Feature

The Increasing Role of Methadone Clinics for HCV Treatment, Education

Injection drug users express willingness to gain knowledge, receive therapy.

Methadone clinics are emerging as an important setting for the education and treatment of patients with hepatitis C virus infection. Programs such as the START Treatment and Recovery Centers in New York City are leading the way in providing a venue for individuals not only to kick their addiction to opiates, but also to receive screening for HCV, learn about disease prevention measures and stay on course with treatment.

Cover Feature 

“Providing methadone under close supervision allows us to provide educational and vocational services,” Roberto Zavala, MD, continuous quality improvement manager and researcher at the START Treatment and Recovery Center, said in an interview. “The methadone clinic model was successful with HIV, and now we are applying many of those same strategies to HCV.”

HCV intervention programs based in methadone clinics are still in the early stages, according to Zavala. Stigma and misinformation surrounding HCV continue to pose challenges in getting patients tested, and the advent of novel direct-acting antiviral therapies has resulted in a need for training clinicians and patients in treatment schedules and the diminution in adverse events as a consequence of elimination of interferon. There also are technological hurdles to clear, such as how to bring specialty care to the drug treatment facility. One potential answer to this dilemma is the use of telemedicine — technology that permits patient interaction with an HCV specialist in a remote location.

HCV Next Editorial Board member Andrew H. Talal, MD, MPH, said HCV diagnosis at a methadone clinic may be a “teachable moment” that clinicians can use as a jumping-off point to encourage patients to make healthier choices.

“Long-term stability on methadone may enable persons who inject drugs to stabilize their lives, thereby increasing the likelihood that they will be adherent to HCV medications,” said Talal, professor of medicine in the division of gastroenterology, hepatology and nutrition at University at Buffalo, State University of New York, and adjunct associate professor of medicine at Weill Cornell Medical College.

A STARTing Point

Methadone programs such as the START Treatment and Recovery Center may play a big role in the future of HCV treatment, Zavala told HCV Next.

The program is set up to “provide primary care onsite that can be supplemented for diseases that require specialty care such as HCV through the use of telemedicine. This has been a major advance for us that helps keep patients compliant with referrals and on track with their treatments. Many of our patients come to the clinic on a daily basis, where they can receive assessment, evaluation and treatment in a familiar setting, with medical personnel they know. They leave satisfied with this one-stop shop,” he said.

Recent data support the effectiveness of programs such as START.

Marija Zeremski, PhD, along with Talal, Zavala and other colleagues, created a 30-item survey about HCV knowledge that was completed by 320 patients on methadone maintenance in the START program. The survey is part of the Prevention, Evaluation and Treatment of HCV in Opiate Agonist Treatment Settings (PET-C) study, which is being conducted in collaboration with researchers at University at Buffalo, Weill Cornell Medical College, START and the CDC. The results were published in the Journal of Addiction Medicine.

The survey respondents had been receiving methadone maintenance for an average of 7 years. The mean age of respondents was 53 years, 60% were men, 55% were black and 40% were Hispanic.

Nearly 7% of respondents reported using injection drugs in the preceding 6 months, and 37.3% had used non-injection drugs. Half (46.3%) self-reported HCV seropositivity. Seventy-eight percent of respondents expressed willingness to participate in HCV education and treatment programs.

More than half (54.7%) of the respondents correctly answers five or more of seven questions about HCV, demonstrating a good fund of knowledge of the infection. As the researchers expected, those with HCV or those who had received prior education about the infection were more likely to demonstrate increased knowledge about HCV.

Some groups were more willing than others to accept HCV therapy, including those who were younger, those willing to attend an HCV-related educational activity and those with more knowledge about HCV. Patients who avoided treatment cited fear of adverse events associated with medication as the main reason.

“These new findings support the premise that addiction-treatment facilities can help provide sustained HCV treatment for this population. These facilities have the added advantage of being able to link HCV care to drug treatment, allowing for closer patient evaluation, which will likely lead to improved adherence to treatment regimens,” Talal said in a press release.

