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Assistant Professor of Medicine
Division of Addiction Medicine
Department of Internal Medicine and Geriatrics
Oregon Health and Sciences University
Assistant Professor of Medicine
Medical Director, Hepatitis C Services Central City Concern
Central City Concern, OHSU Inpatient Addiction Medicine
Andrew Seaman, MD, has disclosed that he has received funds for research support from Gilead Sciences.
The Transformative Potential of HCV Treatment for People Who Use Drugs
People who inject drugs are disproportionately affected by HCV, including in the United States, where approximately three quarters of acute HCV infections are linked to injection drug use. Prevalence of HCV varies geographically. In my home state of Oregon, 1.6% of the adult population is HCV RNA positive, one of the highest prevalence rates across the country.
In our clinic, which provides healthcare for the homeless in Portland, Oregon, approximately 35% of people using the service have HCV. Of those who inject drugs, at least 35% to 40% were HCV viremic on entering the clinic. Homeless people struggle to engage in specialty care and often encounter many barriers to care in specialty settings. It is very challenging to make appointments when you are homeless or need to hustle to navigate the chaos of addiction, often just to avoid withdrawal. Those who do make it to an appointment often report feeling stigmatized, and some of that stigma may come from providers and from state institutions. When we started treating HCV in our program in 2015-2016, people who use drugs had to be abstinent for 6 months before they would be considered for treatment. Although restrictions to treatment were gradually removed, we continued to find that providers with an addiction management background were still not screening for HCV or HIV, and people self-identifying as living with these diseases were rarely referred for treatment. Even if people met the criteria for treatment, there was still a perception that prescribing treatment was too complicated or somehow not within the scope of practice of an addiction medicine provider. Now, there are no Medicaid restrictions on access to HCV therapy, but the persistence of stigma remains a real barrier to treatment for many people who use drugs.
What are the misconceptions that lay behind this reluctance to treat? The data suggest that active drug use has very little to no meaningful effect on cure rates for HCV treatment. In studies that have observed differences in SVR12 rates for people who use drugs, the literature suggests that these differences are more attributable to a lack of follow-up for evidence of SVR12 than real differences in treatment outcomes. For someone who is actively injecting drugs, may not have access to treatment for addiction, may not be fully engaged in care, or may have no income, the opportunity cost of missing a day of hustle or work to come in for a laboratory test is disproportionately higher than someone not living with addiction, particularly when that person has already been told they have a 98% chance of being cured. Not surprising, people commonly do not return for their SVR12 visit and so are counted as nonresponders under an intention-to-treat analysis of clinical trials. This is a major contributor to the difference in cure rates between an 88% to 90% cure rate in people who are using drugs and 95% to 96% in people who are not using drugs. In our clinical experience in Portland, we have had 3 HCV treatment failures out of the 600 or so people whom we have treated, who are often homeless, actively using drugs, and may or may not be engaged in treatment for their substance use disorder. Our experience is that it is very possible to treat this population.
Far from being complicated, HCV treatment has become progressively easier to treat over recent years. HCV management guidelines now recommend 2 therapies that can be used in treatment-naive people regardless of their cirrhotic serostatus: either glecaprevir/pibrentasvir for 8 weeks or sofosbuvir/velpatasvir for 12 weeks. Providers no longer have to wade through a complex morass of fibrosis scores to determine what to treat people with. There are limited exclusions to this simple approach to prescribing, such as decompensated cirrhosis, HIV or HBV coinfection, prior treatment experience, or pregnancy, but these are easily assessed. The treatment course is short, with limited need for follow-up, and people do really well. In almost every case, if you are an addiction medicine provider and you have a clinical degree, you can treat HCV.
Another important point to be made regarding best practices in providing care for patients with opioid use disorder relates to the critical role of naloxone for preventing overdose deaths. In addition to demonstrating that HCV treatment is feasible and effective among people with ongoing injection drug use, recent data from the ANCHOR study also found high rates of personal and witnessed overdose among people who inject drugs who were receiving HCV therapy. It is important that all prescriptions for HCV treatment in this group be supported by a prescription for naloxone and education on its use.
