Medicine Today Internal Medicine Webcast Series

Hepatitis C Management:

The Team Approach to Hepatitis C
Management

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Key Points

  • The team approach requires communication, mutual respect, and a clear understanding of each team member's roles and responsibilities.

  • The medical team must make clear from the outset that patients are expected to assume personal responsibility for their care behavior; they are not passive bystanders.

  • The case manager should conduct both one-on-one and group counseling sessions with patients, and these should be scheduled well in advance.

  • Group counseling sessions are a cost-effective way to educate patients and can serve as a strong patient support mechanism.

  • The key to a good outcome is adherence to therapy, which can be maximized if patients are educated in coping with side effects.

Drug regimens for treating HCV infection are not easy for patients to complete. Most patients experience side effects, and nonadherence is common. However, adherence to the prescribed regimen is crucial to the success of the treatment plan, so the treatment team must take an aggressive approach to helping patients follow their treatment regimen.

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The Team Approach

The management of HCV therapy is greatly aided by the involvement of physician assistants or nurse practitioners. Other professionals who are involved to varying degrees include dieticians, social workers, mental health professionals, pharmacists, and other specialist physicians who are called on as needed. To be successful, the team approach requires communication and mutual respect among all team members as well as a clear understanding of each member's roles and responsibilities. Physician assistants and nurse practitioners are licensed to perform many aspects of the management of hepatitis, including ordering and interpreting tests and prescribing medications. In some states, nurse practitioners participate in end-stage liver disease clinics, and they serve as pre- and post-transplant coordinators. Likewise, physician assistants in some states perform liver biopsies.

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Patient Roles and Responsibilities

The medical team approach extends, of course, to the patient (Figure 22). Active engagement of patients with medical team members can establish camaraderie among all parties and should reassure patients that they are not alone as they cope with their disease.

The medical team must make clear from the outset that the patient is not a passive bystander in the management of his or her disease. Patients are expected to assume personal responsibility for their care. They must keep their appointments, attend training and educational classes, and take their medications as prescribed. Just as important, they must communicate and let the medical team know when they are experiencing side effects or any other problems.

Many institutions ask their patients to sign contracts. Such a contract is a statement of understanding that spells out the plan of action and specifies the roles and responsibilities of both the patient and the members of the medical team. Contracts must be written in simple and understandable prose. When necessary, patients should be reminded that they have signed a contract.

Patients are responsible for understanding and maintaining their insurance coverage.

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A Rational Model for Hepatitis C Management

The remainder of this section of the monograph outlines a model for the effective marshaling of resources that some centers have found helpful for managing patients with hepatitis C. The model presents a way for centers to organize their practices to better and more efficiently take advantage of the team approach to HCV management. The model calls for a case manager to be in charge of all the counseling and educational tasks described here. For the purposes of this monograph, the nurse practitioner serves as the case manager.

It is important to note that this model will be applicable only to those HCV-infected patients who are appropriate candidates for IFN-based therapy. Most patients with HCV infection do not prove to be candidates for IFN-based therapy, owing to failure to show up for appointments or tests, severe medical or psychiatric comorbidities, ongoing substance abuse, or other factors.

Following diagnosis, only patients deemed to be stable enough to undergo anti-HCV therapy are referred by the physician to the nurse practitioner's counseling sessions. These sessions involve at least three separate interactions over at least a 3-month period, which provides further opportunities to identify patients without the stability or commitment to undergo therapy.

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Preparing Patients for Therapy: Counseling, Education and Support

Despite the central role of the nurse practitioner in this model, it is the physician who first interacts with the patient following diagnosis and who directs the overall treatment plan. Because of the complexity and chronicity of HCV infection, its management generally requires a heightened degree of trust and comfort between patient and physician. Successful management of HCV infection demands that physicians draw on their best patient interaction skills, such as active listening, empathy, collaborative decision-making, education, and reassurance.

At the time of diagnosis, after explaining the benefits and risks of treatment, the physician develops a proposed treatment plan together with the patient. At that point, the patient is referred to the nurse practitioner, who will build on the physician's initial counseling to prepare the patient for the formidable challenges posed by HCV infection and its treatment. This preparation consists of both education and support, and should be provided to both the patient and his or her family. The more education and coping tools that patients and their families are exposed to up front, the fewer calls that physicians and nurses will field later in the course of management.

At the first office counseling session, the nurse practitioner and the patient should formulate the schedule that the patient will follow for the next year or so. This schedule includes one-on-one visits during appointments for injections, reviewing blood tests, and managing side effects, as well as group counseling and education sessions.

