select patients carefully and prepare them assiduously, said Gary L. Davis, MD, director of general and transplant hepatology at Baylor University Medical Center, Dallas. “This means that any issues that might impact compliance, tolerance and drug access should be dealt with before treatment starts. Educating the patient is essential,” he said, adding that patients and others involved in their care “need to clearly understand the importance of dosing compliance, lab monitoring and treatment stopping rules/end points.”
Follow Through: Monitor For Response, Resistance, Reactions, Interactions Once treatment begins and throughout treatment, the entire treatment care team, including physicians, pharmacists, and nurse practitioners, needs to remain in close contact with the patient to reinforce adherence and offer feedback on the process. Careful follow-up, with monitoring for any viral breakthroughs is essential to prevent unwarranted continuation of treatment in patients when a breakthrough has occurred. A breakthrough “would signal the emergence of resistant variants. Upon discovery, it would be paramount to discontinue the entire regimen to