The “Nonmedical Benefits” of HCV Cure
A recent qualitative study from our clinic found that people who use drugs commonly engage in harm reduction activities after receiving HCV treatment. People rarely acquire HCV because they wanted to become intoxicated and risk their health; they get HCV because they are “dopesick” or because they are in a destabilized relapse pattern, and both of those are associated with severe shame. The presence of HCV in people’s bodies can feel like an endogenous reminder of past decisions for which they feel shame. So, curing people of HCV can feel like a step in the direction away from their addiction and the weight of societal shame associated with their past choices. It is often a profound transformational process for people. It is also an engagement tool for addiction treatment. If you prescribe HCV treatment to a person who uses drugs, he or she may be more likely to be more engaged in addiction treatment after being cured of HCV.
The Role of Addiction Medicine Specialists in HCV Testing and Treatment
Depending on the setting, addiction medicine specialists who are predominantly treating people with opioid use disorder will see a population in whom the prevalence of HCV antibody positivity is 70% to 90%, and the prevalence of HCV RNA positivity might be 30% to 60%, representing a very high–risk population. It is also likely that the addiction care provider might be the only person who is seeing such patients for medical care. For these reasons, HCV screening should be offered to every person engaged in an addiction medicine setting, and this should be a universal offer that is not based on reported risk factors. Providers in these settings should always use an HCV antibody screen with reflex HCV RNA testing, rather than antibody screening alone.
When my group first began talking to local opioid treatment programs about providing HCV testing and treatment, none was screening for HCV. This was not because of resistance to screening—it was simply that providers did not know how to screen their patients for HCV or where to send them if they tested positive. Complex federal regulations around opioid treatment programs that prescribed methadone also played a role but were navigable. The key to improving access to HCV treatment for these vulnerable populations is through developing relationships with community organizations, so that strong linkages can be made and experiences shared.
One of the real benefits of integrating HCV care with addiction care, especially for opioid use disorder, is that often people come to the clinic with some frequency, maybe even daily. When you combine therapies for HCV with medications for opioid use disorder, patient adherence is improved. The PREVAIL study showed that people with active drug use had excellent adherence to HCV therapy with SVR rates of 90% or higher, regardless of how treatment was administered (individual [standard] therapy, group treatment, or directly observed therapy). HCV cure rates were numerically a little bit higher when medications were given in a directly observed manner alongside methadone. Ideally, every opioid treatment program in the country would be offering HCV treatment in a directly observed therapy manner for patients who want this option. If we did that, we would have a real shot at HCV elimination.
Preventing HIV Infection
In our clinic in Portland, we recommend annual opt-out HIV and HCV screening for all people in opioid treatment programs and in all persons who inject drugs. We have a screening algorithm that includes HBV, HIV, and HCV testing for all new intakes. Reactive HCV antibody testing automatically reflexes to HCV PCR and all the remaining labs required to initiate treatment with direct-acting antivirals. This reduces visits and means that people who test positive can get their prescription at the first visit.
Although in most communities the risk of HIV infection among people who use drugs is relatively low compared with HCV infection, we have seen outbreaks in several communities in Indiana, Massachusetts, Oregon, Washington, Kentucky, and elsewhere. I am convinced that treating HCV is an HIV prevention measure in that when you treat HCV, people tend to use drugs in a safer manner, at least for a while, and they might therefore be less likely to contract other blood-borne infectious diseases.
I do prescribe pre-exposure prophylaxis for people who are at higher risk of HIV infection, particularly those who inject methamphetamines. This practice is based on local behavior patterns in which methamphetamine use tends to be associated with higher risk injection practices, men who have sex with men, and people who exchange money or services for sex—groups with higher HIV risk.
What are your thoughts about overcoming barriers to HCV treatment for persons who use drugs? Do you have concerns about prescribing HCV treatment for them? Please join the conversation and share your experiences in the comments box below.