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Expert Critique
FROM THE ASCO Reading Room
Access to healthcare continues to be a common theme in the medical world. As we now have the medications for curing hepatitis C with excellent cure rates, reduction of morbidity from end stage liver disease, and presumably reduction of mortality, we must expand the treatment force. If specialists are not overwhelmed by the sheer number of hepatitis C patients waiting to be treated, they may be able to spend more time with the more complicated hepatitis C patients. The overall goal is decreased morbidity and eventually, decreased mortality from liver disease.
Primary care providers can successfully manage direct-acting antiviral (DAA) treatment for hepatitis C, though some complicated cases should still be referred to specialists, experts say.
Recent studies have shows that hepatitis C treatment by primary care physicians and nurse practitioners can result in cure rates similar to those achieved by hepatologists and infectious disease specialists. Increasing the number of providers is key to expanding access to effective new therapies.
"There is no reason that a primary care provider cannot successfully treat the uncomplicated patient with chronic hepatitis C," Raymond Chung, MD, chief of hepatology at Massachusetts General Hospital in Boston, told MedPage Today. "However, it is important that prospective treaters receive proper education and training first."
The advent of DAAs has made treatment of chronic hepatitis C shorter, easier, and much more effective compared with the old interferon-based therapy.
Because of its complexity and poor tolerability, interferon treatment was typically handled by hepatologists, gastroenterologists, or infectious disease specialists. Treatment was usually deferred until patients were found to have advanced liver fibrosis or cirrhosis, which required liver biopsies. Viral load was monitored frequently to determine which patients were responding to therapy and which ones could stop treatment that was unlikely to work. In addition to interferon and ribavirin, various adjunct therapies -- ranging from antidepressants to blood transfusions -- were often needed to manage side effects.
Today, using interferon-free DAA regimens, treatment duration has fallen from a year to 8 or 12 weeks, and sustained virological response (SVR) rates exceed 95% even for hard-to-treat patients. A growing number of experts maintain that all hepatitis C patients should be treated, and that biopsies are no longer necessary.
"The short duration of therapy and the few serious adverse events related to the new hepatitis C medications present an opportunity to expand the number of mid-level practitioners and primary care physicians in the management and treatment of HCV infection," according to HCV guidelines developed by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA).
Some people may find it difficult to follow-up on referrals to specialists after a hepatitis C diagnosis. Seeing additional providers can involve extra time, effort, and expense. But this may not be necessary if patients can be treated by their regular care provider -- if they have one -- or in locations where they receive other health and social services, such as in methadone clinics or homeless shelters.
"We have seen a sizable number of patients diagnosed with HCV who fail to follow through with visits to specialists who might otherwise benefit from HCV care centered in their primary care provider's office," Chung said.
The influx of patients seeking these new therapies has led to a backlog. Access to treatment has been limited not only by the high price of DAAs and the restrictions imposed by some private insurers and public payers, but also by the lack of enough specialists to treat everyone. This shortage is expected to only worsen with stepped-up efforts to encourage all baby boomers and others at risk to get tested for HCV.
"Hepatologists and infectious disease specialists alone cannot carry the burden of treating the estimated 3.5-plus million people living with HCV in the United States," said Emalie Huriaux of Project Inform, an HIV and hepatitis C treatment advocacy group. "Advocates must demand that health insurers currently imposing prescriber restrictions, by only allowing specialists to prescribe treatments that cure HCV, remove these restrictions immediately."
Studies show that many, or even most, hepatitis C patients do not need to be treated by specialists in the DAA era.
Starting in the interferon era, telemedicine was used to facilitate collaboration between primary care providers and specialists to offer hepatitis C treatment to rural and underserved patients. For example, Project ECHO (Extension for Community Healthcare Outcomes) showed that videoconferencing could be used to connect primary care providers with multidisciplinary teams that included gastroenterologists, infectious disease doctors, and pharmacists, leading to good treatment outcomes.