Importance of Education

Zeremski and colleagues concluded that most patients reported willingness to receive HCV-related education and treatment. She said she believes that willingness is tied to another data point from the study: 61% of the respondents had previously attended educational sessions on HCV. This type of knowledge base increases patient willingness to be further educated and treated, according to Zeremski, senior research associate in medicine at Weill Cornell Medical College and research assistant professor of medicine at University at Buffalo.

The START program has sponsored yearly educational sessions and, because of federal funding, more patients are arriving with some background knowledge about HCV.

“This fact was reflected in the high number of people who indicated that they had previously attended such sessions and the substantial knowledge that was detected in this cohort as indicated in the response to the knowledge questions,” Talal said. “Most of the people who answered the survey were aware of the fact that injection drug use is the primary route of HCV transmission, that there is treatment for the infection, and that spontaneous resolution of the infection or clearance upon treatment does not provide protection against future infections. The only question that was not answered correctly by most people was whether an HCV vaccination exists.”

The increasing knowledge base is reflective of a broader recognition of HCV, according to Zavala.

“HCV was not a target for federally funded programs until a few years ago,” he said. “HCV was flying under the radar for quite a while. When the money started coming in, it facilitated training of all different types. Physicians and patients have benefited from it.”

Accordingly, another component of the education program is ongoing education of medical staff to keep pace with the rapidly evolving world of DAA therapies. “What was new 6 months ago is no longer new today. So, our training is for clinicians as well as patients,” Zavala said.

Similar to many clinicians, Zavala predicts further changes to the treatment landscape by the end of 2014, and then possible more options in 2015.

Attempt to Dispel Myths

One major barrier to successful HCV treatment is misconception about the infection and its treatment, as noted by respondents of the aforementioned survey.

“When we started educating our patients and staff, we had to re-wire them to accept that interferon is old and that newer stuff is coming down the pipeline,” Zavala said.

Zeremski noted that many patients often believe that HCV treatment is worse than the infection itself.

“Most patients do not have any symptoms and therefore believe that HCV will not ‘harm’ them. On the other hand, many have heard about the bad side effects of interferon, while others have unsuccessfully undergone treatment in the past and are not willing to go through it again,” she said.

Andrew H Talal

Andrew H. Talal

Talal built on this point. “Many of the patients whom I have evaluated have been told previously that they did not need therapy because their liver enzymes were not elevated. While people with normal aminotransferase levels may progress more slowly, fibrosis still does progress in these individuals and they can eventually develop cirrhosis. This is one of the reasons why linkage to care for HCV-infected people is so important.”

A companion fear to the adverse effects of interferon is the worry that taking an HCV treatment by injection would lead to a relapse of heroin use. It is because of these persistent fears that the development of a broad spectrum of DAA therapies — along with widespread education — is so important, according to Talal.

“We need to get the word out about the improvements that have been made if we are going to be able to improve treatment outcomes,” he said. He said that most of these fears “will be obviated when interferon is fully eliminated from the HCV treatment spectrum.”

The age of populations with HCV is also a factor in dispelling myths. “Many of our patients are in the fifth or sixth decade of their lives and have had HCV for decades,” Zavala said. “They have been told a lot of things about their HCV over the years and we have to re-teach them.”

A Stabilizing Force

An important reason for the success of methadone programs lies in the stabilizing force that methadone represents.

“Patients do not have control over their heroin addiction. Methadone is stabilizing them,” Zeremski said. “Patients who are stabilized and linked to care are much more likely to enroll and adhere to HCV treatment.”

Marija Zeremski

Marija Zeremski

According to Talal, although methadone has more recently been identified as a drug of abuse, particularly among individuals who use it for pain control, its use in this context is as a treatment for opiate dependence. “Consequently, methadone is being used as the treatment for the patient’s dependence on heroin,” he said.

Methadone and methadone clinics are associated with improvement in HCV because patients are stabilized, linked to care and educated about their infection, Talal said. There are data to support this claim as well.

