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Continuum of Care: HCV and the Primary Care Provider

Editor’s Note: Part 2 of 3

A natural consequence of expanded screening protocols and the advent of the direct-acting antiviral era is that a flood of patients with HCV is entering the health care system. Accordingly, the number of non-HCV specialists required to treat the disease also is on the rise. HCV Next will be publishing a three-part series on the successes achieved and obstacles faced by clinicians in three different fields — infectious diseases, gastroenterology and primary care — as they grapple with everything from screening and diagnosis to resistance variants and liver compensation. This is the second in the series and features input from primary care providers.

PCPs are often the first clinicians to see the signals of HCV infection. Awareness of risk factors and familiarity with testing and treatment protocols can go a long way in swiftly moving a patient into care and setting them on the road to a cure. What primary providers may lack in detailed knowledge of HCV, they frequently make up for by having the trust of individuals they see on a regular basis. If professional societies can disseminate the proper information in a clear and uniform way, PCPs can be a key component to eradicating this disease.

Each expert, including two HCV clinicians and a public health authority, was asked the same series of questions. These specialists include Colleen Flanigan, RN, MS, director of the Viral Hepatitis Section at the New York State Department of Health AIDS Institute; Christine Kerr, MD, director of HIV, Hepatitis, and Specialty Care at Hudson River HealthCare; and Michael S. Saag, MD, professor of medicine, Jim Straley Chair in AIDS Research and director of the Center for AIDS Research at the University of Alabama at Birmingham. Saag is also the Co-chief Medical Editor of HCV Next.

Q: Given that PCPs will have their own busy practices and challenges, which aspect of this continuum should they be most focused on?

Kerr: Primary care providers must be screening all patients, both with age-based screening and comprehensive risk factor assessment. All patients with a positive HCV antibody should have a quantitative hepatitis C viral load performed. The burden of this responsibility lies with primary care providers and without this, the HCV epidemic will not be slowed.

Risk factor assessment is surprisingly difficult to implement on a wide-scale basis. With the epidemic of drug use in this country, we are missing too many patients who are at risk because of providers’ stigma and stereotypes regarding drug users. We should also make sure that patients have had HIV testing and Hepatitis A and B screening and vaccination. Primary care providers should also be routinely assessing alcohol use and counseling regarding this.

Not all providers will be interested in treating their own patients, but all providers should make sure that their patients are screened and basic screening for comorbidities is completed.

Flanigan: At a minimum, all primary care providers should properly screen for HCV and ensure persons with a reactive HCV screening test receive an HCV RNA test to confirm (or rule out) active HCV infection. In addition, PCPs should make appropriate referrals for preventive services and further HCV care and treatment, if needed.

Saag: Primary care providers need to be screening all their patients for hepatitis C. That’s a given. It doesn’t take much time or effort, but it needs to ordered and followed up on. When the antibody test comes back positive, they need to follow up with a viral load and a genotype. This gets us halfway there to treatment.

The next thing is to then do an assessment of liver fibrosis. Once those data are together, then the provider can initiate therapy themselves if it is a patient without cirrhosis. If the patient has cirrhosis, of course there should be a referral, but PCPs can and should begin treating patients without cirrhosis immediately. When you break it down and put it all together, none of this is terribly burdensome.

Q: What can professional societies do to improve and ensure the quality of care provided by PCPs for patients with HCV?

Flanigan: Professional organizations need to work together to promote the role of PCPs in HCV prevention, care and treatment. They need to develop and share resources such as evidence-based guidelines, performance measures and trainings. These resources should be tailored to PCPs and their practice settings.

Saag: The first thing is that they can provide continuing education. That can take the form of workshops on how to treat HCV and include materials, review articles, pamphlets and other literature. There should be supplements to journals. The International Antiviral Society-USA has a wealth of information and materials.

The societies can also encourage their members to become involved. The AASLD and Infectious Diseases Society of America are creating an atmosphere in which hepatologists and ID docs are more comfortable with the idea of PCPs treating patients with HCV. As for general medicine and family medicine groups, they can also encourage their members to engage in HCV treatment.

