Hepatitis C Treatment Viable in Primary Care

Medscape Medical News > Conference News

Hepatitis C Treatment Viable in Primary Care

Fran Lowry

March 18, 2014

Hepatitis C infection is typically treated by gastroenterologists and hepatologists, but primary care physicians can feel confident that they too can treat this illness — especially if they have the right interdisciplinary team to help, say clinicians wanting to expand care.

"We found that in our urban primary care practice, hepatitis C treatment was feasible; we achieved good treatment initiation and response rates," said Keith Sigal, MD, from the Mount Sinai School of Medicine in New York City. "Plus, we achieved these results in the era of the first generation of direct-acting antiviral medications and in a very vulnerable population," he told Medscape Medical News.

Dr. Keith Sigal
The treatment of hepatitis C infection "tends to be difficult," Dr. Sigal said. "At the time we were doing this study, the shortest treatment course was about 6 months and involved weekly injections of interferon and then a lot of pills. The reason it had been handled by specialists is because there are a lot of complexities regarding the decision-making process to put people on treatment, and the monitoring can be intense as well," he explained.

Dr. Sigal described the experience of his primary care practice, which has been serving very vulnerable patients since 2003, at the International Conference on Viral Hepatitis 2014 in New York City.

"We're at Mount Sinai, which is at the intersection of the Upper East Side and Harlem. There is a pretty significant burden of hepatitis C in our community, and we recognized that people were not getting evaluated and treated," he said. "The protocol that we've developed over the years takes a lot of the complexity out of the treatment process. We feel it is a program that anyone could potentially do."

The primary care clinic is composed of physicians, nurse practitioners, and patient navigators.
This is a treatment that can be delivered in primary care, but the system does require a bit of extra help.

"We rely heavily on patient navigators, who act as case managers and help guide the patients through their complex evaluation and treatment," Dr. Sigel noted. "This is a treatment that can be delivered in primary care, but the system does require a bit of extra help."

Dr. Sigal presented data on 125 patients with genotype 1 hepatitis C virus infection who were treated at the clinic from August 2011 to April 2013.

Of these patients, 39 (31%) were started on triple therapy (weekly injections of pegylated interferon plus ribavirin, with either telaprevir or boceprevir).

"Traditionally, initiation rates of treatment have been very low, ranging from 10% to 40%; our number is actually at the high end," he noted. "It's especially gratifying because our patient population had a very significant burden of mental illness and pretty significant drug-abuse histories."
Patients who started treatment were younger than those who did not, but the demographic characteristics and severity of liver fibrosis were similar in the 2 groups.

Also, patients who were treated and achieved sustained viral suppression at 4, 12, or 24 weeks were less likely to have a history of major depression or substance abuse than patients who did not achieve viral suppression.

Post-treatment viral suppression was achieved by 16 patients (45%), although 2 (6%) relapsed, and viral breakthrough was achieved by 6 (16%).

The treatment regimen was toxic and this caused 9 (25%) patients to stop treatment early. Additionally, 3 (8%) patients were nonadherent.

Dr. Mark Nelson
"With the rapid advances in hepatitis C therapy and the availability of potent, relatively nontoxic, and increasingly shorter durations of therapy, it is essential that we make these treatments sourceable by those in need," said Mark Nelson, MD, from Chelsea and Westminster Hospital in London, United Kingdom.
"Primary care — properly educated and supported — will need to be an important player in this aim," he told Medscape Medical News.

This study was funded by the New York State AIDS Institute of the New York State Department of Health and the RobinHood Foundation. Dr. Sigal has disclosed no relevant financial relationships. Dr. Nelson reports financial relationships with Bristol-Myers Squibb, Gilead Sciences, Janssen Pharmaceuticals, Merck Sharpe & Dohme, Roche Laboratories, ViiV Healthcare, and Boehringer Ingelheim,

Medscape Coverage 
International Conference on Viral Hepatitis (ICVH) 2014: Abstract 62. Presented March 17, 2014.

Dr. Douglas Dieterich - Huge need for hepatitis C education in the primary care

Medscape Medical News > Conference News

Viral Hepatitis Meeting a Must for Healthcare Providers

Fran Lowry
March 13, 2014

The growing concern about undetected hepatitis C infection, exciting developments in the management of the disease, and the realization that all healthcare providers — not just liver specialists — have a role to play in helping care for patients make the International Conference on Viral Hepatitis (ICVH) 2014 an important one for all stakeholders.

The conference will be held March 17 and 18 at the Icahn School of Medicine at Mount Sinai in New York City, and will be cohosted by the International Association of Providers of AIDS Care (IAPAC), in partnership with the International Association for the Study of the Liver (IASL).

"The conference presents an opportunity for a variety of clinicians — not just doctors, but pharmacists, nurses, and psychologists — to learn about the state of the art with respect to hepatitis B and hepatitis C, although at this point the highlights are in the hepatitis C area," José Zuniga, PhD, president of IAPAC, told Medscape Medical News.