In one study, Anthony D. Martinez, MD, and colleagues aimed to improve the continuity of care and increase HCV treatment effectiveness in individuals from the methadone maintenance treatment program at Weill Cornell Medical Center. The program featured an internist/addiction medicine specialist who worked to integrate strategies at the methadone and hepatitis clinics.

According to results published in the Journal of Viral Hepatitis, anti-HCV antibodies were detected in 257 of 401 participants who underwent evaluation. Sixty-five antiviremic individuals were identified among 222 individuals who were assessed for HCV RNA, leaving 157 individuals with detectable HCV RNA. Of those, 125 were eligible for referral to the hepatitis clinic, 76 of whom accepted the referral and adhered to it. Men who engaged in the methadone maintenance treatment program for less than 36 months were significantly less likely to visit a hepatitis clinic compared with women or men who remained in the program for more than 36 months (OR=7.7; 95% CI, 2.6-22.9). In other findings, moderate to advanced liver disease was reported in 83% of 63 individuals evaluated for liver histology. Among 24 individuals who started therapy with pegylated interferon and ribavirin, 19 completed treatment and 13 demonstrated sustained virologic response.

“Integrated care between the [methadone maintenance treatment program] and the hepatitis clinic improves adherence with HCV evaluation and treatment compared to standard referral practices,” Martinez and colleagues concluded.

Adherence to methadone is typically not an issue, Zeremski told HCV Next. “Adherence to HCV medications could be affected by frequent use of illicit drugs. Patients who are well stabilized on methadone, especially those who are attending methadone treatment programs for prolonged period of time, are more likely to adhere to HCV treatment,” she said.

Previous research by Zeremski and colleagues demonstrated that men who attended a methadone maintenance treatment program for more than 36 months were more likely to visit a liver clinic for HCV evaluation vs. men who attended a program for less than 36 months.

Furthermore, Rositsa B. Dimova, MD, and colleagues conducted a meta-analysis of studies of pegylated interferon and ribavirin combination therapy administered to injection drug users. Among 36 studies comprising 2,866 patients, treatment of addiction during HCV therapy resulted in higher treatment completion, and the rate of SVR was positively correlated with involvement of a multidisciplinary team (P<.0001), according to data published in Clinical Infectious Diseases.

Extended Benefits

The benefits of methadone clinics go far beyond the individual, according to Zavala.

“Treating injection drug users with methadone gives them the freedom to think of other aspects of their lives. Once they are able to do that, the education and information we are providing for them comes into play,” he said. “That is how we have been successful in educating, screening and treating our patients.”

Rates of both HCV and HIV are improved when there are fewer people sharing needles and injecting drugs, Zavala said. Also, “study after study has shown that methadone has been very cost effective compared to other drugs.”

Although programs such as START, which offer methadone as a treatment for heroin addiction, and those that specialize in the more recently approved medication buprenorphine are still finding their footing nationwide, experts said they believe that the benefits will be far-reaching.

“We anticipate all patients who deserve to be treated will be treated for both their addiction and their HCV infection,” Zavala said. – by Rob Volansky

Sidebar: Novel HCV Regimens Provide Hope for Managing Opiate Addiction

References:
Dimova RB. Clin Infec Dis. 2013;56:806-816.
Martinez AD. J Viral Hep. 2012;19:47-54.
Zeremski M. J Addic Med. 2014;4:249-257.

For more information:
Andrew H. Talal, MD, MPH, can be reached at the University at Buffalo, State University of New York, 875 Ellicot St., Suite 6090, Buffalo, NY 10065; email: ahtalal@buffalo.edu.
Roberto Zavala, MD, can be reached at 22 Chapel St., Brooklyn, NY 11201; email: rzavala@startny.com.
Marija Zeremski, MD, can be reached at 1300 York Ave., Room F231, Mail Box 319; New York, NY 10065; email: maz2003@med.cornell.edu.

Disclosures: Zavala and Zeremski report no relevant financial disclosures. Talal reports associations with Abbott, AbbVie, Chronic Liver Disease Foundation, Gilead, Pfizer and Tibotec.