Internists and family medicine providers are capable of treating the disease. Also, there just aren’t enough specialists in ID or hepatology to take care of the large number of patients. Therefore, PCPs are needed to provide sufficient HCV treatment capacity and the respective PCP societies need to encourage their members to become engaged.

Finally, the biggest barrier to all of us is gaining access to medications. There is a lot of case management and social work required to get insurance companies to cover these drugs. Societies can aid in the activism for this negotiation with the manufacturers and insurance companies by simultaneously encouraging drug companies to lower their prices and, in return, compelling payers to cover the costs of the medications for all patients who have chronic HCV.

Kerr: Guidelines aimed at primary care doctors with clear algorithms and guidance to move providers along a continuum from screening, testing, diagnosis, assessment, and treatment are very important. Cross-disciplinary care coordination is so important. With 4 million people in this country with HCV, the burden of disease is much more than specialists can treat alone. However, if patients are getting care primarily in the primary care setting, good communication and care coordination for more complex patients is important so that the quality of care remains high.

Q:What are primary care providers doing right in terms of treating HCV? And, similarly, what positives do they bring to the table in terms of experience and background?

Saag: The most positive thing I’ve seen to date is the remarkable interest PCPs have taken in treating HCV. We’re not seeing a lot of primary care providers starting to treat just yet, but they really have intent to treat, pardon the pun. It’s my opinion that they will be treating in large numbers over the next 12 to 18 months. What’s heartening is the number of primary clinicians that are expressing interest in treating patients in their clinics or offices without referring to another provider.

The unique feature of a PCP taking care of their patient’s hepatitis C is that there is a relationship already established. The patient doesn’t have to go to another office or meet a new provider, which is uncomfortable and inconvenient for the patient. You eliminate the communication barrier between provider A and provider B.

The reward for the PCP is the incredible joy when the patient comes back SVR12 value of “target not detected” and they look them in the eye and say, “You’re cured!” It’s nice to have that opportunity. That experience reinforces the PCPs interest in treating HCV.

Kerr: There are so many reasons that treating HCV in the primary care setting is valuable. Patients usually know and trust their provider already, which markedly reduces barriers to care. People always like “one-stop shopping.”

Telling people that their HCV is curable is often a catalyst for improving other health care issues. We have had so many patients stop smoking, have their blood pressure treated, stop drinking alcohol or using drugs, and engage in care for depression once they have engaged in treatment for their hepatitis C.

Primary care providers are perfectly poised to ask about risk factors for HCV and to implement routine screening as part of a routine physical for those who fall in age-based screening cohorts. Primary care providers are used to acting as a coach and cheerleader to help patients through the implementation of new treatments already. Since adherence is so important with new DAA regimens, providers can use skills they already have regarding medication and side effect counseling.

Flanigan: Primary care providers with HCV experience and knowledge are helping to increase the capacity to treat persons living with HCV at a time when resources in specialty clinics are limited.

Since 2010, the New York State Department of Health (NYSDOH) AIDS Institute has been funding primary care settings to integrate HCV care and treatment. At each of these settings, the model includes a PCP and a multidisciplinary team to manage and treat persons infected with HCV. Each PCP works in partnership with an experienced HCV provider to gain the knowledge, skills and experience to safely and effectively manage and treat HCV. Data from these programs on performance measures and treatment outcomes show that PCPs can effectively manage HCV and achieve optimal treatment outcomes.

PCPs have established a relationship and gained the trust of their patients. Therefore, these patients may be more likely to initiate and remain adherent to HCV treatment. In addition, PCPs may have a broader view of the patient’s overall health and other comorbidities that may impact their HCV disease and treatment outcomes.

Q: What areas need improvement?

Flanigan: PCPs need to be more aware of their role along the HCV care continuum. PCPs are on the front line when it comes to HCV screening, diagnosis and linkage to care.

The majority of people infected with HCV do not know they have the disease. Improvements are needed in the areas of HCV screening and diagnosis, especially now that the HCV screening recommendations have been expanded to include all persons born between 1945 and 1965 (baby boomers). Studies have also found that people with a reactive HCV screening test often times do not receive an HCV RNA test to confirm HCV infection. PCPs need to be aware of CDC’s simplified HCV testing algorithm, the availability of HCV reflex testing and who in their community is providing HCV treatment, if it is not them.

