By Greg Dober
Hepatitis C (HCV) is a blood-borne virus that is typically spread through intravenous drug use (i.e., sharing needles), tattooing with non-sterile needles, and sharing razors, toothbrushes, nail clippers or other hygiene items that may be exposed to blood. It is often a chronic disease and, if left untreated, can lead to severe liver damage.
Recent good news in the battle against HCV, in the form of two new drugs that are highly effective in eliminating the virus, is tempered by the fact that the companies that produce the drugs have priced them at $60,000 to $80,000 per 12-week course of treatment. This high cost prices the medications beyond the reach of most prison and jail systems – which is especially troubling considering that a substantial number of prisoners are infected with HCV.
The new drugs, approved by the FDA in late 2013, are simeprevir, branded as Olysio and manufactured by Janssen Therapeutics (a Johnson & Johnson company), and sofosbuvir, branded as Sovaldi and manufactured by Gilead Sciences. Based on clinical trials, Sovaldi has an 84-96% cure rate while Olysio has an 80-85% cure rate. Both drugs are used in combination with other HCV anti-viral medications, peginterferon alfa and/or ribavirin, and their cure rates vary depending on HCV genotype – specific variations of the virus.
Unlike the current treatments for hepatitis C, Olysio and Sovaldi have fewer side effects, greater efficacy and reduce treatment durations by up to 75% (12 to 24 weeks rather than 48 weeks). In addition, the new drugs are administered orally rather than by injections. However, given tight corrections budgets and the high cost of the new HCV medications – Sovaldi costs approximately $1,000 per pill – getting them into prisons and jails ranges from difficult to impossible.
According to the Centers for Disease Control, “The prevalence of HCV infection in prison inmates is substantially higher than that of the general U.S. population. Among prison inmates, 16%-41% have ever been infected with HCV, and 12%-35% are chronically infected, compared to 1%-1.5% in the uninstitutionalized U.S. population.”
Josiah Rich, director of the Center for Prisoner Health and Human Rights at the Miriam Hospital Immunology Center in Rhode Island, noted that “With more than 10 million Americans cycling in and out of prisons and jails each year, including nearly one of every three HCV-infected people, the criminal justice system may be the best place to efficiently identify and cure the greatest number of HCV-infected people.”
Despite the need for improved drugs to treat prisoners with hepatitis C, the cost of the new medications is prohibitive for prisons and jails. Rich estimated that treating all prisoners currently infected with HCV would cost $33 billion.
“I agree with the premise that prisons are an important point to address this problem,” said Dr. Joe Goldenson, director of health services for San Francisco’s jail system. “But this has to be addressed from an overall strategy of public health and the funding has to come out of that system. Corrections is not a place that can handle these costs.”
Since 2011, spending on HCV treatment in correctional settings has climbed rapidly. The increase has been attributed to the introduction of two HCV drugs produced by pharmaceutical companies Merck and Vertex. However, with the recent introduction of the new and more effective treatments, costs are expected to rise again.
The federal Bureau of Prisons (BOP), which houses approximately 216,800 prisoners, may have an easier time affording the drugs. Through a U.S. Department of Veterans Affairs program, the BOP will receive a 44% discount on Olysio and Sovaldi. In February 2014, the federal prison system began making the new HCV medications available to some prisoners.
According to a May 2014 BOP clinical practice guidelines report, titled “Interim Guidance for the Management of Chronic Hepatitis C Infection,” the use of sofosbuvir and simeprevir in combination with peginterferon and/or ribavirin is the “preferred treatment regimen.” State prisoners, however, may not be as fortunate.
In Washington State, prison officials have established a committee of healthcare providers that meets twice a month to review HCV cases for treatment eligibility with the new drugs. In April 2014, Kevin Bovenkamp, the Washington DOC’s assistant secretary for health services, said that of ten cases reviewed by the committee, none were approved for treatment.
Dr. Lara Strick, an infectious disease specialist for the Washington DOC, told a reporter from The News Tribune that HCV is a progressive disease and not all prisoners need immediate treatment. She also noted that it might be better for certain patients to wait until newer treatments, with even fewer side effects, are available.
However, it is likely that future HCV treatments that are more effective and have fewer side effects than Olysio and Sovaldi will demand an even higher price, and patients who are currently denied treatment due to fiscal constraints will eventually face the same cost-based roadblocks in the future. On the other hand, additional HCV drugs may lead to greater competition and thus lower prices. Merck, for example, is currently developing a two-drug hepatitis C regimen that reportedly has a 98% cure rate.