Patient education and support should be targeted at three broad categories of patients' needs, as outlined below.

Clinical education. Women of childbearing age should be warned at the first visit that they must practice double-barrier contraception during the entire treatment course and for 6 months thereafter. If a patient does become pregnant, treatment must be discontinued immediately, and the patient's obstetrician consulted. The risk of birth defects should be explained, and abortion services should be thoroughly discussed.

The natural history of HCV infection and its symptoms (both current and anticipated) should be explained in language that is appropriate and understandable to the patient. The patient's suspected means of contracting HCV should be identified, and the risks of HCV transmission should be explained. Both patients and their families should be reassured that HCV transmission is virtually always via blood-to-blood contact (Table 18) and that the risk of transmission through routine household contact is extremely low.

Table 18: Risks of HCV Transmission
HCV May Be Transmitted By HCV is Not Transmitted By
Blood transfusions prior to 1992 Hugging
Needlestick Shaking hands
Dialysis Casual contact
Sharing of IV needles or nasal straws Breastfeeding (assuming no cracking or bleeding at the nipple)
Sharing of personal items that may contact blood (razor, toothbrush) Food or water
Sex with multiple partners or with an infected person or IV drug user, particularly in the setting of other sexually transmitted diseases Sharing of drinking glasses or eating utensils
Tattooing/body piercing Delirium, depression. or bipolar disorder

Management of side effects should begin before the first dose is administered. Therapy for chronic HCV infection is long-term, and patients may not fully appreciate the commitment they must make to improve their health. It is the healthcare practitioner’s duty to educate them. Patients are generally hardest hit by side effects after their first dose. Adequately preparing patients for this eventuality should decrease their anxiety when the side effects do occur. Patients who are informed about how to manage their side effects are less likely to discontinue therapy or to seek emergency care. (Side effects are discussed in greater detail later in this section.)

Emotional/psychological support. Patients newly diagnosed with chronic disease generally go through a range of emotional stages, including denial, anger, depression, and acceptance. At the first office counseling session, the nurse practitioner should make it clear that emotional upheavals are normal and that patients can maximize their chance for a good outcome by accepting their disease, taking control, and developing a positive attitude toward achieving a good outcome.

Education, encouragement, and support from both the medical team and the patient's family and friends are crucial to helping patients maintain a positive attitude. Patients should be encouraged to continue their normal lifestyle during therapy, including working, socializing, and fulfilling their family roles.

Once the nurse practitioner determines that the patient is in a proper frame of mind, the two of them can collaborate in scheduling group counseling sessions in addition to their regular one-on-one sessions.

Social support and employment issues. It is important to determine early on what degree of social support a patient has. Involvement of family and friends is an important part in helping a patient adjust to the diagnosis and persevere through therapy, and including a family member in education and counseling sessions will facilitate this. For many patients, however, the healthcare provider may be the primary source of support.

The nurse practitioner should be sensitive to social stigmas that the patient may face as a result of HCV infection; honest and accurate information should be presented to the patient and family members to address such stigmas and help them talk about the disease.

The nurse practitioner can help patients develop sources of physical and practical support as well. Family members and friends should be identified who can assist with the patient's activities of daily living (eg, household chores, errands), especially during the first month of therapy. For patients with limited social support networks, other resources can be considered, such as local agencies, church ministries, or support groups.

HCV infection and its treatment can put an extreme financial burden on patients and their families. Managing work issues can be a particular challenge. The nurse practitioner should be prepared to inform patients, as necessary, of federal and state laws that can protect their job security, such as the Family and Medical Leave Act and the Americans with Disabilities Act (ADA). To claim protection under the ADA, a patient must still be able to perform the essential functions of his or her job. The nurse practitioner may be able to help the patient develop a plan with his or her employer to allow for continued employment during therapy without disrupting the business. At the same time, the need to resort to legal remedies to protect against HCV-related job discrimination is infrequent, and most patients should be encouraged to stop therapy if side effects are so severe that they prevent them from working.

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Group Sessions

Small-group educational seminars provide an excellent and cost-effective means of putting patients—typically 5 or 6 per session—on the right track. Patients are strongly encouraged to bring a companion with them, someone who is willing and able to help them throughout the treatment course. Some patients bring their Alcoholics Anonymous sponsor.

The initial group session typically lasts 1.5 to 2 hours. At this session, the nurse practitioner explains exactly what each patient can expect throughout the course of treatment. Drug therapy, side effects, laboratory tests, duration of therapy, and response to therapy are all covered.

