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Continuum of Care: HCV and the Gastroenterologist

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 four different fields — infectious diseases, gastroenterology, primary care and addiction medicine — as they grapple with everything from screening and diagnosis to resistance variants and liver compensation. This is the third in the series and features input from gastroenterologists.

HCV Next reached out to three experts for opinions on the role of gastroenterology in treating the disease. Each clinician was asked the same series of questions. The experts include Donald M. Jensen, MD, a retired professor of medicine at the University of Chicago; Brian R. Edlin, MD, associate professor of medicine at Weill Cornell Medical College and senior principal investigator at the Institute for Infectious Disease Research at the National Development and Research Institutes, New York City, NY; and Robert S. Brown Jr., MD, MPH, vice chair, Transitions of Care, and interim chief, division of gastroenterology and hepatology at Weill Cornell Medical College in New York.

Early detection of HCV by gastroenterologists is critical to getting patients into care and on their way toward sustained virologic response at 12 weeks, according to the experts. They are usually the first or second clinician to see signals of the disease, and their ability to make a diagnosis and provide a work-up of the patient’s overall condition and state of liver decompensation can go a long way in shortening the journey. Although the days when gastroenterologists avoided treating HCV due to the challenges presented by interferon-based therapies are becoming history, the rapidly moving therapeutic environment requires constant attention. Teamwork with hepatologists and ID specialists, along with guidance from professional organizations, can go a long way in helping gastroenterologists stay on top of what is quickly becoming a manageable disease.

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

Brown: Gastroenterologists are central in treating hepatitis C because they are usually the first people involved in the diagnosis and staging of the disease. They know how to work a patient up. They are much less reluctant to get involved in treatment now that the interferon days are behind.

As for being the first clinician involved, people with cirrhosis or abnormal liver function tests will be referred to a gastroenterologist, at which point the GI doctor will make the HCV diagnosis. Even going back to the interferon days, most of the HCV treatment was done by gastroenterologists. So they were involved through the beginning well into the treatment.

Because of this experience, they have adequate case volume, which is another thing they bring to the table. HCV therapy at the moment is fairly straightforward, but there are some complexities. You have to know staging, you have to know the approved regimens for each genotype, you have to know the drug-drug interactions. You can’t be treating just one or two cases per year. A GI specialist usually has adequate numbers. In a large GI practice, it’s possible to have one or two people who do a really big volume. This also helps.

Jensen: Gastroenterologists represent the ‘second line’ of diagnosis (after primary care), and the ‘front line’ of treatment. They are certainly knowledgeable about HCV and its consequences and seem to have done an excellent job in the initial evaluation of such patients (confirming diagnosis, genotyping, staging).

Edlin: Many gastroenterologists and hepatologists and other physicians, advocate for treatment in many ways — speaking, educating physicians and the public, and aggressively pursuing approval for the new drugs for their patients. These are very important efforts. Many have also begun to reach out to underserved communities where hepatitis C is prevalent to try to address the needs there. This is very important because many of the groups most affected by the epidemic have the least access to hepatitis C treaters.

Q: What areas need improvement?

Jensen: Because the treatment field is moving so fast, they may be less aware of newer therapies ‘around the bend’ and, therefore, when to treat now and when to wait. I also believe that occasionally, patients are referred late to a transplant center, or sometimes not referred at all if they have liver cancer.

Edlin: One idea that some physicians have begun to endorse is the notion that because the drugs are so expensive, we need to ration care and treat only the sickest patients. That is erroneous thinking. It is the duty of physicians to avoid unnecessary, wasteful care that drives up the cost of health care in our country. Many physicians have admirably taken this to heart. But hepatitis C treatment is neither unnecessary nor wasteful. It is safe, highly effective, curative therapy for a life-threatening infection. It is not our job as physicians to withhold highly effective, cost-effective, life-saving care from patients who need it in the name of cost containment. Hepatitis C treatment improves quality of life and reduces mortality at all stages of the disease. When we defer treatment, we know it will be the most vulnerable patients who will be least likely to remain in follow-up and benefit from treatment later on.

Brown: We are not doing as good a job at educating primary care doctors to screen for HCV. It is our job as leaders in the field to not only adhere to the screening guidelines, but to make sure primary care doctors who treat baby boomers follow those recommendations as well.

If every time a patient came through who hadn’t been screened, we sent a letter to the primary care telling them to screen because the patient was born between 1945 to 1965, it wouldn’t take long before primary care doctors would start doing screening on their own. That reminder would be helpful, because screening is about habit. Once you get into the habit, it becomes automatic.

But even gastroenterologists are not doing enough screening. This is something that needs to improve.

