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Parameters for PCPs who treat patients with HCV
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The availability of oral antiviral medications without interferon, with very high efficacy rates and safety levels, combined with the large number of as-yet undiagnosed or untreated people, as well as those previously treated unsuccessfully, raises the question of whether there is a sufficient number of already established providers to treat the number of patients with hepatitis C virus who will need treatment over the next several years. A particular focus has been on how to expand the pool of primary care physicians who add hepatitis C virus treatment to the broad spectrum of services they already offer.
We begin with the premise that HCV therapy can indeed be undertaken successfully by PCPs who have the level of commitment necessary to familiarize themselves with the body of data underlying our present regimens and the practical nuances involved. For many such physicians, the motivation may come from a practice with a high prevalence of HCV infection. Alternatively, or in addition, many primary care physicians have experience with the treatment of HIV infection and may frequently be called upon to care for HIV/HCV coinfected patients.
The elements of mastery required for HCV treaters involves several considerations. Most obviously, we still do not have pangenotypic regimens with durations of therapy that are uniform across the broad spectrum of HCV infected populations. Treatments still vary with regards to the components of the available regimens, whether or not to use ribavirin and the duration of therapy. All of these vary according to host and viral characteristics; thus, for example, the regimens for genotype 1 are different from the regimens for genotype 2 or 3. Patients with cirrhosis often still need a longer duration of therapy and/or the addition of ribavirin.
Ira M. Jacobson
Another critical requirement for PCPs involved in HCV treatment is an understanding of the underlying liver disease, in particular necro-inflammation leading to fibrosis, the different stages of fibrosis, and the critical importance of distinguishing patients with advanced fibrosis or cirrhosis from those with mild disease. Not to be forgotten is the need to exclude other etiologies of liver disease, which may coexist with HCV infection.
With current treatment regimens, either all cirrhotics or treatment-experienced cirrhotics need extension of treatment duration from 12 to 24 weeks, or the addition of ribavirin, depending on the regimen.
Moreover, patients with cirrhosis are at risk for hepatocellular carcinoma (HCC) and need screening with imaging every 6 months from diagnosis, even after virologic cure is attained. Despite the substantial reduction in risk for HCC after virologic cure, it does not revert to that of the background population.
The means to assess patients for degree of fibrosis and cirrhosis are currently concepts that are most familiar to gastroenterologists, hepatologists or infectious disease physicians. All physicians are familiar with liver biopsy as the traditional tool to assess liver fibrosis, but liver biopsy has been supplanted by noninvasive techniques, including serum panels of markers directly measuring components of liver matrix deposition or degradation, or indirectly by formulaic assessments of universally available measurements. Tissue elastography has become widely adopted and is often utilized with peripheral blood markers to assess fibrosis with high levels of confidence. Many PCPs are unfamiliar with these tools, or may lack a refined understanding of their accuracy, and must become familiar with them and make appropriate referrals.
A final consideration that underscores the importance of significant immersion in this field for prospective treaters in the primary care community is the emerging importance of viral drug resistance. Still without consensus is the question of whether testing for baseline resistance before treatment has a role in selecting treatment regimens, but unquestionably the emergence of resistance in patients who fail direct-acting anti-viral therapy has potential impact on retreatment options, and even now, efforts are underway to develop “salvage” regimens to address this problem. Physicians treating HCV patients must understand the concept of resistance, impart to patients the possibility of emergent resistance if treatment fails, be familiar with the assays available to test for resistance, and be aware of emerging regimens that can treat patients with emergent resistance effectively. Infectious disease physicians and primary care physicians who treat HIV will have a “head start” in this area, while others may require more extensive education. In the end, physicians who provide treatment of HCV should be equipped to address with patients the slight possibility of failure and the current state of the art in managing those patients afterward.
There are many opportunities for obtaining the knowledge needed for proficiency in treating HCV-infected patients. Case-based teleconferencing is a great way to educate PCPs, along with interspersed didactic presentations to provide updates on treatment. I had the opportunity to participate in such an activity with providers around New York City through the auspices of the Department of Health when the first protease inhibitors became available with interferon, and I found the PCPs in the group to be eager to learn, thoroughly committed, and quick to attain proficiency. In-person precepting helps by spending a day together and mixing didactics with patient visits. PCPs should be aware of the numerous educational venues — CME or non-CME — that are available in their communities. Many high quality resources are available online with leading experts providing education on all facets of HCV therapy. I am also a strong believer that physicians would do very well to dedicate themselves to an intensive review of the primary literature consisting of the classic papers in their field of interest, in this case the papers reporting phase 3 data that have led to the approved regimens used in practice. The single most useful document at the present time is the web-based, frequently updated and well-referenced AASLD/IDSA Guidance document on HCV therapy available at www.hcvguidelines.org.
PCPs need to understand the nuances, the subtle and not so subtle differences in regimens for different categories of patients. They need to be able to speak with a fair degree of accuracy of efficacy rates, and they need to know about the side effects, though that burden has become lighter.
Lastly, drug-drug interactions are very important to know.
Providers would be well served with information about drug-drug interactions — including language available directly from package inserts — that can be posted on office walls where you see patients. You have to refer to that information dozens of times before you have it memorized.
An invaluable resource for PCPs who want to pursue HCV therapy consists of relationships with one or two experts in their geographic community, if you do not have one already. Most of us in large centers welcome queries from colleagues who need advice on occasion, as long as there is an understanding that the most appropriate way to provide assistance in more complicated situations is to see the patient and all relevant records in an in-person consultation.
Editors note: This article was previously published in HCV Next, a SLACK Incorporated publication.
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Ira M. Jacobson, MD, is chair of the department of medicine at Mount Sinai Beth Israel and Co-Chief Medical Editor of HCV Next, a sister publication of Infectious Disease News.
Disclosure: Jacobson reports various financial relationships with AbbVie, Achillion, Alnylam, Bristol-Myers Squibb, Enanta, Gilead Sciences, Janssen Therapeutics, Merck and Tobira.