By Stephen P. Wood
The opioid epidemic and the toll it is taking is on American lives has resulted in the declaration of a public health emergency by the Trump administration.
There were 42,000 deaths from suspected opioid overdose in 2016, more than in any previous year to date. These deaths illuminate the direct impact of the epidemic, but this is only the tip of the iceberg. Hepatitis C is another epidemic that goes increasingly hand-in-hand with the opioid crisis, and is likely to take a long-term toll on American lives as well. Intravenous drug use accounts for approximately 80 percent of new cases of hepatitis C virus (HCV) infection in the United States, and without intervention these numbers could continue to climb.
HCV is a virus that is spread as a blood-borne and sexually transmitted pathogen. While it can resolve on its own, many untreated cases result in chronic infection which can lead to cirrhosis and liver malignancy. Patients with opioid use are at particular risk, especially those who inject drugs or who share needles. The incidence of infection is increasing while the number of individuals who are treated has remained stagnant — estimates at only 1-2 percent annually.
The long-term effects include not only hepatic effects, but also renal, neuropsychologic and cardiovascular issues. While intravenous drug use has significant mortality risk on its own, the HCV epidemic is likely to add to these already grim numbers.
The incidence of hepatitis C infection has been increasing in line with opioid epidemic, from 0.3 cases per 100,000 in 2010 to 1 case per 100,000 in 2016. New infections are occurring most rapidly in the 20-29 year old age group, the same group most devastated by the opioid epidemic.
Hepatitis C is now the leading cause of death from reportable infectious disease in the United States. If this trend continues, there could be an estimated 41,000 cases annually, almost matching the number of lives lost to opioid overdose.
One of the main issues with hepatitis C is that it is often asymptomatic and many people are unaware they even have the disease. As a result, many of these people go untreated and go on to develop chronic hepatitis C virus (HCV). Of these, 20 percent will develop cirrhotic liver disease and around 5 percent who have cirrhotic disease go on to develop liver cancer. It is estimated that upwards of 20,000 Americans died from HCV related disease last year and these numbers will likely continue to rise.
While there is not a currently available vaccine, many cases of hepatitis C can be treated. Few do however, and as a result, this is an infection that is reaching epidemic proportions.
The financial impact
The newer direct acting anti-viral medications have demonstrated amazing efficacy, achieving a cure rate of around 90-95 percent. There are few side effects and the treatment regimens are relatively short, making them attractive. However, this comes at a cost: A 12-week course of one of the more popular drugs, Sovaldi, can be upwards of $95,000 dollars. Harvoni, another popular drug is even more startling, at $189,000 per course.
Estimating 41,000 new cases a year, if all of these cases were to receive treatment, the financial cost comes out to around $4 – 8 billion dollars a year. Many of the individuals with opioid use disorder and concomitant HCV are under- or uninsured and may not be able to afford this costly treatment. There is an imperative then, for the healthcare system to start planning for the potential that thousands, possibly hundreds of thousands of Americans may require treatment for HCV, and that the cost of this treatment may be quite high.
The alternative is that left untreated, around 8,200 people a year will develop cirrhotic liver disease, and 400 or so will develop liver cancer. The long-term costs of these diseases, both on quality of life as well as the financial impact, are also quite high.
Screening, prevention and treatment
To address this, there must be a push towards enhanced screening, implementation of prevention practices and treatment of those with known disease. There are many individuals who inject drugs and have concomitant HCV, which if left untreated puts other individuals at risk for exposure and infection. Prevention is key and this starts with education.
It is important to provide education to individuals with substance use disorder (OSUD) around sharing needles as well as sexual transmission of HCV. There is some data to suggest that peer-to-peer education can help to reduce risky injection behaviors, although this hasn’t entirely correlated to decreased rates of HCV infection. What is likely needed is a multi-faceted approach that includes increased access to needle-exchange, peer-to-peer education and increased use of supervised injection facilities. Promotion of condom use, similar to that of the HIV campaign, may also be effective.
Screening will also be a key component, and it will likely have to occur in non-traditional settings. The emergency department (ED) is one such setting. The ED can often be the only point of care for people with SUD. While some would argue that we shouldn’t be screening for something we can’t treat in the ED and requires long-term follow-up, at the very least it provides the patient with a diagnosis so that they can make informed choices. Certainly, any patient who is screened can be discharged with information about the disease as well as treatment resources. Similar efforts can be done at needle-exchanges, homeless shelters, supervised injection facilities or other non-traditional sites.
Treatment, and specifically the cost of treatment, is the biggest barrier. Getting people to treatment, especially those who live transient lives can be difficult. A common fear is that treatment might be interrupted and resistance could emerge as a result. Treatment also requires fairly regular monitoring, which can be a barrier for many with SUD. The biggest barrier however is cost.
As mentioned previously, the cost of treatment is astronomical. And that doesn’t account for the millions that already have HCV. It is difficult to estimate the overall financial impact of HCV, but surely, treatment will result in an increased in quality of life and decrease the downstream co-morbidities of this disease. It will also save lives. The price tag of $95,000 for a cure however, remains a huge deterrent. Not surprisingly, this price tag isn’t entirely justified. The cost of making a full 12-week course of Sovaldi is only $138 dollars, a pittance compared to the cost for the end-user. While these manufacturers often cite the risk and cost of development, the cost of these drugs remains high even after years of sales. Gilead, who makes both Sovaldi and Harvoni, posted $44 billion in sales of these drugs in the last three years.
The is an ethical issue at hand here as well. Patients will pay anything for a cure for a debilitating, and possibly cancer-inducing disease. For the new HCV drugs, the cure rate is high, there are few side effects and the course of treatment is short, making them even more attractive. Drug companies benefit from knowing that people will pay a pretty high price for something that can save their lives. The risk of exploitation is high and it is up to the public and federal regulators to address these issues as demand will very likely continue to increase in the next several years. Powerful lobbies, the blank-check approach to Medicare reimbursement, and tax-exempt employer-sponsored health insurers have all been barriers to reform.
This will be difficult to sustain and there will at some point be a breaking point. The unfortunate consequence is that sick people will pay, not only financially, but with their lives. There is a need then, to fix what 75 years of inadequate policy has built and start to reform how pharmaceutical companies operate.
Template for success
The good news is that there is already a template for success. Egypt has the highest prevalence of HCV in the world (oddly enough because of fresh-water snails), but through public health measures that included markedly reduced drug prices, the impact of this disease has been dramatically reduced. The country negotiated with Gilead, the pharmaceutical company that markets two high-impact drugs, and was able to reduce the cost from $95,000 dollars, to just $900 for the 12-week course. When generics moved into the market this was reduced even more, to a mere $84 per patient to complete the therapy. As a result, more than 1.6 million Egyptians have been successfully treated for HCV.
Why can’t we then do the same?
We can, but it will require some public outcry as well as federal regulation. As we face the opioid epidemic, we have to also be weary or the fallout. HCV is matching the grim statistics of marching hand-in-hand with the opioid epidemic and we must make sure treatment is available to everyone.
This needs to be coupled with screening, prevention and evidence-informed research. There is a need to invest research efforts and funds into interventions that decrease transmission, as well as the development of newer and cheaper pharmaceuticals. Policy needs to address pharmaceutical transparency and help to alleviate the astronomical costs of treatment. A lack of access to care should not result in lives lost to the opioid epidemic, to HIV, to hepatitis C, or to any preventable and treatable disease.