Methadone clinics are emerging as an important setting for the education and treatment of patients with hepatitis C virus infection. Programs such as the START Treatment and Recovery Centers in New York City are leading the way in providing a venue for individuals not only to kick their addiction to opiates, but also to receive screening for HCV, learn about disease prevention measures and stay on course with treatment.

Cover Feature 

“Providing methadone under close supervision allows us to provide educational and vocational services,” Roberto Zavala, MD, continuous quality improvement manager and researcher at the START Treatment and Recovery Center, said in an interview. “The methadone clinic model was successful with HIV, and now we are applying many of those same strategies to HCV.”

HCV intervention programs based in methadone clinics are still in the early stages, according to Zavala. Stigma and misinformation surrounding HCV continue to pose challenges in getting patients tested, and the advent of novel direct-acting antiviral therapies has resulted in a need for training clinicians and patients in treatment schedules and the diminution in adverse events as a consequence of elimination of interferon. There also are technological hurdles to clear, such as how to bring specialty care to the drug treatment facility. One potential answer to this dilemma is the use of telemedicine — technology that permits patient interaction with an HCV specialist in a remote location.

HCV Next Editorial Board member Andrew H. Talal, MD, MPH, said HCV diagnosis at a methadone clinic may be a “teachable moment” that clinicians can use as a jumping-off point to encourage patients to make healthier choices.

“Long-term stability on methadone may enable persons who inject drugs to stabilize their lives, thereby increasing the likelihood that they will be adherent to HCV medications,” said Talal, professor of medicine in the division of gastroenterology, hepatology and nutrition at University at Buffalo, State University of New York, and adjunct associate professor of medicine at Weill Cornell Medical College.

A STARTing Point

Methadone programs such as the START Treatment and Recovery Center may play a big role in the future of HCV treatment, Zavala told HCV Next.

The program is set up to “provide primary care onsite that can be supplemented for diseases that require specialty care such as HCV through the use of telemedicine. This has been a major advance for us that helps keep patients compliant with referrals and on track with their treatments. Many of our patients come to the clinic on a daily basis, where they can receive assessment, evaluation and treatment in a familiar setting, with medical personnel they know. They leave satisfied with this one-stop shop,” he said.

Recent data support the effectiveness of programs such as START.

Marija Zeremski, PhD, along with Talal, Zavala and other colleagues, created a 30-item survey about HCV knowledge that was completed by 320 patients on methadone maintenance in the START program. The survey is part of the Prevention, Evaluation and Treatment of HCV in Opiate Agonist Treatment Settings (PET-C) study, which is being conducted in collaboration with researchers at University at Buffalo, Weill Cornell Medical College, START and the CDC. The results were published in the Journal of Addiction Medicine.

The survey respondents had been receiving methadone maintenance for an average of 7 years. The mean age of respondents was 53 years, 60% were men, 55% were black and 40% were Hispanic.

Nearly 7% of respondents reported using injection drugs in the preceding 6 months, and 37.3% had used non-injection drugs. Half (46.3%) self-reported HCV seropositivity. Seventy-eight percent of respondents expressed willingness to participate in HCV education and treatment programs.

More than half (54.7%) of the respondents correctly answers five or more of seven questions about HCV, demonstrating a good fund of knowledge of the infection. As the researchers expected, those with HCV or those who had received prior education about the infection were more likely to demonstrate increased knowledge about HCV.

Some groups were more willing than others to accept HCV therapy, including those who were younger, those willing to attend an HCV-related educational activity and those with more knowledge about HCV. Patients who avoided treatment cited fear of adverse events associated with medication as the main reason.

“These new findings support the premise that addiction-treatment facilities can help provide sustained HCV treatment for this population. These facilities have the added advantage of being able to link HCV care to drug treatment, allowing for closer patient evaluation, which will likely lead to improved adherence to treatment regimens,” Talal said in a press release.

