The Silent Epidemic
An appeals court restricts prisoners’ access to hep C treatment
by Jay Vithalani
The treatment of hepatitis C infection was revolutionized in 2013, with the introduction of sofosbuvir, a direct-acting antiviral (DAA) drug that is highly effective and well-tolerated. Fixed-dose combinations of two DAAs now lead to a cure rate of 95% or more in patients with acute or chronic HCV infection. The treatment course is most commonly eight to twelve weeks.
That’s the good news. The bad news, unsurprisingly, is the cost of HCV drugs. The sticker price for a twelve-week course of some medications used to be as high as $95,000. More recently, drug companies have lowered or stabilized prices for their patent-protected medications to about $25,000 for a full treatment course.
In May 2017, three inmates with chronic HCV infection sued the Florida Department of Corrections (FDC) in federal court for not providing them with necessary medical treatment. (They were represented by lawyers from the Florida Justice Institute, which provides pro bono legal services to the incarcerated.) Plaintiffs alleged that the FDC’s inaction showed “deliberate indifference” and violated prisoners’ Eighth Amendment rights against cruel and unusual punishment, and that the FDC discriminated on the basis of disability in violation of the Americans with Disabilities Act. The prisoner-plaintiffs argued that their constitutional rights had been disregarded, and the FDC-defendant claimed that, after modifying its testing and treatment guidelines, constitutional guarantees had been satisfied.
The case, Hoffer v. Jones, has had a long and complicated journey through the legal system. Chief Judge Mark E. Walker (Northern District of Florida) ruled largely in favor of the prisoners. After a series of hearings, certifications, injunctions, and judgments between 2017 and 2019, Walker ordered the FDC to test inmates for HCV (opt-out rather than opt-in testing), to provide treatment for all who are HCV-infected, regardless of disease progression, and not to drag its feet and rely on cost as the main factor in providing or withholding treatment. The Florida Department of Corrections challenged the orders and appealed to the 11th Circuit—that is, one of the thirteen appellate courts in the federal system just below the Supreme Court. On August 31 of this year, a three-judge panel reversed Walker’s rulings.
Florida has roughly 100,000 inmates, and the FDC has screened (after the lawsuit was initiated) about 55,000 for chronic hepatitis C. Approximately 7,200 have been diagnosed with hepatitis C, and treatment with DAAs has been given to about 5,000 inmates. It’s important to note here that the state has not tested all prisoners, and that the 7,200 number is almost certainly an undercount. Conservative estimates put the number of prisoners in Florida with chronic hepatitis C at 20,000. Treatment is not provided to all HCV-infected prisoners: that is a central issue in the case. The FDC successfully argued in the appeals court that it would continue testing but provide treatment only to those inmates who have another disease or infection, such as HIV, and to those who have moderate to severe fibrosis (scarring that can lead to cirrhosis). Inmates with a low “fibrosis number” will be monitored but not treated.
Judge Kevin Newsom, who wrote for the 2-1 majority, noted the following: (a) half of all HCV infections spontaneously clear without treatment; (b) the Eighth Amendment does not require that each patient receive the best possible or even very good care; (c) there is no constitutional argument forbidding states from considering cost, at least to a certain degree; (d) the FDC’s current testing and treatment protocols do not amount to “deliberate indifference”; and (e) that “ordinary Americans forgo or delay beneficial—and even life-altering—medical treatment because it’s just too expensive….What a topsy-turvy world it would be if incarcerated inmates were somehow immune from that cold—and sometimes cruel—reality.”
Putting aside the issues raised by Hoffer v. Jones for a moment, what do scientists, doctors, epidemiologists, and public health advocates have to say about hepatitis C? There are at least 2.4 million people living with chronic HCV infection in the United States, double the number of PLWHA. Advanced disease kills between 15,000 and 20,000 people a year; hepatitis C is sometimes called “the silent epidemic.” The CDC recommends that all adults get a hepatitis C screening test at least once (this is important in part because chronic HCV infection can be asymptomatic for years, even decades). Routine periodic testing is recommended for injection drug users and those who share needles.
