Medication-assisted Treatment of Opioid Addiction Reduces Incidence of Hep C

AAAHEP C

We already know that medication-assisted treatment of opioid addiction reduces the incidence of HIV. Indeed, people in active opioid addiction contract HIV six times more often than patients on medication-assisted treatment (Metzger et al, 1993). But previous studies haven’t shown clear reduction in the transmission of Hep C.

Until now.

This new study does show a reduction in the incidence of Hepatitis C in opioid addicts who enter medication assisted treatment.

This prospective observational study by Tsai et al of 552 opioid addicts was done in San Francisco from 2000 to 2013. All subjects tested negative for Hep C in order to enter the study, and all were under thirty years old. These addicts enrolled in various forms of treatment: opioid agonist detoxification with methadone or buprenorphine, opioid agonist maintenance treatment with either methadone or buprenorphine, or non-opioid agonist forms of treatment. Some of the group elected not to get any form of treatment. Follow up testing for Hep C was done quarterly.

One-hundred and seventy-one study subjects tested positive for Hep C as the study progressed, giving an incidence rate of 25% per 100 patient-years. However, the study subjects who entered opioid agonist maintenance treatment were significantly less likely to become Hep C positive as compared to the addicts who got non-opioid agonist treatment or opioid agonist detox treatment. Addicts who enrolled in opioid-agonist maintenance treatment had a 60% reduction in the incidence of Hep C compared to the other study groups, which was statistically significant.

The patients on opioid agonist maintenance therapy had an incidence of 8.6 new cases of Hep C during 100 person-years of the study, while the group of subjects who entered non- opioid agonist forms of treatment, which included 12-step recovery and other abstinence-based forms of treatment, had an incidence of 17.8 over 100 person-years. People who didn’t get any treatment had an incidence of 28.2 per 100 person-years, while opioid addicts who underwent detox only had the highest Hep C conversion rate of 41% per 100 person-years.

As alarming and confusing as this last bit was, the data didn’t reach statistical significance, so we shouldn’t draw any conclusions about that bit.

Other studies have suggested a lower rate of Hep C transmission in opioid addicts who enter medication-assisted treatment, but none showed this as definitely as did this study.

Several things stood out to me as I read the study – first, these were young people. The average age was 23, and the study purposely excluded addicts over age 30. Maybe younger age means less time of exposure to Hep C. Older populations may already have Hep C.

This study looked at opioid addicts who sound like they are sicker than addicts I admit to treatment. For example, a whopping 69% were homeless. Do the homeless re-use needles at a higher rate? I don’t know, but perhaps homeless people have fewer resources to get clean needles, and could be at higher risk for Hep C than the rural inhabitants I treat.

The most common drug of use was heroin, used by 60% of the study population. While heroin has just started to invade my rural area, most of my new patients use opioid pain pills. It seems possible that intravenous heroin users have progressed further into addiction than pain pill users.

Even if the subjects in this study aren’t exactly the same as patients I see, this is good evidence that medication-assisted treatment reduces the risk of Hep C. It’s not the best reason for entering MAT; not dying from an opioid overdose is the best reason. But still, reducing the risk of Hep C is a good thing.

A 1980’s Flashback

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Brownish-purple bumps covered the face and torso of the patient lying in the hospital bed, and I watched as tears puddled just above a particularly prominent nodule. Then I looked at his partner, a fit young man, who had turned his face and body away from the patient. With his head propped against the wall, I could see his shoulders shaking with sobs. With a detached and distant part of my brain, I wondered if he was crying for his sick partner, or if he was crying because he had a vision of what likely lay ahead for him as well.

I didn’t know what to say. I had just informed the patient, my patient for only three days, that he tested positive for HIV. The nodules all over his body were Kaposi’s sarcoma. I knew he already suspected all of this, but now we knew for sure. Not for the first time, I thought about how ill-equipped I was at dealing with the aftermath of giving bad news. I yearned for a nurse or social worker who could come spout words of comfort to this young man and his partner.

