Wednesday, October 9, 2013

Will Evolving Hepatitis C Therapies Reduce the Need for Specialized Care?

Clinical Care Options - Clinical Thought

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Enter the Nonspecialist: Will Evolving Hepatitis C Therapies Reduce the Need for Specialized Care?

Graham R. Foster, FRCP, PhD - 10/8/2013  More from this author

When I first started treating hepatitis C, therapy was complicated primarily by interferon-associated adverse events such as flulike symptoms, thrombocytopenia, neutropenia, depression, and thyroiditis requiring a specialist to manage treatment. These specialists learned how to anticipate, manage, and work around these predictable adverse events to maximize adherence and outcomes. The addition of ribavirin and the anemia associated with its use resulted in hepatitis C treatment remaining firmly in the hands of specialists with experience in managing the complications of therapy. Nor did the availability of peginterferon alter the need for hepatitis C therapy to remain the purview of hepatologists, gastroenterologists, and infectious disease specialists. For the better part of 10 years, this standard of care remained unchanged.

The Direct-Acting Antivirals (DAAs) Evolution
In 2011, our field underwent an evolutionary leap forward with the introduction of the first DAAs, boceprevir and telaprevir. The addition of these new protease inhibitors to peginterferon and ribavirin finally allowed us to attack the virus directly and deliver to patients (at least those infected with genotype 1 hepatitis C) significant increases in sustained virologic response. However, the realities of adverse events, especially anemia, have persisted and nothing about the new protease inhibitor–based regimens have made treating patients any easier or less complex.

Hepatitis C treatment, therefore, has remained firmly in the hands of specialists. Nonspecialist, primary care physicians have been reluctant to take up these new tools, often due to limited or no exposure to them and to concerns about administering the complex treatment paradigms and managing the complex adverse event profiles. In some ways, their reluctance mirrors the reluctance I observed with the advent of potent hepatitis B therapies. Nonspecialists were properly concerned about their lack of familiarity with the new agents and were afraid of “getting it wrong” while using some very expensive drugs that had few alternatives if treatment failed. In addition, many patients influenced by the negative experiences and opinions of their peers have been skeptical about initiating treatment and even less willing to initiate treatment with anyone other than a hepatitis C specialist. Treatment uptake has been further limited by the recognition that patients with advanced or rapidly progressive liver disease experience reduced efficacy, tolerability, and potentially more severe adverse events requiring very careful consideration before initiating care and specialized management if care is initiated.

The Nonspecialist Future
For my part, I see positive change coming. Although the next wave of regimens for genotype 1 will continue to require interferon, before too long, I anticipate additional regimens that will remove the need for interferon. At some point thereafter, I expect ribavirin will go by the wayside, finally eliminating the last of the adverse events associated with the peginterferon/ribavirin-based regimens. Once this occurs, the numbers of patients initiating therapy will likely explode and the numbers and types of providers treating them will also increase significantly. This expansion of patients and providers will mirror improving efficacies and gentler adverse event profiles, but ongoing complexities of care probably will remain as a limiting factor for many nonspecialist providers. This is only likely to change with the introduction of a single-tablet regimen (STR) for HCV therapy—a development that will propel hepatitis C care to its future in nonspecialist providers offices. We must recognize that to take full advantage of these new agents, educating these providers and their patients must remain a priority. Information will be the key to overcoming preconceptions about adverse events and regimen complexities, finally allowing nonspecialists to take a central role in caring for HCV-infected patients.

After the advent of the STR, what will be the place of the specialist? We will take a step back as nonspecialists gradually assume a larger role managing patients with few comorbidities and little or no liver disease. For myself, I expect the face of my practice will change; 5 years from now, it will probably be composed entirely of a subset of very complicated patients who may need the benefits of interferon and the experience using it that a specialist provides. These patients, such as those with previous failure of the more straightforward treatment regimens, will require close monitoring and careful management as they navigate the complexities of a 5- or 6-drug regimen.

Your Thoughts?
I’m interested to hear your thoughts. Do you think the time is approaching when HCV therapy will be managed primarily by nonspecialists? Maybe you yourself are a nonspecialist who is already using the current HCV regimens without difficulty? How do you see the future unfolding?

Topics: HCV - Prognosis 

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