Patients are also given information prepared by other sources. Pharmaceutical companies provide a wealth of educational resources, including pamphlets, newsletters, websites, and telephone support lines. Information is also provided by the American Liver Foundation, the Hepatitis Foundation International, the NIH, and the CDC. Of course, educational materials should be selected carefully to avoid overwhelming the patient with information overload.

Subsequent group sessions are held once or twice a month for 1 hour each. These sessions function more as support meetings, and each patient may attend these according to his or her needs and the focus of each particular session. At these sessions, patients are encouraged to discuss their progress, share their experiences, and ask questions. Guest speakers can add variety to these sessions. Patients should also be instructed to call the office between sessions if they find it necessary.

Group sessions offer a number of advantages. First, they serve as a powerful support mechanism for patients, providing camaraderie and a sense that they are not alone in their disease. This tends to encourage treatment adherence and continuation. Second, they are an efficient way of using limited resources, enabling a degree of patient education and counseling that would not be affordable on an individual basis. Moreover, these sessions are reimbursable for the nurse practitioner's time, and even for a physician's time if the physician is needed to answer questions during a portion of the session.

From our experience, centers that conduct group sessions report virtually no patient objections to taking part in group counseling. One potential barrier, privacy concerns, can be overcome by having patients sign a Health Insurance Portability and Accountability Act (HIPAA) consent form that is specific to participation in the group sessions. For non-English-speaking patients, one-on-one sessions with an interpreter will generally have to take the place of group sessions.

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One-on-One Sessions

An individual counseling session should be held every time the patient visits the office during treatment. Each should last approximately 15 or 20 minutes. At each session, the nurse practitioner should discuss the patient's clinical and emotional progress. The patient also should complete a quality-of-life questionnaire at every visit, and the nurse practitioner should track the scores from month to month to look for trends that should be addressed. Depending on the patient's emotional status, it is sometimes helpful to have a relative or close friend sit in on an individual session. A companion can often offer insight that the patient cannot.

These counseling sessions are reimbursable, and they are much more cost-effective than a similar session conducted by a physician. If all is going well, physicians generally see the patient only at weeks 12, 24, and 48 of treatment.

Two critical aspects of these one-on-one visits are discussions of side effects and adherence to the treatment regimen.

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Managing Side Effects

As mentioned, patients should be told in advance what side effects to expect and how to deal with them. Patients must also be continually reminded to report all side effects and other adverse events to the nurse practitioner. The degree of side effects usually varies from mild to moderate, and they are most intense during the first month of therapy.

Interferon. As detailed earlier in the monograph, side effects of IFN include flu-like symptoms, some neuropsychiatric disorders (eg, depression and mood lability), alopecia, thyroiditis, nausea, diarrhea, injection-site reactions, neutropenia, anemia, and thrombocytopenia. PEG-IFNs induce neutropenia to a greater degree than do standard IFNs, and neutropenia is the most common reason why patients do not adhere to PEG-IFN regimens. Adjunctive therapy with a granulocyte colony-stimulating factor such as filgrastim will increase neutrophil counts and decrease the risk of infectious complications. Thrombocytopenia does not usually interfere with adherence.

Ribavirin. Side effects of ribavirin include hemolytic anemia, birth defects, cough, dyspnea, rash, pruritus, insomnia, and anorexia. Anemia causes fatigue and sometimes alters the patient's ability to function normally. Adding therapy with an erythropoietic growth factor to elevate hemoglobin levels should increase the patient's energy, improve quality of life, and allow for higher doses of ribavirin to continue.

Some other side effects can be self-managed and ameliorated by simple interventions such as good hydration, altering doses according to work activities, using analgesics and antipyretics, and exercising regularly.

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Adherance to Therapy

Management of side effects is a key to ensuring that patients adhere to their regimen, and adherence is the most important factor in achieving a good outcome. We prefer the term adherence to compliance because adherence connotes that the patient is an active partner in treatment rather than merely the obedient subject of a medical experiment.

At every encounter, the nurse practitioner should encourage patients to adhere to treatment and praise them when they do. Involving family members is another way to improve adherence.

In addition to side effects, other factors that can hamper adherence are the seriousness of the illness, the cost and complexity of treatment, a poor understanding of the disease management process, and the long duration of treatment. Some of these obstacles can be overcome, or at least mitigated, by individualizing and altering the regimen when appropriate, by creatively revising patient contracts, by offering rewards, and by instituting other patient-centered strategies.

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Other Resources

Some pharmaceutical companies have established drug-assistance programs to help patients with the financial burden of therapy, and these are excellent programs.