But there were no words of comfort. In 1988, I was in my second year of my Internal Medicine residency, and the only anti-retroviral we had was AZT, zidovudine. The virus mutates quickly, so resistance developed to our only treatment. We could treat opportunistic infections as they emerged, and even give antibiotic prophylaxis to stave off some of the infections like pneumocystis, but every patient I treated progressed towards physical debilitation and death.

Patients in the late 1980’s often came to medical attention as a result of one of the many devastating infectious diseases seen with immunosuppression. If they were poor or had no established physician, they were assigned to the Staff Medicine services and we residents took care of them, under the supervision of our attending physicians. New AIDS cases were diagnosed every week by the resident physicians at Charlotte Memorial Hospital and accounted for a full fourth of our patient case load.

At morning report, where we discussed our new admissions , Cryptococci meningitis, pneumocystis carinii pneumonia, toxoplasmosis, and other opportunistic infectious diseases seen only in patients with severely compromised immune systems were as common as uncontrolled diabetes mellitus and COPD exacerbations. At morning report, it was… ho-hum… just another case of progressive multifocal leukoencephalopathy.

But then in the early 1990’s, scientists developed HAART, an abbreviation for highly-active anti-retroviral therapy. Suddenly HIV became more of a chronic disease. Though it still causes significant illness and suffering, it’s no longer the inevitable death sentence it was in the 1980’s.

My current patient had the worst case of Kaposi’s sarcoma that I had ever seen, and I’d already seen more cases in two years as a resident physician than prior generations of doctors saw in a lifetime.

My generation of physicians trained at an unusual time in history. We saw strange and exotic diseases from immunosuppressed HIV patients that hopefully no generation will see in the future, and half of those new cases were diagnosed in IV drug addicts, mostly addicted to opioids.

How is it, then, that IV opioid addicts were not given appropriate treatment?

I still plead ignorance. I didn’t know any better. I took my cue from my teachers and mentors, who communicated verbally and nonverbally that addicts weren’t sick, but “bad” people, even weak people who would not stop doing something that put them at risk for dying from AIDS, a dreadful disease caused by HIV.

I still marvel at the mismanagement of my drug-addicted patients back then. About half of the new HIV diagnoses were made in IV drug abusers, yet I don’t recall ever hearing of needle exchange programs or methadone maintenance, though there was a methadone maintenance program in Charlotte at that time.

We should have been calling to arrange intakes at that methadone maintenance program before our opioid-addicted patients even left the hospital. If they didn’t have HIV, getting them into medication-assisted treatment could have been life-saving from several points of view. Not only would they be less likely to overdose and die, but they would be three times less likely to contract HIV.

I lament all of those wasted opportunities and every patient who didn’t get the care she should have had.

Now, let’s at learn from the past, and not repeat mistakes in this generation.

At present, we’re quibbling about increasing access to medication-assisted, office-based treatment with buprenorphine, out of fear these patients won’t get appropriate counseling. Even AATOD wants to wait until precautions can be put in place to assure office-based programs will provide good counseling, which is an essential part of treatment.

It’s a legitimate concern, but perhaps not the most pressing issue of the opioid addiction epidemic when people are dying from overdoses and being put at risk for Hep C and HIV.

It’s a little like worrying about how badly your house needs painting while part of it is on fire.

Alcohol and Opioids (and Benzos) Don’t Mix!

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The Centers for Disease Control and Prevention (CDC) released a report in October of 2014 that analyzed data regarding the contribution of alcohol in opioid overdose deaths and in emergency department visits for opioid misuse. They also looked to see if alcohol was present in benzodiazepine overdose deaths, and emergency department visits related to benzodiazepine misuse. This information was gathered in 2010 by the Drug Abuse Warning System, (DAWN). [1]

The report found that alcohol was a contributing factor in at least twenty percent of the opioid overdose deaths. When they looked at emergency department visits for opioid misuse complications, alcohol was present in about eighteen percent of patients.

In other words, alcohol is a contributing factor in one-fifth of serious opioid overdoses deaths and near-overdoses.

