David Proulx was diagnosed with hepatitis C in 2003, but he suspects he contracted the virus decades earlier. He injected drugs in the 1970s and picked up several tattoos when he was first incarcerated in the early 1980s. Over the years, the infection wreaked havoc on his liver. Within a year of diagnosis, he received antiviral drugs to treat the disease, but the medicine failed to eliminate the virus. Proulx had run out of options. In 2011, however, the US Food and Drug Administration approved two new medications to treat hepatitis C. Clinical trials indicated that these drugs could help individuals like Proulx who had previously failed other therapies. But Proulx can’t access them. He’s incarcerated at the Massachusetts Treatment Center within the correctional complex in Bridgewater, and the state has not yet begun administering the new medications to inmates, according to Joel Thompson, a lawyer and prisoner advocate based in Boston.
The hepatitis C virus is the leading cause of liver cancer and the most common blood-borne infection in the US, affecting approximately 3.2 million people. Among prisoners, the infection is rampant. Between 12% and 30% of the roughly 1.6 million people living in state or federal prisons in the US are infected with the virus, as a result of exposures such as injection drug use and unsafe tattooing.
Fortunately, the infection can be cured. Antivirals can eliminate the infection in about half of all cases. Adding to the case to treat incarcerated individuals, a paper published this month by researchers at the University of Wisconsin–Madison concluded that inmates receiving traditional hepatitis C therapy fare just as well as individuals being treated in the community (Hepatology 56, 1252–1260, 2012). However, the newest, most effective medicines cost tens of thousands of dollars. Today, prison officials are facing tough choices about which inmates to treat and which medicines to administer.
“Prisoners are guaranteed access to community-standard health care,” says Josiah Rich, an infectious disease expert at Brown University’s Alpert Medical School in Providence, Rhode Island, and director of the university’s Center for Prisoner Health and Human Rights. But “this community-standard treatment is now, all of a sudden, god-awful expensive.”
The American Association for the Study of Liver Diseases, a Virginia-based professional society for hepatologists, now recommends that people infected with the most common strain of hepatitis C receive the traditional combination of two antiviral medications, pegylated interferon and ribavirin, as well as one of two new protease inhibitors approved in 2011, Victrelis (boceprevir) from New Jersey’s Merck or Incivek (telaprevir) from Massachusetts-based Vertex Pharmaceuticals. The traditional combination therapy already costs between $15,000 and $30,000 per patient, depending on the length of treatment. The new protease inhibitors will add at least $26,000 and as much as $50,000 to the cost. “It could potentially be a budget buster,” says Robert Trestman, executive director of Correctional Managed Health Care at the University of Connecticut Health Center in Farmington, which cares for inmates in the state’s penitentiaries.
Patient selection and drug adherence are additional challenges. Not every individual who is infected with hepatitis C is eligible for treatment. “They need to meet certain criteria,” says Trestman. For example, because the medications have serious side effects, individuals must have signs of liver damage to receive them. That may happen years after the initial infection. Prison officials also want to be sure that inmates can complete their treatment, which typically lasts a year, before they’re released. That’s because inmates often have trouble accessing the drugs and sticking with the complicated dosing regimen once they’re back in the community, and missing just two or three doses of the new protease inhibitors can “eliminate the significant portion of the benefits,” according to Owen Murray, vice president of offender health services at the University of Texas Medical Branch (UTMB), which provides care for most of the state’s inmates.
Rules about treatment eligibility were at the heart of a lawsuit filed in 2005 in which four current and former inmates of the Logan Correctional Center in Lincoln, Illinois sued the medical director of the state’s Department of Corrections after they were denied treatment. Some were turned down because of insufficient evidence of liver damage, others had sentences that were deemed too short to complete the therapy while incarcerated.
In 2008, the jury ruled in favor of the plaintiffs, awarding damages in excess of $8 million. A year later, however, a district court overruled the judgment for three of the four inmates. Only in the case of Edward Roe did the court find that the medical director showed deliberate indifference to the inmate’s medical condition by failing to biopsy Roe’s liver and to consider him as a candidate for treatment. Roe died in 2007 from cirrhosis. A federal appeals court upheld the district court’s decision.