The conference will help stakeholders gain valuable perspective on the tremendous progress that has been made in the management of hepatitis C in a variety of clinical practice settings, he said.

"Through the conference and the various means by which we disseminate the outcomes — whether it's the live webcasts, the archived webcasts, the coverage on Medscape, etcetera — our goal is to ultimately expand the universe of clinicians who are managing viral hepatitis, from screening to treatment and, in the case of hepatitis C, to cure," he said.

The recent development of new drugs has made treatment protocols for hepatitis C easier and successful, Dr. Zuniga said.

Paradigm Shift in Management of Hepatitis C
Dr. José Zuniga

"Over the past several years, we have seen a complete paradigm shift in the clinical management of hepatitis C. That progress has continued through to looking at regimens that are interferon-sparing, meaning eliminating some of the side effects related to that specific drug," Dr. Zuniga said.

"We're also looking at more convenient dosing, which will make it as it is in the HIV world — much more possible for people to adhere to their regimens and ultimately achieve the goals of treatment, which in this instance is a cure."

Several presentations will offer information about treating hepatitis C patients in a general practice setting and stress the role of other members of the healthcare team, in addition to physicians.

The universe of liver specialists is not capable of managing the hepatitis C epidemic in the United States, let alone globally.

"These talks are extremely important because the universe of hepatologists and gastroenterologists — liver specialists — is not capable, from the shear perspective of volume of people, of managing the hepatitis C epidemic in the United States, let alone globally," Dr. Zuniga said.

"From our perspective as an association that represents a variety of providers, and now increasingly primary care physicians and clinicians, it's important that we provide them with the type of education that will allow them to screen, test, and treat," he explained.

"Any number of educational and structural interventions that will be discussed at the conference should make it easier to integrate larger numbers of nonliver specialists into the health workforce dealing with hepatitis," Dr. Zuniga noted.

A talk on the role of social workers in hepatitis C treatment is one that has been highlighted by conference organizers.

"To use the much-used cliché, it takes a village. We've learned this with HIV, and we're applying it to hepatitis. It's not just about the physician. In fact, at times, the physician is a barrier to the type of quality care that we want to deliver to people," Dr. Zuniga said.

"We know, for example, that if we want to improve adherence among patients on complicated regimens, or even lifetime regimens in the case of HIV, a nurse can do a far better job. Our interest as a group that represents all providers of HIV care, and by extension those who provide care to coinfected patients, is to ensure that the voices of nurses, pharmacists, psychologists, and peer educators are heard."

Baby Boomers Important Target for Screening

People born between 1945 and 1965 represent an important group for hepatitis C screening. Initiatives to increase awareness of screening in various settings, including emergency departments, will be discussed at the conference.

"Centers for Disease Control and Prevention guidelines focus screening activities on those most at risk, rather than on the general public. These guidelines have been out for a few years, and the US Preventative Services Task Force has endorsed them, which is a wonderful thing because it means that screening activities are reimbursed by insurance companies," Dr. Zuniga said.

This population is at risk because of a variety of risk-taking behaviors, such as injection drug use, that were prevalent when the baby boomers were coming of age. The lack of knowledge about hepatitis means that the bulk of these people have never been tested for hepatitis C.

The CDC has articulated deep concern about a potential wave of mortality related to liver cancers in undiagnosed baby boomers within the next 5 to 10 years.

"This is extremely frightening," Dr. Zuniga said. "Large numbers of people could be diagnosed with late-stage liver disease. That is why we are trying to educate as many clinicians as possible on the continuum of hepatitis C care.

There has been talk about the possibility of eradicating hepatitis C, at least in resource-rich settings like the United States and Western Europe. But that is not going to happen without the workforce, the infrastructure, and the financial resources to implement a robust response, Dr. Zuniga said.

"Amazing" Time in Hepatitis C 
Dr. Douglas Dieterich

Meeting cochair Douglas Dieterich, MD, from the Icahn School of Medicine at Mount Sinai, told Medscape Medical News that this is an amazing time in hepatitis C, "both from the perspective of the CDC recommendations for screening baby boomers and the New York State law for screening baby boomers, and the confluence of new therapies that are all extremely effective, approaching 100% cure rates with virtually no side effects."

Because of these developments, there is now a growing need to equip more healthcare providers with the tools to manage patients, Dr. Dieterich explained. "We are going to need more providers who are able to treat hepatitis C and, of course, more primary care people who are willing to screen for hepatitis C and refer for treatment to gastroenterologists or liver specialists if they're not comfortable treating it themselves," he said.

Dr. Dieterich added that there will be a huge need for hepatitis C education in the primary care, infectious disease, HIV, gastrointestinal, and liver communities for the next decade or so.

Dr. Zuniga noted that the fact that the meeting is being held in partnership with the IASL is important.