The data was similar for alcohol combined with benzodiazepines; twenty percent of benzodiazepine-related deaths had alcohol present in the decedent’s body as a contributing factor. For emergency department visits related to benzodiazepine use, alcohol was present in over a fourth of these patients.

I don’t find this data to be surprising. If anything, I’d expect a higher percentage of decedents to have alcohol as a contributing factor to both opioid and benzodiazepine overdose deaths. Alcohol and benzos both act on the same type of brain receptors, and have the same sedative effect on the brain. They both also act of the portion of the brain that tells us to breathe while we are asleep. Since opioids have the same effect, particularly at higher doses, any combination of these three substances can result in death. The person goes to sleep, stops breathing, and dies.

Other bits of data in this report were interesting. For example, more men than women had alcohol as a contributing factor in opioid-related and benzodiazepine-related emergency department visits. That’s not a surprising finding, since men have a higher rate of binge-drinking than women.

In this study, older people were more likely to have used alcohol along with their opioid than younger people. Overdoses in people aged 40 to 59 had alcohol in around one-fourth of the deaths.

The study found people who used hydrocodone were more likely to consume alcohol. That’s an interesting finding. Maybe opioid addicts who have hydrocodone available, as compared to stronger opioids like oxycodone, tend to supplement with alcohol in order to boost the effect of the opioid. That’s merely conjecture on my part, but it’s based on conversations with opioid-addicted patients over the last ten years. Opioid-addicted patients will use anything to ease opioid withdrawal symptoms: alcohol, benzos, even cocaine or methamphetamine

For people who overdosed on benzodiazepines, twenty-eight percent were over age 60. There’s another good reason to avoid or reduce benzodiazepines in people over sixty.

I think this data shows we need to do a better job of educating patients not only of the danger of benzodiazepines and opioids mixed together, but that alcohol can be just as deadly with either benzodiazepines or opioids.

I really worry about my patients who drink alcohol while being prescribed either methadone or buprenorphine (Suboxone). Too many of my patients are cavalier about mixing alcohol with other drugs and medications. Many of them say they don’t see alcohol as a real problem, because they’ve been able to start and stop alcohol, unlike opioids. They say alcohol is legal, so what’s all the fuss? They say they don’t drink any more than their friends. Everybody drinks, don’t they?

No, they don’t. About thirty percent of the U.S. population doesn’t drink alcohol at all. Only fifty-six percent have had an alcoholic drink over the past month, which means nearly half of the people in this country haven’t had any alcohol over the last month.

One of my patients told me it was his right as an American to drink alcohol, and was angry at me when I told him of the dangers of mixing alcohol with methadone. I told him I didn’t know if drinking was a right or not; I was only telling him about how alcohol and drugs affect the body.

Sometimes I ask patients what they think about the warning label on their pill bottle that says, “Do not take with alcohol.” Some patients say they don’t believe warning labels because they’ve had alcohol with buprenorphine or other opioids before, and nothing bad happened. Some say they think the warning labels are put on all medicine bottles to protect the pharmacy from being sued.

Just because something has never happened before doesn’t mean it can’t or won’t happen in the future. Many factors can influence overdose risk, and it’s dangerous to assume an overdose can’t happen because it hasn’t happened before.

1. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6340a1.htm

Just for Fun

Holiday 2014

I’d like to wish all my readers a Happy Thanksgiving, whether you are in the U.S. or in another country.

To celebrate at my opioid treatment program, we all decided to dress up as either Pilgrims or Native Americans. You can see from the picture above that no one actually came as a Pilgrim (although a few said they were dressed as descendants of Pilgrims). I guess everyone had clothing more suitable to be a Native American.

I participated a little reluctantly, but I’m glad I did. This is a fun group of people that I work with. To a person, they are dedicated to helping their patients recovery from addiction and achieve their goals. They are passionate about their work, and even though they come from very different backgrounds, work together well as a team. I am honored and blessed to be able to work with them.

I am so thankful for my co-workers and the wonderful patients that we serve.

I’ve said it before…I have the best job in the world.