More recently, the ASCEND study showed that primary care doctors and nurse practitioners in a community-based setting can provide safe and effective treatment with DAAs, even for hard-to-treat hepatitis C patients. As described at last year's AASLD Liver Meeting, Sarah Kattakuzhy, MD, of the University of Maryland School of Medicine in Baltimore, and colleagues enrolled 600 patients with genotype 1 chronic HCV infection at community health centers in Washington, D.C. Nearly a quarter were co-infected with HIV, 18% had prior treatment, and 20% had liver cirrhosis.
About half of the patients were assigned in a non-randomized manner to receive treatment managed by a hepatologist or an infectious disease specialist, while about a quarter were managed by primary care physicians and another quarter by nurse practitioners. Providers received uniform training on the AASLD/IDSA HCV guidelines, and all patients were treated with sofosbuvir/ledipasvir (Harvoni), usually for 12 weeks.
SVR rates did not differ significantly according to the type of provider: 95% for primary care providers, 94% for nurse practitioners, and 92% for specialists in a per-protocol analysis. However, among patients who completed therapy, cumulative adherence was higher among those treated by nurse practitioners (73%) or primary care doctors (63%) compared with specialists (56%). Given that the study was non-randomized, more challenging patients may have been sent to specialists, although the fibrosis levels were similar across groups.
Another study presented at the Liver Meeting found that non-specialist physicians and nurse practitioners can be quickly trained to treat hepatitis C, with a high level of treatment success and provider satisfaction.
Sophy Wong, MD, and colleagues from the Alameda Health Consortium in California evaluated a simple model for building capacity among primary care providers to treat people with hepatitis C at community health centers. The participating centers together serve more than 200,000 mostly low-income patients, a majority of them covered by Medicaid.
The training program, led by experienced non-specialist providers, included half-day workshops on HCV management and treatment; quarterly updates; locally developed treatment protocols based on the AASLD/IDSA guidelines; and email, text, or phone access to mentors.
A year-and-a-half into the program, providers had identified nearly 800 patients with chronic hepatitis C. At the start of the effort only a few local hepatologists would treat Medicaid patients, and the one hospital that accepted uninsured patients had a 6-month waiting list, Wong said. Training community-based providers increased the number of facilities able to treat low-income or uninsured hepatitis C patients to more than a dozen.
As of October 2016, a total of 50 primary care providers had been trained and 22 were providing HCV treatment. Of the more than 100 patients who underwent therapy and were followed for 12 months post-treatment, the cure rate was 96%. All surveyed providers said they would like to continue to include hepatitis C treatment as part of their clinical practice.
However, not all hepatitis C patients are good candidates for treatment by primary care providers, according to Chung. Some people with complicated cases or comorbidities should be referred to experienced specialists, such as hepatologists for advanced liver cirrhosis or infectious disease specialists for HIV/HCV coinfection.
"Patients with advanced liver disease should be under the care of specialists, as should those patients who have failed prior antiviral treatments, and those on complex medication regimens that could interact with HCV treatment. Patients with HIV coinfection or those who have undergone organ transplantation should also be treated by specialists," he said.
Chung also stressed the importance of people with cirrhosis receiving ongoing screening for hepatocellular carcinoma, a well-known protocol among liver disease specialists that may be less familiar to primary care providers: "A very important point that can't be overstated is that regardless of where the patient is treated, even with successful cure of infection, those patients with significant fibrosis will continue to require screening for liver cancer, as this risk is not eliminated with viral cure."
Many patients with advanced disease had been awaiting interferon-free therapy and were among the first to be treated as DAAs became available. The much bigger pool of people with recent HCV infection, and those who have long-term infection but have not yet developed serious liver disease, are the best candidates for treatment by primary care providers. Reaching and treating this larger group is key to ending hepatitis C as a public health concern.
"If we are to succeed in our goal of eliminating HCV, one of the main facets of that success will be expansion of the treater workforce," Chung said "Primary care providers can be an important part of that workforce."