Treatment for hepatitis C virus (HCV) infection is changing at a pace almost too rapid for the average physician to keep up with. Until recently, HCV treatment required weekly interferon injections plus oral ribavirin for up to a year and was effective in only about half of patients with genotype 1. During the past 2 years, however, several highly effective, fast-acting, all-oral, interferon-free regimens have been approved, raising the possibility of eradicating HCV in many patients. However, treatment for HCV infection has become increasingly controversial, especially considering the prioritization of whom to treat and the cost considerations.
What the Hepatitis C Guidelines Say
According to joint guidelines from the AASLD (American Association for the Study of Liver Disease) and the IDSA (Infectious Diseases Society of America), HCV treatment should be considered in all chronically infected patients except those with short life expectancies due to comorbid conditions. This recommendation is assigned a Class I, Level A rating, which means it is formulated based on high-quality scientific evidence. Patients at risk for more imminent, serious complications due to their liver disease should be prioritized for immediate treatment.
Prioritization based on liver disease and comorbid conditions, while controversial to some, is intended to acknowledge the strain that widespread treatment will place on the health care system. A 12-week course of direct-acting antivirals for HCV treatment currently costs roughly $100,000 per patient, and there are an estimated 2.7 million people in the United States with chronic HCV infection.
The Intersection of HCV Treatment Guidelines and Real-World Practice
I practice medicine in the state of California where new MediCal (Medicaid) guidelines released July 1, 2015, are largely concordant with the AASLD/IDSA guidelines in listing the indications for treatment and coverage by MediCal. In addition to including patients at high risk for liver complications and cirrhosis, the MediCal guidelines also include active injection-drug users and men who engage in high-risk sex with other men. Thus, in my primary care practice, I am able to consider treatment for most of my HCV-infected patients. Although some providers choose not to treat active drug users, I certainly do. People with a lifetime history of drug use (both past and present) are a sizeable percentage of my patient population; many of them have advanced liver disease, risks for progressing, and risks for transmitting, so treatment is warranted.
Whenever I consider treating a patient with recent or active drug use, I think about the importance of prevention, the need to facilitate adherence, and, of course, the cost of the drugs relative to their effectiveness.
HCV Treatment as Prevention
HCV treatment is prevention, in that eradicating the virus in one patient will prevent its spread to others. In my practice, care prior to treatment always involves obtaining a comprehensive social history from patients to assess their risk for both acquiring other infections and spreading HCV. Injection-drug use (which some patients deny when asked by their doctor) is a common mode of transmission, but there are many other modes as well, including sexual exposures, the sharing of drug paraphernalia (cookers, cotton balls, pipes, water, and more), and even the sharing of everyday items, such as razors and toothbrushes. Patients should be educated about preventing transmission even if they will not be treated. I also counsel all my patients about the existence of harm reduction-oriented resources, such as needle exchanges, which are important both for preventing initial transmissions and for preventing reinfection in patients who have been treated and cured.
Before initiating treatment, I always assess the patient’s ability to adhere to the regimen. From an efficacy perspective, I want to ensure that the patient can take medications daily and also that they will attend medical appointments regularly. I often consider control of other chronic diseases — such as HIV infection, diabetes, or hypertension — as a proxy for predicting success with HCV treatment. I have many patients who use drugs regularly but still have excellent control of their HIV infection, diabetes, or other chronic conditions. This reassures me that they can also control their HCV infection.
I regularly treat HIV patients, so I understand all too well that poor medication adherence can lead to the development of drug resistance. Studies of resistance to HCV direct-acting antivirals are in the early stages, but I still provide extensive pretreatment counseling about the risk of developing resistance. Once a patient starts treatment, I partner with a nurse at my clinic to provide tailored support based on the patient’s needs. We often have patients come in every 1 to 2 weeks to obtain a new mediset prefilled with medications, and we use those visits to check on adherence and monitor for side effects. Patients tend to respond very well to this level of attention, and it helps them to remain engaged. Even though many of my patients lead chaotic lives, with active substance use throughout treatment, I have yet to have a patient “lost to follow-up” during the course of HCV treatment. I attribute this success to a team-based approach.
The cost of the new HCV medications is always on my mind when I’m considering treatment for a patient. As noted above, these drugs are very expensive, but they have also been shown to be very cost effective when cure is attained. If a patient is at risk for being lost to follow-up or for poor adherence because of uncontrolled drug use, I choose to wait until the patient’s ability to successfully complete treatment improves. My experience has been that the opportunity to cure HCV is an extremely powerful motivator to engage in care for patients, many of whom have long been denied treatment because of substance-use or mental-health problems. The following vignette describes this perfectly.
A View from the Clinic
This morning in clinic, I saw a patient with chronic HCV infection who has a long history of injecting methamphetamines and who is currently injecting. He has been under my care for three years and is well engaged with our clinic, using our behavioral health services and, intermittently, substance-use counseling. During the past five years, he has made significant changes to his behavior by using needle-exchange services in the community. He lives alone but has a group of acquaintances with whom he regularly uses. He acknowledges that while these friends are a trigger for his drug use, they are also his primary social support system — and the reason he is not willing to stop using drugs altogether.
Although some providers would not treat this patient, I engaged in a long discussion with him about treatment, and together we decided that now is the right time to start treatment. This decision stemmed from the patient’s desire to improve his own health and also to protect the people with whom he uses. I suspect he has been infected for over 20 years. He does not currently use alcohol but has more heavily in the past. He has HCV genotype 1b and no evidence of cirrhosis based on a recent ultrasound or serum calculations (FIB-4 and APRI). He has been interested in treatment for many years but was scared of interferon-based treatment because he has a significant history of PTSD, with auditory hallucinations and chronic depression at times. When I asked him if he’s ever pursued treatment before, he replies, “They don’t treat people like me.”
I hope, in the years to come, that no patient will feel this way — and that we can expand this lifesaving treatment to all patients in a manner that is cost-effective, sustainable, and satisfying to both providers and patients alike.
Kelly Eagen, MD, is a primary care provider at San Francisco Department of Public Health’s Tom Waddell Urban Health Clinic. Her primary interests include homelessness, HIV and hepatitis C care, mental illness, and substance use.