State of affairs
Earlier this year, the Federal Bureau of Prisons released new guidelines for hepatitis C treatment that recommend the use of the new protease inhibitors, which its representatives say it has implemented. Treatment policies in state prisons, however, vary widely. In Connecticut, for example, 17 of the state’s 17,500 inmates are currently receiving the new protease inhibitors. Yet, in neighboring Massachusetts, the state’s Department of Correction has not even developed a protocol for the use of the new medications.
Thompson, a staff attorney at Prisoners’ Legal Services in Boston, has fielded calls from at least 25 inmates—most of whom are still infected with hepatitis C despite previous treatment with interferon and ribavirin—wanting to know how they can receive the newer drugs. That’s a question state officials have yet to answer. “We’ve been very vocal with the department and with its medical contractor about the need to get a protocol in place and to bring these new medications online,” Thompson told Nature Medicine.
In a July 2012 letter, Lawrence Weiner, assistant deputy commissioner for the Massachusetts Department of Correction’s Clinical Services Division, wrote that the state was considering adopting practices that match the federal guidelines and noted that the University of Massachusetts Medical School in Worcester, which oversees inmate health care, had committed to completing the new protocol by the end of that month. At press time, however, the revision had not yet been completed, according to Diane Wiffin, a Department of Correction spokesperson. Because of the high cost of the newer agents, “there is an enormous incentive to make this move as slowly as possible,” Thompson says.
A 2011 report on inmate healthcare costs commissioned by the Massachusetts Department of Corrections suggested that one way to cut medication costs would be to offer inmates who require hepatitis C treatment the older medications initially and save the new drugs for inmates who don’t respond within the first 12 weeks.
Treatment options going south
Texas, the state with the largest prison population in the US, hasn’t yet made the drugs available to its inmates, either. “We’re working on our guidelines right now for these newer therapies,” says Murray. The protease inhibitors must be administered every eight hours with a snack. Given those requirements, Murray says it may make sense to create special hepatitis C treatment facilities. The committee charged with developing the new guidelines, which includes representatives from UTMB as well as the Texas Department of Criminal Justice, is considering all these possibilities. In the meantime, Murray says, UTMB physicians have restricted the number of new inmates starting the older two-drug therapy. The need for treatment is rarely urgent, he says. “There is no reason to put patients on suboptimal therapy.”
Inmates in Georgia are in a similar situation, according to Anne Spaulding, an infectious disease physician at Emory University’s Rollins School of Public Health in Atlanta who was hired in 2003 by the Georgia Department of Corrections to care for inmates with hepatitis C. “I was told I could use the new antivirals when they came out,” she says. But even after the new drugs were approved, Spaulding couldn’t access them. “I kept on being strung along,” she says.
Spaulding says she developed a protocol for the use of the medications, but it was never implemented. It’s not clear whether any inmates in Georgia are taking the protease inhibitors today. Spaulding was let go at the end of this past summer due to budget cuts. At that time, the medications were not available, she says. Dabney Weems, a spokesperson for the Georgia Department of Corrections, declined to say whether the new drugs are being used. She wrote in an email that all inmates “receive individualized care based on their patient factors.”
For inmates such as Proulx, who couldn’t be cured by the old regimen, these new drugs may mean the difference between life and death. “I worry if I do not get treatment in the near future, my condition will worsen,” he wrote last year in a letter to the Massachusetts Department of Public Health. “I should not be denied medical treatment when the drugs to treat [my] condition are available, based on my status as a prisoner.”
Thompson agrees. He and his colleagues have already talked about filing a lawsuit if they don’t see progress. “There is no shortage of clients willing to participate if that’s what it takes to get triple therapy implemented,” he says.
Photo credit: Vertex Pharmaceuticals
A print version of this article appears in the November 2012 issue of Nature Medicine.