Kerr: For many years, because of the difficulty of treatment, patients and providers both became complacent about HCV infection. For many people, HCV has fallen lower and lower on their problem list and neither the provider nor the patient has tracked or followed it actively. Some patients were referred out years ago and providers assumed they were following up regularly, but once a decision was made not to pursue interferon-based treatments, patients stopped following up with specialists. Many of those patients may not be aware of the effectiveness and improved side effect profiles of the newer medications.

Another area where primary care providers may need help is developing methods to track and follow patients during and after treatment to make sure that they are reminded of their appointments, labs, imaging and follow-up. These tracking methods are often easily created with electronic medical records, but they do require some development and continued evaluation.

Because primary care providers are not used to screening for advanced fibrosis or cirrhosis or tracking these patients over time, this is one area that is absolutely crucial for education and systems development. All patients with HCV need to be screened for advanced fibrosis or cirrhosis. If advanced fibrosis or cirrhosis is present, hepatocellular cancer screening with imaging is crucial to catch the development of cancer early enough so that it is easily treatable. In a patient with advanced fibrosis or cirrhosis, screening for hepatocellular carcinoma continues throughout the patient’s life, even if their HCV is cured.

Saag: The biggest area of concern is that PCPs need to become more comfortable assessing fibrosis. The treatments vary based on the degree of fibrosis. Gaining access to elastography and other methods is difficult for a primary care provider, so we’re left with using more of the seromarkers or ratio scales like Aspartate Aminotransferase to Platelet Ratio Index (APRI) or FIB-4 to determine the degree of fibrosis. If the patient falls into one of those gray zones and there is concern about cirrhosis, but it can’t be proven, then the patient has to get a liver biopsy, which is performed by an interventional radiologist orgastroenterologist/hepatologist.

The second area we need to constantly reinforce is that when there is a patient in our practice that has cirrhosis, those patients need to be co-managed with a hepatologist.

Q: Could you comment on when it might be necessary for a PCP treating a patient with HCV to hand that patient off to someone more qualified?

Saag: Patients with any degree of cirrhosis should be referred to a hepatologist as soon as possible. Another population is those who have already been treated with DAAs. There may be some resistance variants emerging that should be in the hands of an ID specialist or hepatologist who is well versed in the nuances of viral resistance and its impact on therapies.

Kerr: In our center, we ask all patients with a history of decompensated cirrhosis to see a hepatologist in a transplant center prior to initiating treatment. We will often treat those patients after they have had a complete assessment, but this allows us to treat comfortably and to make sure that if there is an adverse outcome or complication, that those patients will receive the best treatment possible. We refer patients with significant renal dysfunction and patients who have a history of being treated with the newer DAAs to clinical trials or we treat with close collaboration with a hepatologist. In our center, we routinely treat patients with HIV co-infection, but other providers may feel more comfortable referring out due to the complexity of drug-drug interactions.

Flanigan: The NYSDOH AIDS Institute is currently updating its guidelines on the management and treatment of HCV patients. The target audience for these guidelines is PCPs. According to the draft guidelines, patients with decompensated cirrhosis are at higher risk for complications during treatment due to the severity of underlying liver disease; therefore, referral to a highly experienced provider is recommended for these patients.

• For more information:
• Colleen Flanigan, RN, MS, can be reached at the New York State Department of Health AIDS Institute, Empire State Plaza, Corning Tower – 429, Albany, NY 12237; email: colleen.flanigan@health.ny.gov.
• Christine Kerr, MD, can be reached at Hudson River HealthCare, 6 Henry Street, Beacon, NY 12508; email: ckerr@HRHCARE.org.
• Michael S. Saag, MD, can be reached at University of Alabama at Birmingham, 845 19th Street South/BBRB 256, Birmingham, Alabama 35294-2170; email: msaag@uab.edu.

Disclosures: Flanigan reports no relevant financial disclosures. Kerr reports being co-chair of NYS Guidelines Committee for HCV mono-infection and being an HCV-Target Site Investigator (HCV Target is funded by multiple funding streams, including pharma). Saag reports receiving grants to his institution from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck and ViiV.