Buprenorphine and the Liver

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When buprenorphine was approved for office-based treatment of opioid addiction in the U.S, doctors worried about possible liver toxicity. We’d seen case reports of acute liver necrosis (death of liver tissue) in patients with Hepatitis C who injected buprenorphine illicitly. So was this damage due to the drug itself, from intravenous use of the sublingual product, or from buprenorphine interaction with Hepatitis C? Until we had more information, experts recommended checking liver function tests before starting buprenorphine and periodically during treatment to monitor for liver damage.

Fortunately, further studies show no liver damage in patients prescribed buprenorphine.

In 2012, Saxon et al followed over 700 patients on buprenorphine or methadone over 24 weeks, and checked their liver function tests periodically, looking for elevations that would indicate liver inflammation or damage. Neither patients on methadone or patients on buprenorphine had significant increase in their liver function test levels, leading the study’s authors to conclude that neither methadone or buprenorphine cause liver damage. Patients with Hep C who were in this study did have elevated liver enzymes, but did not get worse over the twenty-four months while taking either medication.

In the November/December, 2014, issue of American Journal on Addictions, a new study by Soyka et. al. found the same thing. This study looked at 181 patients on buprenorphine/naloxone and followed their liver enzymes for over a year. Thirty-six percent of these patients had Hepatitis C, a group who may be at increased risk for liver damage due to drugs and medications. Liver tests were done at baseline, then at 12 and 24 weeks, and at the end of the first year at 52 weeks. One to two percent of these patients showed mild elevation of liver tests but none had evidence of drug induced liver injury.

This latest study adds to the medical literature that shows buprenorphine isn’t damaging to the liver, even in patients with Hepatitis C, in patients who take the medication as intended. (For obvious reasons, no one would ever do a study asking patients to inject the sublingual form of buprenorphine, since the medication isn’t sterile and the study would put test subjects at risk for all sorts of complications.)

So do we still need to check liver function tests for patients on buprenorphine? Most of the published guidelines about how to prescribe buprenorphine in an office setting still recommend checking liver function tests, but this data from Saxon study and the Soyka study seem to indicate this isn’t a particularly helpful thing to do.

About half of my buprenorphine patients have no insurance. After reading these studies, I’ve decided not to ask my patients to get routine liver function tests. I still think they need screening for Hepatitis C. Some doctors would say liver function tests can suggest Hep C if they are elevated, but since it’s possible to have Hep C and normal liver function tests, I think their money would be better spent on Hep C testing. Patients who test positive would then need to get further testing, which would likely include liver function tests, as well as confirmatory testing for Hep C.

Let’s use new information to spend health care dollars wisely.

ABAM EXAM

asam

I’ve neglected my blog lately, because I’ve been doing extra reading, preparing for my American Board of Addiction Medicine (ABAM) re-certification exam. I took the exam yesterday, so now I’ll have more time.

I took (and passed) this test for the first time in 2004. Doctors who wish to remain certified in Addiction Medicine need to take the test (and pass it) every ten years. We also have to demonstrate commitment to lifelong learning by doing a certain number of continuing education hours each year, and a few other things.

This exam used to be administered by the American Society of Addiction Medicine (ASAM). The first time I took the exam in 2004, ASAM sponsored the testing. But in order to get recognition from the American Board of Medical Specialties, a separate entity had to be created, and ABAM was born in 2007. ABAM’s purpose is to establish standards for physician education in the field, to assess competency of the physicians it certifies, and to track life-long learning of these physicians.

I didn’t mind studying for the exam, because I find the material to be so interesting. Our main textbook is “Principles of Addiction Medicine,” and at over 1700 pages, it’s a long read. There’s also a great review course, sponsored once every other year by ASAM, called “ASAM’s Review Couse of Addiction Medicine.” I couldn’t go to the meeting in Orlando, Florida, but I listened to the whole thing on ASAM’s e-learning site. On that, I could listen to each of the over 20 hours of information over and over again if I desired. The lecturers were fantastic, and among the top in the field. Even though it’s supposed to be a review I always learn new things.