PAGE BREAK

Importance of Education

Zeremski and colleagues concluded that most patients reported willingness to receive HCV-related education and treatment. She said she believes that willingness is tied to another data point from the study: 61% of the respondents had previously attended educational sessions on HCV. This type of knowledge base increases patient willingness to be further educated and treated, according to Zeremski, senior research associate in medicine at Weill Cornell Medical College and research assistant professor of medicine at University at Buffalo.

The START program has sponsored yearly educational sessions and, because of federal funding, more patients are arriving with some background knowledge about HCV.

“This fact was reflected in the high number of people who indicated that they had previously attended such sessions and the substantial knowledge that was detected in this cohort as indicated in the response to the knowledge questions,” Talal said. “Most of the people who answered the survey were aware of the fact that injection drug use is the primary route of HCV transmission, that there is treatment for the infection, and that spontaneous resolution of the infection or clearance upon treatment does not provide protection against future infections. The only question that was not answered correctly by most people was whether an HCV vaccination exists.”

The increasing knowledge base is reflective of a broader recognition of HCV, according to Zavala.

“HCV was not a target for federally funded programs until a few years ago,” he said. “HCV was flying under the radar for quite a while. When the money started coming in, it facilitated training of all different types. Physicians and patients have benefited from it.”

Accordingly, another component of the education program is ongoing education of medical staff to keep pace with the rapidly evolving world of DAA therapies. “What was new 6 months ago is no longer new today. So, our training is for clinicians as well as patients,” Zavala said.

Similar to many clinicians, Zavala predicts further changes to the treatment landscape by the end of 2014, and then possible more options in 2015.

Attempt to Dispel Myths

One major barrier to successful HCV treatment is misconception about the infection and its treatment, as noted by respondents of the aforementioned survey.

“When we started educating our patients and staff, we had to re-wire them to accept that interferon is old and that newer stuff is coming down the pipeline,” Zavala said.

Zeremski noted that many patients often believe that HCV treatment is worse than the infection itself.

“Most patients do not have any symptoms and therefore believe that HCV will not ‘harm’ them. On the other hand, many have heard about the bad side effects of interferon, while others have unsuccessfully undergone treatment in the past and are not willing to go through it again,” she said.

Andrew H Talal

Andrew H. Talal

Talal built on this point. “Many of the patients whom I have evaluated have been told previously that they did not need therapy because their liver enzymes were not elevated. While people with normal aminotransferase levels may progress more slowly, fibrosis still does progress in these individuals and they can eventually develop cirrhosis. This is one of the reasons why linkage to care for HCV-infected people is so important.”

A companion fear to the adverse effects of interferon is the worry that taking an HCV treatment by injection would lead to a relapse of heroin use. It is because of these persistent fears that the development of a broad spectrum of DAA therapies — along with widespread education — is so important, according to Talal.

“We need to get the word out about the improvements that have been made if we are going to be able to improve treatment outcomes,” he said. He said that most of these fears “will be obviated when interferon is fully eliminated from the HCV treatment spectrum.”

The age of populations with HCV is also a factor in dispelling myths. “Many of our patients are in the fifth or sixth decade of their lives and have had HCV for decades,” Zavala said. “They have been told a lot of things about their HCV over the years and we have to re-teach them.”

PAGE BREAK

A Stabilizing Force

An important reason for the success of methadone programs lies in the stabilizing force that methadone represents.

“Patients do not have control over their heroin addiction. Methadone is stabilizing them,” Zeremski said. “Patients who are stabilized and linked to care are much more likely to enroll and adhere to HCV treatment.”

Marija Zeremski

Marija Zeremski

According to Talal, although methadone has more recently been identified as a drug of abuse, particularly among individuals who use it for pain control, its use in this context is as a treatment for opiate dependence. “Consequently, methadone is being used as the treatment for the patient’s dependence on heroin,” he said.

Methadone and methadone clinics are associated with improvement in HCV because patients are stabilized, linked to care and educated about their infection, Talal said. There are data to support this claim as well.