"A liver association and an HIV association wanted to get together to communicate to the world that it's okay for liver specialists and nonliver specialists to work together to eradicate hepatitis," he said. "There is a gulf between the liver world and the nonliver world that we are trying to bridge. Given the magnitude of the epidemic and the health workforce restraints we have because of the numbers who can actually treat at this moment, this is a very powerful message that our associations are sending."

Dr. Zuniga and Dr. Dieterich have disclosed no relevant financial relationships.

 Medscape Medical News from the

• International Conference on Viral Hepatitis (ICVH) 2014 

Mobile Unit Links Hepatitis C Patients to Care

Conference News

Medscape Medical News from the
International Conference on Viral Hepatitis (ICVH) 2014

Related Coverage: Viral Hepatitis Meeting a Must for Healthcare Providers
 
Mobile Unit Links Hepatitis C Patients to Care

Fran Lowry

March 17, 2014

NEW YORK CITY — An innovative program that goes into at-risk neighborhoods to identify people infected with HIV and hepatitis C virus is proving to be very successful at finding and linking these people to care.

"We recognize that there are a multitude of barriers to care for individuals living with hepatitis C and HIV, and we know that 50% to 75% of people who have hepatitis C are unaware of their infection," said lead investigator Stacey Trooskin, MD, from the Drexel University College of Medicine in Philadelphia.

"Most at risk are people with a history of injection drug use, those who received a drug transfusion before 1992, and those who have had multiple sexual partners. Our concern is that many of these at-risk individuals may not have access to medical care or see their doctor regularly," Dr. Trooskin explained.

She described the campaign to test and link patients to care — called Do One Thing, Change Everything — here at the International Conference on Viral Hepatitis 2014.

Dr. Trooskin and her team went into a Philadelphia neighborhood known to have one of the highest prevalences of HIV and hepatitis C and the lowest number of medical resources.

"It's a guerrilla-based street and door-to-door campaign," she explained. We invite people who are walking on the street or who answer their doors to "come out to our van to be tested for hepatitis C and HIV."

Dr. Trooskin presented results from 1001 individuals who were tested for HIV and hepatitis C from December 2012 to October 2013.

It's a guerrilla-based street and door-to-door campaign.

The OraQuick rapid antibody test was used to identify hepatitis C infection. Immediately after a reactive test result, reflexive confirmatory testing with the hepatitis C nucleic acid test was done with a blood draw.

"Our hepatitis C testing uses a very unique algorithm," Dr. Trooskin said.

"We know that 15% to 25% of individuals who are exposed to hepatitis C clear it on their own, so they will have antibodies but do not have the virus. If they only get the antibody tested, it doesn't really tell them the true nature of their status," she explained. With our protocol, "not only are we out on the street pulling people into the van to get tested, when somebody has a reactive rapid antibody test for hepatitis C, we immediately draw their blood and automatically run a second test."

The program has been very successful, Dr. Trooskin said.

She reported that 42 individuals (4.2%) had a seroprevalence of anti-hepatitis C antibodies.

Of these 42 people, 37 (88%) underwent confirmatory testing and 31 (84%) turned out to be chronically infected. For 13 (42%) of these chronically infected people, the hepatitis C diagnosis was new.

None of the people who tested positive for hepatitis C were receiving subspecialty care at the time they were tested. In addition, 9 (29%) of the people who were chronically infected had no medical insurance.

Three uninsured patients were lost to care, but the other 6 were able to get insurance.

High Rates of Care

With aggressive case management, 18 (58%) of those chronically infected with hepatitis C were linked to subspecialty care, and all of the others are now actively engaged in the linkage process, Dr. Trooskin reported. However, 10 (35%) people said they had difficulty obtaining a referral for subspecialty care from their primary care physician.

"Many of these individuals we find have not been to a primary care provider in many years. We have had great success linking individuals to care who wouldn't otherwise have had access," she said.

"The bottom line here is that testing for hepatitis C in a nonclinical setting is a necessary and effective means of identifying new hepatitis C infections. It also re-engages individuals who sort of knew they had something wrong with them and might have been told along the way that they might have hepatitis C, but didn't know they needed to do anything about it," Dr. Trooskin said.

Such testing "facilitates linkage to myriad clinical and behavioral services," said José Zuniga, PhD, president of the International Association of Physicians in AIDS Care.

"If successful, this can mean a diagnosis and cure for countless undiagnosed individuals, as well as reduced risk behaviors and reduced transmission rates," he told Medscape Medical News.

"Going to where hepatitis C is establishing a foothold is an important means by which to use the epidemiology of an evolving epidemic to ensure that recent progress in hepatitis C clinical management benefits patients in rural and urban settings alike," Dr. Zuniga explained.

This study was funded by Gilead Sciences. Dr. Trooskin is on the Gilead Sciences board for hepatitis C. Dr. Zuniga has disclosed no relevant financial relationships.

International Conference on Viral Hepatitis (ICVH) 2014: Abstract 61. Presented March 17, 2014.