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.
Adherence
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.
Cost
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.
Thank you for this excellent essay on Hepatitis C treatment and your approach to selecting patients for treatment. I hope this is read by all physicians who treat patients with Hepatitis C. In particular I hope your methods are adopted by the Veterans Administration system in New York where I practice.
Very clear and comprehensive dissertation. I’m fully in agreement whith your aproach to the patients and hopefully other collegues can have your team work access;it’s a “political” issue when the problem of cost/benefits is a prority.Thanks for your excellent essay. .
I’m a community pharmacist who works closely with GI docs in Anchorage, Alaska. How I wish all payers and providers shared your views about treating patients. Our pharmacy manages the state ADAP program too, and we see so many people who are marginalized in our society and often considered NOT appropriate for Hep C treatment. Thank you for sharing your perspective.
Really great to see this get published. I find it especially encouraging to see physicians who wholeheartedly treat active substance users.
Although I agree with Dr. Eagen’s analysis and sentiment 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,” I think it is impractical, but not impossible.
As Dr. Eagen pointed out, “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.” Therefore, the total cost to treat all these patients is about: $ 270 billion, which is about 10% of the federal budget, which is $3.8 trillion in fiscal year 2015.. We cannot afford to spend 10% of the total budget just on one disease. Can we? If we can afford the cost, then it is possible.
The only way to accomplish this goal would be to SUBSIDIZE THE DRUG, i.e., the government pays 100% cost of medication and care needed. By doing this we accomplish two important goals:
a. Taking care of the sick immediately by providing the best care available, irrespective of their financial situation; thereby preventing the spread of the disease, which would be beneficial to the entire society in the long run.
b. Supporting the constitutional mandate of providing monopoly to an inventor of a new invention, i.e., branded drug manufacturers such as BMS (Daklinza), Abbvie (w-ribavarin), Merck (grazoprevir/elbasvir), Gilead (sofosbuvir) and Gilead (Harvoni- $1125 per pill) etc. It is important to support the development of new drugs, by respecting the short-term monopolies given to new drug producers, so that they continue to develop new drugs for the greater good of the society.
This strategy can be extended to all medications and tests, including Myriad’s test kits, without destroying the legitimate and constitutionally mandated and beneficial monopolies to inventors such as Abbvie, BMS, Myriad, Gilead etc. .
It would be detrimental to invalidate the monopoly for the immediate political gains by appeasing the sick and the so-called “kind-hearted” for their immediate political gains, because it would kill the incentive and increase the cost of new drugs due to litigation costs.
Without interfering with the constitutionally mandated and very beneficial monopolies in the US, however, Natco Pharma Ltd., a mid-sized pharmaceutical company in India, has made a deal with Gilead Sciences to produce generic versions of Gilead’s newest hepatitis C virus (HCV) medications, and will be able to distribute those meds in 91 developing countries.
I am delighted to see the support for Dr. Eagen’s essay, and to see more thought being given to how we can afford to use the new therapies in the way we clearly need to.
I’d like to correct a few misconceptions, however. It does not cost $100,000 to treat each patient for hepatitis C. With the discounts available (Gilead says they’re giving 46% discounts), it is more in the range of $40,000-$50,000. And 33% less for patients who can be cured in 8 weeks, who are probably the majority of patients. And a new regimen is coming January 28, and another one later in 2016, so prices may fall further.
It is also unfair to multiply the price by 2.7 million and compare it to annual expenses or the annual federal budget. Even if it were a realistic number, it would be a one-time expense, not an annual one. If we did actually spend all that money and treat every single person in the US with hepatitis C in one year, we would never have to pay for another HCV treatment ever again.
But it would obviously be impossible to do that. Most people with hepatitis C don’t know they have it. Screening the entire population, or even just baby boomers, will clearly take many years and will never proceed to completion. Screening doesn’t work that way. We have barely made a dent in the 3 years since the CDC recommended baby-boomer screening.
Plus, many people with hepatitis C don’t see a doctor if they are not feeling sick. A disproportionate number of people with hepatitis C don’t have access to care, or have other more pressing problems, especially in the current economy. Many people don’t follow through with referrals, or don’t trust doctors or drug companies, or won’t start treatment for other reasons. Many don’t have access to a hepatitis C treater. A more realistic estimate (Clin Gastroenterol Hepatol 2015;13:1711-3) is that it would cost about $7.4 billion for about 5 years, at current drug prices. That’s actually a quarter of a percent of what we spend on healthcare every year ($2.9 trillion). So we can easily afford it. Of course, it could be more for a shorter period of time, or less for a longer period of time. Either way, though, the price will fall quickly and dramatically after we’ve treated everyone we can. Can we afford to increase our healthcare spending by 0.25% for five years, to end the largest and deadliest bloodborne viral disease epidemic in our country?
I think so. For no other disease are we rationing a lifesaving, medically indicated, cost-effective cure. Hepatitis C has seemed like a good place for insurers (and pharma) to take these outlandish stands because of the stigma associated with the disease. As Ryan Clary, executive director of the National Viral Hepatitis Roundtable, has said recently, “If there were a cure for Alzheimer’s disease or breast cancer that cost $40,000 or $50,000, we would not be having this conversation.” (Are Alzheimer’s disease and breast cancer rarer than hepatitis C? I don’t think so.) He’s right. If this were childhood cancer, we would be falling over each other to make sure every child who needed it got it.
The story should stop there. But it doesn’t, because all this is calculated based on current prices. The current prices, however, are unconscionable. Drug company monopolies are permitted, not mandated, in the U.S. Constitution. Drug patents are provided by the Hatch-Waxman Act of 1984, which gives drug companies monopolies for the explicit purpose of fostering the development of drugs for the public benefit. When the same companies use the monopolies to price the drugs out of reach of the public, the justification for monopoly pricing rights becomes very thin. Moreover, it has never been shown that monopolies are necessary to drive drug development. That is a view propounded the pharmaceutical industry. But that industry has a profit margin greater than any other, and it spends far more money on advertising drugs than developing new ones. Giving in to their threat to stop developing new drugs if they can’t keep on making huge profits is simply drug pricing policy by blackmail. That policy serves no one except the drug companies. It has to stop.