In one study, Anthony D. Martinez, MD, and colleagues aimed to improve the continuity of care and increase HCV treatment effectiveness in individuals from the methadone maintenance treatment program at Weill Cornell Medical Center. The program featured an internist/addiction medicine specialist who worked to integrate strategies at the methadone and hepatitis clinics.

According to results published in the Journal of Viral Hepatitis, anti-HCV antibodies were detected in 257 of 401 participants who underwent evaluation. Sixty-five antiviremic individuals were identified among 222 individuals who were assessed for HCV RNA, leaving 157 individuals with detectable HCV RNA. Of those, 125 were eligible for referral to the hepatitis clinic, 76 of whom accepted the referral and adhered to it. Men who engaged in the methadone maintenance treatment program for less than 36 months were significantly less likely to visit a hepatitis clinic compared with women or men who remained in the program for more than 36 months (OR=7.7; 95% CI, 2.6-22.9). In other findings, moderate to advanced liver disease was reported in 83% of 63 individuals evaluated for liver histology. Among 24 individuals who started therapy with pegylated interferon and ribavirin, 19 completed treatment and 13 demonstrated sustained virologic response.

“Integrated care between the [methadone maintenance treatment program] and the hepatitis clinic improves adherence with HCV evaluation and treatment compared to standard referral practices,” Martinez and colleagues concluded.

Adherence to methadone is typically not an issue, Zeremski told HCV Next. “Adherence to HCV medications could be affected by frequent use of illicit drugs. Patients who are well stabilized on methadone, especially those who are attending methadone treatment programs for prolonged period of time, are more likely to adhere to HCV treatment,” she said.

Previous research by Zeremski and colleagues demonstrated that men who attended a methadone maintenance treatment program for more than 36 months were more likely to visit a liver clinic for HCV evaluation vs. men who attended a program for less than 36 months.

Furthermore, Rositsa B. Dimova, MD, and colleagues conducted a meta-analysis of studies of pegylated interferon and ribavirin combination therapy administered to injection drug users. Among 36 studies comprising 2,866 patients, treatment of addiction during HCV therapy resulted in higher treatment completion, and the rate of SVR was positively correlated with involvement of a multidisciplinary team (P<.0001), according to data published in Clinical Infectious Diseases.

PAGE BREAK

Extended Benefits

The benefits of methadone clinics go far beyond the individual, according to Zavala.

“Treating injection drug users with methadone gives them the freedom to think of other aspects of their lives. Once they are able to do that, the education and information we are providing for them comes into play,” he said. “That is how we have been successful in educating, screening and treating our patients.”

Rates of both HCV and HIV are improved when there are fewer people sharing needles and injecting drugs, Zavala said. Also, “study after study has shown that methadone has been very cost effective compared to other drugs.”

Although programs such as START, which offer methadone as a treatment for heroin addiction, and those that specialize in the more recently approved medication buprenorphine are still finding their footing nationwide, experts said they believe that the benefits will be far-reaching.

“We anticipate all patients who deserve to be treated will be treated for both their addiction and their HCV infection,” Zavala said. – by Rob Volansky

Sidebar: Novel HCV Regimens Provide Hope for Managing Opiate Addiction

References:
Dimova RB. Clin Infec Dis. 2013;56:806-816.
Martinez AD. J Viral Hep. 2012;19:47-54.
Zeremski M. J Addic Med. 2014;4:249-257.

For more information:
Andrew H. Talal, MD, MPH, can be reached at the University at Buffalo, State University of New York, 875 Ellicot St., Suite 6090, Buffalo, NY 10065; email: ahtalal@buffalo.edu.
Roberto Zavala, MD, can be reached at 22 Chapel St., Brooklyn, NY 11201; email: rzavala@startny.com.
Marija Zeremski, MD, can be reached at 1300 York Ave., Room F231, Mail Box 319; New York, NY 10065; email: maz2003@med.cornell.edu.

Disclosures: Zavala and Zeremski report no relevant financial disclosures. Talal reports associations with Abbott, AbbVie, Chronic Liver Disease Foundation, Gilead, Pfizer and Tibotec.

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