Q: What can the professional societies do to improve and ensure the quality of care provided by gastroenterologists for patients with HCV? (AGA, ASGE, AASLD, etc.)

Edlin: Our professional societies need to advocate vigorously for wider access to treatment, and they have begun to do so. Access to hepatitis C treatment is in crisis because of the decisions of pharmaceutical companies to charge extremely high prices for the drugs and those of payers (public and private) who have reacted by abandoning their responsibility to cover medically necessary health care for their beneficiaries. Each group is pursuing its own financial interests to the exclusion of its responsibility to patients and to the public.

The result of these decisions has been the wholesale rationing of therapies that we could be putting to use right now to end the hepatitis C epidemic. Effectively, where it comes to our national hepatitis C treatment policy, there have been no adults in the room. We can’t prevent advanced liver damage if payers won’t cover the drugs until patients already have advanced liver disease, and we can’t stop the spread of the virus if we can’t give the drugs to those most likely to transmit it. Doctors and patients are both shackled by the current situation.

Professional societies, and government, need to step up and start demanding that all patients and physicians who need to use these drugs be given access to them. We need to make clear that the behavior of these two multibillion-dollar sectors — drug makers and payers who have decided that their financial interests outweigh the importance of patients’ lives — is unacceptable. Millions could be cured, but instead they are keeping the drugs under lock and key. We need to insist that they take the necessary steps — by dropping prices and removing restrictions — to make the drugs freely available so we can begin the work of ending the rising morbidity and mortality caused by hepatitis C.

The AASLD/IDSA guidance, which now states unequivocally that treatment is indicated in all patients, unless they have a life expectancy less than 12 months due to another disease, is an important step forward. On November 5, 2015, the federal Centers for Medicare and Medicaid Services took the step of sending a notice to state Medicaid directors informing them that federal law requires them to cover effective, clinically appropriate, and medically necessary treatments using the new drugs for beneficiaries with hepatitis C. That was another very important step. On November 16, 2015, AASLD issued a statement calling again for the removal of all restrictions on access to the drugs.

Our voices on behalf of patients and the public must continue becoming louder and stronger until the barriers are removed.

Brown: Given how rapidly hep C is changing, we can’t have all of the newest treatment data presented only at the AASLD and EASL meetings. We need to make sure that at the American College of Gastroenterology and at DDW we have a focus on hep C. There should be prominent education at those meetings on what’s new and what the most recent treatment recommendations are so that GI physicians don’t have to rely on pharmaceutical companies to educate them. We want people who got out of the habit of treating HCV because of interferon or the telaprevir (Incivek, Vertex Pharmaceuticals)/boceprevir (Victrelis, Merck Sharp Dohme) first-generation protease inhibitor days to get back into the fray.

We need our GI societies also to do more advocacy for HCV patients. ID societies did a lot of advocacy to help get patients access to HIV drugs. We have to do a better job as professional societies at advocating for access to hep C drugs for all patients, not just cirrhotic patients.

Jensen: The AASLD/IDSA HCV Guidance offers a spectacular reference site (www.HCVguidelines.org). The site is sponsored by AASLD and IDSA with IAS-USA as a managing partner, but is also co-sponsored by the AGA and CDC, thus making this the premier site for information on diagnosis and treatment. The site is web-based with information that is up to date and thoroughly reviewed and vetted. Drop down boxes allow for quick access to the key recommendations. However, this has now become a very lengthy document with often multiple treatment options for each clinical scenario. They need simplification.

Q: Given that gastroenterologists will have their own busy practices and challenges, which aspect of this continuum should they be most focused on? How might they best serve the overall effort to eradicate HCV?

Jensen: I fear that the increasing complexity of treatment options (by disease stage, prior treatment, genotype, subtype) will drive many busy gastroenterologists away from treatment. Hopefully, this will change as we get closer to a ‘one size fits all’ therapy. However, in the meantime, having a consistent approach to screening (eg, baby boomers referred for endoscopy), diagnosis (including viral load, genotype and staging), along with a good handle on which patients with advanced liver disease should be treated or referred, will be critical.

Edlin: Yes. We may have busy practices, but we’re going to get a whole lot busier as the number of patients with end-stage liver disease continue to increase. So it is in everyone’s interest to get people with hepatitis C diagnosed and treated before they develop advanced liver disease.

The most important thing gastroenterologists and all physicians can do, besides advocating for access to treatment, is to stay up-to-date on treatment and treat hepatitis C aggressively and effectively. At present, this requires substantial expertise in securing approval for coverage from payers.