Dr. Strick acknowledged that future pricing of new HCV treatments may dictate whether the epidemic of hepatitis C among prisoners can be eradicated as a public health issue.
Since 2010, before Olysio and Sovaldi were available, the cost of HCV treatment for the Washington DOC had more than doubled by 2013 – rising from approximately $834,000 per year to $1.8 million annually. The DOC is trying to determine if a discount from the manufacturers of the new HCV drugs can be negotiated. Gilead has defended its pricing for Sovaldi, citing the drug’s potential to prevent longer-term costs resulting from HCV such as liver transplants and treatment for cirrhosis or cancer.
In Illinois, prison officials estimate there are approximately 100 to 150 prisoners afflicted with HCV in each of the state’s prisons. They acknowledge that not every HCV-positive prisoner will receive the new drugs; consideration will be given to severity of medical condition, length of sentence and overall health of each prisoner. Still, state corrections officials indicated that even if one-third of the prisoners with HCV receive the new medications, treatment costs would increase to $61 million annually from the current $8 million.
Other states like New York and Wisconsin are dispensing the new HCV drugs on a limited case-by-case basis. A spokesperson for the New York DOC told the Wall Street Journal that nearly 60 prisoners with the most serious cases of HCV had begun treatment with the new drugs. Oregon is reportedly providing the new medications to HCV-positive prisoners with a life expectancy of under one year.
Although prison officials must provide adequate healthcare to prisoners with serious medical needs, as required by the Eighth Amendment pursuant to Estelle v. Gamble, 429 U.S. 97 (1976), failing to supply the new HCV drugs might not be considered deliberate indifference. Many of the court decisions regarding prison healthcare have required corrections officials to provide adequate treatment that meets minimal constitutional standards – which is not necessarily the best care available. If the new drugs become the community standard of care for hepatitis C, though, the argument can be made that that standard should equally apply to prisoners.
Critics of making the new HCV medications available to prisoners argue the drugs may not be covered under health insurance plans for people who are not incarcerated; thus, prisoners would receive better treatment than those in the general population. Yet this ignores the reality that the less costly and older treatments for HCV currently available to prisoners are routinely denied. [See: PLN, July 2013, p.16; March 2013, p.36].
Prison medical officials can deny HCV treatment for a variety of reasons, including the length of a prisoner’s sentence, if they have recently used or been found in possession of illegal drugs or alcohol, or have recently received tattoos. Thus, even should Olysio and Sovaldi become available in prison systems, it is unlikely that many prisoners will actually receive the costly medications.
Gilead has been criticized for pricing Sovaldi based on a scale relative to a country’s per-capita income. For example, the drug is offered in Egypt at a 99% discount to the U.S. list price, resulting in treatment costs of approximately $900. Therefore, a U.S. nongovernmental organization based in Egypt could more readily afford to treat Egyptian prisoners using Sovaldi than state prison officials could treat prisoners in the U.S. The company fails to take into account that many of the people infected with HCV in the United States live below the federal poverty level or are incarcerated, on Medicaid or otherwise under the average per-capita income in the U.S.
Janssen Therapeutics spokesman Craig Stoltz said the company continues to “work with public and private payers and health systems” to make simeprevir available to “marginalized and underserved populations,” including prisoners.
Eventually, the question of public health ethics must be asked and answered. By not providing the most effective treatment to HCV-positive prisoners, are we endangering the health of the general public? According to a study published in the March-April 2014 issue of Public Health Reports, prisoners represent 28.5-32.8% of the total HCV cases in the United States, based on 2006 data. Prisoners who are untreated, or not effectively treated, are more likely to infect others after they are released.
For Gilead Sciences and Janssen Therapeutics, however, that may be welcome news, because they can then sell their high-priced HCV drugs to even more patients. Until affordable HCV medications are made available to everyone who needs them – including prisoners – the hepatitis C epidemic might be slowed but will not be stopped.
Author: Gregory Dober has been a contributing writer for PLN since 2007.
Sources: KOVR-TV, https://sacramento.cbslocal.com/, www.cbsnews.com, www.pewstates.org, Public Health Reports (March-April 2014), www.kuow.org, Quad-City Times, Wall Street Journal, The News Tribune, www.cdc.gov, Forbes, Reuters, www.olysio.com, www.sovaldi.com, BOP Clinical Practice Guidelines (May 2014)