Testing is particularly important in prisons, since an estimated 12 to 35% of the incarcerated population has chronic HCV infection. An advocacy group notes that “[o]ne reason for the high prevalence is that many populations who are most affected by incarceration such as the poor, injection drug users, and the mentally ill, are also more likely to have HCV.” According to the American Association for the Study of Liver Disease and the Infectious Disease Society of America: “Only 16% of prison facilities tested all inmates with an HCV-antibody test upon entry. Selection of patients for antiviral therapy also varied across prison systems…. [A]ntiviral therapy for chronic HCV was available in 90% of prisons. However, few inmates actually received treatment, primarily due to antiviral therapy expense and lack of availability of trained staff.” States use “a variety of factors to prioritize HCV treatment among inmates, particularly cirrhosis, sentence length, likelihood of recidivism, potential for antiviral adherence, and chance of HCV reinfection.”
A comprehensive 2017 report prepared by the National Academies of Science, Engineering, and Medicine, with support from the CDC and the Department of Health and Human Services, recommended a national strategy to eliminate viral hepatitis (B as well C) by 2030. Apart from other necessary measures—prevention and harm reduction, awareness and education, increased testing—the report stressed the importance of universal treatment for HCV as a matter of public health urgency:
“While unrestricted, mass treatment of hepatitis C will be necessary to eliminate the disease as a public health problem by 2030, no direct-acting drug will come off patent before 2029. Furthermore, delaying mass treatment would result in billions of dollars in wasted medical costs—and tens of thousands of needless deaths.”
The report also makes the point that “cost-effective” and “expensive” are not antonyms, even though they are treated as such: “Delaying such treatments only increases a patient’s risk of cirrhosis, liver cancer, and death; it also preserves a disease reservoir that hurts society. Although hepatitis C drugs are cost-effective, they are expensive—especially for public payers—so Medicaid patients are frequently denied treatment.” As for the fibrosis score, disease models have shown that treating only those with advanced liver-tissue scarring results in a mortality rate two to five times greater than if everyone was treated, regardless of fibrosis level.
There is a lot to be unpacked from these facts and from the legal arguments. If the incarcerated are the only group who have a constitutional right to healthcare, there is an uneasy tension within that idea. On the one hand, since the state holds them in custody, even if for punitive reasons, the state must be responsible for their wellbeing. On the other hand, since millions of the non-incarcerated population lack proper access to healthcare, and often forgo state-of-the-art treatment because they can’t afford it (or their insurance won’t cover it as “medically necessary,” which amounts to the same thing), it seems peculiar to make such treatments fully available to those whom society has chosen to imprison. This is precisely the tension between Judges Walker, a Barack Obama appointee, and Newsom, a Donald Trump appointee.
Local governments have a strong interest in keeping infectious diseases out of their communities, and, since 90% of the incarcerated population will eventually be released, it only makes sense that prisoners re-enter society with as low of a virus burden as possible. But does the Eighth Amendment take public health into account? Should it? Scholars have noted that court orders which mandate expensive treatments for hepatitis C for every infected prisoner could have the unintended consequence of shunting available (limited) funds away from the medical needs of other prisoners.
In any case, legislators and governors are unlikely to approve higher budgets for Departments of Correction, especially in times of declining tax revenues and novel virus threats. Governor Ron DeSantis of Florida vetoed the money allocated in the state budget this year for hepatitis C treatment, $28 million.
In short, the science is clear about testing and treatment, if the goals are to eliminate hepatitis C and save money in the long run. But a lack of knowledge about HCV infection, austerity budgets, and sluggish change in prison systems make these goals hard to achieve. Lawyers and advocates continue to fight for prisoners’ rights. And cases such as Hoffer v. Jones have at least this effect: they have likely prodded other states to be proactive about hepatitis C treatment for the incarcerated, in order to avoid expensive and drawn-out lawsuits.
Jay Vithalani is a writer and editor. He grew up in Mumbai, and studied English literature, philosophy, and creative nonfiction at Amherst College, Harvard University, and the University of Iowa. Vithalani lives in New York City. He can be reached [email protected].