It was a fair exam. I won’t know if I passed until February of 2015, but I’m feeling confident.

If you want to know if your physician has been trained in Addiction Medicine, ask her if she is a member of ASAM, or is certified by ABAM. Doctors don’t have to be certified to be good, but if you want to know for sure that your doctor is well-educated, ask about that certification, or the equivalent in the psychiatric field, the American Association of Addiction Psychiatry.

Office-based Treatment of Opioid Addiction

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When DATA 2000 was passed, the office-based treatment it created was envisioned
as another option for opioid-addicted people. There was, and still is, a large gap between the numbers of people in the U.S. who need medication-assisted treatment for opioid addiction, and the number of treatment slots available at traditional opioid treatment programs. DATA 2000, it was hoped, would create treatment slots to shrink that gap.

DATA 2000 succeeded in making medication-assisted treatment more available, but there are still too many opioid addicts dying from their addiction.

Just like with other chronic diseases, opioid addiction exists on a continuum. Some opioid addicts get to treatment only after they’ve lost everything, have serious co-occurring mental health issues, and have few emotional supports. Others are able to reach for help earlier in the course of addiction, have no co-occurring mental health issues, and a supportive network of friends and family. One opioid-addicted patient will need more intensive treatment than another, just like some patients with diabetes are so ill that they need hospitalization. Other diabetics manage fine with outpatient doctor visits every three months. One form of treatment doesn’t fit all patients.

The American Society of Addiction Medicine (ASAM) created the Patient Placement Criteria over twenty years ago. This textbook, just revised again late last year, is widely used to determine the appropriate level of care for a patient with addiction. The Patient Placement Criteria describes the levels of care needed for addiction treatment. ASAM says there are six dimensions doctors should look at before deciding what intensity of care the patient needs:
Dimension 1 – Acute Intoxication and/or withdrawal potential
Dimension 2 – Biomedical conditions and complications
Dimension 3 – Emotional/behavioral/cognitive conditions and complications
Dimension 4 – Readiness to change
Dimension 5 – Relapse/continued use/continued problem use
Dimension 6 – Recovery environment

Depending on the severity in these six dimensions, the appropriate level of treatment can be recommended. This can be anything from an early intervention service to intensive outpatient treatment to inpatient hospital care. The length of treatment at each level of care is based on the patient’s severity of illness, with frequent re-evaluations of the patient’s status as it changes. This is a more objective and scientific way to treat addiction, as opposed to treating all patients with addiction with inpatient treatment for twenty-eight days.

Prescribers of medication-assisted treatments for opioid addiction should use the ASAM criteria when deciding which level of care is most appropriate. Ideally, MAT could be provided at any level of care, though in real life, many abstinence-based programs won’t admit patients on methadone or buprenorphine. In real life, at least in my neck of the woods, MAT is provided at opioid treatment programs, which follow more stringent federal, state, and local regulations, and at office-based programs, with few regulations.

I think it makes good sense to save office-based treatment for the most stable patients on MAT. Opioid-addicted patients with a higher severity of illness should be treated at an opioid treatment program, at least initially, due to the added accountability built into the system at an OTP. The patient can be re-evaluated periodically, and if the patient is doing well on buprenorphine, could be encouraged to transition to an office-based program.

That’s what we do at one of the opioid treatment programs where I’m medical director. I have patients in three types of treatment: in the OTP on both methadone and buprenorphine, and then office-based patients on buprenorphine. Having an office-based option for buprenorphine patients encourages then to meet treatment goals of stability in order to transition to a less restrictive treatment setting. Sadly, there is no office-based option for patients on methadone, due to the increased risk of the medication.

Patients can move seamlessly from one treatment to another as needed. If an office-based patient suffers a bad and continuing relapse, I can move him back to the opioid treatment program arm, where he can be seen and dosed every day until stability is regained. With this model, the intensity of treatment is determined by patients need.

In an ideal world, providers at both opioid treatment programs and office-based programs would work together in a cooperative rather than adversarial manner. This would benefit the patients and the treatment programs.

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