Likewise, specialty pharmacies have designed programs to promote all facets of care and to offer support to patients, their families, and their caregivers. These programs encourage cost-effective approaches to care.

Some of these programs offer information on insurance coverage, in-home instruction on self-injection, telephone counseling, and/or home delivery of drugs and supplies, all at no out-of-pocket cost to the patient. The program bills the patient's insurer directly.

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Clinical Management Algorithm

Many HCV-infected patients cannot tolerate full doses of IFN and ribavirin therapy. It is recognized that many of the thresholds for dose reduction of IFN or ribavirin are arbitrary and may vary from center to center. The important point is that every practitioner who treats HCV infection should construct an algorithm with predefined decision points. It is increasingly the goal to keep as many patients as possible on full-dose IFN and ribavirin therapy, even if the patient becomes anemic, neutropenic, or thrombocytopenic.

What follows is the ideal (although not always achievable) algorithm for a management strategy directed by the nurse practitioner (Figure 23).

  • Assess patients for symptoms and side effects and perform blood tests at weeks 1, 2, and 4. Thereafter, perform these assessments at regular intervals every 4 to 8 weeks. If significant anemia occurs (ie, hemoglobin <10 g/dL or hematocrit <30%), adjust the ribavirin dose downward in 200-mg increments. If severe anemia occurs (ie, hemoglobin <8.5 g/dL or hematocrit <26%), discontinue ribavirin and consider intervention to treat the anemia. We recommend adjunctive therapy with an erythropoietic growth factor at the physician's discretion. We also recommend weekly monitoring of blood parameters and blood pressure.

  • If side effects become intolerable or if there are marked decreases in the absolute neutrophil count (<500 cells/mm3) or platelet counts (<30,000 cells/mm3), adjust the dose of PEG-IFN downward. Again, we recommend adjunctive therapy with a granulocyte colony-stimulating factor at the physician's discretion as well as more frequent monitoring of blood parameters. The clinician must keep in mind that the dose-reduction recommendations contained in package inserts are overly cautious, and most clinicians do not adhere to them.

  • Following the completion or discontinuation of therapy, measure aminotransferase levels at 2-, 6-, and 12-month intervals. For responders, repeat the HCV RNA assay 6 months after the end of treatment. Thereafter, the decision whether or not to continue monitoring should be made on an individual basis.

  • For patients with genotype 1 HCV, repeat the HCV RNA assay at week 12. If HCV RNA levels have decreased by at least 2 log or have disappeared altogether, continue therapy for the full 48 weeks while continuing to monitor at 4- to 8-week intervals. If HCV RNA levels have not decreased by at least 2 log, consider discontinuation of therapy. This "12-week stopping rule" should be flexible and open to discussion.

  • For patients with genotype 2 or 3 HCV, assess aminotransferase and HCV RNA levels at the completion of treatment at 24 weeks, and base further management on the results of this determination.

  • Measure thyroid-stimulating hormone levels every 3 to 6 months during therapy.

  • If a patient becomes pregnant at any time, discontinue treatment immediately. The patient should be counseled regarding the possibility of birth defects and the options available. If the pregnancy is continued to term, the child should be monitored for 2 years both for late-appearing birth defects and for HCV infection. Because of the presence of maternal antibodies, monitoring in the first year should be by HCV RNA PCR.

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Monitoring

One useful schedule for laboratory tests is illustrated in Table 19.

Table 19: Laboratory monitoring for patients undergoing anti-HCV therapy
 
Baseline
Tx Week 12
Monitoring During Tx 6 Mos/End Tx Monthly x 6
Mos Post-Tx
6 Mos After Tx Completion
Pregnancy
X
 
X
 
X
 
HCV RNA
X
X
*
X
 
X
Hemoglobin
X
X
X
     
CBC/DIFF
X
X
X
     
WBC
X
X
X
     
Platelets
X
X
X
     
ALT/AST
X
X
*
     
TSH
X
  Every 12 weeks      

*At discretion of physician, if clinically appropriate
CBC = complete blood cell count; DIFF = differential blood count; WBC = white blood cell count; ALT/AST = alanine/aspartate aminotransferase; TSH = thyroid-stimulating hormone

In addition, all patients older than 50 years should undergo electrocardiography, and those with cardiac risk factors should undergo a stress test. Finally, any patient who develops ophthalmic symptoms should undergo an eye examination. Routine pretreatment ophthalmic examinations, while suggested in the package insert for IFNs, seem impractical and not particularly useful to our panel of experts; however, many practitioners conduct routine eye examinations before starting therapy.

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