Another big contribution hepatitis C treaters can make is to educate patients, other physicians, and the public about the importance of hepatitis C screening and treatment. Many recent studies have reported on the effects on morbidity, mortality and quality of life, and the cost-effectiveness, of hepatitis C treatment. Experts are needed to speak to other physicians and the public. Advocacy for treatment access by speaking with policymakers whenever possible is also important.

It is also true that many of the groups most affected by the epidemic have the least access to hepatitis C treatment. Experts in hepatitis C care can fill this gap by reaching out to those serving high-risk populations and providing education, collaboration and access to effective treatment. Examples include substance use treatment providers, mental health providers, prison and jail systems, and community-based organizations, including harm reduction providers serving people who use drugs. Collaborating with state and local health departments can also be very helpful, to find out what assistance is needed to provide screening, treatment, and advocacy.

We need a strong cadre of doctors willing to do this work. It doesn’t matter if they are gastroenterologists or not. They just have to be willing to get up to speed on this, treat patients, and do the kind of outreach I described above in their communities.

Brown: We talked about how they could be a part of the screening effort. They certainly are a big part of the diagnosis. They are often the first line of referral even for a known hep C positive patient, particularly if there isn’t a hepatologist nearby. And they certainly can treat most of the spectrum of HCV disease. They can be involved in HCC screening of cirrhotic patients, what I call cirrhotic health care maintenance.

As for more challenging patients, only very experienced gastroenterologists who have a focus on hepatology should be treating decompensated disease. That should likely be in the realm of a transplant-focused hepatologist. However, a GI can certainly work in conjunction with a transplant specialist, particularly if a transplant specialist is not nearby. A GI can collaborate with this specialist to provide care close to home, including doing the HCV treatment after the transplant management has been taken care of.

Q: When might it be necessary for a gastroenterologist treating a patient with HCV to hand that patient off to someone more qualified? Will that be necessary, and, if so, is there a way to define that point or patient population?

Jensen: Certainly any patient with hepatocellular carcinoma (HCC) and those with decompensated cirrhosis who may be eligible for transplant (MELD score > 14) should be referred early. Other difficult management situations, such as renal failure and HIV co-infection, where choice of therapy will perhaps be different, should also be referred (or at least considered).

Brown: Certainly the management of HCC requires an evaluation for transplantation, but where I draw the line for referral is at the development of decompensation, ie, ascites and encephalopathy.

Edlin: This is something individual physicians have to decide for themselves. The treatments are starting to get very complicated. Simple cases, anyone can treat — for example, patients with genotype 1 (1a or 1b) or 2 who have never been treated before and don’t have cirrhosis. Patients that are more complex might be those with cirrhosis, those who have undergone unsuccessful prior treatment, those with genotype 3 or unusual genotypes, pregnant patients, and maybe patients with renal insufficiency. These groups might benefit from a physician with expertise in managing hepatitis C.

One group that can sometimes be difficult to manage is patients who use illicit drugs. Occasional alcohol or drug use shouldn’t interfere with hepatitis C treatment, but patients with ongoing drug use that dominates their daily life or interferes with their functioning may benefit from the involvement of care or service providers with experience working with such individuals. Physicians who are uncomfortable treating patients who are heavily involved in illicit drug use should get help from someone who is. But this is not an excuse to ‘hand off’ the patient to someone who doesn’t have expertise treating hepatitis C. The hepatitis C needs to be attended to, and the patient not abandoned.

• Reference:
• Robert S. Brown, Jr., MD, can be reached at New York-Presbyterian Hospital/Columbia PH Room PH 14, 105, 622 W. 168th St., New York, NY 10032; email: rb464@cumc.columbia.edu.
• Brian R. Edlin, MD, can be reached at Weill Cornell Medical College, 4805, 1300 York Ave, New York, NY 10065, New York, NY 10065; email: bredlin.nyc@gmail.com.
• Donald M. Jensen, MD, can be reached at the Center for Liver Diseases, University of Chicago Medical Center, 5841 S. Maryland Ave., MC7120, Chicago, IL 60637; email: djensen@medicine.bsd.uchicago.edu.

Disclosures: Brown reports consulting and research relationships with AbbVie, Bristol=Myers Squibb, Janssen, Merck and Gilead Sciences. Edlin reports no relevant financial disclosures. Jensen reports receiving lecture honoraria from Gilead and being on the scientific advisory board for Merck.

Editor’s Note: Due to the success of this series, HCV Next will be adding another installment looking at the addiction specialist. To read Part 1, or Part 2 please follow the links. If you have interest in participating or a suggested source, please email Melinda Stevens at mstevens@slackinc.com.